STUDIES IN OXCARBAZEPINE MICROSPHERES EMPLOYING PLACKETT AND BURMAN DESIGN

Authors

  • Hiral Koradia Pharmaceutics department, L. M. College of Pharmacy, Navrangpura, Ahmedabad
  • Shital Butani Pharmaceutics department, Institute of Pharmacy, Nirma University, Ahmedabad
  • Mukesh Gohel Consultant, Pharmaceutical Industry, Ahmedabad, India.

Keywords:

Microspheres, Multiple emulsion solvent evaporation technique, Modified release, Plackett Burman design

Abstract

Objective: The present work was aimed to screen material and processing parameters affecting encapsulation efficiency and drug release from microspheres.

Methods: Oxcarbazepine loaded microspheres were prepared employing multiple emulsion solvent evaporation technique. Ratio of chitosan to ethyl cellulose, ratio of drug to polymer, stirring speed, ratio of dichloromethane to methanol, amount of Span 80 and the volume of aqueous phase were selected as independent variables in the Plackett and Burman design. The microspheres were characterized for percentage yield, percentage encapsulation efficiency, particle size distribution and in vitro drug release.

Results: The critical material and processing parameters affecting encapsulation efficiency were chitosan to ethyl cellulose ratio, volume of water, stirring speed and drug to polymer ratio. Initial burst release was affected by volume of water, temperature, dichloromethane to methanol ratio, amount of Span 80 and drug to polymer ratio. FTIR study showed compatibility of the drug with excipients.

Conclusion: The outcome of the study shall be used to calculate risk priority number (RPN) and for devising suitable control strategies for the critical factors at industry.

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References

Davis SS, Illum L. Polymeric microspheres as drug carriers. Biomaterials1988;9:111-5.

Ritschel WA. Biopharmaceutics and pharmacokinetic aspects in the design of controlled release peroral drug delivery systems. Drug Development and Industrial Pharmacy1989;15:1073-103.

Synowiecki J. Mycelia of Mucor rouxii as a source of chitin and chitosan. Food Chem1997;60:605-10.

Roberts GAF. Chitin Chemistry:Macmillan Publishers Limited;1992.

Kas HS. Chitosan:properties, preparation and application to microparticulate systems. Journal of Microencapsulation1997;14:689-711.

Lehr CM, Buwstra JA, Schacht EH, Junginger HE. In vitro evaluation of mucoadhesive properties of chitosan and some other natural polymers. International Journal of Pharmaceutics1992;78:43-8.

LueBen HL, Lehr CM, Rentel CO, Noach ABJ, Boer AGD, Verhoef JC, et al. Bioadhesive polymers for the peroral delivery of peptide drugs. Journal of Controlled Release1994;29:329-38.

Kurita S. Controlled functionalization of the polysaccharide chitin. Polymer Science2001;26:1921-71.

Eldridge JH, Hammond CJ, Meulbroek JA, Staas JK, Gilley RM, Tice TR. Controlled vaccine release in the gut-associated lymphoid tissues. Part I. Orally administered biodegradable microspheres target the peyer’s patches. Journal of Controlled Release 1990;11:205-14.

Akbuga. Furosemide-loaded ethyl cellulose microspheres prepared by spherical crystallization technique:morphology and release characteristics. International Journal of Pharmaceutics1991;76:193-8.

Hyppola R, Husson, Isabelle, Sundholm, Franciska. Evaluation of physical properties of plasticized ethyl cellulose films cast from ethanol solution Part I. International Journal of Pharmaceutics1996;133:161-70.

Bhatt, inventor Supernus pharmaceuticals, assignee. Modified release preparations containing oxcarbazepine and derivatives thereof patent US 8,017,149 B2. 2011 Sep 13.

Murray J. Statistical Experimentation Design, Data Analysis and Nonlinear Optimisation. New York:John Wiley and Sons;1994.

Alonso MJ, Cran LP, Lorenzo-Lamosa ML, Vila-Jato JL. Development of new chitosan–cellulose multicore microparticles for controlled drug delivery. European Journal of Pharmaceutics and Biopharmaceutics1998;45 49-56.

El-Kamel AH, Sokar MS, Al-Gamal SS, Naggar VF. Preparation and evaluation of ketoprofen floating oral delivery system. International Journal of Pharmaceutics2001;220(1-2):13-21.

Basavaiah K, Rajendraprasad N, Cijo MX, Vinay KB and Ramesh PJ. Development and validation of stability indicating spectrophotometric methods for determination of oxcarbazepine in pharmaceuticals. Journal of science and industrial research2011;70:346-51.

Gilberto CH and Leticia CA. Differences in the dissolution profile, suggesting a lower oral bioavailability, of a novel formulation of oxcarbazepine (actinium®) compared with the innovator product (Trileptal®) Proc West Pharmacol Soc2006;49:83-5.

Martin A, Bustamante P, Chun AHC. Physical Pharmacy. New Delhi:BI Waverly Pvt. Ltd;1996.

19.Lorenzo-Lamosa ML, Remunan-Lopez C, Vila-Jato JL, Alonso MJ. Design of microencapsulated chitosan microspheres for colonic drug delivery Journal of Controlled Release 1998; 52:109-18.

Jkrome R, Schugens CH, Laruelle N, Nihant N, Grandfils CH, Teyssie PH. Effect of the emulsion stability on the mo~hology and porosity of semicrystalline poly I-lactide microparticles prepared by w/o/w double emulsion-evaporation Journal of Controlled Release 1994;32:161-I76.

Hernádez RM, Igartua M, Gascón AR, Calvo MB, Pedraz JL. Influence of shaking and surfactants on the release of bsa from plga microspheres. European Journal of Drug Metabolism and Pharmacokinetics1998;23(2):92-6.

Yang YY, Chia CH, Chung TS. Effect of preparation temperature on the characteristics and release profiles of PLGA microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. Journal of Controlled Release 2000;69(1):81-96.

Rao KR, Das Mk. Evaluation of zidovudine encapsulated ethylcellulose microspheres prepared by water-in-oil-in-oil (w/o/o) double emulsion solvent diffusion technique. Acta Poloniae Pharmaceutica-Drug Research2006;63(2):141-8.

Ravi, Peh KK, Darwis Y, Krishna Murthy B, Raghu Raj Singh T, and Mallikarjun C. Development and characterization of polymeric microspheres for controlled release protein loaded drug delivery system. Indian Journal of Pharmaceutical Sciences2008;70(3):303-9.

Chopra S, Patil GV, Motwani SK. Release modulating hydrophilic matrix system of losartan potassium:optimisation of formulation using statistical experimental design. European Journal of Pharmaceutics and Biopharmaceutics2007;66:73-82.

Rane YM, Mashru RC, Sankalia MG, Sutariya VB, Shah PP. Investigations on factors affecting chitosan for dissolution enhancement of oxcarbazepine by spray dried microcrystal formulation with an experimental design approach. Drug Development and Industrial Pharmacy2007;33(9):1008-23.

Silva CM, Ribeiro AJ, Figueiredo IV, Goncalves AR, Veiga F. Alginate microspheres prepared by internal gelation: Development and effect on insulin stability. International Journal of Pharmaceutics2006;311:1-10

Published

01-07-2014

How to Cite

Koradia, H., S. Butani, and M. Gohel. “STUDIES IN OXCARBAZEPINE MICROSPHERES EMPLOYING PLACKETT AND BURMAN DESIGN”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 7, July 2014, pp. 305-10, https://journals.innovareacademics.in/index.php/ijpps/article/view/1738.

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