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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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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

Related Keywords: Anderson de Oliveira Ferreira, MS, Carla Holandino, PhD, enteric release hard gelatin capsules, enteric coating, diclofenac sodium, pain relief, analgesia, analgesic, cellulose acetate phthalate, polymer coatings, methacrylic acid copolymer, formulation, dissolution, capsule sealing

Related Categories: PAIN MANAGEMENT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, TECHNOLOGY, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS

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