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DISSOLUTION
Apparatus
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Goals of predictive dissolution test
To accessing therapeutic efficacy.
Monitoring batch to batch consistency.
High cost of in vitro dissolution test. Assessment of bioequivalence.
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FUNCTIONS OF DISSOLUTION
Optimization of therapeutic effectiveness during product
development and stability assessment
Routine assessment of production quality to ensure
uniformity between production lots
Assessment of bioequivalence, that is to say, production of
the same biological availability from discrete batches of
products from one or different manufacturers
Prediction of in-vivo availability, i.e. bioavailability (where
applicable)
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TYPES OF APPARATUS
BASKET APPARATUS
PADDLE APPARATUS
RECIPROCATING CYLINDER
FLOW-THROUGH CELL
PADDLE OVER DISK
CYLINDER
SHAFTwww.bpharmstuf.com
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BASKET
a) Vessel :-Made up of borosilicate
glass -Semi hemispherical bottom -
Capacity 1000ml
b) Shaft : -Stainless steel 316 -Rotates
smoothly without significance
wobble
c) Basket :- Stainless steel 316 -Gold
coatings up to 0.0001 inch
d)Waterbath : Maintained at
370.5c
Use: Capsules,tablets,delayed release,
suppositories,floating dosage forms
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PADDLE APPARATUS
METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT
COMPRISING OF SINGLE ENTITY
SINKERS (A SMALL, LOOSE PIECE OF NON-REACTIVE
MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO
AVOID FLOATING
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RECIPROCATING CYLINDER
1.Vessel:Cylindricalflat bottom glassvessel
2.Agitation type: -Reciprocating -Generally 5-35 rpm
3.Volume ofdissolution fluids :200-250 ml 4.Water bath:Maintain at 370.5c
Use : Extendedrelease
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FLOW-THROUGH CELL
1.Reservoir:For dissolution medium
2.Pump:-Forces dissolution
medium through cell -holding a
sample -Flow rate 10-100 ml/min -
Laminar flow is maintained -peristaltic/centrifugal pumps are
not recommended
3.Water bath: Maintain at 370.5c
Major advantage : -to maintain sink
conditions -Large volumedissolution media is used.
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PADDLE OVER DISK
1.Vessel 2.Shaft:
3.Stirring elements
4.Sample holder : -Disk assembly that hold
the product in such a way that release surfaceis parallel with paddle. -Paddle is directly
attached over disk assembly . -Samples are
drawn away b/w the surface of medium and
top of paddle blade. 5.Volume:900ml 6.Temperature:32 c
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SHAFT
POSITIONED IN SUCH A WAY THAT ITS AXIS IS
NOT MORE THAN 2MM FROM VERTICAL AXIS
OF THE VESSEL
SHOULD ROTATE SMOOTHLY WITHOUT
SIGNIFICANT WOBBLE
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MEDIA FOR DISSOLUTION
POINTS TO BE REMEMBERED WHILE
SELECTING A MEDIUM
VOLUME
DEAERATION
EXAMPLES OF TYPICAL MEDIA
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STANDARD VOLUMES
Paddle: 900/1000ml
Basket: 1-4 lit.
Reciprocating cylinder: 200-250ml
Paddle over Disk: 900ml
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DEAERATION
AIR BUBBLES CAN :
INTERFERE WITH THE RESULT
CAN CAUSE PARTICLES TO CLING TO THE
APPARATUS AND VESSEL WALLS
DEAERATION CAN BE DONE BY:
HEATING
FILTERING
VACUUM
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EXAMPLES OF TYPICAL MEDIA
WATER
PHOSHATE BUFFER, BORATE BUFER
BUFFERS OF pH RANGE 1.2 TO 7.5
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FILTERS
USED TO PREVENT UNDISSOLVED DRUG PARTICLESFROM ENTERING THE ANALYTICAL SAMPLE
USED TO REMOVE INSOLUBLE EXCIPIENTS WHICH
MAY CAUSE TURBIDITY
PORE SIZE MAY RANGE FROM 0.45 TO 70 m
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SAMPLING
MANUAL : USING PLASTIC OR GLASS SYRINGE,
A STAINLESS STEEL CANNULA
AUTOSAMPLING :
BEST FOR SEVERAL TIME POINTS
CAN BE SEMI OR FULLY AUTOMATIC
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TIME POINTS
FOR IMMEDIATE RELEASE : 15 TO 60 MINS
FOR EXTENDED RELEASE : AT LEAST THREE
TEST TIME POINTS ARE SELECTED
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Dissolution test for tablets
tablets or capsules taken orally remain one of the most effective means of
treatment available. The effectiveness of such dosage forms relies on the drug
dissolving in the fluids of the gastrointestinal tract prior to absorption into the
systemic circulation. The rate of dissolution of the tablet or capsule is therefore
crucial.
One of the problems facing the pharmaceutical industry is to optimise the
amount of drug available to the body, i.e. its bioavailability. Inadequacies in
bioavailability can mean that the treatment is ineffective and at worst
potentially dangerous (toxic overdose).
Drug release in the human body can be measured in-vivo by measuring the
plasma or urine concentrations in the subject concerned. However, there arecertain obvious impracticalities involved in employing such techniques on a
routine basis. These difficulties have led to the introduction of official in-vitro
tests which are now rigorously and comprehensively defined in the respective
Pharmacopoeia.
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. The principle function of the dissolution test may be summarised asfollows:
Optimisation of therapeutic effectiveness during product development
and stability assessment.
Routine assessment of production quality to ensure uniformity between
production lots.
Assessment of bioequivalence, that is to say, production of the samebiological availability from discrete batches of products from one or
different manufacturers.
Prediction of in-vivo availability, i.e. bioavailability (where applicable).
Dissolution test for tablets
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Dissolution test for suppositories
Testing for the rate of individual release of drugsubstance from suppositories has always posed
a difficult problem owing to melting deformation
dispersion in the dissolution medium
In early testing is carried out by a simple
placement in a beaker containing a medium
In an effort to control the variation in a mass
medium interface various.
like Wire mess basket or membrane
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T b l f
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Name ofthedosage
APPARA
TUSR p m Refer to
USPstandard
volume
Temp
Capsule II (Paddle) 50 Water(deaerated)
900 10, 20, 30,45 and 60
Capsule I (Basket) 100 Water 900 10, 20, 30,45 and 60
Tablet II (Paddle) 50 Water 900 10, 15, 30,45, and 60
Tablet IIPaddle 50 water 900/1000 15, 20, 30
Tablet I basket 100 water 1000 10, 20, 30.
Tabular form
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NAME OF THE
DOSAGE
APPARAT
USRPM Refer to
USPSTANDAR
D VOLUME
TEMP
Tablet I Paddle 50 Refer toUSP
900 5,10,15
Tablet II (Paddle) 50 0.1 NHCl
900 5, 10, 15,20 and 30
Capsule
(Extended
Release)
II (Paddle) 75 AcetateBuffer,
pH 4.5
with 2.2%
Tween 20
900 1, 2, 5, 7, 9,12 and 14
hours
Tablet IIBasket Refer toUSP
1000 10, 15
Capsule I (Basket) 100 3% SLSin water,
pH 9.6
900 10, 20, 30and 45
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CONCLUSION
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REFERENCE
USP NF
IP1996
Industrial pharmacyBYLacchmann Liebermann
www.dissolutiontech.com
www.usp.org
www.aapspharmaceutica.com
www.authorstream.compharmtech.findpharma.com
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Q U E R I E S
QUERIES..??
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