Formulation and evaluation of fast dissolving oral film of promethazine hydrochloride using different surfactant

Abstract

Fast-dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. This facilitates the rapid absorption in the oral cavity and reduces first-pass effects. The aim of this study is to formulate and evaluate the Fast dissolving Oral film of Promethazine hydrochloride as a strong antihistamine which are used to reduce nausea, motion sickness and improved bioavailability of drugs as compared to conventional solid oral dosage forms. The films were prepared Hydroxy propylmethyl cellulose E15 as a film base synthetic polymer and PEG400 (Poly Ethylene Glycol 400) as a plasticizer by solvent casting method. SLS (Sodium Lauryl Sulfate) and MCC (Micro Crystalline Cellulose) used as a surfactant in different concentration. Sucrose used as a sweetening agent and strawberry as a flavoring agent. Films were found to be satisfactory when evaluated for thickness, weight uniformity, in-vitro drug release, folding endurance, drug content and disintegration time. The surface pH of all the films was found to be neutral or minor change. Films in vitro drug release studies also done by using USP dissolution apparatus. The in vitro drug release in optimized formulation F2 was found to be 14.36% in 2 min. The optimized formulation F2 also showed satisfactory pH, drug content (97.41±0.54%), effective in vitro drug release (96.03±0.68% in 16 min), disintegration time of 09 seconds and satisfactory stability. The Promethazine hydrochloride fast dissolving oral film was formulated. The given film disintegrates within nine seconds which release drug rapidly and gives action