ABSTRACT:
Objective: The objective of the present study was to assess the interaction between the Galantamine HBr pellets and alcohol. Concomitant administration of alcohol and formulation can affect the plasma concentration of drug or give dose dumping effect or failure of the dosage form as the number of excipients especially polymers used in the modified dosage form cannot withstand in the presence of alcohol. Materials and Methods: The modified release pellets of galantamine hydrobromide were formulated incorporating a waxy polymer – Compritol 888 ATO and a hydrophobic polymer – Ethocel using extrusion spheronization technique. In vitro drug release of galntamine pellets was performed in distilled water and 10-40% ethanol containing distilled water. The saturated solubility of galantamine was measured in different dissolution media and pure ethanol. Results and Discussion: In vitro drug release study showed similarity at all the levels of alcohol (10-40%) as f2 value was found to be more than 50. In vitro drug release was slightly reduced in the presence of alcohol as the galantamine is slightly less soluble in ethanol compared to distilled water. There was change observed in drug release kinetics and mechanism but no significant change was observed in drug release. Conclusion: The suitability of Compritol 888 ATO and Ethocel as a matrix forming excipient in the formulation of pellets can resist the effect of alcohol makes it suitable for the alternative polymer in the wider application for designing of modified release dosage form.