AC-DI-SOLCroscarmellose Sodium USP/NF, EP, JP
Ac-Di-Sol is a crosslinked sodium CMC that facilitates rapid
disintegration and drug dissolution in tablets, capsules and other
solid dosage forms. It performs dual functionality of water wicking
and rapid swelling resulting in it's superior disintegration
characteristics.
GradeDescriptionApplication
Ac-Di-Sol SD-711Cross linked Sodium CMC or Modified Cellulose
GumHighly effective in wet granulation & direct compression
products, independent of tablet hardness with low use level and
excellent stability. Best known super disintegrant that is
effective intra and extra-granularly.
ALVEOSUCREAgglomerated Sucrose USP/NF, EP, JP
Alveosucre is obtained by wet granulation of pure icing sugar
followed by subsequently drying in a fluidized air bed and then
sieved.
GradeDescriptionApplication
Alveosucre fineHighly absorbent, allows for structured mixtures
with homogenetic distribution of active ingredients while avoiding
sedimentation or separation of ingredients. Instant cold
dissolutionFast dissolution instant sugar for homogenous dry mixes
and sachet filling.
Alveosucre with dextrinDesigned for dry mixes formulae and
direct compression. Has high compaction rate.
SHIN-ETSU AQOAT (HPMCAS)Hypromellose Acetate Succinate USP/NF,
JPE
AQOAT is an enteric coating material which was first approved in
Japan in 1987. Subsequently the product was approved in Korea,
Europe and USA.
Hypromellose acetate succinate is manufactured from highly
purified pulp and involves introduction of acetyl and succinoyl
groups into the hydroxyl backbone of Hypromellose. Various grades
of AQOAT are available which differ in the particle size and
chemical substitution levels.
The polymer, Hypromellose acetate succinate, lends itself to use
in different coating techniques - aqueous, solvent based, ammonia
neutralization and dry / deposition coating. It can also be
recommended in solid dispersions to enhance the bioavailability of
poorly soluble drugs as well as in the design of controlled release
dosage forms for targeting drug release to specific
gastrointestinal sites.
GradeDescriptionMean particle sizeApplication
Dissolving pH*Acetyl (%) / Succinoyl (%)
Aqoat AS-LF 5.58 / 155 mMicronized grades or aqueous and dry
coating.
Aqoat AS-MF 6.09 / 11
Aqoat AS-HF 6.512 / 7
Aqoat AS-LG 5.58 / 151 mmGranular grades for solvent-based
coating.
Aqoat AS-MG 6.09 / 11
Aqoat AS-HG 6.512 / 7
* In Mcllvaine's buffer (citric acidNa2HPO4) and USP Phosphate
Buffer (NaOHKH2PO4)
AQUACOAT CPD - 30Cellulose Acetate Phthalate aqueous dispersion
USP/NF, EP, JP
Aquacoat CPD is a 30 percent solid polymer aqueous dispersion of
cellulose acetate phthalate (CAP) for enteric coating. Enteric
coatings allow acid sensitive drugs to pass through the stomach
unaffected or to keep stomach upsetting drugs like aspirin from
releasing in the stomach. Although CAP polymer is hydrophobic, the
Aquacoat CPD process allows the product to be delivered in a
totally aqueous pseudo-latex form that is easy to use and clean up,
almost similar to that of solvent coating.
GradeDescriptionApplication
Aquacoat CPD-30A water based pseudo-latex system comprising of
Cellulose Acetate PhthalateNo ammonia usedEnteric coating of
tablets and capsules (hard and soft gelatin). Can also be coated
onto beads for filling into hard gelatin capsules.
AQUACOAT ECD - 30Ethylcellulose aqueous dispersion USP/NF, EP,
JPAquacoat ECD is a 30 percent solid polymer aqueous dispersion of
ethylcellulose for film coating of pharmaceutical dosage forms. It
is designed for a variety of coating applications to achieve
sustained release, taste-masking and moisture-barrier/sealant
coatings. As ethylcellulose is a hydrophobic polymer, various kinds
of release patterns can be achieved by use of suitable
plasticizers, pore formers, etc.
GradeDescriptionApplication
Aquacoat ECD-30A water based pseudo-latex system comprising of
Ethylcellulose, Cetyl alcohol & sodium lauryl sulphate. Allows
a wide choice of plasticizer. No ammonia usedSustained release
beads for use in capsules / tablets, moisture barrier / sealant
coating and for taste masking of powders, granules, tablets and
capsules.
CALCIUM PHOSPHATES
Calcium phosphates are widely used in pharmaceutical
formulations as capsule or tablet diluents. It has many positive
characteristics as an excipient including good compressibility,
excellent stability and white colour. Due to their inherent
property of good compatibility, they find use in both direct
compression and wet-granulation process. Two particle size grades
of calcium phosphate are available. The Milled or Powder grade is
typically used in wet granulation process or roller compaction
while the Unmilled or Granular grade is used in direct compression
process due to its good flow properties.
Granular grades USP/NF, EP, JP
GradeDescriptionApplication
A-TabDibasic calcium phosphate AnhydrousTablet and capsule
diluent / filler, used in direct compression. Non-hygroscopic,
stable at room temperature adding to better product stability.
Source of calcium and phosphorous.
Di-TabDibasic calcium phosphate DihydrateTablet and capsule
diluent / filler, used in direct compression. Flow agent, blend
densifier, tablet punch polishing agent, time release agent and
carrier of actives. Source of calcium and phosphorous.
Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule
diluent / filler, used in direct compression and as filler binder
in vitamin mineral formulations. Also used as a glidant due to high
surface area and carrier of actives. Higher calcium and phosphorous
content.
Tri-Cal WGTribasic calcium phosphate Anhydrous Special high
density grade for use in wet granulation. Benefits similar as
Tri-Tab
CALCIUM PHOSPHATES
Calcium phosphates are widely used in pharmaceutical
formulations as capsule or tablet diluents. It has many positive
characteristics as an excipient including good compressibility,
excellent stability and white colour. Due to their inherent
property of good compatibility, they find use in both direct
compression and wet-granulation process. Two particle size grades
of calcium phosphate are available. The Milled or Powder grade is
typically used in wet granulation process or roller compaction
while the Unmilled or Granular grade is used in direct compression
process due to its good flow properties.
Granular grades USP/NF, EP, JP
GradeDescriptionApplication
A-TabDibasic calcium phosphate AnhydrousTablet and capsule
diluent / filler, used in direct compression. Non-hygroscopic,
stable at room temperature adding to better product stability.
Source of calcium and phosphorous.
Di-TabDibasic calcium phosphate DihydrateTablet and capsule
diluent / filler, used in direct compression. Flow agent, blend
densifier, tablet punch polishing agent, time release agent and
carrier of actives. Source of calcium and phosphorous.
Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule
diluent / filler, used in direct compression and as filler binder
in vitamin mineral formulations. Also used as a glidant due to high
surface area and carrier of actives. Higher calcium and phosphorous
content.
Tri-Cal WGTribasic calcium phosphate Anhydrous Special high
density grade for use in wet granulation. Benefits similar as
Tri-Tab.
AVICEL CE - 15Microcrystalline Cellulose and Guar Gum
Avicel CE-15 is a patented combination of Microcrystalline
cellulose and Guar gum specially engineered to improve the
organoleptic properties of chewable tablets by providing smoother
and creamier mouthfeel, less grittiness, minimum chalkiness and
reduced tooth packing. It can be used even in direct compression
applications and yields softer tablets with reduced friability.
Avicel CE-15 in chewable tablets results in dramatic differences
for end users, primarily in the areas of overall sensory experience
and perceived taste, when compared to other tablet binders. It
helps to improve overall patient compliance by improving the
formulation palatability.
GradeDescriptionApplication
Avicel CE-15Free flowing powder, co-processed blendUsed for
improved mouthfeel / superior sensory characteristics in chewable
tablets.
AVICEL DGSpray dried compound of Microcrystalline Cellulose and
Anhydrous Dibasic Calcium Phosphate
Avicel DG is a synergistic combination of 75% of
Microcrystalline Cellulose and 25% of Anhydrous Dibasic Calcium
Phosphate produced using spray dried, co-processing
technology.Avicel DG offers good flow characteristics, a high
quality initial compactability, required for the production of
robust ribbons, and excellent recompactability, resulting in
enhanced tabletting performance and fewer rejected
tablets.GradeDescriptionApplication
Avicel DGWhite, odourless uniform particle size powderDry
granulation binder for roller compaction process
AVICEL HFE - 102Spray dried compound of Microcrystalline
cellulose and Mannitol
Avicel HFE-102 is a novel, proprietary, co-spray dried
Microcrystalline cellulose (MCC) and Mannitol excipient for direct
compression. The co-processing of MCC and Mannitol creates a
synergistic functionality, providing superior benefits compared to
the use of individual or dry-blended components.
Avicel HFE-102 is a highly compactible excipient and exhibits
improved flow, superior compactibility and better disintegration
properties compared to traditional MCC grades. The product also
exhibits less sensitivity to lubrication.
GradeDescriptionApplication
Avicel HFE-102Medium particle size powderHigh functionality
excipient for direct compression of tablets, chewable tablets, fast
dissolving tablets, MUPS technology tablets etc. Helps accelerate
tablet development, reduces sensitivity to lubricant thus enabling
higher lubricant levels to reduce sticking problems in full-scale
production.
Avicel PHMicrocrystalline Cellulose USP/NF, EP, JPAvicel PH is
the innovators brand of microcrystalline cellulose. It is a
purified, partially depolymerized alpha-cellulose made by acid
hydrolysis of speciality wood pulp controlled to a stringent degree
of polymerization than required by global pharmacopeia.
The unique properties of Avicel PH makes it an indispensable
formulation tool and excipient of choice in direct compression
applications on account of its superior compactibility, drug
carrying capacity and rapid disintegration. These properties also
benefit dry granulation process such as roller compaction or
slugging. When used in wet granulation process, Avicel reduces the
risk of over-granulation, avoids screen blockage and promotes
uniform, rapid drying. Avicel PH is an excellent
extrusion-spheronization binder. The inclusion of Avicel PH in
capsule formulations improves flow, facilitates plug formation and
aids capsule disintegration.
Avicel PH continues to set new standards with enhanced grades
designed to boost productivity and meet any formulation
challenge.GradeDescriptionApplication
Avicel PH 101Fine particle sizeFor conventional applications,
specially in wet granulation and roller compaction.
