Formulation And Evaluation Of Controlled Release Transdermal Patches Of Theophylline - Salbutamol Sulphate

Murthy, Narasimha S; Hiremath, Shobha Rani R
January 2002
Internet Journal of Pulmonary Medicine;2002, Vol. 2 Issue 1, p15
Academic Journal
Transdermal formulations containing theophylline and salbutamol sulphate were formulated using hydroxy propyl methyl cellulose. Theophylline was loaded by adsorption with the aid of co-adsorbate, sodium chloride. The formulations were subjected to in vitro release studies and the dose of salbutamol and theophylline were optimized to yield the desired flux. The films were uniform and of 200 � 40 micron thickness. The in vitro flux of theophylline and salbutamol sulphate from the formulation was 1.22 � 0.4 mg/hr/sq.cm and 13.36 � 1.02 mcg/hr/sq.cm respectively. The formulation was subjected for pharmacodynamic studies in guinea pigs. The PCT of guinea pigs increased significantly after 4th hour the same was observed even after 24 hours. Pharmacokinetic studies were carried out in healthy human volunteers. Theophylline was analyzed in saliva and salbutamol in the blood plasma. The Tmax of the drugs was 3 hours and appreciable concentrations of the drugs above their MEC could be analysed even after 12 hours. The half-lives of the drugs were significantly prolonged compared to tablets. There was no signs of erythema or oedema in volunteers on observation for a period of 7 days.


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