Saol International Limited

Medtronic, Inc.

Lanchi T Le

Jianwei Li

Deanna S Lane

Michael C Schmitz

Thomas E Keene

Carmen E Snaza

Corinne Dominguez

Ngoc T Lu

Charlene X Yuan

Methods for preparing sterilized baclofen solutions include adjusting the pH to below a desired pH, and steam sterilizing the solution with adjusted pH, which results in the solution having the desired pH. Such solutions may also have low concentrations of 4-CPP. Injectable baclofen solutions having greater than 2 mg/mL baclofen include between 5 mM and 25 mM of a phosphate or sulfate species. The solution has an ionic strength equivalent of about 1.5 M NaCl. The present application also provides baclofen formulations for use in treating spasticity, brain injury, cerebral palsy, spinal cord injury, cervical injury, multiple sclerosis, thoracic injury, or withdrawal symptoms.

Baclofen formulations and methods for making same

A formulation for use in an implantable infusion device includes between about 5 mg/ml and about 500 mg/ml (e.g., about 10-25 mg/ml) of a TNF inhibitor polypeptide, 10 mM-25 mM of a phosphate or citrate buffer, has an ionic strength of the combined buffer and an optional salt of the equivalent of about 0.1-0.2 NaCl (e.g., about 0.15 M), 5% to 10% of a carbohydrate (e.g., trehalose or sucrose), has a pH of between 6 and 7, is fluid at room temperature and at 37&#xb0; C., and has a viscosity of less than about 10 centipoise (e.g., between about 1 centipoise and 9 centipoise, between about 1 cp and about 5 cp, between about 1 cp and about 3 cp, or between about 1 cp and about 2.5 cp) at room temperature.

TNF inhibitor formulation for use in implantable infusion devices

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Lake Elmo, MN, United States of America

Lanchi T Le