Avicel PH 102Medium particle sizeFor improved flow in direct
compression, dry phase of wet granulation and dry granulation.
Avicel PH 103Low moisture with fine particle sizeWell suited for
moisture sensitive actives.
Avicel PH 105Extra fine particle sizeFor use in direct
compression of coarse or hardtocompress materials.
Avicel PH 112Very low moisture with medium particle sizeBest for
direct compression of moisture sensitive actives with increased
flow.
Avicel PH 113Very low moisture with fine particle sizeImproves
product stability by extending the shelf life, particularly of
moisture sensitive actives.
Avicel PH 200Largest particle sizeFor best flow in direct
compression and dry granulation applications while maintaining high
levels of compressibility with minimum weight variation and content
uniformity issues.
Avicel PH 200 LMVery low moisture with largest particle sizeBest
for direct compression of moisture sensitive actives with superior
flow rate than PH 112.
Avicel PH 301High bulk density with fine particle sizeFor
manufacture of small tablets. reduces powder stratification and
tablet weight variation by efficient mixing.
Avicel PH 302High bulk density with medium particle sizeFor
manufacture of thin tablets despite high API content. Prevents
powder segregation and gives good flow.
AVICEL RC/CLMicrocrystalline Cellulose and
Carboxymethylcellulose Sodium USP/NF, BP, JPEAvicel RC/CL are water
dispersible, colloidal, spray dried blends of microcrystalline
cellulose and carboxymethylcellulose sodium used in pharmaceutical
suspensions, emulsions, nasal sprays and creams. Avicel RC / CL
products produce highly thixotropic, low viscosity, structured
vehicles that yield desirable permanent suspensions without
settling or sedimentation. It also eliminates lengthy hydration
time while increasing formulation stability.
When used in reconstitutable suspensions, Avicel RC / CL
facilitates hydration of the dry mix. Avicel dispersions are stable
to heat and freeze/thaw over a wide pH range. Avicel thixotropy
reduces the clearance of nasal spray formulations. It is an
excellent stabilizer for oil-in-water emulsions, reducing oil
droplet movement and coalescence. The wide range of thixotropies,
viscosities, gel strengths, and dispersion characteristics of this
product line provide unparalleled suspension stability and
functional versatility.
GradeDescriptionApplication
Avicel RC-581Bulk dried powder requiring high shear mixing for
dispersionConventional suspending agent and dispersion aid.
Avicel RC-591Spray dried powder requiring low shear mixing for
dispersionUsed for oral suspensions, nasal sprays, topical sprays,
lotions, liquid and semi-solid dosage forms. Provides a structured
dispersion vehicle, acts as a protective colloid and facilitates
dispersion.
Avicel CL-611Spray dried powder requiring low shear mixing for
dispersion. Has more CMC contentRecommended for reconstitutable /
dry suspensions. Also for oral suspensions.
BLANOSESodium Carboxymethylcellulose USP/NF, EP, JPBLANOSE,
Carboxymethylcellulose Sodium is the sodium salt of
carboxymethylcellulose (CMC) which is an anionic, water-soluble
polymer derived from cellulose reacted with sodium
monochloroacetate. BLANOSE is soluble in cold or hot water,
insoluble in organic solvents, compatible with water / alcohol
systems & imparts low water and oxygen transmission to
coatings. BLANOSE grades find application as thickeners, binders,
stabilizers, suspending agents and rheology modifiers. The grades
designated P or PH are purified grades which meet pharmaceutical
standards. A wide range of substitution types are also available,
based on number of carboxymethyl groups present on the cellulose
backbone. The low substitution grades (7 types) provide thixotropy
whereas the higher substitution grades (9 and 12 types) provide
smooth solutions without thixotropy.GradeViscosity in mPas (%
w/w)*Application
Blanose 7H4F-PH2500 - 4500 (1%)Tablet coatings - Film former
Mucoadhesives - Absorbency
Syrups & Suspensions - Thickener & suspending agent
Sustained Release - Thickener, diffusion barrier
Bulk Laxative - Inert, high water binding agent
Ointments, Creams & Lotions - Stabilizer, thickener, film
former
Blanose 7HF-PH1500 - 2500 (1%)
Blanose 7MF-PH400 - 600 (2%)
Blanose 7M1F-PH50 - 100 (2%)
Blanose 7LF-PH25 - 50 (2%)
Blanose 9M31F-PH1500 - 3100 (2%)
Blanose 9M8F-PH400 - 800 (2%)
Blanose 12M8P200 - 800 (2%)
Blanose 12M31P1500 - 3100 (2%)
*Also avaialbe in finely (X) ground grades.
*Viscosity in milli Pascal per second (mPas or cps) determined
on aqueous solutions as per indicated weight %. at 250 C + 0.50 C
using a Brookfield SyncroLectric LVF viscometer.DSTypeSubstitution
rangeSodium content, %
70,65 to 0,90 **7,0 - 8,9
90,80 to 0,959,2 - 9,3
12 (for USP grades)1,15 to 1,4510,4 - 12,0
12 (for EP grades)1,12 to 1,2110,2 - 10,8
Cellulose Acetate Non-enteric celluose esterCellulose Acetate is
cellulose in which a portion or all of the hydroxyl groups are
acetylated. It is prepared from highly purified cellulose by
treatment with acid catalysis and acetic anhydride. It occurs as a
white, odourless, tasteless, free-flowing powders. They are mainly
used for sustained release applications and taste masking.
Cellulose Acetate is used as a semi-permeable coating on
tablets, especially on osmotic pump-type tablets and implants. This
allows for controlled, extended release of actives. Cellulose
acetate films, in conjunction with other materials, also offer
sustained release without the necessity of drilling a hole in the
coating as it is typical with osmotic pump systems. Cellulose
acetate and other cellulose esters have also been used to form
drug-loaded microparticles with controlled-release
characteristics.GradeDescriptionApplication
CA-320-SWater insoluble powder with viscosity of 170 280 cps in
pyridine.Used in controlled-release applications as water permeable
membrane in osmotic systems; direct compression matrix component;
barrier component in taste masking.
CA-398-10Water insoluble powder of low viscosity solutionUsed
for oral sustained release matrix drug delivery and in film coating
applications.
CALCIUM PHOSPHATESCalcium phosphates are widely used in
pharmaceutical formulations as capsule or tablet diluents. It has
many positive characteristics as an excipient including good
compressibility, excellent stability and white colour. Due to their
inherent property of good compatibility, they find use in both
direct compression and wet-granulation process. Two particle size
grades of calcium phosphate are available. The Milled or Powder
grade is typically used in wet granulation processes or roller
compaction while the Unmilled or Granular grade is used in direct
compression processes due to its good flow properties.
Powder grades USP/NF, EP, JP
GradeDescriptionApplication
Calipharm ADibasic calcium phosphate AnhydrousFiller in wet
granulation, multivitamin chewable tablets and nutritional
drinks.
Calipharm DDibasic calcium phosphate Dihydrate.Filler in wet
granulation, vitamin premixes and nutritional drinks.
Calipharm TTribasic calcium phosphate AnhydrousFiller in wet
granulation, particularly antacid formulations for its buffer
action. Also used in nutritional drinks and calcium / phosphorous
fortifications.
STURCAL L & CALOPAKE Extra Light(Precipitated) Calcium
Carbonate USP/NF, EP, JP
Precipitated Calcium Carbonate (PCC), alternatively known as
purified, refined or synthetic calcium carbonate is produced by
direct carbonation of hydrated lime by a simple process called Milk
of lime process. The process involves combining lime (CaO) with
water to form slaked lime, addition of carbon dioxide and
precipitation of calcium carbonate in a very fine, white form. The
precipitated calcium carbonate is then washed, purified, dried and
packaged.
Specialty Minerals Inc. uses high quality limestone sources for
its PCC products, including some from the 150 year old SMI
limestone mine in Adams, Massachusetts. Although a number of
different calcite crystal forms are possible, Sturcal L &
Calopake Extra Light consist of agglomerates of scalenohedral
calcite crystals. The two grades differ in particle size and
apparent densities and are compliant as per USP/NF, EP &
JP.
GradeDescriptionMedian Particle size (m)Application
Sturcal LHeavy grade, apparent density: 0.78 0.9675 Used mainly
in antacid tablets and liquids, in dentifrices &therapeutically
as calcium supplement in pharmaceuticals & fortified foods.
Calopake Extra LightExtra light grade, apparent density: 0.42
0.5045 Used as abrasive in dentifrice products, for
calciumsupplementation in nutritional and pharma products, also as
antacid, pH modulator and flocculent.
CASTER SUGARScreened Sucrose USP/NF, EP, JPSieved sucrose or
screened sucrose is obtained by purification and crystallization of
juice extracted from sugar beet and subsequently screening it
continuously. It is a highly pure crystalline powder recommended
for applications requiring high quality clear solutions or for
coatings.GradeDescriptionApplication
Caster Sugar 250Extremely pure, crystalline powder with low
dispersion particle size. Dust free and free flowingIdeal for dry
syrups, suspensions, granulation and coating. Facilitates
dissolution and ensures homogenous mixture.
Caster Sugar 400Highly pure, fine grain crystalline powder. Dust
free and free flowingFacilitates preparation of dry syrups, liquid
syrups due to higher dissolution rate than crystal sugar. Also used
for coating.
CELLULOSE ACETATE PHTHALATE (C-A-P)Cellacefate USP / NF, EP,
JP
C-A-P is a cellulose in which about half the hydroxyl groups are
acetylated, and about a quarter are esterified with one of two acid
groups being phthalic acid, where the remaining acid group is free.
It is a pH-sensitive cellulose derivative designed for enteric
coating of pharmaceutical dosage forms like tablets or granules. It
can also be used for matrix drug delivery.
C-A-P can withstand prolonged contact with acidic gastric fluids
while being able to dissolve readily in the mildly acidic to
neutral environment of the small intestine. C-A-P is commonly
applied to solid-dosage forms either by coating from organic or
aqueous solvent systems or by direct compression. C-A-P is
compatible with many plasticizers and the addition of plasticizers
improves the water resistance of this coating material thus making
the formulations more effective.GradeFormApplication
C-A-P PelletsWhite pelletsUsed as enteric film coating material
for solid dosage forms like tablets, pellets and capsules. Also
used as a matrix binder.
C-A-P PowderWhite powder
CELPHEREMicrocrystalline Cellulose USP/NF, EP, JP, JPE
Celphere represents 100% pure microcrystalline cellulose (MCC)
spheres or seed cores and is a product of cellulose particle
research, development and process technology at Asahi Kasei. It is
used in manufacturing of granules for sustained / controlled
release, taste masked and other special properties.
