DESIGN AND CHARACTERIZATION OF DONEPEZIL HYDROCHLORIDE SUSTAINED RELEASE MATRIX TABLETS
Abstract
The ultimate aim of the present study was to develop sustained release (SR) tablets of Donepezil Hydrochloride by employing natural polymers (Guar gum and Xanthan gum) as the matrix material in different proportion by wet granulation method. Initially drug-excipients compatibility studies were carried out using FTIR and DSC which showed no interaction between drug and excipients. Granules of prepared batches were evaluated for bulk density, tapped density, carr’s index, hausner’s ratio, angle of repose. Tablets were evaluated for various physicochemical parameters like hardness, thickness, friability, weight variation test, drug content and in vitro drug release. All the formulation showed compliance with pharmacopoeial standards. 32 full factorial design was applied in which Guar gum (X1) and Xanthan gum (X2) were taken as independent factor and %CDR at 2hr (Y1) and at 12hr (Y2) were taken as response. In-vitro drug release study revealed that as the amount of polymers increased, % CDR decreased. Contour plots as well as response surface plots were constructed to show the effect of X1 and X2 on %CDR and predicted at the concentration of independent variables X1(40mg) and X2(40mg) for maximized response. The kinetic release treatment showed that korsmeyer peppas equation has shown of r2 0.9517 which was close to one indicating that the dissolution profile fits in Korsmeyer-Peppas model and the mechanism of drug release from these tablets was by non-fickian diffusion mechanism. The optimized batch was kept for stability study at 40 ± 2oC/ 75 ± 5 % RH for a period of 1 month according to ICH guidelines and found to be stable after 1 month of study.
Keywords: Sustained release matrix tablet, Donepezil hydrochloride, Guar gum, Xanthan gum, 32 full factorial design.
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References
2. Mandhar P, Joshi G, “Development of Sustained Release Drug Delivery System: A Reviewâ€, Asian Pacific Journal of Health Sciences, 2015; 2(1):179-185.
3. Sweetman SC, Martindale: the complete drug reference, 2009.
4. Deepthi PR, Prasad V, Diwan P, “Preparation and In-Vitro Evaluation of Donepezil Hydrochloride Sustained Release Matrix Tablets Using Non-Gelling Polymer†IOSR Journal of Pharmacy and Biological Sciences, 2014; 9(5):83-91.
5. Tripathi AR, Patel KN, Patel PA, Nayak BS, Shah V, “Formulation and Evaluation of Bilayer Tablets Containing L-Arginine†International Journal for Pharmaceutical Research Scholars 2015; 4(1):1-18.
6. Patel KN, Mehta TA, “Formulation Design and Characterization of an Elementary Osmotic Pump Tablet of Flurbiprofen†PDA Journal of Pharmaceutical Science and Technology, 2014; 68:333-346.
7. Gangurde H, Chordiya M, Tamizharasi S, Senthilkumaran K, and Sivakumar T, “ Formulation and Evaluation of Sustained Release Bioadhesive Tablets of Ofloxacin using 32 Factorial Design†International Journal of Pharmaceutical Investigation, 2011; 1(3):148-156.
8. Bankar A, Bankar V, Gaikwad P, and Pawar S, “Formulation Design and Optimization of Sustained Release Tablet of Ambroxol hydrochloride†International Journal of Drug Delivery, 2012; 375-385.
9. Patel J, Dhingani A, Dabhi M, Patel N, Raval M, Sheth N, “Design and Development of Sustained Release Microspheres of Quetiapine Fumarate using 32 Full Factorial Design†Journal of Pharmacy Research, 2010; 3(12):2871-2875.
10. Shailender M, “Compression Physics of Pharmaceutical Powders: A Review†International Journal of Pharmaceutical Sciences and Research, 2012; 3(6):1580-1592.
11. Gupta DK, Sharma RD, Gupta R, Tyagi S, Sharma KK, Choudhary A. “Formulation and Evaluation of Orodispersible Tablets of Salbutamol Sulphate†International Journal of Pharmaceutical Sciences and Research, 2012; 3(8):2675.
12. Costa P, Manuel J, “Modeling and Comparison of Dissolution Profiles†Journal of Pharmaceutical Sciences, 2000; 123-133.
13. ICH Guidelines Q1A (R2), Guidance for industry, stability testing of new drug substances and products, World Health Organization, WHO Technical Report Series, no. 953, 2009.
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