"High Dose Solid Unit Oral Pharmaceutical Dosage Form Of Mycophenolate Sodium And Process For Making Same"

Abstract: Provided are high dose solid unit oral pharmaceutical dosage form compositions comprising mycophenolate sodium as active agent in an amount of from greater than about 360 mg to about 3000 mg preferably from about 400 mg to about 1600 mg calculated as mycophenolic acid, and one or more pharmaceutically acceptable excipient(s) exhibiting a delayed release or extended release of the active agent. The invention is also directed to process of manufacturing the high dose formulations, and prophylactic and/or therapeutic methods of using such dosage forms. The composition of the present invention are easy to formulate, safe, effective and well-tolerated, and are useful for the management such as prophylaxis, amelioration and/or treatment of immunosuppressant indicated disease(s)/disorder(s) especially for the treatment or prevention of organ, tissue or cellular allograft or xenograft rejection, e.g. after transplant, or the management of immune-mediated diseases (autoimmune diseases).

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