Celphere enables greater accuracy and consistency in drug
layering and coating as it is highly spherical, has narrow particle
size distribution and exhibits optimum water absorption. It has low
chemical reactivity and hence can be freely used to layer high
dose, moisture sensitive & potent actives. Its high mechanical
strength and low friability allows it to withstand the rigors of
fluidized bed or wurster coating process. It is conveniently
available in various particle size grades ranging from 75 to 850
m.
GradeParticle size range (m)Application
Celphere SCP-10075 - 212Used as spherical seed cores for drug
layering & film coating. Also used in manufacture of granules /
beads with sustained / controlled release, taste masking &
other special properties.
Celphere CP-102106 - 212
Celphere CP-203150 - 300
Celphere CP-305300 - 500
Celphere CP-507500 - 710
Celphere CP-708710 - 850
CEOLUS KG / UFMicrocrystalline Cellulose USP/NF, EP, JP
Ceolus KG / UF are super-compactibility Microcrystalline
Cellulose (MCC) powder grades. The unparalleled compactibility is
attributed to its distinctive rod-form particle configuration.
Ceolus KG / UF grades thus enable lowest friability, reduced
compression force, low addition rate and reduced tablet size. Even
at 5% addition, they are very effective.
Ceolus KG / UF finds use in direct compression, wet granulation,
roller compaction as well as for adsorption of oily actives for
direct compression. They occupy a unique position among dry binders
in its combination of three salient performance characteristics far
higher compactibility, together with an optimum balance of powder
flowability and tablet disintegration.
GradeParticle size (m)Application
CEOLUS KG 80250Effective in tableting of high dose actives,
poorly compressible actives, pressure -sensitive actives, coated
granules / pellets and orally disintegrating tablets. It is ideal
in formulations based on MUPS (Multiple unit particulate systems)
technology.
CEOLUS KG 1000Similar applications like KG grades. However, flow
is more superior compared to KG types.
CEOLUS UF 711
COMPRESSUCSpray Dried Sugars USP/NF, EP, JP
Compressuc represents a new generation of sugar for direct
compression, produced from an innovative and patented spray drying
process. Anhydrous, fully soluble in water with a sweet taste;
Compressuc is probably one of the most efficient excipient
available on the market for direct compression tabletting.
GradeDescriptionApplication
Compressuc MSDirectly compressible sucrose with maltodextrins /
inverted sugar.Excellent diluents, binder for direct compression of
chewable, effervescent and orodispersible tablets. Has remarkable
free-flow, mixing, compaction properties.Also used in sachet
fillings and dry syrups.
Compressuc PSDirectly compressible pure sucrose (without
additives)
CREMOPHORNon-ionic solubilizers / Emulsifiers
Cremophor RH 40 is a non-ionic solubilizer and emulsifying agent
obtained by reacting 45 moles of ethylene oxide with one mole of
hydrogenated castor oil.
Cremophor EL is a non ionic solubiliser and emulsifier made by
reacting castor oil with ethylene oxide in a molar ratio of 1:35.
Cremophor ELP is a purified grade of Cremophor EL specially
developed to give stable formulations of sensitive APIs, especially
in injectable form.
The Cremophor A types are prepared by reacting higher saturated
fatty alcohols with ethylene oxide, with the degree of ethoxylation
being indicated by the numeral in the name.
GradePharmacopoeial NameAppearanceApplication
Cremophor RH 40Polyoxyl-40Hydrogenated Castor OilWhite to
yellowish, nearly odourless, tasteless, pasteUsed to solubilize
vitamins, hydrophobic actives, and essential oil-in-water or
hydroalcoholicmixtures, to improve bioavailability in soliddosage
forms and as solubilizer in oral / topical liquid and semi-liquid
dosage forms.
Cremophor ELPolyoxyl-35 Castor Oil(Standard grade)Pale yellow
oily liquid
Cremophor ELPPolyoxyl-35 Castor Oil(Extra pure grade of
EL).White to yellowish paste or cloudy liquidUsed as solubilizer
and emulsifier inliquid formulation for oral, topical and
parenteral use.
Cremophor A 6Macrogol-6-cetostearyletherWhitish waxy
substanceNon-ionic emulsifiers used for production of ointments,
creams, gels based on oil-in wateremulsions / water-in-oil
emulsions. Also usedfor emulsification of hydrophobic APIs toform
very stable oilinwater emulsions.
Cremophor A 25Macrogol-25-cetostearyletherFree flowing,
nondusting micro beads
CRYSMEBMethyl Betacyclodextrin
Kleptose Crysmeb is a new generation, low metylated
betacyclodextrin which is a purified polydisperse product resulting
from the controlled reaction of a methylation agent and native
betacyclodextrin. This unique patented product of Roquette has good
water solubility, enhanced stability to form inclusion compounds
and a good potential for biological tolerance.
GradeDescriptionApplication
CrysmebMethyl Betacyclodextrin with low molar
substitutionSuitable for encapsulation of low solubility, volatile
or unstable active ingredients. Used for injectables, syrups,
solutions and oral suspensions.
GLUCOSEDextrose USP/NF, EP, JPGlucose or Dextrose is the monomer
of natural starch polymer. It is white, odourless, sweet, in
crystalline or granular powder form and freely soluble in water.
This monomer is also the natural physiological sugar in the human
body. In its crystalline form this doubly natural sugar has long
been used both as a filler for oral dosage forms and as a
sweetener. It also helps in improving the stability of API
sensitive to oxidation due to its slight reducing properties.
Therapeutically it is used as a preferred source of carbohydrate in
parenteral nutrition. Roquette has a range of dextrose products
wide enough to meet any of manufacturers different
requirements.GradeDescriptionApplication
Lycadex PFPyrogen free dextrose monohydrateOsmotic agent in
injectables and dialysis solutions, for parenteral nutrition and
treatment of hypoglycemia.
Dextrose Anhydrous PFPyrogen free dextrose anhydrous
Dextrose GCAgglomerated dextrose monohydrateDirect compression
diluent with excellent compressibility and flowability for use in
tablets, sachets and capsule formulations.
RoferoseDextrose MonohydrateDiluent for tablets, capsules and
sachets.
Dextrose Anhydrous CCrystalline dextrose anhydrous
RoclysDextrose syrup without extensive hydrolysisFor inhibiting
sucrose crystallization as texturizer and bulk sweetener in syrups,
lozenges, pastilles and pharmaceutical chewing gums.
FlolysDextrose syrup with extensive hydrolysis
CALCIUM PHOSPHATES
Calcium phosphates are widely used in pharmaceutical
formulations as capsule or tablet diluents. It has many positive
characteristics as an excipient including good compressibility,
excellent stability and white colour. Due to their inherent
property of good compatibility, they find use in both direct
compression and wet-granulation process. Two particle size grades
of calcium phosphate are available. The Milled or Powder grade is
typically used in wet granulation process or roller compaction
while the Unmilled or Granular grade is used in direct compression
process due to its good flow properties.
Granular grades USP/NF, EP, JP
GradeDescriptionApplication
A-TabDibasic calcium phosphate AnhydrousTablet and capsule
diluent / filler, used in direct compression. Non-hygroscopic,
stable at room temperature adding to better product stability.
Source of calcium and phosphorous.
Di-TabDibasic calcium phosphate DihydrateTablet and capsule
diluent / filler, used in direct compression. Flow agent, blend
densifier, tablet punch polishing agent, time release agent and
carrier of actives. Source of calcium and phosphorous.
Tri-TabTribasic calcium Phosphate Anhydrous Tablet and capsule
diluent / filler, used in direct compression and as filler binder
in vitamin mineral formulations. Also used as a glidant due to high
surface area and carrier of actives. Higher calcium and phosphorous
content.
Tri-Cal WGTribasic calcium phosphate Anhydrous Special high
density grade for use in wet granulation. Benefits similar as
Tri-Tab.
DOCUSATE SODIUM USP/NF, EPDioctyl Ester of Sodium Sulfosuccinate
(DSS)Docusate Sodium (DSS) enjoys the reputation of being one of
the most versatile and effective anionic surfactants (surface
active agents) used by the Industry. It has excellent wetting,
solubilizing, dispersing and emulsifying properties allowing it to
be used in a multiplicity of applications in pharmaceutical
formulations especially in oral dosage forms. Cytecs DSS is of
exceptionally high purity and has a valid Drug Master File no. with
the USFDA.
DSS is virtually free from adverse reactions, non habit-forming
and causes the least possible disturbance of normal body
physiology. It is effective alone or in combination with
peristaltic stimulants and bulking agents in the treatment of
constipation. It is also an effective wetting agent in topically
applied medical preparations like creams, lotions and
ointments.GradeDescriptionApplication
Docusate Sodium (100 %)Rolls of white wax-like plastic
sheetsAids the granulation process, improves tablet disintegration
and dissolution, facilitates tablet coating, emulsifies gels &
suspensions.
Also used in laxatives and stool softeners, prenatal and
geriatric vitamin preparations, colon cleansing aids (used before
Xray or surgery) and in ear wax removal formulations.
Docusate Sodium (85%)with Sodium Benzoate (15%)White crystalline
powder
Docusate Sodium (50%) in Polyethylene glycol (50 %)White to
yellow, clear viscous liquid
DUB DBHGGlyceryl Dibehenate EPGlyceryl Behenate is prepared by
the esterification of glycerin by behenic acid without the use of
catalysts. It is a mixture of diacylglycerols, mainly
dibehenoylglycerol, together with variable quantities of mono and
triacylglycerols. It is generally regarded as a relatively
non-irritant and non-toxic material.
GradeDescriptionApplication
DUB DBHGFine, micronized powder with a faint odourUsed as
lubricant for tablets. Also can be used as lipidic matrix for
sustained release.
DUB DBSDibutyl Sebacate USP/NFDibutyl Sebacate is manufactured
by the esterification of n-butanol and sebacic acid in the presence
of a suitable catalyst, and by the distillation of sebacic acid
with n-butanol in the presence of concentrated acid. DUB DBS is
stable and is not reactive with water and thus hazardous
polymerization does not occur. However it is incompatible with
strong oxidizing materials and strong alkalis.
GradeDescriptionApplication
DUB DBSClear, colorless, oily liquid with a bland to slight
butyl odour.Used in oral pharmaceutical formulations as a
plasticizer for film coatings on tablets, beads and granules, in
controlled-release tablets and microcapsule preparations.
