Formulation and In-vitro evaluation of mucoadhesive buccal tablets of Atorvastatin Calcium
Keywords:
Atorvastatin calcium, Buccal tablets, linear drug release, Zero order kineticsAbstract
The objective of present study is to prepare buccoadhesive buccal tablets of Atorvastatin calcium (AVC-8mg) using the bioadhesive polymers Carbopol 974P (CP), Guar Gum, and Gum Ghatti as matrix forming agent and Ethyl cellulose (EC-25mg) as impermeable backing layer. The solubility studies were conducted along with PEG 4000 in different medias. Twelve formulations of mucoadhesive buccal tablets of AVC were prepared, which contain the polymers in various combinations. Tablets were prepared by direct compression method and characterized for swelling studies, % matrix erosion, surface pH, bioadhesive properties, in-vitro drug dissolution and in-vitro diffusion studies. All the formulations shows the satisfactory results in terms of bioadhesive performance. The swelling index was proportional to polymer content. The surface pH of all tablets was found to be satisfactory, close to neutral pH; the AVC released and drug diffusion from these tablets was depended on the ratio and type of the natural polymers used in the formulation. Tablets containing CP (10%) and Guar Gum, HPMCK4M and Gum Ghatti in the ratio of 1:3 (F3, F7 and F8) shows near zero order kinetics release, with non-Fickians diffusion and followed anomalous release. The ex vivo permeation concluded that PEG 4000 enhanced the permeability of AVC from the tablets. FT-IR studies revealed that there is no interaction between drug and polymer used in the study.
References
. Santanu RC, Rajesh G, Sourav Saha. A Review on Buccal Mucoadhesive Drug Delivery Systems. Indo-Global Journal of Pharmaceutical Sciences 2011; 1(3): 223-233.
. Surapaneni MS, Das SK, Das NG. Effect of excipient and processing variables on adhesive properties and release profile of pentoxifylline from mucoadhesive tablets. Drug DevInd Pharm 2006; 32(3): 377-87.
. Gandhi RE, and Robinson JR., Bioadhesion in drug delivery, Int. J. Pharm. Sci., 1988; 50:145-152.
. Pranshu T, Satheesh NV. Oral mucoadhesive drug delivery systems: A review. Int. J. of Bio pharmaceutics 2011; 2(1): 36-46.
. Nakhat P, Kondawar A, Babla I, Rathi L, Yeole P. Studies on Buccoadhesive Tablets of Terbutaline Sulphate. Indian J Pharm Sci 2007; 69(4): 505-10.
. Yamsani VV, Gannu R, Kolli C, Rao ME, Yamsani MR. Development and in vitro evaluation of buccoadhesive carvedilol tablets. Acta Pharm 2007; 57(2): 185-97.
. Lakshmi NV, Kalyan RB, Raj Kumar M, Kiran KA, Raju Ch, Sanjeeva KA and Venkateshwara Reddy. Improved dissolution rate of Atorvastatin calcium using solid dispersions with PEG-4000, J Chem Pharm. Res., 2010; 2(3): 304-311.
. Higuchi T. Mechanism of sustained-action medication: theoretical analysis of rate of release of solid drug dispersed in solid matrices. J Pharm Sci 1963; 52:1145–1149.
. Korsmeyer RW, Gurny R, Peppas N. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm 1983; 24: 25–35.
. Peppas NA. Analysis of Fickian and non-Fickian drug release from polymers, Pharm. Acta Helv 1985; 60: 110–111.
. Gohel MC, Panchal MK, Jogani VV. Novel mathematical method for quantitative expression of deviation from the Higuchi model. AAPS Pharm Sci Tech 200; 1: 45-50.
. Ahagon A, Gent AN. Effect of interfacial bonding on the strength of adhesion. J. Polym. Sci. Polym. Phys 1975; 13: 1285-1300.
. Lee VHL, Lee VHK, Robinson JR. Controlled drug delivery. 2nd Ed., vol 29, New York; Marcel Dekker Inc: 1987, 4.
. Bomberag LE, Buxton DK, Friden PM. Novel periodontal drug delivery system for treatment of periodontis. J. Control. Rel 2001; 71 (3): 251-259.
. Jimenez-Castellanous MR, Zia H, Rhodes CT. Mucosal drug delivery system. Drug Dev. Ind.Pharm 1993; 19,143-194.
. Tiwari D, Goldman D, Sause R, Madan PL. Evaluation of polyoxy ethylene homopolymers for buccal bioadhesive drug delivery formulations. AAPS Pharm SciTech 1999; 1:E13.
. Nakamura F, Otha R, Machida Y, Nagai T. In vitro and in vivo nasal mucoadhesion of some water soluble polymers, Int J Pharm. 1996; 134: 173-181.
. Mathias NR, Hussain AM. Non-invasive systemic drug delivery: develop ability considerations for alternate routes of administration. J. Pharm. Sci 2010; 99: 1-20.
. Shojaei Amir H. Buccal Mucosa as a route for systemic drug delivery. Journal of Pharmacy and Pharmaceutical Sci. 1998; 1(1): 15-30.
. Hoogstraate JAJ, Wertz PW. Drug delivery via the buccal mucosa. Pharm Sci Techn Today 1998; 1(7): 309-316.
. Khairnar GA, Sayyad FJ. Development of buccal drug delivery system based on mucoadhesive polymer. International Journal of Pharm Tech Research 2010; 2(1): 719-735.
. Mathews BR, Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm. 1999; 25: 831–856.
