Abstract
A method for developing sustained release multiple unit dosage form consisting of pellets of a proteolytic enzyme blend using extrusion spheronization as a process is demonstrated in this paper. Effect of Cellulose and Methacrylate based polymers and plasticizers on stability of the enzyme blend are determined. The effect of type & concentration of the sustained release polymer, spheronization rpm and plasticizer on the yield & sphericity of pellets is studied. The results indicated that the SR pellets could be formulated for this enzyme blend using both HPMC K15 and EUDRAGIT® RSPO. The best rpm for spheronization turned out to be 1200 rpm. Use of plasticizer improved yield and sphericity. Triethyl citrate was better over polyethylene glycol 400 and EUDRAGIT® RSPO was better over HPMC K15 with respect to yield and sphericity of pellets. The pellets could be suitably enteric coated for protection of enzyme blend in lower pH of GIT. The in vitro release profile indicated release extension could be extended up to 12 hours in intestinal condition postulating to an acceptable bioavaliablity in vivo.
Keywords: Pellets, Sustained release, EUDRAGIT® L 100, –, 55, Proteolytic Enzymes, Enteric Coating, HPMC K15, EUDRAGIT® RSPO
Current Drug Delivery
Title: Designing, Optimisation & Characterization of Sustained Release Matrix Pellets Prepared by Extrusion Spheronization Containing Mixture of Proteolytic Enzymes
Volume: 5 Issue: 4
Author(s): Amit Ashok Chivate and Sushilkumar Sharatchandra Poddar
Affiliation:
Keywords: Pellets, Sustained release, EUDRAGIT® L 100, –, 55, Proteolytic Enzymes, Enteric Coating, HPMC K15, EUDRAGIT® RSPO
Abstract: A method for developing sustained release multiple unit dosage form consisting of pellets of a proteolytic enzyme blend using extrusion spheronization as a process is demonstrated in this paper. Effect of Cellulose and Methacrylate based polymers and plasticizers on stability of the enzyme blend are determined. The effect of type & concentration of the sustained release polymer, spheronization rpm and plasticizer on the yield & sphericity of pellets is studied. The results indicated that the SR pellets could be formulated for this enzyme blend using both HPMC K15 and EUDRAGIT® RSPO. The best rpm for spheronization turned out to be 1200 rpm. Use of plasticizer improved yield and sphericity. Triethyl citrate was better over polyethylene glycol 400 and EUDRAGIT® RSPO was better over HPMC K15 with respect to yield and sphericity of pellets. The pellets could be suitably enteric coated for protection of enzyme blend in lower pH of GIT. The in vitro release profile indicated release extension could be extended up to 12 hours in intestinal condition postulating to an acceptable bioavaliablity in vivo.
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Chivate Ashok Amit and Poddar Sharatchandra Sushilkumar, Designing, Optimisation & Characterization of Sustained Release Matrix Pellets Prepared by Extrusion Spheronization Containing Mixture of Proteolytic Enzymes, Current Drug Delivery 2008; 5 (4) . https://dx.doi.org/10.2174/156720108785914989
DOI https://dx.doi.org/10.2174/156720108785914989 |
Print ISSN 1567-2018 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5704 |
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