47. Formulation and Evaluation of Mucoadhesive Buccal Bilayered Tablets of Salbutamol

Salbutamol is a short-acting 2-adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease. The salbutamol buccal mucoadhesive tablets were fabricated with objective of avoiding first pass metabolism and prolonging duration of action. Salbutamol mucoadhesive bilayered tablets were prepared by direct compression method using the bioadhesive polymers such as xanthan gum, sodium alginate and carbopol 937P along with ethyl cellulose as an impermeable backing layer. The prepared tablets evaluated for post-compressional parameter like weight variation, thickness, hardness, and friability, surface pH, mucoadhesive strength, in vitro drug release and Ex-vivo permeation study. The compatibility of drug with other ingredients was checked by FTIR studies. FTIR results revealed that there was no interaction between dug and other excipients. All the post-compressional parameter are evaluated were prescribed limits and results were within acceptable limits. The in vitro release study was carried out by using pH 6.8 buffer. The invitro drug release was in the range of 69.74% to 98.52% in eight hrs from the formulations of F1 to F6. The formulation F4 and F5 % shows the drug release 74 % and 69.74 % respectively. The results were revealed that the release of salbutamol buccal tablets was slower in formulation F4 and F5, may be due to the high concentration of xanthan gum, in comparison to other formulations. Xanthan gun, carbopol and Na-alginate were selected as the bioadhesive polymers because of their excellent bioadhesive properties. Among the all formulations studied F4 and F5 were found to be the best formulations. All the formulations showed the first order release. The stability study conducted as per the ICH guidelines and the formulations were found to be stable. The present study concludes that mucoadhesive buccal tablets of salbutamol can be a good way to bypass the extensive hepatic first-pass metabolism, provides controlled release of the drug and to improve the bioavailability of salbutamol.

Author(s): Dr. N.G Raghavendra Rao, Gururaj S. Kulkarni

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