DUB MCTMedium Chain Triglycerides USP/NF, EPMedium chain
triglycerides are a class of fatty acids obtained by esterification
of glycerol with mixtures of caprylic and capric fatty acids which
are fractionated from coconut or palm kernel oils. They are
specially processed to achieve superior oxidative stability and low
colour and then are further refined to remove residual fatty acids
resulting in a product with no odour or flavor.
Their chemical composition is of a shorter length than the
long-chain fatty acids present in most other fats and oils. They
are also different from other fats as they have a slightly lower
calorie content and are more rapidly absorbed and metabolized as
energy resembling a carbohydrate more than fat. The unique
metabolic and functional properties, a consequence of their
chemical structure make them versatile ingredients in a number of
pharmaceutical and food
formulations.GradeDescriptionApplication
DUB MCT 5545Oily liquidEnergy source for patients with fat
malabsorption syndrome. Used as plasticizer, tablet lubricant and
as a liquid base for parenterals. Also used as low calorie fats in
diet preparations and in capsule filling.
DUB MCT 7030
DUB MCT 6535
DUB MICROLUBStearic Acid USP/NF, EPStearin or Stearic acid is a
mixture of stearic acid and palmitic acid derived from an edible
source. The content of stearic acid is not less than 40% while that
of palmitic acid is also not less than 40% and the sum of the two
not less than 90%. It occurs as a hard, white or faintly yellowish,
somewhat glossy, crystalline solid or as white or yellowish white
powder, with a faint odor and taste, suggesting
tallow.GradeDescriptionApplication
DUB MICROLUB 70Stearic Acid 70% - Micronised powderUsed as a
tablet lubricant. Micronized grade imparts a smooth, shiny surface
to film coated tablets. Also used as emulsifying and solubilizing
agent in topical formulations like ointments and creams.
DUB MICROLUB 50Stearic Acid 50% - Micronised powder
Also available is STEARIC ACID 95% (in flakes form) and STEARIC
ACID 50% (in pellets or powder form)
DUB PPHemi-synthetic Glycerides USP/NF, EPDUB PP are hard fat
suppository bases and are a mixture of triglycerides, diglycerides
and monodiglycerides which may be obtained either by esterification
of natural fatty acids with glycerol or by inter-esterification of
natural fats. Each type of hard fat is characterised by its melting
point, its saponification value and its hydroxyl value. These
suppository bases, DUB PP, are made from vegetable fatty acids.
They are presented in non-toxic, neutral pellet form allowing for
easier use. Moreover, they do not contain any oxidizing or
stabilizing agent.GradeSaponificationValueMelting Point(C)Hydroxyl
ValueApplication
DUB PP C 3230 24033 3520 30Multipurpose Suppository Bases
DUB PP CDL 1225 24533.5 35.5 15
DUB PP D 1234 24734 36 10
DUB PP E 1235 24535 36.5 10
DUB PP E 3235 24535 36.520 30
DUB PP F 1235 24536 37.5 10
DUB PP H 1230 24038 40 10
DUB PP M 1223 23342 44 10Specific Suppository Bases
DUB PP KC 3225 24033.5 35.520 30
DUB PP KCD 1235 24533.5 35.5 15
DUB PP KD 3225 24034 3620 30
DUB PP KE 3215 236Ac-Di-Sol SD-71120 30
DUB PP KF 1235 250 35.5 37.5 15
DUB SESucrose Esters USP/NF, EPSucrose esters are natural
surfactant materials obtained by the esterification of one or more
of the hydroxyl groups of the sucrose molecule with vegetable fatty
acids. These compounds are non-ionic and have excellent
emulsifying, wetting and dispersing properties. By modifying the
esterfication degree of the sucrose, it is possible to obtain a
range of different emulsifiers with HLB from 3 to 16.
Sucrose esters are tasteless, odorless and non-toxic. They are
non-irritant, mild to the skin and find use in pharmaceuticals,
cosmetics and foods.
GradeDescriptionApplication
DUB SE 3SSucrose TristearateLow HLB grades used as tablet /
capsule lubricant while high HLB grades are used to make easy
dispersible tablets. Also used as a solubilizer, foam enhancer and
as an emulsifier - stabilizer in oil-in-water emulsions. Their
nonionic nature makes them co-emulsifiers as well.
DUB SE 5SSucrose Distearate
DUB SE 11SSucrose Stearate
DUB SE 15PSucrose Palmitate
DUB SE 16PSucrose Palmitate
AQUALON ETHYL CELLULOSE PHARMEthylcellulose USP/NF, EP,
JPAQUALON EC is a non-ionic ethyl ether of cellulose, soluble in a
wide range of organic solvents. Typically, ethylcellulose is used
as a non-swellable, insoluble component in matrix or coating
systems. When water soluble binders cannot be used in dosage
processing because of water sensitivity of the active ingredient,
ethylcellulose is often chosen.
Ethylcellulose can be used to coat one or more active
ingredients of a tablet to prevent them from reacting with other
materials or with one another. It can prevent discoloration of
easily oxidizable substances such as ascorbic acid, allowing
granulations for easily compressed tablets and other dosage forms.
Ethylcellulose can be used on its own or in combination with
water-soluble polymers to prepare sustained release film coatings
that are frequently used for the coating of micro-particles,
pellets and tablets.
GradeViscosity in mPas (% w/w)*Application
EC N 7 Pharm6 to 8Microencapsulation - Stabilizes against active
interactions, hydrolysis and oxidation.
Tablet coating Film coating for sustained release.
Tablet Binder - Plastic flow, suitable for direct compression,
injection molding and melt extrusion.
Taste Masking - improved taste through suppression of bitter
taste & strong odours of actives.
EC N 10 Pharm8 to 11
EC N 14 Pharm12 to 16
EC N 22 Pharm18 to 24
EC N 50 Pharm18 to 24
EC N 100 Pharm80 to 105
EC T 10 Pharm8 to 11Directly compressible, micronized grade with
high ethoxyl content and low viscosity for optimum compactibility
and good powder flow. Eliminates the need for solvents in direct
compression controlled release matrices.
* Determined using 5% ethyl cellulose solution (by weight) in 80
parts toluene & 20 parts ethanol
GLUCOSEDextrose USP/NF, EP, JPGlucose or Dextrose is the monomer
of natural starch polymer. It is white, odourless, sweet, in
crystalline or granular powder form and freely soluble in water.
This monomer is also the natural physiological sugar in the human
body. In its crystalline form this doubly natural sugar has long
been used both as a filler for oral dosage forms and as a
sweetener. It also helps in improving the stability of API
sensitive to oxidation due to its slight reducing properties.
Therapeutically it is used as a preferred source of carbohydrate in
parenteral nutrition. Roquette has a range of dextrose products
wide enough to meet any of manufacturers different
requirements.
GradeDescriptionApplication
Lycadex PFPyrogen free dextrose monohydrateOsmotic agent in
injectables and dialysis solutions, for parenteral nutrition and
treatment of hypoglycemia.
Dextrose Anhydrous PFPyrogen free dextrose anhydrous
Dextrose GCAgglomerated dextrose monohydrateDirect compression
diluent with excellent compressibility and flowability for use in
tablets, sachets and capsule formulations.
RoferoseDextrose MonohydrateDiluent for tablets, capsules and
sachets.
Dextrose Anhydrous CCrystalline dextrose anhydrous
RoclysDextrose syrup without extensive hydrolysisFor inhibiting
sucrose crystallization as texturizer and bulk sweetener in syrups,
lozenges, pastilles and pharmaceutical chewing gums.
FlolysDextrose syrup with extensive hydrolysis
Marine Colloids CarrageenanCarrageenan USP/NFCarrageenan is a
family of naturally-occurring high molecular weight polysaccharides
extracted from red seaweed. The main seaweed types include
Eucheuma, Chondrus and Gigartina which yields kappa, iota and
lambda carrageenan.
The carrageenan structure is made up of repeating galactose and
3,6 anhydrogalactose units, both sulfated and non-sulfated joined
by alternating alpha 1-3 and beta 1-4 glycosidic linkages. The
kappa, iota and lambda carrageenans differ in properties mainly due
to the number and position of ester sulphate groups on the
galactose units. While kappa forms a brittle gel, iota forms an
elastic gel and lambda does not form a gel. Based on their
properties, they find use as stabilizers, thickeners, suspending
agents, gelling agents and flow regulators in pharmaceutical dosage
forms.GradeDescriptionApplication
Carrageenan TypeViscosityGel Type
Gelcarin GP-379IotaHigh thixotropicElastic, Medium
strengthCreams and suspensions. Is polyol and protein reactive.
Promotes freeze thaw.
Gelcarin GP-812KappaLowBrittle, StrongGives stronger gels than
GP 911 with higher syneresis.
Gelcarin GP-911KappaLowBrittle, FirmUsed in encapsulation /
delivery systems. Is polyol and protein reactive.
Viscarin GP-109LambdaMediumNongellingUsed in creams and lotions.
Is polyol and protein reactive.
Viscarin GP-209LambdaHighNongellingUsed in creams and lotions.
Is polyol and protein reactive.
SeaSpen PFIotaMediumthixotropicElastic, WeakUsed in suspensions,
reconstitutables, topical lotions and creams.
GLUCIDEXGLUCIDEX is a large family of maltodextrins and dried
glucose syrups, obtained from starch by hydrolysis, followed by
purification and spray drying. Glucidex grades exhibit good
stability and range from slightly sweet-to-sweet products.
Depending on the grade used, GLUCIDEX products can help adjust and
control the properties of viscosity and texture, sweetness,
anti-crystallizing power, browning reactions, fermentability and
freezing point depression.GLUCIDEX MaltodextrinsMaltodextrin
USP/NF, EPMaltodextrins are dried starch hydrolysis products with a
dextrose equivalent (D.E.) lower than 20. These are fine white,
neutral or slightly sweet tasting powders, soluble in water and
with a high standard of organic, mineral and bacteriological
purity.GradeDescriptionApplication
Glucidex 2 DMaltodextrin with dextroseequivalent of maximum
5Diluent for tablets, capsules, sachets, carrier for spraydrying,
carbohydrate source in infant and enteral foods. Can also be used
for DC formulations of vitamins ormineral supplements.
