Formulation and In-Vitro evaluation of Nortriptyline Hydrochloride mucoadhesive buccal films

Abstract

This contemporaneous research was aimed to formulate buccal mucoadhesive DDS to enhance bioavailability and avoid pre systemic metabolism. The mucoadhesive film was fabricated by solvent casting method with base polymer chitosan and a combination of hydrophilic polymer like PVP or Gelatin. The films were then evaluated. All the formulations were found to have optimum strength to withstand folding endurance. The films' consistent size, thickness, and weight variation were discovered. The drug content uniformity of films was exceptionally well. Given that the film's surface pH falls between 6.6 and 6.7, buccal administration is appropriate for it. The pH near to the neutral region decreases the chances of mucosal irritation. The invitro adhesion ability of the formulations were affected by the composition of chitosan and PVP or Gelatin. The lower and higher concentration of chitosan was not sufficient for invitro adhesion of films. The formulation having chitosan and hydrophilic polymers in the ratio 1:1.5 showed strong invitro adhesion. The invitro bioadhesion time of the formulations containing chitosan and gelatin or PVP was less due to poor ionization of gelatin. On increasing the concentration of hydrophilic polymers, the invitro bioadhesion time increased. The highest concentration of the polymers decreased the adhesion time. The formulation NF5 with chitosan and gelatin within the proportion of 1:1.5 exhibited drug release of 98.1% at 6 hours. The sole purpose of this work is to adhere the buccal film with the mucosa, hence formulation NF5 was selected as best formulation. Thus, current investigation's goal to develop a buccal mucoadhesive drug delivery was fulfilled.

Keywords: Buccal film, Nortriptyline HCl, depression, in vitro studies, mucoadhesive