Patent Application: Solid Medicinal Forms with Stabilised Active Ingredient
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)
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
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