Mucoadhesive system for Drotaverine Hydrochloride: A Novel approach

In the present work an attempt has been made to have a faster antispasmodic action of Drotaverine HCl (DH) through combined approaches of enhancement of solubility and formulation (Buccal) approach. Enhancement of solubility was obtained through its complexation with CDs. DH-MbetaCD systems allowed a marked improvement of the initial drug water solubility. In particular, an increase of about 22 times was obtained for kneaded product. DSC, FTIR, and PXRD studies indicated that complexes can be formed by kneading method. The use of such drug-CD binary systems prepared by kneading method enabled preparation of directly compressible buccal tablets which showed better Diffusion cell studies and dissolution values compared to marketed formulation and tablets containing drug alone. Thus, it can be concluded that the kneading method can be used to prepare DH-MbetaCD complexes, to enhance the solubility and dissolution profile of drug which can be further enhanced by converting the complexes into a buccal formulation. The prepared formulation can be further investigated for its in vivo behaviour.