[EN] AQUEOUS INJECTABLE PREPARATIONS OF DICLOFENAC AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS<br/>[FR] PRÉPARATIONS AQUEUSES POUR INJECTION DE DICLOFÉNAC ET DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
申请人:HETERO HEALTHCARE LTD
公开号:WO2018142313A1
公开(公告)日:2018-08-09
The present invention relates to the stable aqueous injectable formulation comprising of Diclofenac or a pharmaceutically acceptable diclofenac salts suitable for intramuscular, intravenous, subcutaneous, nasal, ocular drops, intra-articular, and otic delivery, which causes significantly less pain at site of injection. The formulations medium comprising of water, along with one or more co-solvent(s)/solubilizer(s), antioxidants, chelating agents, buffers, alkali and stabilizers, which cause significantly less pain at the site of injection. The invention further provides a method for preparing said composition, wherein the dose of the diclofenac or a pharmaceutically acceptable diclofenac salts thereof is less than 75 mg, i.e. from about 18.75 mg to 37.5 mg. The present invention is also directed to methods of treatment or prevention of Prophylaxis of postoperative pain, Sprains, Bursitis and Strains, Tendinitis, Acute gout, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis and for treatment of inflammation after surgery or during surgical procedures, Dysmenorrhoea, Renal colic, pain control of total hip replacement arthroplasty.