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BACLOFEN FORMULATIONS AND METHODS FOR MAKING SAME
专利权人:
SAOL INTERNATIONAL LIMITED
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:
US16544128
公开号:
US20200078327A1
申请日:
2019.08.19
申请国别(地区):
US
年份:
2020
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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