Use of higher doses of modified release huperzine formulations
AssigneeBiscayne Neurotherapeutics, Inc.
InventorsStephen D. Collins, Peter J. Goldstein, Joshua T. Johnstone
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Abstract
The present application discloses pharmaceutical compositions and methods of treating neurological disorders and seizure disorders with the high dose modified release compositions of huperzine. The pharmaceutical compositions and methods described herein, allow for higher dosing of huperzine, while avoiding rapid peak plasma levels, thereby avoiding the dose-limiting adverse events associated with the immediate release formulations.
Claims11
A method of treating a disorder selected from a neurological disorder or a seizure disorder, comprising orally administering to a patient in need thereof a composition comprising a therapeutically acceptable amount of huperzine, said pharmaceutical composition comprising:
- 74 weight % to 86 weight % of a sugar sphere core wherein the sugar sphere core has a particle size of 500-710 μm;
- a huperzine layer coating the sugar sphere, wherein the huperzine layer comprises 0.4 to 1 weight % huperzine or a pharmaceutically acceptable salt of huperzine that is equivalent to 0.95% to 1 weight % huperzine, and one or more excipients, wherein the total amount of excipients is 5 weight % to 9 weight %;
- 7 weight % to 16 weight % of a plasticized ethyl cellulose polymer layer coating the huperzine layer, wherein the huperzine layer contains a therapeutically effective amount of huperzine;
- and
- wherein the therapeutically effective amount of huperzine is a twice a day dose of from 3.0 mg to a maximum tolerated dose.
Dependencies are inferred from the claim text.