DEVELOPMENT OF COATED MESALAMINE PELLET FOR COLON DELIVERY USING ACRYL-EZE® AND OPTIMIZATION OF COATING USING FLUID BED DRYER
Mesalamine is anti inflammatory drug that widely used in the treatment of ulcerative colitis. Mesalamine is well absorbed in upper GIT. The aim of this research was to develop a mesalamine enteric-coated pellets which targeted to release the drug in colon and prevent premature release in upper GIT....
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/78944 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Mesalamine is anti inflammatory drug that widely used in the treatment of ulcerative colitis. Mesalamine is well absorbed in upper GIT. The aim of this research was to develop a mesalamine enteric-coated pellets which targeted to release the drug in colon and prevent premature release in upper GIT. Mesalamine pellets were prepared by wet granulation method, extrusion, and spheronization. Pellets were firstly coated with Pharmacoat@603 as a seal—coat, which then followed by application of Acryl-Eze as an enteric coating. Optimization of coating process using FBD was performed involving fillet temperature, peristaltic to deliver the solvent, and ratio of spraying and drying time. Pellets were evaluated for particle size distribution, friability, mesalamine content, weight gain, and drug release profile. Dissolution of mesalamine were performed using type 3 dissolution equipment in three different media; HCI 0.1 N, phosphate buffer pH 6.8 and 7.4, respectively. Pellets with particle size between 630-1180 um was selected to be coated. Results showed that the pellets have a friability of 0.13% and ercent recovery of mesalamine was 103.27 1.10%. Seal coat of Pharmacoat 603 and EC of Acryl-Eze with weight gain of 9.83% and 16.42%, respectively, showed the release of mesalamin in acid media for 2 hours was 4.51 ± 0.76%. And cumulative release in phosphate buffer pH 6.8 in 3 hours was 54.51 ± 1.96%, and in phosphate buffer pH 7.4 for 3 hours Was 99.61 ± 1.92%. Coating effiency using FBD equipment was 20-25% for SC Pharmacoat@603 and 20-30% for EC Acryl-Eze , respectively. Formulation of delayed release of mesalamine pellets prevented drug release in gastric fluid and optimized mesalamine release in the colon. Improvement is still needed to obtain a better coating efficiency with FBD equipment.
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