# US 11,304,992 B2 · Inhalable dry powder pharmaceutical composition

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- Number: US 11,304,992 B2
- Document ID: US11304992B2
- Status: Granted
- Kind: B2
- Application number: 16/721,357
- Filed: 2019-12-19
- Published: 2020-05-14
- Granted: 2022-04-19
- Earliest claimed: 2002-08-01
- Assignees: MannKind Corporation
- Applicants: MannKind Corporation
- Inventors: Donald Costello; Peter Richardson; Robert A. Baughman; Mark T. Marino
- Web page: https://patentgrep.com/patent/US11304992B2

## CPC

- A61K 38/26: Glucagons
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 31/4965: Non-condensed pyrazines
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/26: 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
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## 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.

## Claims

### 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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.