DESIGN AND IN-VITRO-IN-VIVO CHARACTERIZATION OF BUCCAL TABLETS OF SIMVASTATIN

The main objective of present study is to develop Bucco adhesive bilayer tablets of Simvastatin using mucoadhesive polymers. Simvastatin has short biological half-life (3h), high first-pass metabolism and poor oral bioavailability (5%), hence an ideal candidate for buccal delivery system. The tablets were prepared by direct compression technique using carbopol-934, sodium carboxy methyl cellulose (Na CMC), Poly vinyl pyrollidine (PVP) and hydroxyl propyl methyl cellulose (HPMC) as mucoadhesive polymers. Soyabean powder is mainly used as a diluent in this formulation as it contain less fats and more protein substances. Formulations were evaluated for weight variation, hardness, friability, drug content, swelling studies, surface pH, bioadhesion strength, invitro drug release, ex-vivo permeation studies, using sheep buccal mucosa, muco irritation test, in-vitro release studies, in-vivo studies, IVIVC and stability studies. Formulation S11 exhibited controlled drug release at (11h) containing polymers like HPMC K100M, carbopol934P and PVP K30. Formulation S11 selected as optimized formulation based on physicochemical parameters and ex-vivo permeation studies and follows zero order drug release. FTIR studies show no evidence on interaction between drug, polymers and other excipients. The results indicate that Simvastatin is a suitable candidate when given through the buccal drug delivery.

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