Pharmaceutical Development of Enteric-Release Hard Gelatin Capsules in the Compounding Setting

de, Oliveira Ferreira Anderson; Holandino, Carla

Abstract

Pharmaceutical Development of Enteric-Release Hard Gelatin Capsules in the Compounding Setting

Author(s): de Oliveira Ferreira Anderson, Holandino Carla

Issue: Mar/Apr 2008 - Compounding Around the World

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Page(s): 163-169

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Abstract

Enteric coated capsules are characterized by their resistance to dissolution in low pH environments, such as the stomach, and by their rapid disintegration in a higher pH environment, such as the intestine. The surface of hard gelatin capsules is usually smooth and nonporous, which limits their coating efficiency. We developed a simple, quick, and easily reproducible compounding preparation method for enteric-release hard gelatin capsules. Twenty-two batches of 60 diclofenac sodium capsules each were prepared and then divided into three groups. Each group was submitted to a different coating process using a small-scale enteric coating machine and a coating process based on the atomization (spraying) of organic solutions of polymers. The results of dissolution testing were compared statistically within the groups and also with a reference drug control (Voltaren DR). Some of the batches in group I and all the batches in groups II and III met the pharmacopeial requirements for enteric release, in both acid and p

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