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Patent Application: Inhalation Formulation for Treating IPF Disease

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Summary

The USPTO has published a patent application (US20260083702A1) detailing an inhalation formulation for treating Idiopathic Pulmonary Fibrosis (IPF) disease. The application describes formulations using specific drugs like apremilast and roflumilast, aiming to improve bioavailability and clinical efficacy compared to oral administration.

What changed

This document is a published patent application from the USPTO, not a regulatory rule or guidance. It describes an "Inhalation formulation for treating IPF disease and preparation method therefor" filed under application number US20260083702A1. The application details various inhalation formulations (aerosol, dry powder, soft mist) containing active drugs such as apremilast, ibudilast, roflumilast, crisaborole, and difamilast, intended to treat Idiopathic Pulmonary Fibrosis (IPF).

As a patent application, it does not impose direct compliance obligations on regulated entities. However, it signifies potential future intellectual property in the pharmaceutical sector related to IPF treatments. Companies involved in drug development or manufacturing for respiratory diseases should be aware of this filing as it may impact their research, development, and patent strategies in this therapeutic area.

Source document (simplified)

← USPTO Patent Applications

INHALATION FORMULATION FOR TREATING IPF DISEASE AND PREPARATION METHOD THEREFOR

Application US20260083702A1 Kind: A1 Mar 26, 2026

Inventors

Kaiqi Shi, Qingzhen Zhang, Fangyan Wang, Xunxun Liu, Riwei Yang, Xiujie Liu, Yingliang Ma, Jingxu Zhu

Abstract

An inhalation formulation for treating an IPF disease. The inhalation formulation is an aerosol inhalation liquid formulation, an inhalation aerosol, a dry powder inhaler or a soft mist inhaler. The inhalation formulation contains an active drug, and the active drug is any one of apremilast, ibudilast, roflumilast, crisaborole, and difamilast. A preparation process for the inhalation formulation is introduced into a conventional formulation. An active component in a conventional oral formulation is prone to being destroyed in the digestive tract, and has low bioavailability, a liver first pass effect, and a slow onset of action. An inhalation formulation capable of significantly alleviating IPF is prepared. Tests prove that the prepared inhalation formulation can effectively increase the bioavailability, and improve the clinical use effect.

CPC Classifications

A61K 31/4035 A61K 9/0075 A61K 9/0078 A61K 9/008 A61K 9/08 A61K 9/1623 A61K 9/1694 A61K 31/421 A61K 31/437 A61K 31/44 A61K 31/69 A61K 47/02 A61K 47/10 A61K 47/12 A61K 47/183 A61K 47/26 A61P 11/00

Filing Date

2025-12-03

Application No.

19407845

View original document →

Classification

Agency
USPTO
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
US20260083702A1

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Development Pharmaceutical Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Legal
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Drug Development Medical Devices

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