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Baclofen formulations and methods for making same
专利权人:
Medtronic; Inc.
发明人:
Michael C. Schmitz,Corinne Dominguez,Thomas E. Keene,Deanna S. Lane,Lanchi T. Le,Jianwei Li,Ngoc T. Lu,Carmen E. Snaza
申请号:
US13661800
公开号:
US09180108B2
申请日:
2012.10.26
申请国别(地区):
US
年份:
2015
代理人:
摘要:
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.
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