Accelerated Stability Testing of a Polyherbal Transdermal Patches Using Polyvinyl Alcohol and Hydroxypropyl Methylcellulose as a Controlling Polymer Layer

摘要

The present work was to evaluate the stability potential of (E)-4-(3,4-dimethoxyphenyl)but-3-en-l-ol (Compound D) in polyherbal transdermal patches. The polyherbal formulation composed of the rhizomes of Zingiber cassumunar and Curcuma longa, leaves and stems of Cymbopogon citratus, rind and leaves of Citrus hystrix fruit, and leaves of Acacia rugata and Tamarindus indica. Polyvinyl alcohol and hydroxypropyl methylcellulose were used as a matrix film, and glycerine was used as a plasticizer. Stability testing was established for 6 months under accelerated conditions as according to International Conference on Harmonisation guidelines. Mechanical properties, moisture uptake, swelling ratio, and in vitro studies were evaluated. New Zealand white rabbits were used as the animal model. Results obtained after 6 months showed that the polyherbal transdermal patches were stable, with a good mechanical properties and hydrophilicity. In vitro study kinetics for active Compound D fitted to the Higuchi model for both release and skin permeation. The transdermal patch containing polyherbal formulation was safe to apply on the skin without irritation. Thus, transdermal patches containing this polyherbal formulation had good stability potential, with no irritation on application.