Glucidex 6 DMaltodextrin with dextroseequivalent of 5 to 8
Glucidex 9 DMaltodextrin with dextroseequivalent of 8 to 10
Glucidex 12 DMaltodextrin with dextroseequivalent of 11 to
14
Glucidex 17 DMaltodextrin with dextroseequivalent of 15 to
18
Glucidex 19 DMaltodextrin with dextroseequivalent of 18 to
20
Note: Also available in IT grades with free flow properties and
better solubilization due to its particular physical
structure.GLUCIDEX Dried glucose syrupsCorn syrup solids USP/NF,
EPCorn syrup solids (earlier known as dried glucose syrups) are
dried starch hydrolysis products with a Dextrose equivalent (DE)
greater than 20. They have greater sweetness as compared to
maltodextrins. These are fine white, neutral or slightly sweet
tasting powders, soluble in water and with a high standard of
organic, mineral and bacteriological
purity.GradeDescriptionApplication
Glucidex 21 DDried glucose syrup with dextroseequivalent of 20
to 23Diluent for tablets, capsules, sachets, carrier in
spraydrying, carbohydrate source in infant and enteral foods.
Glucidex 33 DDried glucose syrup with dextroseequivalent of 31
to 34
Glucidex 47 DDried glucose syrup with dextroseequivalent of 43
to 47
Note: Also available in IT grades with free flow properties and
better solubilization due to its particular physical structure.
GLYCOLYSSodium Starch Glycolate USP/NF, EP, JPESodium Starch
Glycolate is the sodium salt of cross-linked carboxymethyl ether of
starch. It is a white-to-off-white, odourless, tasteless, free
flowing powder which is sparingly soluble in 95% ethanol and
practically insoluble in water. GLYCOLYS is potato starch based and
has the capacity to swell upto 300 times its original volume in
water, a property that attributes to its use as a
superdisintegrant.
Roquette has been producing SSG for more than 20 years now and
has developed different grades of GLYCOLYS to meet the specific
needs of viscosity, moisture, pH or solvent-free properties.
GradeDescriptionApplication
GlycolysStandard grade SSG - Type ASuper disintegrant for solid
dosage forms. Used in both wet granulation and directcompression
processes.
Glycolys LVLow viscosity grade SSG - Type ADesigned to withstand
high shear in wet granulation processes.
Glycolys LMLow moisture grade SSG - Type AFor moisture sensitive
actives.
Glycolys Low pHAcid stable grade SSG - Type BDesigned to resist
acidic pH and stabilize products containing strongly acidic
drugs.
HI-SWEETHigh Fructose Corn Syrup (HFCS)High Fructose Corn Syrups
(HFCS) products are sweet, clear, clean-tasting, odorless liquids
manufactured by controlled hydrolysis of starch polymers thus
resulting in high fructose compositions with valuable bulk
sweetening profiles. Roquette offers two grades of HFCS differing
in sweetness and viscosity.
GradeDescriptionApplication
Hi-Sweet 55Solid content of minimum 55% fructose on dry
basis.Used as a bulk sweetener and viscosity enhancer in medicated
syrups and suspensions. Provides high sweetness and clean mouth
feel compared to sucrose and invert sugar.
Hi-Sweet 42Solid content of minimum 42% fructose on dry
basis.
HPMCPHypromellose Phthalate USP/NF, EP, JPHypromellose Phthalate
(Hydroxypropyl Methylcellulose Phthalate) is a phthalic half ester
of Hypromellose and the threshold pH value for rapid disintegration
of HPMCP can be controlled by varying the phthalyl content.
HPMCP is a solvent based enteric coating agent used to protect
drugs from gastric degradation or to protect the gastric mucosa
from irritant drugs.
Two types of HPMCP are available based on the pH solubility,
HP-50 and HP-55. Additionally, there is a special type viz, HP-55S
which has a higher molecular weight and gives films of greater
strength and gastric resistance.
GradeDescriptionApplication
Dissolving pH*Viscosity (cst)
HPMCP HP55 5.540Regular grade
HPMCP HP55S170Greater film strength
HPMCP HP50 5.055Soluble at low pH
* In Mcllvaine's buffer solution (citric acidNa2HPO4) and
Clark-Lubs buffer solutionICING SUGARMilled Sucrose USP/NF, EP,
JPIcing Sugar is obtained by continuous grinding of sugar crystals.
The range of icing sugar is particularly adapted to any use
requiring a finely milled and high purity sugar.
GradeDescriptionApplication
Icing Sugar PureVery fine powder, impalpable (100% sucrose)Used
for granulation, coating and in sachets. Easily compressible and
dissolves quickly in water than regular sugar.
Icing Sugar with StarchVery fine powder, impalpable (with maize
starch added as an anti-caking agent)
ALGINATES and ALGINIC ACIDS USP/NF, EP, JPAlginates are natural
hydrocolloids of vegetable origin that occur as a structural
component in marine brown algae, where they give strength and
flexibility to the plant. In contrast to most other polysaccharide
gels, alginate gels can develop instantaneously in the presence of
divalent cations into acid gels at low pH and constant temperature.
The gelling gives rise to a three dimensional network which
determines the gel strength. Alginates with high content of
G-blocks give stronger gels & M-rich alginates give softer and
more fragile gels. The molecular weight determines the viscosity of
alginate solutions while the ratio of mannuronic acid guluronic
acid (M/G) determines the relative strength of the gel.
FMC range of alginates and alginic acids offer unique
gel-forming, film-forming, thickening and stabilizing
properties.
GradeDescriptionApplication
Alginate TypeViscosity (mPas)
Protacid F 120 NMAlginic Acid-Used in antireflux and
effervescent tablets. Also as a natural disintegrant in wet and
direct compression granulation.
KelacidAlginic Acid-
Alginic Acid DCAlginic Acid,Directly Compressible-
Protanal LFR 5/60Sodium300 700 (10%)AntiReflux Suspensions (Raft
formation).
Protanal LF Mg 5/60*Magnesium1000 - 1800 (7.5%)
Manugel LBASodium300-700 (10%)
Manugel LBBSodium8000 (10%)
Protanal LF 240 DSodium70 200 (1%)Controlled release.
Protanal LF 120 MSodium70 150 (1%)
Keltone LVCRSodium35 (1%)
Keltone HVCRSodium400 (1%)
Manucol LKXSodium60-170 (1%)
KelcosolSodium1000-1500 (1%)Gelling.
Manugel LBASodium500 (10%)
Manucol LBSodium4 (1%)Viscosity enhancer.
Kelcoloid SPropylene Glycol25 (1%)
Manucol DHSodium40-90 (5%)Thickener and stabilizer for syrups,
emulsions.
Manucol DMFSodium300 (1%)
Kelvis *Sodium760 (1%)
Protanal Ester SD-LBPropylene Glycol700 - 1800 (2%)
Kelcoloid K3B426Propylene Glycol120 (1%)
Kelcoloid HVF *Propylene Glycol400 (1%)
Kelcoloid LVF *Propylene Glycol120 (1%)
Manucol Ester E/RK *Propylene Glycol125 (1%)
Manucol Ester M *Propylene Glycol200 (1%)
Protanal KF 200 *Potassium200 400 (1%)Dental Impression
materials.
Protanal TA 250 *Triethanolamine200 400 (1%)
Kelmar *Potassium400 (1%)
Manucol SS / LLSodium200 (1%)Dental Fixtures.
KelsetSodium-Calcium500 1000 (0.5%)Selfgelling polymers for
controlled release.
Keltose *Ammonium-CalciumSemi-gel (1%)
Protanal LF 200 MSodium200 400 (1%)Wound Healing.
Protanal LF 10/60Sodium20 - 70 (1%)
Manucol LFSodium25 (1%)
* Non-pharmacopeial gradesKLEPTOSEBetadex USP/NF, EP, JPEThe
complexes formed with betacyclodextrin are of monomolecular type
leading to the concept of molecular encapsulation.
Betacyclodextrins can improve the solubility of poorly soluble
compounds and finds use as encapsulating agents, solubility and
stability enhancers for tablets, capsules, sachets and oral
suspensions. They are also used for taste masking of bitter or
unpleasant active ingredients.
GradeDescriptionApplication
Kleptose STDStandard gradeFor inclusion in liquid phase.
Kleptose DCGranular gradeFor direct compression.
Kleptose 10Micronized gradeFor aerosols.
Kleptose 7PCLow moisture gradeFor inclusion in dry phase.
KLEPTOSE HPB / HPHydroxypropyl Betadex (HPBCD) USP/NF, EP,
JPEHydroxypropyl Betadex (HPBCD) are purified polydisperse products
resulting from controlled reaction of propylene oxide and native
betadex under base catalysis. By virtue of its amorphous
polydisperse composition, it overcomes the low solubility and
inadequate biological tolerance of the native betacyclodextrin.
Kleptose HPB is produced in a purpose built, state-of-the-art
manufacturing plant following USFDA type GMP quality guidelines for
API and is perhaps the only brand supported by toxicology data.
GradeDescriptionApplication
Kleptose HPBHPBCD with medium molar substitution (Endotoxin
controlled)Increases water solubility of poorly soluble drugs by
encapsulation. Suitable for parenteral solutions, syrups, oral
suspensions and dry formulation. Increases bioavailability and
improves organoleptic properties of bitter and unpleasant
actives.
Kleptose HPHPBCD with high molar substitution (Oral grade)
KLUCELHydroxypropyl Cellulose USP/NF, EP, JPKLUCEL HPC is
non-ionic water-soluble cellulose ether, formed by reaction of
cellulose with propylene oxide. KLUCEL provides a remarkable set of
physical properties for tablet binding, modified release and film
coating. It combines organic solvent or aqueous solubility,
thermoplasticity and surface activity with aqueous thickening and
stabilizing properties.
GradeViscosity in mPas (% w/w)*Application
Klucel LF Pharm75 - 150 (5%)Tablet binding for immediate release
- Yields unmatched tablet hardness and friability in wet
granulation and direct compression or dry granulation.
Modified release - Provides effective diffusion limiting matrix
systems.
Tablet coating - Imparts good flexibility and adhesion to films
while providing a good barrier to water and oxygen
transmission.
Klucel LXF Pharm (extra fine)
Klucel GF Pharm150 - 400 (2%)
Klucel GXF Pharm (extra fine)
Klucel JF Pharm150 - 400 (5%)
Klucel JXF Pharm (extra fine)
Klucel EF Pharm300 - 600 (10%)
Klucel EXF Pharm (extra fine)
Klucel HF Pharm1500 - 3000 (1%)
Klucel HXF Pharm (extra Fine)
Klucel MF Pharm4000 - 6500 (2%)
Klucel MXF Pharm (extra fine)
*Viscosity in milli Pascal per second (mPas or cps) determined
on aqueous solutions as per indicated weight %. at 250 C + 0.50 C
using a Brookfield - Syncro-Lectric LVF viscometer.
