Storage of Dosage Forms

STORAGE OF DOSAGE FORMS

CONTENTS :• DEFINITIONS • CLASSIFICATION• NEED FOR STORAGE OF DOSAGE FORM• STORAGE CONDITIONS FOR DOSAGE FORM • DIFFERENT CONTAINERS FOR STORAGE• CONCLUSION

DOSAGE FORMSSOLIDS

TABLETSCAPSULESPOWDERS

LIQUIDS

MONOPHASICBIPHASIC

SEMISOLIDS

OINTMENTSCREAMSPASTES

SUPPOSITORY

GASES

INHALATIONSAEROSOLS

DEFINITIONS : -DOSAGE FORM:• Completed form of the pharmaceutical

preparation in which prescribed doses of medication are included.

• Examples: Tablets, Liniments, Ointments,

Powders ,Lotions etc.STORAGE:• It simply means keeping things at a

place ,till it is used ,so as to preserve the same properties.

NEED FOR STORAGE OF DOSAGE FORMS

• If the drug is not properly stored and on exposure to air,heat, light and microbes results in degradation ,loss of efficacy and even cause toxicity.

• Light can bring about photolytic decomposition due to exposure to certain wave length of light.

• Air present inside the container may catalyse oxidative degradation or other chemical changes.

• Moisture effects the stability of moisture sensitive preparation.

Sterile products are required to maintain sterility implying exclusion of microbes.

Certain drugs on exposure to air undergoes auto-oxidation and emulsified lipids are sensitive to attack.

So proper storage of drugs is required which are sensitive to air,light,moisture.

The stability of drug depends on temperature and pH.

ex:- Ampicillin is stored at low temperatures (2 – 8 c).

Ampicillin in solution is not stable at pH > 7.

contd

STORAGE CONDITIONS INDIAN STANDARDS AS PER I P-1996 .COLD TEMPERATURE NOT EXCEEDING 8 C AND USUALLY BETWEEN 2 - 8 C COOL ANY TEMPERATURE BETWEEN 8 – 25 CWARM ANY TEMPERATURE BETWEEN 30–40 CEXCESSIVE HEAT ANY TEMPERATURE ABOVE 40 CFREEZER TEMPERATURE BETWEEN -25 TO -10 CROOM TEMPERATURE TEMPERATURE PREVALING AT WORKING AREA DRY PLACE AVERAGE RELATIVE HUMIDITY NOT EXCEEDING 40%

If no specific storage directions are given then conditions include protection from moisture ,freezing and excessive heat.

ON THE LABEL MEANSDO NOT STORE OVER TO BE STORED IN 8 C REFRIGIRATOR (2 -8 C)DO NOT STORE OVER TO BE STORED AT 30 C ROOM TEMPERATUREDO NOT FREEZE KEEP IN REFRIGERATORPROTECT FROM AT NORMAL HUMIDITY& MOISTURE AT ROOM TEMPERATUREPROTECT FROM STORE IN LIGHT LIGHT RESISTANT CUP-BOARD

STORAGE CONDITIONS FOR STORING DIFFERENT

DOSAGE FORMSDosage form

Drug Storage condition Use

Tablets Paracetamol Store it at room temperatureKeep away from excess heat and moisture.

Analgesic,Anti-pyretic,Anti- inflammatory

Capsule B-complex Keep in brown colour/amber colour glass bottles to protect from light.store it room temperature.

vitamin supplement

syrup codeine Keep it in brown colour glass bottle to protect from light. Keep in cool place.

Anti-tussive, Anti-diarrhoel, Analgesic.

Lotion Calamine Store in well closed container

protective

Emulsion Liquid parrafin

Porcelis pestis emulsion.

Store in glass container and keep in cool placeStore at 2 – 8 c . Should be 15 – 25 c before use.

laxative.

To decrease swine fever in pigs.

Suspension Milk of msagnesia

Store in a cool in and dark place and keep in air tight plastic containers.

Antacid.

Ointment clotrimazole Store in acool and dark place.keep in plastic tubes.

Anti-fungal.

Cream Extract of jivanti,manjistha (ayurvedic)

Store in cool and dark place. Keep in plastic tubes.

Healing and soothing of wounds.

Parenterals Ampicillin Vials should be stored at 2 – 8 c for 3 weeks.For long storage they should be stored at -20 c for 4 – 6 months.

Anti-biotic

Opthalamic Tetrazoline Hcl Store in low temperature and keep them in amber colour glass bottles.

used when irritation and redness caused by cold

Powders clotrimazole Store in cool and dark place in a plastic container.

Anti-fungal

Gel aloe Store in cool and dark place away from direct sunlight

DIFFERENT CONTAINERS USED FOR STORAGE

1. WELL CLOSED:-It protects the container from contamination with extraneous solids under normal conditions of storage, handling, transport & prevent unintentional release of the contents.

2. AIR TIGHT :-It gives protection against extraneous solids, liquids, vapours under normal conditions of storage, handling, transport. It prevents changes due to efflorescence, deliquescence, & evaporation.

3.SECURELY CLOSED:- This is a air tight container with a means of preventing unintentional displacement of the closure.

4.HERMETICALLY CLOSED:-It is impervious to air and other gases under normal conditions of storage, handling & transport. Ex:- Glass ampoule sealed by fusion.

Liquid oral preparations

a) Intended to be swallowed (elixirs ,emulsions)

-Glass bottles

b) Not intended to be swallowed ( mouth washes , gargles)

- Ribbed oval glass bottles

Semisolid preparations - creams ,jellies ,ointments

-Collapsible metal or plastic tubes

-Glass or plastic pots.

CONTAINERS FOR DIFFERENT DOSAGE FORMS

• Solid unit dose preparations :- a) Intended to be swallowed or sucked

(Cachets, soft & hard capsules, pills ) b) Intended for use in body cavities

-Glass ,plastics ,aluminium -plastic ,metal containers

c) powders

1)For oral administration Bulk powders -Glass & plastic

2) For external use –

Dusting - used in body cavities . insuffalations -Air tight glass/plastic

container

Gaseous dosage forms (aerosols , inhalations ) - Metals -Tin coated steel Aluminium Stainless steel -Glass -uncoated g lass coated glass

GLASS Advantages: 1)Inert , strong and transparent. 2) Entry of micro organisms can be prevented with a

proper closure.3)Readily available in different shapes and sizes.4)Glass has good ageing qualities.5)Coloured glass can be used to protect light sensitive

products.Disadvantages:1) Heavy and fragile. 2) Leaching of alkali.3) Loss of brilliance.4)Flaking.

PLASTIC Advantages:1) Flexible in nature.2) Less brittle than glass/ non breakable .3)Light weight.4)Easily moulded in to number of shapes and sizes.5)Suitable for container & closure.Disadvantages:1)Only few withstand heat with out softening.2)permeability to water vapour & atmospheric gases is less.3)May sorb substances.4)Leach out stabilizers & plasticizers in to solutions.5) May interact with certain chemicals & become soft.6)Relatively expensive.7)Light transmission .

METALS :ADVANTAGES:1.Impermeable to light, moisture and gases2.Rigid and unbreakable.3.Lables can be directly printed on their surface.

DISADVANTAGES:1.Shed metal particles into product.2.Expensive.3.Chemically reactive in nature.

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