Enhanced Stable Oral Suspensions of Baclofen

Publication ID: 24-11857524_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Stable Oral Suspensions of Baclofen,” Published Technical Disclosure No. 24-11857524_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857524_0001_PTD

This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,524.

Summary of the Inventive Concept

The present inventive concept provides improved oral suspensions of baclofen, overcoming the limitations of existing formulations by enhancing stability, shelf-life, and usability.

Background and Problem Solved

The original patent disclosed stable oral suspensions of baclofen, but the formulations may still be susceptible to degradation, oxidation, and viscosity issues. The present inventive concept addresses these limitations by introducing novel components and methods to improve the overall performance of baclofen suspensions.

Detailed Description of the Inventive Concept

The new claims introduce a system for stabilizing oral suspensions of baclofen by controlling the atmosphere, adding antioxidants, and using pH-adjusting agents. Additionally, the inventive concept includes methods for improving shelf-life, reducing viscosity, and preparing stable suspensions. These innovations enable the creation of more robust and user-friendly oral suspensions of baclofen.

Novelty and Inventive Step

The present inventive concept's novelty lies in the combination of controlled atmosphere storage, antioxidant addition, and pH-adjusting agents, which provide a synergistic effect in enhancing the stability and shelf-life of baclofen suspensions. The inventive step is the recognition of the need to address the limitations of existing formulations and the development of these novel solutions.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different antioxidants, pH-adjusting agents, or solubilizers. Variations could also involve different container materials, storage conditions, or mixing protocols to further optimize the performance of the oral suspensions.

Potential Commercial Applications and Market

The enhanced stable oral suspensions of baclofen have significant commercial potential in the pharmaceutical industry, particularly in the treatment of spasticity and other muscle-related disorders. The improved formulations could also expand into new markets, such as pediatric or geriatric care, where ease of use and stability are critical factors.

CPC Classifications

Section	Class	Group
A	A61	A61K31/197
A	A61	A61K9/0053
A	A61	A61K9/10

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Pharmaceutical formulation and drug delivery, specifically focusing on liquid oral suspensions of neurological medications, with expertise in pharmaceutical chemistry, stability testing, and suspension preparation techniques

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical formulation scientist with advanced degree (MS/PhD) in pharmaceutical sciences, experience in drug stability, excipient selection, and suspension preparation, familiar with techniques for enhancing pharmaceutical product stability and performance

Obviousness Rationale

A PHOSITA would recognize that the PTD's variations represent predictable engineering solutions to known challenges in baclofen suspension stability. The disclosed modifications of controlled atmosphere, antioxidant addition, and pH adjustment are standard pharmaceutical formulation techniques for addressing drug degradation and suspension performance. These variations represent incremental improvements that would be obvious to a skilled practitioner seeking to optimize the existing baclofen suspension technology.

Obvious Combinations & Variations

Source Patent Element

Stable liquid suspension of baclofen with pharmaceutically acceptable excipients

PTD Variation

Adding controlled atmosphere storage with humidity control

Obviousness Reasoning

Humidity control is a known technique for preventing pharmaceutical degradation, representing a predictable solution to extend suspension stability

Source Patent Element

Suspension with pH between 4 to 8

PTD Variation

Narrowing pH range to 5.5 to 6.5 with specific pH-adjusting agents

Obviousness Reasoning

Precise pH optimization is a routine formulation design choice to improve drug stability and performance

Source Patent Element

Suspension including pharmaceutically acceptable excipients

PTD Variation

Adding antioxidants and UV-resistant packaging

Obviousness Reasoning

Preventing oxidative degradation through standard pharmaceutical preservation techniques represents a known approach to improving drug product shelf-life

Source Patent Element

Aqueous suspension of baclofen

PTD Variation

Introducing solubilizers to reduce viscosity

Obviousness Reasoning

Viscosity modification through solubilizer addition is a standard pharmaceutical formulation technique for improving suspension properties

Source Patent Element

Suspension with stabilizers and liquid vehicle

PTD Variation

Creating a preparation kit with mixing instructions

Obviousness Reasoning

Providing user-friendly preparation instructions is an obvious extension of pharmaceutical product design to improve patient usability

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857524 and the disclosed variations, a person of ordinary skill in pharmaceutical formulation would find the claimed innovations obvious. The PTD demonstrates that the proposed modifications represent predictable engineering solutions using known pharmaceutical techniques, thereby rendering subsequent claims of novelty invalid under 35 U.S.C. § 103.

Original Patent Information

Patent Number	US 11,857,524
Title	Stable oral suspensions of baclofen
Assignee(s)	ANI Pharmaceuticals, Inc.