Intranasal formulation of rotigotine
AssigneeSRZ Properties, Inc.
InventorRobert Kramer
Life of this patent
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Abstract
This invention pertains to a liquid intranasal pharmaceutical formulation comprising a pharmaceutically acceptable acid addition salt of rotigotine and α-cyclodextrin, preferably in the form of a buffered aqueous solution having a viscosity of 0.5-1.5 mm2/s
Claims18
Liquid intranasal pharmaceutical formulation comprising a pharmaceutically acceptable acid addition salt of rotigotine and α-cyclodextrin.
Intranasal formulation according to any of the preceding claims characterised in that it further contains a viscosity-enhancing substance so as to give a viscosity of 0.5-1.5 mm2/s.
Intranasal formulation according to any of the preceding claims characterised in that it has a pH-value in the range of 5-6.5.
Intranasal formulation according to any of the preceding claims characterised in that it further contains a pharmaceutically acceptable acid for the adjustment of the pH-value.
Intranasal formulation according to any of the preceding claims characterised in that the formulation does not contain a solubility enhancer.
Intranasal formulation according to any of the preceding claims characterised in that it does not contain any preservative.
Intranasal formulation according to any of the preceding claims characterised in that it does not contain any antioxidants.
Intranasal formulation according to any of the preceding claims characterised in that it further contains an absorption enhancer selected from non-ionic surfactants.
Intranasal formulation according to any of the preceding claims characterised in that the pharmaceutically acceptable acid addition salt of rotigotine is rotigotine hydrochloride.
Intranasal formulation according to any of the preceding claims characterised in that it contains 1-6 mg/ml rotigotine-HCL in an aqueous buffered solution.
Intranasal formulation according to any of the preceding claims characterised in that the formulation contains between 0.03 and 0.1 g/ml α-cyclodextrin in the solution.
Intranasal formulation according to any of the preceding claims characterised in that it consists of 2-5 mg/ml rotigotine-HCl, 0.05-0.1 g/ml α-cyclodextrin and 2.2-3% glycerol in phosphate buffered saline (PBS).
Dependencies are inferred from the claim text.