Variation of active raw materials on properties of hard gelatin capsule dosage form

Abstract

The study of physical properties of Active Raw Materials Tetracycline Hydrochloride, Cimetidine and Mefenamic Acid from various sources showed no difference among the sources except bulk density, tapped density and compressibility. Cimetidine which is a water slightly soluble drug and Mefenamic Acid which is a water insoluble drug, showed statistically significant differences in dissolution rate while Tetracycline Hydrochloride which is water soluble drug showed no difference. Evaluation of the physical properties of the experimental capsules, results from this study showed that all the lots investigated comformed to the requirements of the pharmacopeias. When the source of active raw materials had been altered, the results showed that Tetracycline Hydrochloride Capsules still showed the physical properties within the pharmacopeia requirement. The variation of sources of Cimetidine and Mefenamic Acid may changed the physical properties exceed the compendial limit.