In Vitro Release Study on Capsules and Tablets Containing Enteric - Coated Granules Prepared by Wet Granulation

Eman B H Al-Khedairy

doi:10.31351/vol15iss1pp49-52

Abstract

Wet granulation method was used instead of conventional pan coating or fluidized â€“bed coating technique to prepare enteric-coated diclofenac sodium granules, using ethanolic solution of EudragitTM L100 as coating, binding and granulating agent .Addition of PEG400 or di-n-butyl phthalate as a plasticizer was found to improve the enteric property of the coat. Part of the resulted granules was filled in hard gelatin capsules (size 0), while the other part was compressed into tablets with and without disintegrant. The release profile of these two dosage forms in 0.1N HCl (pH 1.2)for 2 hours, and in phosphate buffer (pH 6.8) for 45 minutes as well as the release kinetic were compared with that of the enteric film coated Voltadin (R) SDI tablets. The results of this study show that, the prepared dosage forms have a good enteric property, with faster release of drug from encapsulated enteric-coated granules in comparison with compressed tablets.

Highlights

Enteric coated granules encapsulated in hard gelatin capsules as a pharmaceutical dosage form were used to get products with fast onset of absorption and better pharmacokinetic properties (1-3), since this dosage form is less influenced by food intake due to faster gastric emptying of granules after dissolving of hard gelatin shell compared with the retention o f relatively large enteric coated tablet in the stomach
The aim of this study is to investigate whether enteric-coated granules could be prepared by ordinary wet granulation method using ethanolic solution of EudragitTM L 100 as coating and granulating agent
The non-steroidal anti-inflammatory drug (NSAID) Diclofenac sodium is used as a model drug for this study

Summary

Introduction

Enteric coated granules encapsulated in hard gelatin capsules as a pharmaceutical dosage form were used to get products with fast onset of absorption and better pharmacokinetic properties (1-3), since this dosage form is less influenced by food intake due to faster gastric emptying of granules after dissolving of hard gelatin shell compared with the retention o f relatively large enteric coated tablet in the stomach.In addition, patients preferred the swallowed gelatin capsules on tablets (4).Different techniques were used to prepare enteric-coated granules or pellets, such as pan coating and fluidized bed coating apparatus (5-8).The aim of this study is to investigate whether enteric-coated granules could be prepared by ordinary wet granulation method using ethanolic solution of EudragitTM L 100 as coating and granulating agent.The non-steroidal anti-inflammatory drug (NSAID) Diclofenac sodium is used as a model drug for this study.MATERIALSand METHOD. Enteric coated granules encapsulated in hard gelatin capsules as a pharmaceutical dosage form were used to get products with fast onset of absorption and better pharmacokinetic properties (1-3), since this dosage form is less influenced by food intake due to faster gastric emptying of granules after dissolving of hard gelatin shell compared with the retention o f relatively large enteric coated tablet in the stomach. Patients preferred the swallowed gelatin capsules on tablets (4). Different techniques were used to prepare enteric-coated granules or pellets, such as pan coating and fluidized bed coating apparatus (5-8). The aim of this study is to investigate whether enteric-coated granules could be prepared by ordinary wet granulation method using ethanolic solution of EudragitTM L 100 as coating and granulating agent.

Objectives

Methods

Results