FOMULATION OF SALBUTAMOL SUSTAINED RELEASE TABLET

Abstract

Background: Salbutamol, a highly selective beta 2 adrenoceptor agonist with bronchodilating property, is widely used for the management of chronic and acute asthma. The biological half life of drug is about 4.5 hour, hence salbutamol is given orally four times daily to maintain a therapeutic blood level. The aim of recent study was to formulate film coated sustained release tablet for 12-hour duration of action. Materials and methods: The core tablet containing salbutamol sulphate, potassium chloride and lactose were prepared using wet granulation process. The resultant tablets were coated with mixtures of ethyl cellulose and hydroxylpropyl methyl cellulose to control the release of salbutamol. Results: Three formulations of the core were chosen to fabricate salbutamol tablets and the core tablets were coated with polymer at various ratio to core weight to control the drug release. It was found that the core containing 68 mg of potassium chloride and 6 % (W/W) of polymer possessed the drug release similar to that of reference product (Ventolin CR). The drug release kinetic of the experimental product was best fit to zero order. Active ingredient was released out of the coated tablet through pores formed by disolving of hydrophyllic one in mixture of polymer in contact with medium. Conclusion: The mixture of ethyl cellulose and hydroxylpropyl methyl cellulose could be used as coating to control the release of salbutamol. The dissolution of resultant coated tablet was similar to that of Ventolin CR 4 mg. The products were ready to be assessed further by conducting stability testing and bioequivalence evaluation in human volunteers.