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Last Updated: March 28, 2024

Claims for Patent: 8,969,414


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Summary for Patent: 8,969,414
Title:Intrathecal baclofen pharmaceutical dosage forms with fewer degradation products
Abstract: The present invention relates generally to a sterile, particulate-free, stable intrathecal baclofen solution with less than 0.5% 4-(4-chlorophenyl)-2-pyrrolidone, a degradation product. These solutions are stable under a variety of storage conditions and for extended periods of time. Also disclosed are methods for preparing such compositions.
Inventor(s): Foster; John J. (Woodbury, MN), Strantz; Angela S. (Mahtomedi, MN)
Assignee: Mallinckrodt LLC (Hazelwood, MO)
Application Number:12/701,342
Patent Claims:1. An aqueous, terminally sterilized pharmaceutical composition suitable for intrathecal delivery, wherein the composition comprises baclofen at a concentration of between about 0.5 mg/mL to about 4.0 mg/mL, and wherein the composition contains 0.5% (by weight of baclofen) or less 4-(4-chlorophenyl)-2-pyrrolidone.

2. The composition as recited in claim 1 further comprising: a) sodium chloride and; b) sterile water.

3. The composition as recited in claim 1, wherein said composition is free of particulates.

4. The composition as recited in claim 1, wherein said composition contains 0.5% (by weight of baclofen) or less of 4-(4-chlorophenyl)-2-pyrrolidone after storage at 25.degree. C. and 60% relative humidity for at least 2 months.

5. The composition as recited in claim 1, wherein said composition contains 0.5% (by weight of baclofen) or less of 4-(4-chlorophenyl)-2-pyrrolidone after storage at 40.degree. C. and 75% relative humidity for at least 1 month.

6. The composition of claim 1, wherein the concentration of baclofen is 0.5 mg/mL.

7. The composition of claim 1, wherein the concentration of baclofen is 2.0 mg/ml.

8. The composition of claim 1, wherein the concentration of baclofen is 3.0 mg/mL.

9. A method of manufacturing the pharmaceutical composition of claim 1 comprising the steps: a) dissolving NaCl in water with stirring; b) dissolving baclofen in said aqueous NaCl solution with stirring; c) diluting said solution of NaCl and baclofen while stirring; d) steam-heating said solution to 121.1.degree. C. so that the F.sub.o for the resulting terminally sterilized solution is 7 minutes.

10. The method of claim 9, wherein the concentration of baclofen is 0.5 mg/mL.

11. The method of claim 9, wherein the concentration of baclofen is 2.0 mg/mL.

12. The method of claim 9, wherein the concentration of baclofen is 4.0 mg/mL.

13. The composition as recited in claim 1, wherein said composition contains 0.5% (by weight of baclofen) or less of 4-(4-chlorophenyl)-2-pyrrolidone after storage at 40.degree. C. and 75% relative humidity for at least 2 months.

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