Comparative study between hard bovine gelatin capsule and vegetarian capsule
INTRODUCTION: Objective of this study is to compare in-vitro performance of hard bovine gelatin capsule (BC) and hard vegetarian capsules (VC). Such study is timely for several reasons: 1) to find alternative for animal-origin capsule especially when the issue like Bovine Sponge Encephalitis (BSE)...
Main Authors: | , , , |
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Format: | Conference or Workshop Item |
Language: | English |
Published: |
2011
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Subjects: | |
Online Access: | http://irep.iium.edu.my/5954/ http://irep.iium.edu.my/5954/ http://irep.iium.edu.my/5954/2/Comparative_Study_between_Hard_Bovine_Gelatin__poster_farahidah_final.pdf |
Summary: | INTRODUCTION: Objective of this study is to compare in-vitro performance of hard bovine gelatin capsule (BC) and hard vegetarian capsules (VC). Such study is timely for several reasons: 1) to find alternative for animal-origin capsule especially when the issue like Bovine Sponge Encephalitis (BSE) arise; 2) to establish scientific data with regard to comparable performance of VC as compared to BC. The model drug that was used was mefenamic acid as it is one of the most widely used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
MATERIALS AND METHOD: The drug and relevant excipients were encapsulated into the two types of capsule using manually-operated capsule filling machine. Several variables including different ratio of disintegrant (corn starch) to filler (lactose alpha-monohydrate) were tested as a function of disintegration test. The capsules were stored in a stability chamber with a controlled condition of 40°c and relative humidity of 65. At pre-determined time (weekly interval) 6 capsules at a time were taken for disintegration test at pH 1 to 3.
RESULTS AND DISCUSSION: The results showed that regardless of the ratio between disintegrant and filler, and regardless of pH of disintegrant media, the disintegration of the vegetarian capsules were consistent (4-5 min) throughout the study period (1 month) with stable physical appearance. In contrast, disintegration test for hard bovine gelatin capsule increase with time and the shells were becoming hardened and dented at week 4. This finding may suggest that the structure of VC were more stable compared to the BC thus required more time for it to disintegrate. The disintegration rate of the two capsules were also affected by the use of sodium starch glycolate as disintegrant as the capsules disintegrated faster when they were filled with sodium starch glyclate.
CONCLUSION: The results demonstrated that the in-vitro performance of vegetarian capsules was not comparable to the hard bovine gelatin capsule. Surprisingly, the VC showed better in-vitro performance in terms of disintegration and stability than the BC which suggests that vegetarian capsule could be a promising alternative dosage form.
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