Poloxamer-based Thermosensitive Hydrogel Suppository for Rectal Administration of Dexibuprofen

Abstract

This study aims to develop a novel sustained-release thermosensitive hydrogel suppository containing dexibuprofen, widely used for its antipyretic, anti-inflammatory, and analgesic effects. Dexibuprofen is known to cause side effects such as gastrointestinal bleeding and peptic ulcers, and a syrup formulation for infants and toddlers is currently available. In this experiment, gel suppositories with varying proportions of the thermosensitive polymers Poloxamer 407 (P407) and Poloxamer 188 (P188) were formulated and comprehensively evaluated. Parameters assessed included appearance, droplet size, polydispersity index (PDI), gelation temperature, gelation time, viscosity, gel strength, adhesiveness and drug release properties. Formulation F11, containing 20 mg/g of dexibuprofen and a 12:10 (%, w/w) ratio of P407 to P188, met the specified criteria of a gelation temperature between 30~36oC and a gelation time of 5 minutes or less. Furthermore, F11 exhibited a nano-sized and colorless or white appearance. It demonstrated suitable gel strength, adhesiveness, and cohesiveness during mechanical testing, and the drug release study confirmed a gradual release over 16 hours while attached to membrane tubes. This formulation presents a promising advancement in providing a controlled and effective delivery system for dexibuprofen, addressing the limitations of conventional formulations.