Author(s): A. R. Gawade, S. P. Boldhane


DOI: 10.5958/0974-360X.2021.00109.8   

Address: A. R. Gawade1, S. P. Boldhane2*
1Maeers Maharashtra Institute of Pharmacy, Paud Road, Kothrud, Pune 411038.
2Sr. General Manager-Formulation Development at Micro Labs Ltd., Bangalore 560001.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021

The sustained release matrix dosage type is favored to prevent blood level variations found in the Dipyridamole drug. The goal of this research was to formulate Dipyridamole's sustained release matrix tablet, Dipyridamole is a thromboembolic risk preventive drug for heart valve replacement and long-term angina pectoris treatment will be well absorbed in the stomach. Maintaining long-term therapeutic plasma concentration and increasing bioavailability by using various polymers to improve bioavailability and to minimize the dosing rate and side effects by integrating a 3-factor, 3-level Box-Behnken statistical design of surface response technique. Sustain release polymers such as HPMC K4M (X1), MCC 101 (X2), and Magnesium Stearate (X3) are the dependent variables and Independent variable is the percentage release of drug at 12 h (Y1) were determined. Response surface plots of Box-Behnken design have been drawn, quadratic models have been statistically validated and optimized formulations have been selected Based on grid search and feasibility. The physical evaluation, drug content and % drug release tests were conducted on all the 13 box Behnken design runs. Zero order, first order, Higuchi, and Korsemayer-peppas in terms of r2 and n-value were generated using various release kinetic models and equations. The response surface plots showed high degree of prediction. The desired batch depicted a steady and sustained release from the confirmatory runs (best fit model– Higuchi model (n=0.9862). Hence, the bioavailability of Dipyridamole cocrystal sustained release matrix tablets was increased using response surface designs.

Cite this article:
A. R. Gawade, S. P. Boldhane. Development and Evaluation of Dipyridamole matrix tablets using Response Surface Methodology. Research J. Pharm. and Tech. 2021; 14(2):610-616. doi: 10.5958/0974-360X.2021.00109.8

A. R. Gawade, S. P. Boldhane. Development and Evaluation of Dipyridamole matrix tablets using Response Surface Methodology. Research J. Pharm. and Tech. 2021; 14(2):610-616. doi: 10.5958/0974-360X.2021.00109.8   Available on:

1.    Chakrabarti S et al, Dipyridamole, cerebrovascular disease and the vasculature. Vascul Pharmacol. 2008; 48: 143–9.
2.    Adimulapu Anilkumar et al “Development of pH Independent Drug Release System for Dipyridamole’ Indian Journal of Pharmaceutical Education and Research. 2018; 52 (3) : 374-380.
3.    Zhang Z et al. Design and evaluation of a novel floating osmotic pump system. J Pharm Sci. 2009; 12: 129–37.
4.    Kincl, M et al, Application of experimental design methodology (DOE) in development and optimization of drug release method, Int J Pharm. 2005; 291: 39-49.
5.    Harekrishna Roy et al,, Box-Behnken Design for Optimization of Formulation Variables for Fast Dissolving Tablet of Urapidil, Asian Journal of Pharmaceutics. 2018;12 (3): 947-954.
6.    Suresh Kumar S et al, Analytical Method Development and Validation for Dipyridamole, Asian Journal of pharmaceutical research and health care. 2010; 2 (4): 333-338.
7.    Guo F, et al. Self-microemulsifying drug delivery system for improved oral bioavailability of dipyridamole: preparation and evaluation. Arch Pharm Res. 2011; 34: 1113–23.
8.    Birajdar Shivprasad et al, development and evaluation of floating-mucoadhesive dipyridamole tablet, Asian journal of pharmaceutical research and health care. 2016; 4 (3):78-89.
9.    Gandhi, C.K. et al, Box-Behnken Design for Optimization of Formulation Variables of Tramadol HCl Sustained Release Matrix Tablet, International Journal for Pharmaceutical Research Scholars (IJPRS). 2012; 1(2) : 99-114.
10.    Kambham Venkateswarlu, et al, Development and Statistical Optimization of Sustained Release Gastro Retentive Floating Tablets of Cephalexin, Marmara Pharmaceutical Journal. 2016; 20: 172-183.
11.    Harshil P. et al, ‘Quality by Design enabled Development and Optimization of Gastro retentive Floating Matrix Tablets of Dipyridamole’, Asian Journal of Pharmaceutics. 2017; 11 (2) S38.
12.    Vanshiv S. D et al, Formulation and Development of Gastro retentive Dipyridamole Microspheres: Proof of Concept by In vitro-In vivo Assessment, Indian J Pharm Sci. 2018; 80(1):181-191.
13.    Viridena A, et al, Investigation of critical polymer properties for polymer release and swelling of HPMC matrix tablets. Eur J Pharm Sci. 2009; 36, 297-309.
14.    Yasunori Miyazaki et al, Application of Response Surface Methodology to Estimate the Design Space of Pharmaceutical Diluents for Dispensing Powdered Formulations , Chem. Pharm. Bull. 2016; 64: 1698–1706.
15.    Prabakaran L et al, Hydrophilic polymers matrix systems of Nifedipine sustained release matrix tablets: Formulation optimization by Response Surface Method (Box-Behnken technique), Der Pharmacia Sinica. 2010; 1 (1): 147-165.
16.    Komarala, E. P. et al, Studies on drug release kinetics and antibacterial activity against drug-resistant bacteria of cefotaxime sodium loaded layered double hydroxide–fenugreek Nano hybrid. New Journal of Chemistry. 2018; 42(1): 129–136.
17.    ICH Q1A (R2): Stability testing of new drug substances and products ( MEDIA419.pdf)
18.    Huiming Jiang et al, ’Formulation and evaluation of gastro retentive floating drug delivery system of dipyridamole’, Drug development and pharmaceutical industry. 2014; Early Online: 1–7.
19.    M. Naga Ganesh et al, Development of Highly Porous Gastro retentive Dipyridamole Tablets Using a Sublimation Method, Indo American. Journal of Pharmaceutical Sciences. 2016; 3(6): 662-671.
20.    Yoshiki Kojo et al, Improved Dissolution of Dipyridamole with the Combination of pH-Modifier and Solid Dispersion Technology Chem. Pharm. Bull. 2017; 65: 426–431.
21.    Dorota Wójcik-Pastuszka et al, Evaluation of the Release Kinetics of a Pharmacologically Active Substance from Model Intra-Articular Implants Replacing the Cruciate Ligaments of the Knee, Materials. 2019; 12: 1-13.
22.    M Himankar Baishya, et al, Application of Mathematical Models in Drug Release Kinetics of Carbidopa and Levodopa ER Tablets, Journal of Developing Drugs. 2017; 6(2):171-178.

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