KOLLICOAT IRPVA-PEG graft copolymerA breakthrough in instant
release film coating, Kollicoat IR is an innovative new coating
polymer derived from BASFs extensive polymer research. They are
basically polyvinyl alcohol-polyethylene glycol graft copolymers
slightly modified to render different application values. All the
grades are in powder form and give an extremely flexible film
without addition of any plasticizer and offer pH independent
release. Kollicoat IR grades are white to faintly yellow
free-flowing powder that is very rapidly soluble in acidic, neutral
and alkaline aqueous media. Such aqueous solutions have low
viscosity.
GradeDescriptionApplication
Kollicoat IRGraft copolymer of 75% polyvinyl alcohol units and
25% polyethylene glycol unitsUsed for instant release coating of
tablets, pellets and particulate matter, as a pore former in
sustained-release coatings, as a binder using a binding solution
for wet granulation.
Kollicoat IR WhiteGraft copolymer of 75% polyvinyl alcohol units
and 25% polyethylene glycol units with white pigmentsReady-to-use,
white colour coating system. Instantaneous dispersion due to a
patented manufacturing process.
Kollicoat ProtectCo-processed product of Kollicoat IR and
Polyvinyl alcoholReady-to-use moisture barrier system for use in
combination with pigments.
KOLLICOAT MAEMethacrylic acid / Ethyl acrylate copolymer USP/NF,
EP, JPEKollicoat MAE 30 DP and Kollicoat MAE 100P are anionic
polymers based on methacrylic acid and methacrylic acid esters and
are used as film-formers for the production of enteric coatings for
solid dosage forms. The ratio of carboxyl groups to ester units is
about 1:1. The films are insoluble below pH 5 and thus resistant to
gastric fluid. By salt formation in the neutral to weakly alkaline
medium of intestinal fluid, the films dissolve step-wise at pH
values above 5.5.
GradeDescriptionApplication
Kollicoat MAE 30 DPAqueous, milky white, low viscosity
dispersion with solid content of 30% and a faint characteristic
odourFor enteric film coating of tablets, pellets, capsules,
crystals, soft gelatin capsules and other solid dosage forms. .
Also used as a moisture barrier, taste odour masking and as a
barrier between incompatible actives.
Kollicoat MAE 100 PWhite, partially neutralized, redispersible
powder with a faint characteristic odourFor the production of an
aqueous dispersion for coating or a solution in organic solvents
for enteric coatings on tablets, pellets, capsules, crystals, soft
gelatin capsules and other solid dosage forms.
KOLLICOAT SR 30 DPolyvinyl acetate dispersion EPKollicoat SR 30
D is a an aqueous dispersion consisting of 27% polyvinyl acetate
stabilized with 2.7% povidone and 0.3% sodum lauryl sulfate. This
dispersion is suitable for the manufacture of pH independent
sustained release formulations. Very effective control of drug
release is achieved by coating pellets, granules and crystals. This
dispersion can also be used for taste masking.
GradeDescriptionApplication
Kollicoat SR 30 DLow viscosity, milky white or slightly
yellowish dispersion with solid content of 30% and a weak
characteristic odourUsed for sustained release coating of pellets,
granules, etc; for sustained release matrix tablets; for taste and
odour masking and protective coatings of interacting
ingredients.
KOLLIDONPovidone USP/NF, EP, JPThe Kollidon range consists of
soluble polyvinyl pyrrolidone which is obtained by radical
polymerization of N-vinylpyrrolidone in water or isopropanol under
cGMP conditions to yield the chain structure constituting
polyvinylpyrrolidone (PVP). By virtue of its solubility in water
and many organic solvents, its high binding power and ability to
form complexes, soluble PVP occupies a special position among the
synthetic colloids.
Kollidon is available in different grades on the basis of their
K-value and molecular weight. All grades are supplied as almost
white, free flowing, tasteless powders with a slight characteristic
odour in pharmaceutically pure form.
GradeDescriptionApplication
KvalueMolecular weight (Mw)
Kollidon 12 PF10.2 - 13.8Low (2000-3000)Pyrogen free grade, used
as solubilizing, stabilizing agents, dispersants and
crystallization inhibitors particularly for injectables; especially
antibiotics in solution or lyophylisate form.
Kollidon 17 PF15.3 - 18.0Low (7000-11000)Same as Kollidon 12 PF.
Can be additionally used as solubilizer, film former or thickener
in ophthalmic preparations.
Kollidon 2522.5 - 27.0Medium (28000 - 34000)Versatile and widely
used as binders in tablets, capsules and granules, stabilizers in
oral suspensions, film formers, dispersants for pigments,
thickeners and bioavailability enhancers
Kollidon 3027.0 - 32.4Medium (44000 - 54000)
Kollidon 90 F81.0 - 96.3High (1000000 - 1500000)Highly effective
binder for wet and dry granulation; stabilizer and thickener for
oral and topical solutions including ophthalmic preparations.
KOLLIDON CLCrospovidone USP/NF, EP, JPECrospovidone grades are
the insoluble grades of Povidone manufactured by a polymerization
process that yields crosslinked insoluble polyvinylpyrrolidone in
the form of a popcorn polymer. The polymerisation is performed
using an aqueous system.
Crospovidones are Super Disintegrants completely insoluble in
solvents. In contrast to many other disintegrants they are also
non-water soluble. As a consequence, there is no influence on the
disintegration of a tablet and the dissolution of the active due to
the increased viscosity. The crosspovidones act as disintegrants by
absorbing water and subsequently swelling. This gain in volume is
responsible for the subsequent disintegration of the tablet. The
different Kollidon CL are distinguished by their different particle
sizes.
GradeDescriptionApplication
Kollidon CLStandard gradeUsed as a tablet disintegrant and for
improving the release of active substances from tablets, capsules
and granules.
Kollidon CL-FFine particle size gradeUsed as disintegrant in
tablets, especially in formulations for small tablets and in wet
granulation (less content uniformity problems).
Kollidon CL-SFSuperfine particle size gradeUsed as disintegrant
in fast dispersible tablets for a smooth mouth-feel.
Kollidon CL-MMicronized gradeUsed as a stabilizer for oral and
topical suspensions and for improving the release of active
substances from tablets, capsules and granules.
KOLLIDON SRBlend of Polyvinyl Acetate and PovidoneKollidon SR is
a blend of polyvinyl acetate and povidone for use as a
matrix-forming agent in directly compressible sustained release
tablets. It consists of 80% polyvinyl acetate and 19% povidone
alongwith small quantities of sodium lauryl sulfate and silica as
stabilizers.
Polyvinyl acetate is a very plastic material that produces a
coherent matrix under low compression forces. When the tablets
formulated using Kollidon SR are introduced into gastric or
intestinal fluid, the water soluble povidone is leached out to form
pores through which the active ingredient slowly diffuses out
through these pores to give sustained action. Kollidon SR contains
no ionic groups and is therefore inert to drug substances. The
sustained-release properties are unaffected by ions or salts.
GradeDescriptionApplication
KvalueCharacteristics
Kollidon SR60.0 - 65.0White or slightly yellowish, free-flowing
powder, insoluble in water (only povidone part is soluble) and very
soluble in NMPUsed in formulation of pH independent sustained
release matrix dosage forms tablets, pellets and granules by either
direct compression, roller compaction, wet granulation or
extrusion.
KOLLIDON VA 64Copovidone USP/NF, EP, JPEKollidon VA 64 grades
are excellent dry binders. Basically they are vinylpyrrolidone -
vinyl acetate copolymers which are soluble in both water and
alcohols. It is white or slightly yellowish powder with a faint
characteristic odour and practically no taste. An important
property of Kollidon VA 64 is its plasticity which distinguishes it
from Povidone (eg. Kollidon). This property often gives granules
and mixtures that are less susceptible to capping during tabletting
and results in tablets that are less brittle.
GradeDescriptionApplication
KvalueCharacteristics
Kollidon VA 6425.2 - 30.8Copolymer of vinylpyrrolidone and vinyl
acetate in a ratio of 6:4 by massDry binder for direct compression
and roller compaction; as a binder for wet granulation in tablets,
capsules and granules; as a film forming agent in tablet coating /
sub-coating and in topical sprays.
Kollidon VA 64 FineFine particle size grade for increased tablet
hardness resulting in less friability and better mechanical
stability.
KRONOS 1171Titanium Dioxide USP/NF, EP, JPKRONOS 1171 Titanium
dioxide is an amorphous, fine, superwhite powder produced by the
sulphate process. It is a special anatase grade of exceptionally
high purity specifically manufactured for the pharmaceutical
industry. Due to its high refractive index, Kronos 1171 Titanium
Dioxide has unique light scattering properties and thus widely used
as a white pigment and opacifier.
Kronos 1171 Titanium Dioxide complies to the latest monographs
of USP/NF, EP, JP etc as well as to several purity regulations of
the EU and USFDA.GradeDescriptionApplication
Kronos 1171Anatase grade, super white, fine particle size and
bacteria controlledUsed as a white pigment and opacifier in film
coating mixes for tablets, gelatin capsules, sugar coated tablets,
films and dermatological preparations. Can also be admixed with
other pigments to lend different colour tones to tablets and
coatings.
LACTOCHEMLactose Monohydrate USP/NF, EP, JPLactochem is a white,
crystalline powder. It is the alpha-isomer of lactose and in
crystalline form it is present as alpha monohydrate lactose. The
water of crystallization is tightly bound and shows no chemical
activity while bound. Moisture sorption is extremely low even at
high relative humidity. Lactochem is available in sieved and milled
forms of different particle size distributions, ranging from coarse
to very fine material.Milled Lactochem products are all
characterized by small particles and high specific surface area,
resulting in good binding properties. Therefore these products are
especially useful in wet granulation tabletting, pelletization as
well as spheronization.
GradeDescriptionApplication
Lactochem PowderMilled LactoseWidely used as fillers in wet
granulation processes. Also used for capsule filling and in powder
mixtures filled into sachets.
Lactochem Coarse Powder
Lactochem Regular Powder
Lactochem Fine Powder
Lactochem Extra Fine Powder
Lactochem Super Fine Powder
Sieved Lactochem products are all characterized by a low Carrs
index, implying good flowability and are therefore ideal for
filling of capsules and sachets where excellent flowability is
needed. These products are also successfully applied as diluents
for direct compression. The finer crystal types are suitable for
pelletization as well.
