Stable Oral Suspensions of Baclofen for Niche Environments

Publication ID: 24-11857524_0004_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Stable Oral Suspensions of Baclofen for Niche Environments,” Published Technical Disclosure No. 24-11857524_0004_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857524_0004_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

Adaptations of stable oral suspensions of baclofen for specific, high-stress operational environments, ensuring reliable delivery of the medication in emergency situations, high-security facilities, disaster relief, and extreme weather conditions.

Background and Problem Solved

The original patent for stable oral suspensions of baclofen provided a significant advancement in the field of pharmaceutical compositions. However, it did not address the specific challenges of administering baclofen in niche environments, such as emergency situations, high-security facilities, disaster relief, and extreme weather conditions, where the suspension's stability and performance are critical. The new inventive concept addresses these limitations by providing specialized variations of the oral suspension tailored to these unique operational environments.

Detailed Description of the Inventive Concept

The new inventive concept comprises four specialized variations of the stable oral suspension of baclofen: (1) a system for providing stable oral suspensions in emergency situations, featuring a portable container and a stabilizer composition designed for extreme temperatures; (2) a method for preparing a stable oral suspension for use in disaster relief, involving mixing and packaging in a portable, tamper-evident container; (3) a stable oral suspension for use in high-security facilities, formulated to be tamper-resistant and detectable by security screening methods; and (4) a kit for preparing a stable oral suspension in remote or resource-limited areas, comprising pre-measured amounts of baclofen, a stabilizer composition, and a liquid vehicle, along with instructions for mixing and administering the suspension. Each variation is designed to ensure the reliable delivery of baclofen in its respective niche environment.

Novelty and Inventive Step

The new inventive concept's novelty lies in its adaptation of the original patent's stable oral suspension of baclofen to specific, high-stress operational environments. The inventive step is the recognition of the need for specialized variations of the oral suspension to address the unique challenges of these environments, and the provision of tailored solutions that ensure the reliable delivery of baclofen in these contexts.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include variations of the portable container, stabilizer composition, and liquid vehicle to accommodate different environmental conditions or operational requirements. Additionally, the concept could be extended to other pharmaceutical compositions or medications that require specialized formulations for niche environments.

Potential Commercial Applications and Market

The new inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the areas of emergency response, disaster relief, and high-security facilities. The market for specialized pharmaceutical formulations is growing, driven by the increasing need for reliable and effective medications in a variety of operational environments.

Field of Art

Pharmaceutical formulation and drug delivery systems, specifically focusing on liquid pharmaceutical suspensions with emphasis on stability, concentration, and specialized environmental adaptations

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical formulation scientist with expertise in drug suspension preparation, stability testing, excipient selection, and packaging design for various environmental conditions, holding at least a Master's degree in pharmaceutical sciences or related field

Obviousness Rationale

A PHOSITA would recognize that the source patent's stable baclofen suspension provides a foundational framework that can be readily adapted to specific environmental challenges through routine pharmaceutical engineering techniques. The PTD's variations represent predictable extensions of the original patent's core teachings about suspension stability, utilizing standard formulation strategies to address niche operational requirements. The modifications involve known pharmaceutical techniques such as selecting appropriate stabilizers, designing specialized containers, and adjusting formulation parameters to meet specific environmental constraints.

Obvious Combinations & Variations

Source Patent Element
Stable liquid suspension with stabilizers and pharmaceutically acceptable excipients
PTD Variation
Specialized stabilizer compositions for extreme temperatures and emergency situations
Obviousness Reasoning
A PHOSITA would recognize that modifying stabilizer compositions to address temperature variations is a predictable design choice within pharmaceutical formulation practices, using known techniques for thermal stability enhancement
Source Patent Element
Aqueous suspension with pH range between 4 to 8
PTD Variation
Tamper-resistant formulation for high-security facilities with security screening compatibility
Obviousness Reasoning
Adapting the base suspension to include security-specific characteristics represents an obvious application of known pharmaceutical formulation principles, involving routine modifications to existing suspension design
Source Patent Element
Ready-to-use suspension with multiple excipients
PTD Variation
Portable kit for preparing suspension in remote or resource-limited areas
Obviousness Reasoning
Creating a modular preparation system using the established suspension framework is an obvious solution for expanding medication accessibility, utilizing standard pharmaceutical packaging and preparation techniques
Source Patent Element
Suspension with antifoaming agent like simethicone emulsion
PTD Variation
Specialized containers with thermal insulation for extreme weather conditions
Obviousness Reasoning
Developing container technologies to complement existing suspension formulations represents a predictable engineering solution for maintaining drug stability across diverse environmental conditions
Source Patent Element
Stable liquid pharmaceutical composition with concentration of 2 mg/mL or more
PTD Variation
Tamper-evident packaging for disaster relief applications
Obviousness Reasoning
Implementing packaging innovations to protect medication integrity is a standard pharmaceutical engineering approach that would be obvious to a skilled practitioner familiar with suspension stability requirements
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857524 and the disclosed variations, a person of ordinary skill in the art would find the proposed technical adaptations of stable baclofen suspensions to be obvious extensions of the prior art, representing predictable applications of known pharmaceutical formulation and packaging techniques to address specific environmental challenges.

Original Patent Information

Patent NumberUS 11,857,524
TitleStable oral suspensions of baclofen
Assignee(s)ANI Pharmaceuticals, Inc.