Formulation Development and Evaluation of Promethazine As A Lozenge

ABSTRACTMotion sickness is a complex syndrome representing symptoms nausea and vomiting. Anti-motion sickness drugs can build up the rate of adaptation without symptoms being evoked. The present study aimed to formulate and evaluate Promethazine hydrochloride as a lozenge to combat flaws in regard to conventional dosage form. The sucking and swallowing process is a simple method for relieving symptoms, the mechanism being development of increased saliva, swallowing and this process equals the Eustachian tubes. Promethazine hydrochloride is a BCS class I, phenothiazine derivative showing antihistamine, sedative and antiemetic effect being a H1 receptor blocking agent, it also acts by blocking the action of acetylcholine and is indefinitely metabolized by the liver. Lozenges were prepared by heating and congealing method with isomalt and sucrose as a base and HPMC E5 in varying concentrations. Preformulation demonstrated compatibility of drugs and excipients coordinated using FT-IR and DSC. Post-compression parameters were studied which included general appearance, thickness, hardness, friability, cooling check, drug content, moisture content and in vitro dissolution as well as microbial test. Factorial design 32 was opted to optimize the formulation. Formulation F3 was considered an engineered medicated confection that met all the requirements showing adequate hardness and disintegration of 10 kg/cm2 and 13.60 seconds respectively with a strong drug release rate of 98.22%. The microbial test showed large inhibition zone which concluded it showed quite good resistance and hence was considered as a promising candidate.Keywords: Motion sickness, Lozenges, Heating, congealing, Zone of inhibition.