Formulation Development and Evaluation of Oro-Dispersible Tablets of Levosalbutamol

Levosalbutamol (albuterol) is a β2-adrenoceptor agonist used as a bronchodilator for the treatment of asthma and as a uterine relaxant for the suspension of premature labour. Salbutamol has been marketed as a racemic mixture, although β2-agonist activity resides almost exclusively in the (R)-enantiomer. The enantio-selective disposition of salbutamol and the possibility that (S)-salbutamol has adverse effects have led to the development of an enantiomerically pure (R)-salbutamol formulation known as levosalbutamol (levalbuterol). The present study is an attempt to develop and formulate fast dissolving tablets of Levosalbutamol with super disintegrants which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action and to prevent the first pass metabolism of Levosalbutamol . In this system direct compression was used, sodium starch glycollate (SSG), were used as super disintegrants, talc is used as flow promoter, magnesium stearate was used as lubricant, mannitol as sweetener and diluent. The drug- polymer compatibility was confirmed by FTIR studies. The results obtained by FTIR studies revealed that there was no chemical interaction between the pure drug and excipients. Direct compression method was employed to formulate the tablets, because of its cost effectiveness and due to reduced number of manufacturing steps. The post-compression parameters like the thickness, hardness, friability and in vitro disintegration time, wetting time, water absorption ratio and in vitro drug release were carried out and the values were found to be within limits. The Formulation F1 shows the maximum dissolution rate and % of drug release was found to be 95.5%. The other Formulations shows F2 - 92.1% F3 – 95% F4 – 90.9% and F5 shows the lesser release 87.5% Based on the % of drug release at 15 minutes shows F1 maximum of 86.8 % and 60 minutes the maximum release of 95.5 %. The formulation of Levosalbutamol tablets containing 7.50% Sodium starch glycollate (F1) revealed that formulated rapid dissolving tablets of Levosalbutamol were effective and better to meet patient compliance. The Real time stability studies for formulation (F1) shows acceptable limit within 3 months period. CONCLUSION: The present work was concluded that to develop a stable, safe, fast release and convenient Oro dispersible tablets of Levosalbutamol for rapid therapeutic action. The formulations were optimized by using design expert software all the Five formulations (F1 to F5) of Oro dispersible tablets of Levosalbutamol were successfully prepared using Sodium Starch Glycollate as a super disintegrants and crospovidone by direct compression method. The Formulations were evaluated for parameters like thickness, hardness, friability, in- vitro disintegration time, wetting time, water absorption ratio, and in- vitro drug release studies. Based on the % of drug release at 15 minutes shows F1 maximum of 86.8% and 60 minutes the maximum release of 95.5 %. The formulation (F1) was subject to stability studies for 3 months by storing them at 30°C/65% RH, 35°C/70%RH and 40°C/75% RH. The Results of physical appearance, hardness, friability, disintegration test, and % drug release have shown that there was no significant change at different storage conditions