Formulation and evaluation of salbutamol sulphate buccal patches for unidirectional buccal drug delivery

Abstract

Buccal mucoadhesive patches of salbutamol sulphate were prepared by the solvent casting technique. Different polymer combinations, based on, Polyvinyl alcohol, Hydroxypropyl methylcellulose and Eudragit-L 100 were carried out. A 32 full factorial design (Design Expert, Version7, Stat-Ease Inc, Minneapolis, MN) was used to design the experiments for each polymer combination. A total of 180 formulations were prepared in triplicate. All the patches were characterized by physico-chemical evaluation. The Formulations A10, A32, B10, B32, C36 and D36 are best fitted to the Higuchi model. The formulations A1, A19, B2, B19, C9, C18, C27, D9, D18, D27, E7, E12, F7 and F12 are best fitted to the Korsmeyer- Peppas model. Stability studies indicated that there were no changes in the chemical and physical characteristics of the patches during the test period. From the above 20 formulations, 6 formulations A10, B2, C18, D36, E12 and F12 were selected to study the effect of various permeation enhancers such as Dimethyl sulphoxide (DMSO), Linoleic acid (LA), Isopropyl myristate (IPM) and Oleic acid (OA) on the permeation of salbutamol sulphate across buccal pig mucosa (These selected formulations were renamed as A, B, C, D, E and F respectively). Among these permeation enhancers, OA, LA, and IPM produced noticeable increase in salbutamol sulphate flux compared with patches without permeation enhancer, where as DMSO increased the flux slightly and in most cases the increase was negligible. OA was the most efficient permeation enhancer increasing the flux gt8-fold compared with patches without permeation enhancer in HPMC based buccal patches when PEG-400 was used as the plasticizer. From this study, it could be concluded that, buccal mucoadhesive patches of salbutamol sulphate are potential drug delivery systems with a considerably good physicochemical characteristics, stability and release profile. newline newline newline