GradeDescriptionApplication
Lactochem CrystalsSieved LactosePrevents segregation in capsule
based formulations and sachets. Used as filler - binder in directly
compressible formulations.
Lactochem Coarse Crystals
Lactochem Fine Crystals
Lactochem Extra Fine Crystals
LACTOPRESSDirectly Compressible Lactose USP/NF, EP, JPLactopress
is a white, free flowing directly compressible Lactose powder. It
is available in two forms; spray dried and anhydrous with different
particle sizes distributions. The good flowability of these powders
in combination with excellent compactibility characteristics make
them ideal for direct compression tabletting. These products are
also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution
and excellent binding properties. It consists mainly of the
beta-isomer of lactose, which contains no water of crystallization
and the free moisture content is low. Lactopress anhydrous does not
absorb water even at high relative humidity which makes it the best
choice for use in direct compression of moisture sensitive
actives.GradeDescriptionApplication
Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle
sizeAs low moisture DC binder and filler in tablets and capsules.
Improves stability ofmoisture sensitive actives as well as their
dissolution due to its high intrinsic solubility.
Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine
particle size
Lactopress spray-dried is produced by spray-drying a suspension
of small crystals of lactose monohydrate. It consists mainly of
spherical particles resulting in excellent flowability and binding.
Lactopress spray-dried contains up to 15% amorphous lactose, which
ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed
tabletting machines.GradeDescriptionApplication
Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs
binder, fillerbinder, and flow aid in direct compression due to its
excellent flow and high compressibility. Ensures good content
uniformity.
Lactopress Spray Dried 260DC Lactose, Coarse particle size
Lactopress Spray DriedDC Lactose, Coarse particle size
LACTOPRESS GRANULATEDLactose monohydrate, modified USP/NF, EP,
JP Lactopress granulated is a highly stable excipient having
excellent flow, low density, low hygroscopicity and good compaction
properties. It has low lubricant sensitivity and offers short
disintegration time on use in formulations. The short
disintegration time together with the sweet taste, makes it and
ideal excipient for use in orodispersible
tablets.GradeDescriptionApplication
Lactochem GranulatedGranulated Lactose monohydrate Direct
compression formulations Orodispersible tablets Low dose
applications Capsules and sachets filling
Directly Compressible Lactose USP/NF, EP, JPLactopress is a
white, free flowing directly compressible Lactose powder. It is
available in two forms; spray dried and anhydrous with different
particle sizes distributions. The good flowability of these powders
in combination with excellent compactibility characteristics make
them ideal for direct compression tabletting. These products are
also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution
and excellent binding properties. It consists mainly of the
beta-isomer of lactose, which contains no water of crystallization
and the free moisture content is low. Lactopress anhydrous does not
absorb water even at high relative humidity which makes it the best
choice for use in direct compression of moisture sensitive
actives.GradeDescriptionApplication
Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle
sizeAs low moisture DC binder and filler in tablets and capsules.
Improves stability ofmoisture sensitive actives as well as their
dissolution due to its high intrinsic solubility.
Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine
particle size
Lactopress spray-dried is produced by spray-drying a suspension
of small crystals of lactose monohydrate. It consists mainly of
spherical particles resulting in excellent flowability and binding.
Lactopress spray-dried contains up to 15% amorphous lactose, which
ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed
tabletting machines.GradeDescriptionApplication
Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs
binder, fillerbinder, and flow aid in direct compression due to its
excellent flow and high compressibility. Ensures good content
uniformity.
Lactopress Spray Dried 260DC Lactose, Coarse particle size
Lactopress Spray DriedDC Lactose, Coarse particle size
LACTOPRESS GRANULATEDLactose monohydrate, modified USP/NF, EP,
JP Lactopress granulated is a highly stable excipient having
excellent flow, low density, low hygroscopicity and good compaction
properties. It has low lubricant sensitivity and offers short
disintegration time on use in formulations. The short
disintegration time together with the sweet taste, makes it and
ideal excipient for use in orodispersible
tablets.GradeDescriptionApplication
Lactochem GranulatedGranulated Lactose monohydrate Direct
compression formulations Orodispersible tablets Low dose
applications Capsules and sachets filling
LACTOPRESSDirectly Compressible Lactose USP/NF, EP, JPLactopress
is a white, free flowing directly compressible Lactose powder. It
is available in two forms; spray dried and anhydrous with different
particle sizes distributions. The good flowability of these powders
in combination with excellent compactibility characteristics make
them ideal for direct compression tabletting. These products are
also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution
and excellent binding properties. It consists mainly of the
beta-isomer of lactose, which contains no water of crystallization
and the free moisture content is low. Lactopress anhydrous does not
absorb water even at high relative humidity which makes it the best
choice for use in direct compression of moisture sensitive
actives.GradeDescriptionApplication
Lactopress Anhydrous 250Roller dried DC Lactose, Coarse particle
sizeAs low moisture DC binder and filler in tablets and capsules.
Improves stability ofmoisture sensitive actives as well as their
dissolution due to its high intrinsic solubility.
Lactopress Anhydrous Fine PowderRoller dried DC Lactose, Fine
particle size
Lactopress spray-dried is produced by spray-drying a suspension
of small crystals of lactose monohydrate. It consists mainly of
spherical particles resulting in excellent flowability and binding.
Lactopress spray-dried contains up to 15% amorphous lactose, which
ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed
tabletting machines.
GradeDescriptionApplication
Lactopress Spray Dried 250DC Lactose, Fine particle sizeAs
binder, fillerbinder, and flow aid in direct compression due to its
excellent flow and high compressibility. Ensures good content
uniformity.
Lactopress Spray Dried 260DC Lactose, Coarse particle size
Lactopress Spray DriedDC Lactose, Coarse particle size
L-HPCLow substituted Hydroxypropyl Cellulose USP/NF, JPL-HPC is
a low-substituted hydroxypropyl ether of cellulose. It is non-ionic
and less reactive to active ingredients. It is insoluble in water
and alcohols but swells in water. It causes changes in the binding
and disintegrating characteristics as a result of subtle changes in
its physical properties like particle size and substituent content.
Hence, it is widely used as a dual-functional excipient
(disintegrant / binder) for tablets, granules or other
pharmaceutical solid dosage forms.GradeDescriptionApplication
Mean particle size (m)Particle type
LHPC LH-1150 Highly fibrousDirect Compression (anticapping).
LHPC LH-2140Moderately fibrousRegular grade (dry mixing, wet
granulation).
LHPC LH-2240Moderately fibrousLower hydroxypropoxy content
(sometimes betterdisintegration).
LHPC LH-3120MicronizedMicronized grade (Pellet extrusion,
layering).
LHPC LH-3220Micronized grade with lower hydroxypropoxy content
(Pellet extrusion, layering).
LHPC LH-B150Non fibrousHigh density grade suitable for direct
compression with good flowability and high loading capability.
* Laser diffraction methodLUDIFLASHCompound of Mannitol,
Crospovidone and Polyvinyl AcetateLudiflash is an innovative,
unique co-processed blend of mannitol (95%), crospovidone (5%) and
polyvinyl acetate (5%) manufactured in a validated patented
process. Ludiflash is practically in a league of its own when it
comes to excipients for direct compression tablets that rapidly
disintegrate in the mouth to form a smooth and creamy texture.
Thanks to its unique composition, Ludiflash produces tablets
with an excellent compression / hardness curve, very low friability
and very high content uniformity even at high tabletting speed. The
oro-dispersible tablets made with Ludiflash can be taken without
water, anytime, anywhere and have extremely rapid disintegration
(within seconds) and fast release
rates.GradeDescriptionApplication
LudiflashAll-in-one system with a mild sweet taste and cooling
effect in the mouth. White to off-white powder with superior
flowability and low hygroscopicity. Does not dissolve completely in
water or organic solventsExcellent excipient for direct compression
of fast-disintegrating solid oral dosage forms (mouth-melts) for
rapid release.
LUDIPRESSCompoud of Lactose Monohydrate and PovidoneLudipress is
the result of an intensive research and development effort by BASF
to produce an advanced excipient for the manufacture of tablets by
the direct compression process. Ludipress is white, free-flowing,
tasteless and odourless granules of lactose monohydrate (93%),
povidone (3.5%) and crospovidone (3.5%) and combines the three
functionalities of a filler, binder and disintegrant into a single,
ready-to-use excipient for direct compression. The versatility of
Ludipress allows very simple formulations resulting in rapidly
disintegrating tablets of excellent hardness and low friability
Ludipress LCE, on the other hand, is a directly compressible
compound of lactose monohydrate (96.5%) and povidone (3.5%). Due to
the absence of a disintegrant, Ludipress LCE is completely soluble
in water and particularly suitable for cost saving production of
lozenges, chewables, effervescent tablets etc.
GradeDescriptionApplication
LudipressGranules of lactose monohydrate, povidone and
crospovidoneDirect compression tabletting (disintegrating tablets)
and as a filler in hard gelatin capsules.
Ludipress LCEGranular compound of lactose monohydrate and
povidoneDirectly compressible production of lozenges, sublingual,
chewable tablets particularly, in effervescent tablets. Also used
as a bulking agent for modified release formulations.
LUSTRECLEAR LC - 103Microcrystalline Cellulose and Carrageenan
based film coating systemLustreClear LC-103 is a highly effective,
proprietary all-in-one aqueous film coating system. This unique
film coating technology combines microcrystalline cellulose (MCC)
and carrageenan to provide a distinctive, smooth, satin finish on
solid dosage forms. It is clearly an innovative, cost-effective,
aesthetic coating system opening new possibilities in aqueous film
coating for a wide variety of tablets and other solid dosage forms.
This advanced technology platform, makes processing easier and
offers distinctive sensory attributes. Its added advantages of
taste masking and ease of swallowing of the coated dosage forms add
to the patients appeal and compliance.
GradeDescriptionApplication
LustreClear LC-103All-in-one, aqueous, clear, conventional film
coating system comprising of microcrystalline cellulose,
carrageenan and polyethylene glycolUsed for film coating of tablets
and other solid dosage forms into elegant, easy to swallow and
taste masked products.
LUTROL EPolyethylene Glycol (Macrogol) USP/NF, EPLutrol E types
are liquid polyethylene glycols manufactured by alkali-catalysed
polymerisation of ethylene oxide with subsequent neutralisation of
the catalyst. Lutrol E grades are readily soluble in water,
ethanol, acetone, glycols and chloroform. The number in the name of
the product is indicative of the average molecular weight. The
higher the molecular weight of the product; the less hygroscopic it
is and lower its solubility in water.
