Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2007-01-30
2007-01-30
Richter, Johann (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
10808113
ABSTRACT:
Injectable compositions containing gabapentin and processes for preparing sterile injectable compositions containing gabapentin are discussed. The process includes subjecting the compositions to heat. Heating results in increased production of gabapentin lactam, which has previously been shown to be toxic. Surprisingly, heated injectable compositions containing gabapentin are found to be non-toxic when administered intrathecally. Thus, heating for the purposes of sterilization or to assure sterility provides a viable option in the production of injectable compositions containing gabapentin.
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Li et al., Database Medline/NLM, Bethesda, MD, “Moist-heat sterilization and the chemical stability of heat-labile parenteral solutions,” Database Accession No. NLM15605602 abstract, 1 pg.
Clarahan David A.
Elsberry Dennis D.
Hildebrand Keith R.
Lane Deanna S.
Page Linda M.
Campbell Keith M.
Medtronic Inc.
Richter Johann
Stitzel David P.
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