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Solid Dispersions Having Stabilized Emulsion Particles Patent Application

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Summary

USPTO published patent application US20260096994A1 for solid dispersion compositions containing active pharmaceutical ingredients and dispersion carriers. The application covers methods of dissolving API with carriers, combining with anti-solvent containing surfactant to form emulsions, and removing solvent to achieve predetermined particle size ranges. The application notably includes Compound (1) (zongertinib).

What changed

USPTO published patent application US20260096994A1 covering methods to prepare solid dispersion compositions comprising active pharmaceutical ingredients and dispersion carriers. The methods involve dissolving API with carrier in solvent, combining with anti-solvent containing surfactant to form emulsions, and removing solvent to generate compositions with predetermined mean particle size. The application covers compositions where API is amorphous and includes Compound (1) (zongertinib).

This patent application establishes prior art in solid dispersion drug delivery technology. Pharmaceutical manufacturers developing amorphous solid dispersions or nanoemulsion-based drug delivery systems should monitor this application as it may affect freedom-to-operate assessments for drug formulations using precipitation or anti-solvent methods to achieve controlled particle sizes.

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Apr 13, 2026

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SOLID DISPERSIONS HAVING STABILIZED EMULSION PARTICLES

Application US20260096994A1 Kind: A1 Apr 09, 2026

Inventors

Michael BRAUN, Tao ZHANG

Abstract

Provided is a method to prepare a solid dispersion composition comprising an active pharmaceutical ingredient (API) and a pharmaceutically acceptable dispersion carrier, which includes (a) dissolving the API and the pharmaceutically acceptable dispersion carrier in a solvent to form a dissolved API/pharmaceutically acceptable dispersion carrier solution; and/or (b) combining the dissolved API/pharmaceutically acceptable dispersion carrier solution and an anti-solvent to form a combination, wherein the anti-solvent comprises a surfactant; and/or (c) mixing the combination to generate an emulsion with a predetermined mean particle size range; and/or (d) removing the solvent from the emulsion to generate the solid dispersion composition, wherein the solid dispersion composition has the predetermined mean particle size range. Preferably, the API in the solid dispersion composition is amorphous. Also provided is an emulsion and/or a solid dispersion composition comprising the API and a dispersion carrier. Also provided is a solid dispersion made by the methods of the invention. In embodiments, the present invention includes Compound (1), also known as zongertinib, and apparatus for continuous processing according to the methods disclosed herein.

CPC Classifications

A61K 9/2095 A61K 9/146 A61K 9/2077 A61K 31/519

Filing Date

2025-10-03

Application No.

19348878

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Last updated

Classification

Agency
USPTO
Published
April 9th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260096994A1

Who this affects

Applies to
Pharmaceutical companies Manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent applications Drug formulation Drug delivery
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Legal
Topics
Pharmaceuticals Healthcare

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