Lutrol E 300 and Lutrol E 400 are colourless, almost odourless
and tasteless liquids at room temperature; while Lutrol E 600 can
be either liquid or pasty at room temperature.
GradeDescriptionApplication
Lutrol E 300Molecular weight : 285 - 315Viscosity : 5.4 - 6.4
mPa.sUsed as solvents and solubilizing agents for oral, parenteral,
topical, ophthalmic and rectal preparations. Carriers for dissolved
or suspended drug in soft gelatin capsules. Widely used as an
ointment base.
Lutrol E 400Molecular weight : 380 - 420Viscosity : 6.8 - 8.0
mPa.s
Lutrol E 600Molecular weight : 570 - 630Viscosity : 9.9 11.3
mPa.s
LUTROL FPoloxamer USP/NF, EP, JPEThe Lutrol F grades or
Poloxamers are block copolymer of polyoxyethylene polyoxypropylene
(Pluronics). While Lutrol F 68 (Poloxamer 188) is a white to
slightly yellowish, waxy substance in the form of microbeads with a
faint odour, Lutrol F 127 (Poloxamer 407) is a white,
coarse-grained powder with a waxy consistency. Both grades are
soluble in ethanol and water.
The Ltrol micro grades - Ltrol F micro 68 and Ltrol F micro 127
are white, micronized Poloxamer powders of average particle size of
~50 m. with a weak odour.
GradeDescriptionApplication
Lutrol F 68Poloxamer 188 (Block polymer of 81% polyethylene
glycol and 19% polypropylene glycol) with an average molecular
weight of 8600 Emulsifier, solubilizer and suspension stabilizer in
liquid, oral, topical and parenteral dosage forms, as a plasticizer
and bioavailability enhancer in solid preparations. Also as
coemulsifier in creams and emulsions and as a tablet lubricant.
Ltrol Micro 68Micronized Poloxamer 188 with a mean particle size
of 50 m for homogenous mixingDissolution enhancer for actives in
solid oral dosage forms; water soluble lubricant for effervescent
tablets and for actives incompatible with stearates.
Lutrol F 127Poloxamer 407 (Block polymer of 73% polyethylene
glycol and 27% polypropylene glycol with an average molecular
weight of 12,000Gel former, thickening agent and solubilizer in
oral and topical solutions and as a stabilizer in topical
suspensions.
Ltrol Micro 127Micronized Poloxamer 407 with a mean particle
size of 50 m for homogenous mixingDissolution enhancer for actives
in solid oral dosage forms; water soluble lubricant for
effervescent tablets and for actives incompatible with
stearates.
MAGNABRITEMagnesium Aluminum Silicate USP/NF, BP
Magnabrite product range are highly refined, naturally
occurring, complex colloidal white smectite clays i.e. Magnesium
Aluminum Silicates manufactured to meet the specifications of the
USP/NF and BP. Chemically Magnesium Aluminum Silicate is a blend of
colloidal montmorillonite and saponite that has been processed to
remove grit and non- swellable ore components. The plate-like
structure and colloidal nature of Magnabrite contributes to a wide
range of applications for stabilization of emulsions, as a
suspending agent, thickener, rheology modifier, binder, and as a
tablet disintegrant. Magnabrite is available in different particle
sizes and varying viscosity to suit the end-user.
GradeDescriptionApplication
TypeViscosity at 5% solids (cPs)
Magnabrite HVHigh viscosity grade, Small flakes, 800 -
2200Excellent suspension and emulsification properties, delivers
high viscosity with excellent rheology in low solid
formulations.
Magnabrite KAcid stable grade, Small flakes,100 - 300Low acid
demand and high acid compatibility, used to reduce thickening and
flocculation in acidic preparations / suspensions.
Magnabrite SStandard grade, Small flakes,225 - 600Excellent
emulsification and thickening abilities, used in formulations
requiring medium viscosity, high brightness and ease of
dispersion.
Magnabrite FMicro fine powder grade, Free flowing150 - 450Used
as an inert low-bulk disintegrant in large tablets. Also used as a
suspending agent.
MAGNABRITE HSPurified Bentonite USP/NF, BPMagnabrite HS is an
absorbent aluminium phyllosilicate, highly refined, naturally
occurring complex colloidal white smectite clay. Chemically it is
colloidal montmorillonite which has been processed to remove grit
and non-swellable ores. The properties of Magnabrite HS are similar
to that of the other Magnabrite grades.
GradeDescriptionApplication
TypeViscosity at 5% solids (cPs)
Magnabrite HSHigh electrolyte stability grade, Small flakes 40 -
200Easily hydrates in hot or cold water, used as suspending,
thickening agent and binder.
MAGNESIUM CARBONATE USP/NF, EP, BP Magnesium carbonate is a
basic hydrated magnesium carbonate or a normal hydrated magnesium
carbonate. DSPs magnesium carbonates are manufactured by an unique
process which ensures freedom from the impurities generated by the
commonly used precipitation processes grades. Their product is thus
of exceptionally high purity and characterized by particularly low
levels of impurities such as lead and other minerals. They are
offered in two grades Basic and Heavy.
GradeDescriptionApplication
Basic Magnesium CarbonateLight grade (Tapped BD: 0.35-0.55
g/cc)For use in the manufacture of antacid preparations and mineral
supplements, Also used in microsphere formulations for the purpose
of stabilizing encapsulated proteins or to absorb flavors, in
tableting processes.
Heavy Magnesium Carbonate Heavy grade (Tapped BD : NLT 0.50
g/cc)To produce tablets with high crushing strength, low
friability, and good disintegration properties.
MAGNESIUM CARBONATE LIGHT USP/NF, EP, BP Magnesium carbonate is
a basic hydrated magnesium carbonate or a normal hydrated magnesium
carbonate. Scoras magnesium carbonate is manufactured by the
Pattinson process which ensures freedom from the impurities
generated by the commonly used precipitation processes grades. The
product is thus of high purity and exceptional quality.
GradeDescriptionApplication
Basic Magnesium CarbonateHeavy grade, free flowingViscosity
regulator, anti-caking and free flow aid. Used in antacid
preparations / tablets, laxatives and in production of
pharmaceutical magnesium derivatives. Also used in mineral
supplements & food additives.
MAGNESIUM HYDROXIDE USP/NF, EP, BPMagnesium hydroxide is an
inorganic compound, not very soluble in water. While the solubility
of magnesium hydroxide is low, all of the magnesium hydroxide that
does dissolve in the water does dissociate. DSPs magnesium
hydroxides are manufactured by an unique process which ensures
freedom from the impurities generated by the commonly used
precipitation processes grades. Their product is thus of
exceptionally high purity and characterized by particularly low
levels of impurities such as lead and other minerals. They are
available as spray dried powders with different bulk densities thus
offering a wide choice of compounding possibilities for tablet and
powder dosage systems.
GradeDescriptionApplication
Magnesium Hydroxide HD5Lowest bulk density gradeSpray dried,
directly compressible powders for use in the manufacture of antacid
preparations and mineral supplements.
Magnesium Hydroxide HD7Low bulk density grade
Magnesium Hydroxide HD9Medium bulk density grade
Magnesium Hydroxide HD12High bulk density grade
MAGNESIUM OXIDE USP/NF, EP, BPMagnesium oxide is a free flowing
white powder, insoluble in alcohol and almost insoluble in water.
It is a source of magnesium and formed by an ionic bond between one
magnesium and one oxygen atom. DSPs magnesium oxides are
manufactured by an unique process which ensures freedom from the
impurities generated by the commonly used precipitation processes
grades. Their product is thus of exceptionally high purity and
characterized by particularly low levels of impurities such as lead
and other minerals. They are available in a variety of grades to
meet the requirements of the formulator.
GradeDescriptionApplication
Magnesium Oxide LightLow bulk density gradeFor use in the
manufacture of tablet-form antacid preparations, pH modifier,
mineral supplements and in the production of pharmaceutical grade
magnesium derivatives.
Magnesium Oxide PHRA 50Heavy grade
Magnesium Oxide DCDirectly compressible grade, Granular
MAGNESIUM OXIDE LIGHT USP/NF, EP, BPMagnesium oxide is a free
flowing white powder, insoluble in alcohol and almost insoluble in
water. It is a source of magnesium and formed by an ionic bond
between one magnesium and one oxygen atom. Scoras magnesium oxides
are manufactured by the Pattinson process which ensures freedom
from the impurities generated by the commonly used precipitation
processes grades. The product is thus of high purity and
exceptional quality.
GradeDescriptionApplication
Magnesium Oxide LightLow bulk density gradeUsed as precursor of
magnesium hydroxide, pH modifier and viscosity regulator in antacid
preparations. Also used in mineral supplements, food additives and
in production of pharmaceutical grade magnesium stearates.
MALIC ACIDD, L Malic Acid USP/NF, EPMalic Acid is widely found
in nature and is the predominant organic acid in many fruits and
berries. Commercially, Malic Acid is manufactured by hydration of
Maleic Anhydride, at high temperature and pressure. The Malic Acid
crystallizes out from aqueous solutions as white, translucent,
anhydrous, non-hygroscopic and non-volatile crystals. It's
properties allow it to be stored under normal conditions for a very
long time without any caking & contribute to its long shelf
life.
Malic Acid works by blending with flavours and essences. Its
acid taste building up slowly at the beginning, but persists for a
long period. The final effect gives a stronger taste and a
pronounced flavor note. It works synergistically with most
sweetners and has the ability to enhance the effect of the aromas
used to mask the undesirable tastes and smell of medicinals. Polynt
offers malic acid in both powder & granule forms.
GradeDescriptionApplication
Malic acid granularWhite crystalline powder or granules with a
distinct acidic taste. Extremely soluble in waterUsed in throat
lozenges, cough syrups, effervescent powders and tablets. Masks
undesired taste and odour of medicinals. Also used in health /
sports drinks and anti-wrinkle creams.
Malic acid fine granular
Malic acid special fine granular
Malic acid powder
MALTISORB & LYCASINMaltitol USP/NF, EPMaltitol is a white
crystalline powder of high purity obtained by the catalytical
hydrogenation of D-maltose using a process patented by Roquette. It
is a dimeric polyol with a cool mouthfeel and sweetness close to
that of Sucrose. Maltitol is a stable polyhy