BACLOFEN FORMULATIONS AND METHODS FOR MAKING SAME

BACLOFEN FORMULATIONS AND METHODS FOR MAKING SAME

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...

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Bibliographische Detailangaben
Hauptverfasser: KEENE, Thomas E, LE, Lanchi T, LU, Ngoc T, LANE, Deanna S, SNAZA, Carmen E, LI, Jianwei, DOMINGUEZ, Corinne, SCHMITZ, Michael C
Format: Patent
Sprache:eng
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Zusammenfassung: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.