Development of Extended Release Formulations of Ilaprazole Tablets
Abstract
Extended release products are designed to release their medication in a controlled manner at a predetermined rate, duration, and location to achieve and maintain optimum therapeutic blood levels of a drug. The objective of the study is to formulate and evaluate Ilaprazole Controlled release tablets comparable to the innovator product. F1-F9 formulations were prepared using varying concentrations of super disintegrates like Crospovidone, Croscarmellose sodium and Sodium starch glycolate in different concentrations. Based on the hardness, friability, weight variation, drug content, F6 formulation was found to be optimised. The selected F6 formulation was sub coated with HPMC P 50 and followed by enteric coating with Acryl-EZE-80 (Eudragit L100-55). 3 formulations (F10-F12) were prepared by using coating. Among the three formulations, F11 formulation was found to be best. FTIR studies were carried out to find out drug and excipient compatibility studies, the studies revealed that there were no interactions. DSC studies also carried out to demonstrate any changes in physical forms of the drug molecule.
Keywords: Ilaprazole, Extended release tablets, Crospovidone, Croscarmellose sodium, Sodium starch glycolate, HPMC P 50, Acryl-EZE-80.
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2. Dashevsky A, Kolter K, Bodmeier R. PH-independent release of a basic drug from pellets coated with the extended release polymer dispersion Kollicoat SR 30 D and the enteric polymer dispersion Kollicoat MAE 30 DP, Eur. J. Pharm. Biopharm, 2004; 58:45-49.
3. Hashmat D, Shoaib MH, Mehmood ZA, Bushra R, Yousuf RI, Lakhani FM. Development of Enteric Coated Flurbiprofen Tablets using Opadry /acryl-eze System - A Technical Note, AAPS Pharm. Sci. Tech., 2008; 9(1):116-21.
4. Kaniwa N, Ogata H, Aoyagi N, Koibuchi M, Shibazaki T, Ejima A, Takanashi S, Kamiyama H, Suzuki H, Hinohara Y, Nakano H, Okazaki A, Fujikura T, Igusa K, Bessho S. Bioavailability of pyridoxal phosphate from enteric-coated tablets: I. Apparent critical dissolution pH and bioavailability of commercial products in humans, Chem. Pharm. Bull, 1985; 33:4045-49.
5. Kranz H, Gutsche S. Evaluation of the drug release patterns and long term stability of aqueous and organic coated pellets by using blends of enteric and gastrointestinal insoluble polymers, Int. J. Pharm, 2009; 380:112–19.
6. Lee DAH, Taylor GM, Walker JG, James VHT, The effect of food and tablet formulation on plasma prednisolone levels following administration of enteric- coated tablets, Br. J. Clin. Pharmacol, 1979; 7:523-528.
7. Basak S.C, Jaya kumar R.B.M, Lucas M.K, Formulation and release behaviour of sustained release Ambroxol hydrochloride HPMC matrix tablet, Indian Journal of Pharmaceutical Sciences, 2006; 68(5):594-597.
8. Surya Bhan Singh Rathore, Anshu Sharma, Ayush Garg, Dharmendra Singh Sisodiya, Formulation and evaluation of enteric coated tablet of Ilaprazole, International Current Pharmaceutical Journal, 2013; 2(7):126-130.
9. Vamshidhar Reddy D, Ambati Sambashiva Rao, Formulation and evaluation of extended release tablets of Tapentadol hydrochloride using hydrophilic-hydrophobic polymer combinations, Journal of Pharmacy Research, 2014; 8(10):1368-1374.
10. Rah man N.U, Sarfaraz M. K, Mohsin S, Naproxen release from sustained Release matrix system and effect of cellulose derivatives, Pak. J.Pharm.Sci, 2006; 19 (3):244-251.
11. Srinivasa Rao Baratam, Siramsetti Dhanalakshmi, Design and Evaluation of Zolpidem Tartrate Matrix Tablets for Extended Release Using Natural Gums and HPMC K100M, Journal of Applied Pharmaceutical Science, 2018; 8(07):072-077.
12. Roldy RK, Midovert S, Redlen S, Once daily matrix tablet of azithromycine in-vitro and in-vivo evaluation, Pharm. Sci. Tech, 2003; 4(4):55-59.
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