Formulation development and in vitro evaluation of bilayer tablets Nicardipine
The present work aims to develop a stable and optimized bilayer dosage form containing immediate release &extended release drug Nicardapine as an extended-release dosage form. A potent calcium channel blocker with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardio depressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents. It has a plasma half-life of about (8.6h) and bioavailability is 15-45% orally. For the formulation of Bilayered tablets polymers such as Ethylcellulose, Sodium CMC, CCS, SSG, Magnesium stearate, Talc, PVP-K30, and MCC. Fourier transform Infrared spectroscopy confirmed the absence of any drug/ polymers/ excipients interactions. Preformulation studies were carried out to optimize the ratios required for various Ethylcellulose, Sodium CMC, CCS, SSG, MCC, and PVP-K30. Based on various evaluation parameters formulation M6 (IR) & M6F3 (SR) were selected as optimized formulation. It was observed that Formulations M6 (IR) & M6F3 (SR) gave maximum drug release within time. All formulations were subjected for drug release kinetics studies viz. Zero-order, First order, Higuchi matrix, Peppasmodel equations, and the formulations of floating sustained-release formulations followed the zero-order release with non-fickian diffusion mechanism. Thus conclusion can be made that a stable dosage form can be developed for Nicardapine as immediate release & sustained release by Bilayered tablets.
Koner P, Saudagar RB, Dharwal J. Gastroretentive drugs: A novel approach towards floating therapy. [Internet]. [Cited on 12th December, 2012]. Available from: http://www.pharmainfo.net/reviews/floating-drug-delivery- systeminnovative-approach-prolong-gastric-retention.
Shah SH, Patel JK, Patel NV. Stomach specific floating drug delivery system: A review. Int. J. Pharm tech research. 2009;1(3):623-33
Patel M, Sockan GN, Kavitha, Tamizh M. Challenges In The Formulation of Bilayered Tablets: A Review. International Journal of Pharma Research and Development. 2010; 2(10): 3 0- 42.
Pawar RG, Gadhave MV, Jadhac SL, Gaikvad DD. Formulation and evaluation of Miglitol sustained release matrix tablet, International Journal of Pharmaceutical Research and Development, 2011; 4(2): 153-159.
Monika Chauhan, Anshul Jain and Satyaveer Singh , Kuldeep Chaurasiya. Formulation and Evaluation of Sustained Release Tablet of Miglitol. World Journal of Pharmacy & Pharmaceutical Sciences 2015, Volume 4, Issue 11, 1194-1205.
Nagaraju. R, Rajesh kaza. Formulation and evaluation of bi-layer sustain release tablets of salbutamol and theophylline. Int J Pharm Sci and Nanotech. 2009; 2(3):638-46.
Ashraful Islam SM, Hosna Banu and Mostafa Reaj Sahariar. Bilayer tablets of paracetamol and aceclofenac: formulation and evaluation. Int J Pharm Tech. 2011; 3 (4): 3668-81.
Chitra Kartikini. S, Jayaprakash. S, Abirami. A, Mohamad Halite S. Design and formulation of Aceclofenac Sodium bi-layer sustain release tablets. Int J Chem Tech Res. 2009; 1(4):1381-5.
Costa P., Sousa L. J. M., Modelling and comparison of dissolution profiles, European Journal Pharmaceutical Sciences 2001; 13:2: 123–133.
Dash S, Murthy PN, Nath L and Chowdhury P: Kinetic modeling on drug release from controlled drug delivery systems. ActaPoloniaePharmaceutica - Drug Research 2010; 67: 217-223.
Marabathuni VJ, Dinesh P, Ravikumar R, Yamini P, Kiran PS, Hussain SP, Rao CM. Chitosan based sustained release mucoadhesive buccal patches containing amlodipine besylate (AMB). Asian J Res Pharm Sci. 2017 Jun 28;7:97-104.
Marabathuni VJ, Bhavani M, Lavanya M, Padmaja K, Madhavi N, Babu P, Rao CM. Formulation and evaluation of mouth dissolving Tablets of carbamazepine. Magnesium. 2017 Sep 27;15(30):15.
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