DEFINITAION TYPES AND STANDARD TESTS:
Pessaries are solid dosage forms containing one or more active drug and are intended for vaginal insertion. These are unit dosage forms, intended for local or systemic effect. These are formulated with suppository bases and they melt at body temperature and releases drug for effect. Absorbents, Diluents, Lubricants, Antimicrobial Preservatives and Permitted colouring agents may be used for formulation of pessaries.
There are two types of suppositories:
1) Moulded Suppositories: These are pessaries manufactured by liquefying by heating. The mass containing the medicaments and additives.
2) Compressed Pessaries: These are Vaginal tablets and are similar to uncoated tablets but they are large and of greater weight.
1. Uniformity of Container Content: The average number of the contents of the content of 10 containers is not less than the labelled amount and the number in any single container is not less than 98% and not more than 102% of the labelled amount.
2. Uniformity of Weight: Not more than 2 of the individual weights deviate from the average weight by more than 5% and none deviates by more than 10%.
3. Uniformity of Content: The average number of content in the 10 containers is not less than the labelled amount and the number in any single container is not less than 98% and not more than 102% of the labelled amount.
4. Disintegration: Limit – Shell Suppositories – Not more than 30 minutes.
Moulded Suppositories – Not more than 60 minutes.
5. Other Test.