FORMULATION AND CHARACTERIZATION OF CLOZAPINE ADHESIVE PATCHES USING VARIOUS PRESSURE SENSITIVE ADHESIVES AND PERMEATION ENHANCERSAbstract
The present research work was intended to develop and characterize the transdermal adhesive patch of clozapine using different types of acrylate, polyisobutylene and silicon adhesives. Various permeation enhancers such as 1, 8 – cineole, D-limonene, Azone, IPM and Oleic acid were also evaluated to achieve desired permeation rate and hence to attain the improved bioavailability as compared to oral formulation. Formulation prepared were evaluated for physicochemical characterization, FTIR, DSC, permeability enhancement potential by ex-vivo, and stability studies. The results of the optimized formulation showed peel strength of 411 ± 3.56 cN/cm, flux of 109.59 ± 1.59 (µg/h/cm2) and % drug content of 99.53 ± 0.42% which was stable up to six months in accelerated condition. The results of the study revealed that the developed transdermal patch of clozapine can be a promising alternative which provides effective management of schizophrenia in terms of improved patient compliance and bioavailability which in turn reduces the dosage frequency and hurdles associated with the caretakers and doctors.
M. B. Agrawal * and M. M. Patel
Department of Pharmaceutics, Institute of Pharmacy, Nirma University, Chharodi, Ahmedabad, Gujarat, India.
01 April 2020
19 July 2020
23 July 2020
01 April 2021