QUALITY CONTROL OF

SUPPOSITORIES

Ms. RIFFAT
 CONTENTS.
• Disintegration test, Uniformity of weight,
Assay of active ingredients, Liquefaction time
test and Breaking Test.
 Objectives
• Identify Suppositories
• Classify the suppositories
• Enlist the suppository bases
• Review their method of preparation
• Enlist & Discuss Quality control tests
of suppositories
 Definition
• Suppositories are solid dosage forms of
various weights, size, shapes usually
medicated, intended for insertion in to body
cavities
 SUPPOSITORY BASES
COCOA BUTTER AND OTHER FATTY

BASES WATER-SOLUBLE/DISPERSABLE

BASES

GLYCERNATED GELATIN
BASE HYDROGELS
 COCOA BUTTER
• Theobroma Oil is triglyceride
• Polymorphism of cocoa butter
• Melts at body temperature
• Immiscible with body fluids
• Difficulty in fat-soluble drug diffusion
WATER-SOLUBLE/DISPERSABLE BASES

• Combination of PEG or Glycol-surfactant

• Suitable for fat soluble drugs
• Do not produce problem of handling,
storage, shipping, melting
 HYDROGELS
• Macromolecular structure which swell but
do not dissolve in water

• GLYCERINATED GELATIN:
Glycerin (70%) + Pharma gel A/B (20%)
+ drug (10%)
 Preparation of Suppositories
• Molding from a melt
• Compression
• Hand rolling and shaping
 QUALITY CONTROL TESTS OF
SUPPOSITORIES
• Appearance of suppositories
• Uniformity of weight
• Liquefaction/Softening Time test
• Melting range test/Disintegration
• Fragility test/Breaking Test.
Chemical testing:
• Dissolution test
• Assay of active ingredients
 OFFICIAL QUALITY CONTROL
TESTS
• Procedures listed in the US Pharmacopeia
(USP30-NF25) for manufactured
suppositories include:
• Identification,
Assay. And in some
cases:
• Water content,
• Residual solvent
• Dissolution
• Content uniformity
Do you have any question…?

THANK YOU
 Reference
• Remington: The Science and Practice
of Pharmacy, pp:883-888