[EN] A NOVEL PHARMACEUTICAL FORMULATION OF ALPHA KETOANALOGUE OF AMINO ACIDS AND ADDITIONAL AMINO ACIDS FOR TREATMENT OF CHRONIC KIDNEY DISEASE AND METHOD OF PREPARATION THEREOF<br/>[FR] NOUVELLE FORMULATION PHARMACEUTIQUE D'ALPHA CÉTOANALOGUE D'ACIDES AMINÉS ET D'ACIDES AMINÉS SUPPLÉMENTAIRES POUR UN TRAITEMENT D'UNE MALADIE RÉNALE CHRONIQUE ET SON PROCÉDÉ DE PRÉPARATION
申请人:RPG LIFE SCIENCES LTD
公开号:WO2012137216A1
公开(公告)日:2012-10-11
A novel pharmaceutical formulation of alpha ketoanalogue of amino acids and additional amino acids for treatment of chronic kidney disease and method of preparation thereof The present invention relates to a pharmaceutical formulation having increased in-vitro dissolution, and reduced and controlled degradation under moisture and heat conditions comprising alpha ketoanalogue of amino acids and additional amino acids as active ingredients, and disintegrant, filler and binder, and coated with moisture barrier coating composition, wherein disintegrant is croscarmellose sodium, filler is microcrystalline cellulose and binder is polyvinyl pyrrolidone, and moisture barrier coating composition comprises film former, plasticizer and solubilizing agent, and stabilizer and suspension agent, wherein film former is polyvinyl alcohol, plasticizer and solubilizing agent is soya lecithin, and stabilizer and suspension agent is xanthan gum. In one embodiment, the present invention also relates to a process for preparation of said pharmaceutical formulation.