Fundamental Evaluation Of Multi -Layered Tablet of Divalproex Sodium
Keywords:
Pharmacopoeial Specification, Release Layer, Divalproex SodiumAbstract
The optimized immediate release layer (IF6) with highest in vitro release of 98.11 was selected for bi-layered tablet formulation. HPMC K4M and HPMC K100M polymer used to retard the drug release from sustained release layer in different proportion and combination and evaluated for physical parameter along with in vitro drug release studies.. The optimized sustained releaselayer (SF8) which extends the Divalproex sodium release more than 18 hrs was selected. In vitro drug release studies were performed using USP type II apparatus (paddle method) in 900 ml of phosphate buffer pH 6.8 at 100 rpm. Finally Bi-layered tablets were prepared by double compression of selected sustained release layer and immediate release layer of Divalproex sodium. The tablets were evaluated for hardness, thickness, weight variation, friability, drug content uniformity and in vitro drug release. All the physical parameters were in acceptable limit of pharmacopeial specification. The stability studies, shown the bi-layer tablet was stable at 40⁰C/ 75% RH for a period of 3 months.
References
Notari, R., Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 3rd Ed., Marcel Dekker Inc., New York, 1980, pp.152-54.
Vinay K, Prajapati S.K., Girish C.S., Mahendra S., Neeraj K. Sustained release matrix type drug delivery system. IRJP. 2012; 1(3): 934-60.
Kumar V., Sharma A., Sharma A., Joshi G., Dhillon V. Recent advances in novel drug delivery system for delivery of anti-hypertensive drugs. Int J D D Res. 2011; 3(1): 252-59.
Basu B., Bagadiya A., Makwana S., Vipul V., Batt D., Dharamsi A. Formulation and evaluation of fast dissolving tablets of cinnarizine using superdisintegrant blends and subliming material. J Adv Pharm Technol Res. 2011; 2(4): 266-73.
http://www.pharmacopeia.cn/v29240/USP29nf24s0-c115/587.htm/
The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, 2014; Vol. II: 959.
Pahade A.A., Jadhav V.M., Kadam V.J. Formulation and development of a bilayer sustained release tablet of isosorbide mononitrate. Int J Pharma Bio Sci. 2010; 1(4): 305-14.
Sahoo P.K. Pharmaceutical Technology: Tablets. New Delhi, 2007, pp.2-3.
The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, 2014; Vol. II: 960-61.
Sandeep N., Gupta M.M. Immediate drug release dosage form: A review. J Drug Delivery & Therapeutics. 2013; 3(2): 155-61.
Pahwa R., Gupta N. A review: Superdisintegrants in the development of orally disintegrating tablets. Int J Pharm Sci Res. 2011; 2(11): 2767-2780.
Patel U., Patel K., Shah D., Shah R. A review on immediate release drug delivery system. Int J Pharm Res Bio-Sci. 2012; 1(5): 37-66.
Chugh I., Seth N., Rana A.C. Oral sustained release drug delivery system. Int Res J Pharm. 2012; 3(5): 57-62.
Gennaro A.R. (Ed.). Remington’s Pharmaceutical Science. 20th Edn., Lippincott Williams and Wilkins Publishing Co., New York. 2000; 1: 905-06.
Kumar K.P.S., Bhowmik D., Chiranjib, Chandira M., Tripathi K.K. Innovations in sustained release drug delivery system and its market opportunities. J Chem Pharm Res. 2010; 2(1): 349-360.
Singh A., Sharma R., Jamil F. Sustained release drug delivery system: A review. Int Res J Pharm. 2012; 3(9): 21-24.
Patel H., Panchal D.R., Patel U., Brahmbhatt T., Suthar M. Matrix type drug delivery system: A review. J Pharmaceut Sci Bio-Sci Res (JPSBR). 2011; 1(3): 143-51.
Reddy P., Rao D., Kumar R.K. Bi-layer technology – An emerging trend: A review. Int J Res Dev Pharm Life Sci. 2013; 2(3): 404-11.
Gopinath C., Bindu V.H., Nischala M. An overview on bi-layered tablet technology. J Glob Trends Pharm Sci. 2013; 4(2): 1077-85.
Jamunadhevi V., Sahoo P.K., Kailasam P. Formulation and in vitro evaluation of bi-layer tablet of cyclobenzaprine hydrochloride ER and diclofenac potassium IR – A novel fixed dose combination. Int J Res Pharm Sci. 2011; 2(2): 170-78.
Kumar A.H., Kavitha K., Kumar S.A.K., Kumar M.R., Singh S.D.J. Novel approach of bilayer tablet technology – A review. Int J Pharm Chem Bio Sci. 2013; 3(3): 887-93.
Debnath M. Bilayer tableting technology: An overview. J Pharm Res. 2012; 5(1): 310-14.
Divya A., Kavitha K., Kumar M.R., Dakshayani S., Singh S.D.J. Bilayer tablet technology: An overview. J Appl Pharm Sci. 2011; 1(08): 43-47.
http://en.wikipedia.org/wiki/central_nervous_system_disease
http://www.sabiosciences.com/CNS_Disorders.php
Sridharan R. Epidemiology of epilepsy. Current Sci. 2002; 82(6): 664-70.
Goodman & Gillman’s The Pharmacological Basis of Therapeutics, 11th ed., McGraw-Hill Medical Publishing Division, 2006.
Lippincott Williams & Wilkins. Lippincott’s Illustrated Reviews: Pharmacology. 4th Edn., Wolters Kluwer.
Downloads
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.