Oral lipid based multiparticulate pastilles: design and effect of pore former
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The purpose of this research work was to design and develop droplet solidification apparatus for lipid based pastilles. Oral lipid based multiparticulate pastilles of solid lipid glycerol monostearate were formulated to control the release of highly water soluble drug metoprolol succinate. The apparatus was optimized at 14G needle size and metallic surface base plate cooled at 4 °C. Pastilles were evaluated for their size, shape, contact angle, density, flow properties, friability, crushing strength, drug content, thermal properties, in vitro and in vivo drug release. Pastilles were hemispherical in shape of size 3.1–4.3 mm. Contact angle was found to be more than 120°. Drug release was controlled for 8 h. Scanning electron microscopy study revealed the smooth external surface with pores to ingress dissolution media to enhance the drug release rate. Increased quantity of pore former enhanced the dissolution rate. Other operating variables like contact angle and height of needle from base plate were found to affect the size of pastilles. The dissolution of optimized batch of pastilles was best fitted to first order kinetic model. In vivo pharmacokinetic study showed correlation with in vitro drug release profile.
KeywordsPastille Pellet Solid lipid glycerol monostearate Pore former Contact angle Crushing strength
This article does not contain any studies with human and animal subjects performed by any of the authors. All authors (A. P. Pandit, G. Divase, T. Chavan, K. Khandelwal) declare that they have no conflict of interest. The authors are thankful to Mylan Laboratories Limited, Nasik, India for providing metoprolol succinate as gift sample. The authors are also grateful to Dr. S. S. Ambavade for his support for in vivo study and Dr. V. P. Chaudhari for guiding on analysis of plasma. Thanks are extended to Principal and Management of Rajarshi Shahu College of Pharmacy and Research, Tathawade, Pune, India.
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