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Journal of Pharmaceutical Research

Article

Formulation Development and Evaluation of Simvastatin Sustained Release Tablets
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Journal of Pharmaceutical Research

Year: 2017, Volume: 16, Issue: 4, Pages: 297-306

Original Article

Formulation Development and Evaluation of Simvastatin Sustained Release Tablets

Abstract

Purpose: The main objective of present research investigation is to formulate the sustained release tablet of Simvastatin using 32 factorial design. Simvastatin, an antihyperlipidemic agent, belongs BCS class-II agent. Methods: The SR tablets of Simvastatin were prepared employing different concentrations of HPMCK4M and SCMC in different combinations by wet granulation technique using 32 factorial design. The concentration of Polymers, HPMCK4M and SCMC required to achieve the desired drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables. Results and Discussion: Totally nine formulations were designed and are evaluated for hardness, friability, thickness, % drug content, In-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the Invitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F4) containing combination of 17.5% HPMCK4M and 30% SCMC, is the most similar formulation (similarity factor f2= 89.652, dissimilarity factor f1= 1.6424 & No significant difference, t= 0.00558) to marketed product (ZOCOR). Conclusion: The selected formulation (F4) follows Zero order, Higuchi's kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.963).

References

  • Swati Jain, Neelesh Kumar Mehra, Akhlesh Kumar Singhai and Gaurav Kant Saraogi.Development and evaluation of sustained release matrix tablet of lamivudine. International Journal of Pharmaceutical Sciences and Research, 2011;2(1): 454-461.
  • R. Ruben Singh. Design, Formulation And In Vitro Evaluation Of Lamivudine Hcl Sustained Release Tablets. International Journal of Research in Pharmaceutical and Nano Sciences, 2014; 3(2): 113 � 121.
  • Raghavendra Kumar Gunda, J. N. Suresh Kumar, Ch Ajay Babu and M. V. Anjaneyulu. Formulation Development and Evaluation of Lamotrigine Sustained Release Tablets Using 32 Factorial Design, International Journal of Pharmaceutical Sciences and Research, 2015; 6(4): 1746-1752.
  • Bankar GS, Rhodes CT. Eds. Modern Pharmaceutics. 3rd edn. Marcel Dekker, Inc. New York; 1996. p. 668-9.
  • Lachmann L, Lieberman HA, Kanig JL. The Theory & Practice of Industrial Pharmacy. Varghese Publishing House, Bombay, 3rd Edition; 1991. p. 430.
  • Raghavendra Kumar Gunda, J. N. Suresh Kumar. Formulation Development and Evaluation of Zidovudine Sustained Release Tablets Using 32 Factorial Design, Der Pharmacia Sinica, 2015, 6(6):59-67.
  • J. N. Suresh Kumar, B. Satyaprasad, Gunji. Venkateswarlu, Chandan Kumar Brahma and Raghavendra Kumar Gunda, Formulation Development and Evaluation of Metoprolol Succinate Sustained Release Tablets Using 32 Factorial Design, Der Pharmacia Lettre, 2015, 7 (7):148-157.
  • Raghavendra Kumar Gunda, Formulation Development and Evaluation of Rosiglitazone Maleate Sustained Release Tablets Using 32 Factorial Design, International Journal of PharmTech Research, 2015, Vol.8(4): 713-724.
  • Raghavendra Kumar Gunda, J. N. Suresh Kumar, Chandan Kumar Brahma, Satyanarayana Viragandham, Design, Formulation and Evaluation of Lamivudine Controlled Release Tablets, Pharmaceutical and Biological Evaluations, 2015; 2(4): 110-121.
  • Prakash P, Porwal M, Saxena A. Role of natural polymers in sustained release drug delivery system:application and recent approaches. Int Res J of Pharmacy 2011;2(9):6-11.
  • Raghavendra Kumar Gunda, J. N. Suresh Kumar, Chandan Kumar Brahma, V. Satyanarayana, K. Naga Prashant. Design, Formulation and Evaluation of Atenolol Gastro Retentive Floating Tablets. Asian Journal of Pharmaceutics, 2015; 9 (4) (Suppl): S34-S42.
  • Rhodes C.T., Robinson J.R., Sustained and controlled drug delivery system; In Banker GS, editor, Modern Pharmaceutics, 4th ed., USA:Marcel Dekker.2003; pp 503-505.
  • Raghavendra Kumar Gunda, J.N.Suresh Kumar, V. Satyanarayana, K. V.Ramananjaneyulu, B.satyprasad. Formulation Development and Evaluation of Carvedilol Phopsphate Gastro Retentive Floating Tablets. International Research Journal of Pharmacy , 2016;7(1): 44-51.
  • Raghavendra Kumar Gunda, J .N. Suresh Kumar, V Satyanarayana, G Swarupa Rani, G Venkateswarlu. Formulation Design, Optimization and Evaluation of Carvedilol Phosphate Gastro Retentive Floating Tablets. Current Research in Pharmaceutical Sciences 2015; 05 (04): 124-135.
  • A. A. Kharia, S. N. Hiremath, a. K. Singhai, l. K. Omray and s. K. Jain. Design and Optimization of Floating Drug Delivery System of Acyclovir, Indian J. Pharm. Sci., 2010, 72 (5): 599-606.
  • Raghavendra Kumar Gunda, J. N. Suresh Kumar, V. Satyanarayana, Ameer Pasha S. K, Swathi Batta . Formulation design, optimization and evaluation of domperidone maleate gastro retentive floating tablets. Der Pharmacia Lettre, 2016, 8 (4):198-207.
  • D. Hasanthi, J. N. Suresh Kumar. Formulation and evaluation of sustained release buccal tablets of simvastatin for unidirectional release. International Journal of Research in Pharmaceutical and Nano Sciences. 2(6), 2013, 704 - 713.
  • Higuchi T. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci 1963; 51:1145-9.
  • Peppas NA. Analysis of Fickian and non-Fickian drug release from polymers. Pharm Acta Helv 1985; 60:110-1.
  • Dortunc B, Gunal N. Release of acetazolamide from swellable HPMC matrix tablets. Drug Dev Ind Pharm 1997; 23:1245-9.

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