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Patent Application: Solid Medicinal Forms with Stabilised Active Ingredient

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Published March 26th, 2026
Detected March 26th, 2026
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Summary

The USPTO has published a new patent application (US20260083677A1) from Astellas Pharma Inc. The application describes solid medicinal forms containing active ingredients stabilized with specific drying agents, aiming for reduced moisture content. This is a new patent filing, not a regulatory rule or guidance.

What changed

This document is a new patent application (US20260083677A1) filed by Astellas Pharma Inc. with the USPTO. The application details a novel solid medicinal form that includes at least one active ingredient and a pharmaceutically compatible, water-soluble drying agent, such as trimagnesium dicitrate or calcium chloride. Key characteristics of the claimed form include a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less, with a specific focus on formulations containing moisture-sensitive active ingredients.

This filing does not impose new regulatory obligations on pharmaceutical companies. However, it represents a new intellectual property filing that could impact future drug development and manufacturing processes within the pharmaceutical sector. Companies involved in drug formulation and stability research should be aware of this patent application as it may relate to their own product development and patent strategies.

Source document (simplified)

← USPTO Patent Applications

ACTIVE INGREDIENT CONTAINING STABILISED SOLID MEDICINAL FORMS AND METHODS FOR THE PRODUCTION THEREOF

Application US20260083677A1 Kind: A1 Mar 26, 2026

Assignee

ASTELLAS PHARMA INC.

Inventors

Peter GRUBER, Dirk SPICKERMANN

Abstract

The invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.

CPC Classifications

A61K 9/2009 A61K 9/1611

Filing Date

2025-04-25

Application No.

19190525

View original document →

Classification

Agency
USPTO
Published
March 26th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260083677A1

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Formulation Intellectual Property Filing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Legal
Topics
Drug Formulation Intellectual Property

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