The evaluation of suppositories is essential to ensure quality, safety, and efficacy. Key parameters assessed include:
A) Weight Variation
Suppositories should have uniform weight for accurate dosing. Individual suppositories are weighed, and the weight variation must fall within pharmacopeial limits.
B) Appearance and Shape
Suppositories should have a smooth, uniform appearance without cracks or air bubbles.
The shape should be consistent with the intended use (e.g., cone-shaped for rectal, oval for vaginal).
C) Melting Range
The melting point should be close to body temperature to ensure proper drug release.
The melting range is tested to confirm stability and performance.
D) Disintegration and Dissolution
Suppositories should disintegrate and dissolve in a timely manner to release the active ingredient.
Tests are conducted in suitable media to measure disintegration time and API release.
E) Drug Content Uniformity
The drug content should be uniform across all suppositories.
Random samples are tested using methods like HPLC or UV spectrophotometry.
F) Stability
Stability tests assess changes in appearance, melting range, drug content, and dissolution over time, helping to determine shelf life and optimal storage conditions.
G) Microbiological Quality
Suppositories, especially vaginal ones, must meet microbiological standards to ensure they are free from harmful microbial contamination.
H) In-Vitro Release Testing
Tests evaluate the rate of drug release using appropriate dissolution apparatus.
This is critical for understanding the pharmacokinetic profile and efficacy of the suppository.