Claims for Patent: 9,066,957

Summary for Patent: 9,066,957

Title:	Dry powder inhaler
Abstract:	This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 .mu.g; and wherein the dose provides a baseline-adjusted FEV.sub.1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 .mu.g; and wherein the dose provides a baseline-adjusted FEV.sub.1 in a patient of more than 150 mL within 30 minutes of receiving the dose.
Inventor(s):	Dalvi; Mukul (Miami, FL), Tee; Seah Kee (Miami, FL)
Assignee:	TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. (Horsham, PA)
Application Number:	14/507,210
Patent Claims:	1. A dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 .mu.g; and wherein the dose provides a baseline-adjusted FEV.sub.1 in a patient of more than 150 mL within 30 minutes of receiving the dose. 2. The inhaler as claimed in claim 1, wherein the baseline-adjusted FEV.sub.1 remains above 150 mL for at least 6 hours after receiving the dose. 3. The inhaler as claimed in claim 1, wherein the dose of salmeterol is less than 25 .mu.g. 4. The inhaler as claimed in claim 3, wherein the doses of fluticasone/salmeterol in .mu.g are 500/12.5, 400/12.5, 250/12.5, 200/12.5, 100/12.5, 50/12.5 or 25/12.5 per actuation. 5. The inhaler as claimed in claim 1, wherein the particle size of the fluticasone propionate is d10=0.4-1.1 .mu.m, d50=11.1-3.0 .mu.m, d90=2.6-7.5 .mu.m and NLT95%<10 .mu.m, measured by laser diffraction as an aqueous dispersion. 6. The inhaler as claimed in claim 1, wherein the particle size of the salmeterol xinafoate is d10=0.4-1.3 .mu.m, d50=1.4-3.0 .mu.m, d90=2.4-6.5 .mu.m and NLT95%<10 .mu.m, measured by laser diffraction as an aqueous dispersion. 7. The inhaler as claimed in claim 1, wherein the lactose carrier is composed of a coarse lactose and fine lactose, wherein the fine lactose is defined by a particle size of <10 .mu.m, measured by laser diffraction as a dispersion in air. 8. The inhaler as claimed in claim 7, wherein the lactose contains 1-10 wt % of fine lactose. 9. The inhaler as claimed in claim 1, wherein the lactose particle size is d10=15-50 .mu.m, d50=80-120 .mu.m, d90=120-200 .mu.m. 10. The inhaler as claimed in claim 1, wherein the inhaler comprises a cyclone deagglomerator for breaking up agglomerates of the dry powder. 11. The inhaler as claimed in claim 10, wherein the deagglomerator comprises: an inner wall defining a swirl chamber extending along an axis from a first end to a second end; a dry powder supply port in the first end of the swirl chamber for providing fluid communication between a dry powder delivery passageway of the inhaler and the first end of the swirl chamber; at least one inlet port in the inner wall of the swirl chamber adjacent to the first end of the swirl chamber providing fluid communication between a region exterior to the deagglomerator and the first end of the swirl chamber; an outlet port providing fluid communication between the second end of the swirl chamber and a region exterior to the deagglomerator; and vanes at the first end of the swirl chamber extending at least in part radially outwardly from the axis of the chamber, each of the vanes having an oblique surface facing at least in part in a direction transverse to the axis; whereby a breath induced low pressure at the outlet port causes air flows into the swirl chamber through the dry powder supply port and the inlet port. 12. The inhaler as claimed in claim 1, wherein the inhaler comprises a reservoir for containing the medicament and an arrangement for delivering a metered dose of the medicament from the reservoir. 13. The inhaler as claimed in claim 1, wherein the inhaler comprises a delivery passageway for directing an inhalation-induced air flow through a mouthpiece, a channel extending from the delivery passageway to the medicament. 14. The inhaler as claimed in claim 1, comprising: a sealed reservoir including a dispensing port; a channel communicating with the dispensing port and including a pressure relief port; a conduit providing fluid communication between an interior of the sealed reservoir and the pressure relief port of the channel; and a cup assembly movably received in the channel and including, a recess adapted to receive medicament when aligned with the dispensing port, a first sealing surface adapted to seal the dispensing port when the recess is unaligned with the dispensing port, and a second sealing surface adapted to sealing the pressure relief port when the recess is aligned with the dispensing port and unseal the pressure relief port when the recess is unaligned with the dispensing port. 15. The inhaler as claimed in claim 1 for the treatment of asthma or COPD. 16. A method for the treatment of asthma or allergic rhinitis or COPD comprising administering to a patient a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 .mu.g; and wherein the dose provides a baseline-adjusted FEV.sub.1 in a patient of more than 150 mL within 30 minutes of receiving the dose. 17. The method as claimed in claim 16, wherein the dose of salmeterol is less than 25 .mu.g. 18. The inhaler as claimed in claim 16, wherein the dose of fluticasone/salmeterol in .mu.g is 500/12.5, 400/12.5, 250/12.5, 200/12.5, 100/12.5, 50/12.5 or 25/12.5 per actuation. 19. A method of measuring a delivered dose of active agent by an inhaler comprising: inserting the inhaler into a mouthpiece adapter; actuating the inhaler to provide a delivered dose through the mouthpiece adapter and into a dosage unit sampling apparatus; rinsing the mouthpiece adapter with a solvent and into the dosage unit sampling apparatus; dissolving the delivered dose in the dosage unit sampling apparatus; filtering the dissolved delivered dose to provide a filtered solution; and analyzing the filtered solution to determine the amount of the active agent in the delivered dose. 20. The method as claimed in claim 19, wherein the method is carried out at the beginning, the middle and the end of the life of the inhaler.