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Lamotrigine Salts, Co-crystals, and Compositions Patent Application

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Published February 14th, 2025
Detected March 26th, 2026
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Summary

The USPTO has published a patent application (US20260083745A1) for lamotrigine oral suspension and its preparation method, filed by Azurity Pharmaceuticals Ireland Limited. The application details a formulation designed to improve the stability and redispersibility of lamotrigine suspensions.

What changed

This document is a USPTO patent application (US20260083745A1) for a lamotrigine oral suspension and its preparation method, filed by Azurity Pharmaceuticals Ireland Limited. The application describes a formulation utilizing specific pharmaceutical adjuvants, including suspending aids and wetting agents like hydroxypropyl methylcellulose, glycerin, and Tween 80, to enhance the stability and redispersibility of the lamotrigine active pharmaceutical ingredient (API).

As this is a patent application, it does not impose direct compliance obligations on regulated entities. However, it is relevant for pharmaceutical companies involved in drug formulation and development, particularly those working with lamotrigine or similar oral suspensions. Companies should be aware of this filing as it pertains to intellectual property in the pharmaceutical sector.

Source document (simplified)

← USPTO Patent Applications

LAMOTRIGINE SALTS, CO-CRYSTALS, AND COMPOSITIONS

Application US20260083745A1 Kind: A1 Mar 26, 2026

Assignee

Azurity Pharmaceuticals Ireland Limited

Inventors

Jordan R. Hunt, Gerold Mosher, Paras P. Jain, Krishna Mohan Lakshmipathula

Abstract

The invention discloses a lamotrigine oral suspension and a preparation method thereof, the lamotrigine oral suspension is composed of lamotrigine and other pharmaceutic adjuvants, the pharmaceutic adjuvants are composed of a suspending aid, a wetting agent, a bacteriostatic agent, a flavoring agent, a defoaming agent, a pH regulator and a solvent, and the wetting agent is hydroxypropyl methylcellulose, glycerin, Tween 80 and the like. According to the invention, the suspending aid is adopted to increase the liquid viscosity and improve the stability of the suspension, and the wetting agent is adopted to improve the hydrophobicity of API, so that the stability and redispersibility of the suspension are improved, and the preparation process is simple and suitable for industrial mass production.

CPC Classifications

A61K 31/53 C07C 57/15 C07D 253/075

Filing Date

2025-02-14

Application No.

19053770

View original document →

Named provisions

Abstract

Classification

Agency
USPTO
Published
February 14th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260083745A1

Who this affects

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

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Research & Development
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Drug Development Intellectual Property

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