Patent ID: 11872314
Assignee: SHIN NIPPON BIOMEDICAL LABORATORIES, LTD.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A

Claim 0:
1. A method, comprising intranasally administering to a subject an intranasal pharmaceutical powder composition, wherein the intranasal pharmaceutical powder composition comprises particles that comprise an active agent, a carrier, and at least one member selected from the group consisting of a thickening agent, a pH adjusting agent, a sugar alcohol, and any combination thereof, and wherein:
the active agent comprises dihydroergotamine (DHE) or a pharmaceutically acceptable salt thereof, indomethacin or a pharmaceutically acceptable salt thereof, or testosterone or a pharmaceutically acceptable salt thereof;
the carrier comprises a microcrystalline cellulose, wherein the microcrystalline cellulose is at least partially coated with the active agent;
at least about 20 percent by weight of the active agent in the particles is amorphous as determined by X-ray diffraction;
wherein the particles are prepared by spray-drying with the microcrystalline cellulose;
when the active agent has a crystalline form, a solubility of the active agent in a crystalline form in an aqueous liquid ranges from about 0.1 μg/mL to about 1 mg/mL in water at a temperature of 37±0.5° C.;
the particles have an average particle size of from about 10 microns to about 300 microns, as measured by laser diffraction; and
the administering improves a pharmacokinetic parameter of the active agent by at least about 15%, compared to an intranasal administration of a corresponding composition that comprises the active agent in a crystalline form when administered intranasally to a comparable human subject, as measured by a same method, and wherein the pharmacokinetic parameter comprises AUC0-10 min, AUC0-15 min, AUC0-30 min, Cmax, or any combination thereof.