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Preparation And Evaluation Of Inclusion Complexes Of Felodipine,

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Abstract

Studies were carried out on the complexation of felodipine with β-cyclodextrin(β- CD) and hydroxypropyl β-cyclodextrin(HP β-CD) with the objective of developing a new oral dosage form with enhanced dissolution rate and bioavailability. Equimolar drug-cyclodextrin binary systems were prepared according to three different techniques (physical mixing, kneading and solvent evaporation) and were characterized by infrared, FTIR studies and comparative invitro studies. The drug solubility improvement obtained by the different binary systems varied from a minimum of 2.5 times up to a maximum of 120 times, depending on both the cyclodextrin type and the method of preparation. Phase solubility studies indicated formation of 1:1 M complex for HP β-CD. Apparent stability constant (Kc) was found to be 582.78 M-1 for HP β-CD complexes. Solid complexes of felodipine-HP β-CD at 1:1 M prepared by kneading method exhibited the highest dissolution rate and dissolution efficiency values than the pure drug and other complexes. It can be reasonably expected that the obtained drug dissolution rate improvement will result in an increase in its bioavailability, with the possibility of reducing dose and side effect. Keywords: Felodipine, β-cyclodextrin, HP β-cyclodextrin, Physical mixture, Kneading method,

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ABSTRACT Aims: The objective of the present investigation was to develop a sustained release (SR)tablet formulation of glipizide by employing two hydrophobic polymers (ethyl cellulose and ethylene vinyl acetate copolymer)and two natural hydrophilic gum resins olibanum resin and colophony) in the design of glipizide SR tablets as rate-controlling matrix former and to compare the formulated glipizide release with commercial Glynase XL tablets. Methods:Different batches of glipizide sustained release tablets were prepared byusing lactose and dicalcium phosphate as diluents by wet granulation technique. All these polymers were used at the same concentration that is at 2% strength in the formula in order to get desired release profile. Results:The results of dissolution study indicated that formulation (SR F3) containing olibanum resin and lactose as diluent in tablet composition increases sustained drug release..Drug release from these tablets was by non-fickian diffusion mechanism. The optimized batch SR F3 tablets formulated employing olibanum resin showed highest similarity factor (f2)value of 147.3. The kinetics of drug release was best explained by Korsmeyer and peppas model. The optimum formulation (SR F3)was stable when it was stored at 40±20C, 270±20 C and 450±20 for 6 months Conclusion: A good sustained release formulation of Glipizide could be developed employing olibanum resin as rate-controlling matrix former and lactose as diluent. Key words: Glipizide, Sustained release tablets, Colophony, Olibanum resin.
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