Inhalable dry powder pharmaceutical composition

Patent metadata

Field	Value
Publication number	US-11304992-B2
Application number	US-201916721357-A
Country	US
Kind code	B2
Filing date	Dec 19, 2019
Priority date	Aug 1, 2002
Publication date	Apr 19, 2022
Grant date	Apr 19, 2022

Abstract

A method for treating hyperglycemia and/or diabetes in a subject is provided. In particular, the method is directed for the treatment of patients with type 2 diabetes mellitus who have a fasting blood glucose concentration greater than about 8 mM, wherein the patient is administered a formulation comprising a GLP-1 molecule and a diketopiperazine by pulmonary inhalation with a dry powder inhalation system.

First claim

We claim:

1. An inhalable dry powder pharmaceutical composition comprising microparticles comprising crystalline plates with irregular surfaces of 2,5-diketo-3,6-di(4 fumaryl-aminobutyl)piperazine or a pharmaceutically acceptable salt thereof and an antiviral compound, derivative, or analog thereof wherein the antiviral compound, derivative, or analog thereof is acyclovir or ganclovir.

2. The inhalable dry powder pharmaceutical composition of claim 1 , wherein from about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm.

3. The inhalable dry powder pharmaceutical composition of claim 1 , wherein the antiviral compound, derivative, or analog thereof is manufactured for pulmonary inhalation.

4. The inhalable dry powder pharmaceutical composition of claim 1 , further comprises from about 1% (w/w) to about 75% (w/w) of the antiviral compound, derivative or analog thereof.

5. The inhalable dry powder pharmaceutical composition of claim 1 , wherein the composition further comprises polysorbate 80.

6. The inhalable dry powder pharmaceutical composition of claim 1 , wherein the composition is provided in amounts ranging from about 0.1 mg to about 30 mg.

Assignees

• Mannkind Corp

Inventors

• Costello Donald
• Richardson Peter
• Baughman Robert A
• Marino Mark T

Classifications

• A61K9/0075

  for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K38/26 Primary

  Glucagons · CPC title

• A61K31/4965

  Non-condensed pyrazines · CPC title