FORMULATION DEVELOPMENT OF SUSTAINED RELEASE INTRA-ARTICULAR INJECTION OF ANALGESIC DRUG
The purpose of this study was to formulate and evaluate Parenteral Intraarticular Sustained-Release Formulation of an analgesic drug using the technology of in situ forming gel, based on temperature change mechanism in order to reduce the frequency of dosing and increase patient compliance in the treatment of knee pain. The formulation was optimized, prepared, filled aseptically, sterilized and evaluated for prerequisites of parenteral and other parameters like gelation temperature, gel strength, viscosity, drug content, in vitro and in vivo studies and stability studies. It was prepared using cold method and optimized by 32 factorial design, comprising of drug, Pluronic F127, HPMC K 100M and HPMC K4M was found to be clear, colorless, isotonic, sterile, pH as 6.8-7, viscosity of 1800 cps, syringeable through 18 gauze needle, forming a stable in-situ gel at knee joint temperature having gel strength of 43.80 gm/cm showing a drug release of 95.88 % in phosphate buffer pH 7.4 at 120hrs. The sterile formulation packed in transparent ampoule was found to the stable with most suitable storage condition at the refrigerator temperature. Thus a biocompatible, stable parenteral formulation was developed which can be an alternative and convenient approach to the patients that require frequent parenteral administration, reducing the frequency of dosing and ultimately increasing patient compliance and comfort.
Keywords: Tramadol HCL, In situ gel, Pluronic F127, intra-articular
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