US 10,376,466 B2
Method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
Bryan R. Wilson, Brewster, NY (US); and Marshall Grant, Newtown, CT (US)
Assigned to MannKind Corporation, Valencia, CA (US)
Filed by MannKind Corporation, Valencia, CA (US)
Filed on Oct. 4, 2018, as Appl. No. 16/151,707.
Application 16/151,707 is a division of application No. 14/971,785, filed on Dec. 16, 2015, granted, now 10,130,581.
Application 14/971,785 is a continuation of application No. 13/942,482, filed on Jul. 15, 2013, granted, now 9,241,903.
Application 13/942,482 is a continuation of application No. 13/239,696, filed on Sep. 22, 2011, granted, now 8,512,932, issued on Aug. 20, 2013.
Application 13/239,696 is a continuation of application No. 11/678,046, filed on Feb. 22, 2007, granted, now 8,039,431, issued on Oct. 18, 2011.
Claims priority of provisional application 60/776,605, filed on Feb. 22, 2006.
Prior Publication US 2019/0029954 A1, Jan. 31, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/495 (2006.01); A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 9/16 (2006.01); A61K 38/28 (2006.01)
CPC A61K 9/0075 (2013.01) [A61K 9/145 (2013.01); A61K 9/1617 (2013.01); A61K 9/1694 (2013.01); A61K 38/28 (2013.01)] 6 Claims
1. A method for delivering an active agent to a patient in need thereof using a reusable inhaler, comprising administering by inhalation to the patient an effective amount of a dry powder medicant; wherein said dry powder medicament exhibits an improved pharmaceutic property, and whose formulation comprises the following steps: a) a step for forming microparticles comprising a diketopiperazine with acidic or basic side chains, resulting in a suspension of microparticles of the diketopiperazine with acidic or basic side chains in a solvent, and a step for loading said microparticles with an active agent, then b) removing solvent by spray drying to obtain a dry powder, wherein the dry powder has an improved pharmaceutic property as compared to a dry powder obtained by removing solvent by lyophilization, and wherein the improved pharmaceutic property is increased density of the powder, increased aerodynamic performance of the powder, or improved stability of the active agent, if present.