International Journal of Medical Laboratory Research (IJMLR)

DEVELOPMENT OF CONTROLLED RELEASE FORMULATIONS OF DEXLANSOPRAZOLE TO IMPROVE BIOAVAILABILITY

 

M. Sai Vishnu, K. Deepika, A. Lakshmana Rao

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Abstract: The present work was aimed to development of controlled release formulations of Dexlansoprazole to improve bioavailability. Dexlansoprazole is the proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step in acid production, thus reducing gastric acidity. Construction of calibration curve of Dexlansoprazole and to investigate the drug and polymer interaction studies by FTIR and DSC. To prepare the different controlled release formulations of Dexlansoprazole tablets with different polymers such as acrylic acid polymer such as Carbopol-974P, HPMC grades for prevalence HPMC-K4M, HPMC-K15M, HPMC-K100M, Natural Polymers akin to Xanthan gum, Guar gum, Sodium Carboxy Methyl Cellulose, and Pectin by Direct Compression method. Evaluation of Dexlansoprazole pre compression parameters such as Bulk density, Tapped density, Hausner’s ratio, Carr’s index, Angle of repose. Evaluation of post-compression parameters of Dexlansoprazole controlled release tablets such as Weight variation, Hardness, Friability test, Thickness, Drug Content and In-vitro dissolution studies. Evaluation of in-vitro dissolution uniqueness of all the formulations of Dexlansoprazole by using USP dissolution apparatus type-II (paddle). To study the mechanism of drug dissolution by applying kinetic parameters. To perform the stability studies of optimized formulations of Dexlansoprazole as per ICH guidelines.

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KEYWORDS: Dexlansoprazole, Carbopol-974P, HPMC-K4M, HPMC-K15M, HPMC-K100M, Xanthan gum, Guar gum, Sodium Carboxy Methyl Cellulose, and Pectin.

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REFERENCES:​

1. Joseph Robinson and Vincent H. L. Lee. Controlled drug delivery Fundamentals and applications. Marcel Dekker Inc; New York, 1987, 2nd edition: 3-59.

2. Gilbert S. Banker. Sustained and Controlled release drug-delivery systems. In Modern Pharmaceutics, Marcel Dekker, New York, 2002, 4th Edition: 501, 505-514.

3. Jain N.K. Controlled and Novel Drug Delivery. New Delhi, CBS, 1997, 1st edition: 1-26.

4. Loyd V. Allen and Howard C. Ansel. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Wolters Kluwer, 2014, 10th edition: 263-298.

5. Yie W. Chien. Novel Drug Delivery Systems. Marcel Dekker Inc; New York, 2007, 2nd edition: 139-196.

6. Leon Lachman, Herbert A. Lieberman and Joseph L. Kanig. The Theory and Practice of Industrial Pharmacy. CBS publications, 2009: 430-456.

7. Niyaz S. Mansuri, Punit B. Parejiya and Moinuddin M Soniwala. Glimpse of Drug Delivery Systems for Proton Pump Inhibitors. Int. J. Pharm. Sci. Rev. Res, 2016, 36(1): 81-88.

8. Rajesh Kumar P, Doddayya H and Rajendra Reddy S. Enteric coated tablets of novel proton pump inhibitor with super disintegrants design, in-vitro evaluation and stability studies. Journal of Applied Pharmaceutical Science, 2011, 01 (06): 106-111.

9. Mohan Varma M and Santosh Kumar M. Formulation and Evaluation of Matrix Tablets of Ropinirole Hydrochloride for Oral Controlled Release. Indian Journal of Pharmacy and Pharmacology, 2015, 2 (1): 27-42.

10. Buchi N. Nalluri, Jyotheermayi D, Anusha D and Maheswari K.M. Controlled release tablet formulations of carvedilol. Journal of Chemical and Pharmaceutical Research, 2012, 4(9): 4266-4274.

11. Shashidhar Reddy D and Prakash Rao B. Development and in Vitro-in Vivo Evaluation of CR Matrix Tablets of Desvenlafaxine. Pharmacology & Pharmacy, 2012, 3: 15-19.

12. Gowda D.V, Aravind Ram A.S, Venkatesh M.P and Khan S. Development and evaluation of Clozapine pellets for controlled release. International Journal of Research in Ayurveda and Pharmacy, 2012, 3(4): 611-618.

13. Shajahan Abdul and Poddar S.S. A flexible technology for modified release of drugs: multi layered tablets. Journal of Controlled Release, 2004, 97: 393- 405.

14. Gul Majid Khan and Zhu Jiabi. Formulation and in-vitro evaluation of ibuprofen-carbopol974P-NF controlled release matrix tablets influence of co-excipients on release rate of the drug. Journal of Controlled Release, 1998, 54: 185-190.

15. Ranendra Narayan Saha, Punna Rao Ravi and Sindhura Ganga. Design and Study of Lamivudine Oral Controlled Release Tablets. AAPS Pharm SciTech, 2007, 8 (4): E1-E9.

16. Sellappan V, Aswani M and Veerabhadra Rao P. Design and evaluation of torsemide controlled release matrix tablets. Asian J Pharm Clin Res, 2015,8(2): 159-163.

17. Punna Rao Ravi, Udaya Kanth Kotreka and Ranendra Narayan Saha. Controlled Release Matrix Tablets of Zidovudine: Effect of Formulation Variables on the In Vitro Drug Release Kinetics. AAPS Pharm Sci Tech, 2008, 9(1): 302-313.

18. Gohel M.C, Soni C.D, Nagori S.A and Sarvaiya K.G. Modulation of Venlafaxine Hydrochloride release from press coated matrix tablet. Indian Journal of Pharmaceutical Sciences, 2008, 70(3): 292-297.

19. Tejraj M. Aminabhavi and Udaya S. Toti. Modified guar gum matrix tablet for controlled release of diltiazem hydrochloride. Journal of Controlled Release, 2004, 95: 567– 577.

20. Yun Seok Rhee, Ju Young Kim, Chun Woong Park, Beom Jin Lee and Eun Seok Park. Design and evaluation of nicorandil extended-release tablet. Asian journal of pharmaceutical sciences. 2015, 10: 108-113.

21. Praveen S. Hiremath and Ranendra N. Saha. Oral matrix tablet formulations for concomitant controlled release of anti-tubercular drugs: Design and in-vitro evaluations. International Journal of Pharmaceutics, 2008, 362:118-125.

22. Shaila A. Lewis and Pushkar R. Sharma. Design and in vitro/in vivo evaluation of extended-release matrix tablets of nateglinide. Journal of Young Pharmacists, 2013, 5:167-172.

23. J.C.O. Villanova, E. Ayres and R.L. Orefice. Design of prolonged release tablets using new solid acrylic excipients for direct compression. European Journal of Pharmaceutics and Biopharmaceutics, 2011, 79: 664-673.

24. Feng-Qian Li, Jin-Hong Hu, Jia-Xin Deng, Hua Su, Shu Xu and Ji-Yong Liu. In-vitro controlled release of sodium ferulate from Compritol 888 ATO-based matrix tablets. International Journal of Pharmaceutics, 2006, 324:152-157.

25. Zaman Md, Rasool Shahid, Yasir Ali Md and Qureshi Junaid. Fabrication and Analysis of Hydroxypropylmethylcellulose and Pectin based Controlled Release matrix tablets loaded with Loxoprofen Sodium. Advances in Polymer Technology, 2015, 34(3): 21493-21499.