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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND DEVELOPMENT
Article No 08
September -2009 / Volume -1 / Issue - 7/ Article No - 9 / Research Article
FORMULATION AND EVALUATION OF HYDRODYNAMICALLY BALANCED SYSTEM OF CIPROFLOXACIN HCL
Ravindra J. Salunke*1, Sadhana R. Shahi1,
Sandeep C. Atram1,
Gajendra B. Neb1, Sandeep Patil1.
September -2009 / Volume -1 / Issue - 7/ Article No - 9 / Research Article
FORMULATION AND EVALUATION OF HYDRODYNAMICALLY BALANCED SYSTEM OF CIPROFLOXACIN HCL
Ravindra J. Salunke*1, Sadhana R. Shahi1,
Sandeep C. Atram1,
Gajendra B. Neb1, Sandeep Patil1.
Mr.Salunke Ravindra
1 Department of Pharmaceutics, Govt. College of Pharmacy, Aurangabad-431001. Maharashtra.
Email : salunke1ravindra@yahoo.co.in
Email : salunke1ravindra@yahoo.co.in
ABSTRACT
The objective of the current study was to develop and optimize a Hydrodynamically balanced system of ciprofloxacin HCL as a single unit capsules using response surface methodology. Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the small intestine. A 32 full factorial design was employed to optimize the formulation wherein hydroxylpropyl methyl cellulose K4M (HPMC K4M) (X1) and Carbopol 934 (X2) were taken as independent variables and amount of drug release after 12 hrs (Y1), t50 (Y2), and t85 (Y3) were taken as the dependent variables. The capsules were prepared by physical blending of drug and the polymers in varying ratios. The release data were evaluated by the model-dependent (curve fitting) method using the PCP Disso v2.08 software. Optimization studies were carried out using the Design Expert Software (Version 7.1.6). Formulations were evaluated for in vitro buoyancy and in vitro release studies. The in vitro drug release followed zero order kinetics and the drug release mechanism was found to be anomalous or non-fickian type. It was found that both HPMC and Carbopol and their interaction had significant impact on the release and floating properties of the delivery system. The similarity factor f2 was found to be 62.32 for the developed formulation indicating the release was similar to that of the marketed formulation (Cifran). Thus, a combination of HPMC K4M and Carbopol 934 can be used to increase the gastric residence time and drug release for a period of 12 hrs.
Keywords: Hydrodynamically balanced system, HPMC K4M, carbopol 934, 32 factorial design
The objective of the current study was to develop and optimize a Hydrodynamically balanced system of ciprofloxacin HCL as a single unit capsules using response surface methodology. Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the small intestine. A 32 full factorial design was employed to optimize the formulation wherein hydroxylpropyl methyl cellulose K4M (HPMC K4M) (X1) and Carbopol 934 (X2) were taken as independent variables and amount of drug release after 12 hrs (Y1), t50 (Y2), and t85 (Y3) were taken as the dependent variables. The capsules were prepared by physical blending of drug and the polymers in varying ratios. The release data were evaluated by the model-dependent (curve fitting) method using the PCP Disso v2.08 software. Optimization studies were carried out using the Design Expert Software (Version 7.1.6). Formulations were evaluated for in vitro buoyancy and in vitro release studies. The in vitro drug release followed zero order kinetics and the drug release mechanism was found to be anomalous or non-fickian type. It was found that both HPMC and Carbopol and their interaction had significant impact on the release and floating properties of the delivery system. The similarity factor f2 was found to be 62.32 for the developed formulation indicating the release was similar to that of the marketed formulation (Cifran). Thus, a combination of HPMC K4M and Carbopol 934 can be used to increase the gastric residence time and drug release for a period of 12 hrs.
Keywords: Hydrodynamically balanced system, HPMC K4M, carbopol 934, 32 factorial design
