Personalized and Adaptive Oral Suspensions of Baclofen
Legal Citation
Summary of the Inventive Concept
A next-generation system for generating customized oral suspensions of baclofen, leveraging advanced formulation engines, real-time monitoring, and digital twins to ensure optimal stability and efficacy.
Background and Problem Solved
The original patent provides stable oral suspensions of baclofen, but it has limitations in terms of customization and adaptability to individual patient needs. The new inventive concept addresses these limitations by introducing a system that can generate personalized oral suspensions, predict stability, and optimize formulation parameters.
Detailed Description of the Inventive Concept
The system comprises a database of patient-specific data, a formulation engine that selects a customized formulation based on the patient-specific data, and a manufacturing module that produces the customized oral suspension. Additionally, the system includes a method for predicting the stability of the oral suspension, a device for real-time monitoring of the pH and concentration, and a computer-implemented system for optimizing the formulation parameters. A digital twin of the oral suspension can also be created to simulate its behavior under different conditions.
Novelty and Inventive Step
The new inventive concept introduces a paradigm shift in the development of oral suspensions of baclofen, moving from a one-size-fits-all approach to a personalized and adaptive system. The use of advanced formulation engines, real-time monitoring, and digital twins is novel and non-obvious compared to the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the system could include the use of machine learning algorithms to optimize the formulation parameters, integration with electronic health records to access patient-specific data, or the development of a portable device for real-time monitoring. Variations of the system could be applied to other pharmaceutical compounds or therapeutic areas.
Potential Commercial Applications and Market
The personalized and adaptive oral suspensions of baclofen system has significant commercial potential in the pharmaceutical industry, particularly in the areas of precision medicine and personalized healthcare. The system could be marketed to pharmaceutical companies, hospitals, and clinics, and could also be used in clinical trials and research settings.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and drug delivery systems, with expertise in liquid pharmaceutical compositions, suspension technologies, and personalized medicine approaches
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with advanced degrees in pharmaceutical engineering or chemistry, experienced in drug formulation, stability analysis, and advanced manufacturing techniques, familiar with digital health technologies and personalized medicine approaches
Obviousness Rationale
A PHOSITA would recognize that the personalized suspension system represents a predictable extension of existing pharmaceutical formulation techniques, applying known digital technologies to enhance the core suspension technology disclosed in the source patent. The fundamental principles of baclofen suspension stability are preserved while introducing computational and adaptive methodologies that are well-established in pharmaceutical engineering.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,524 |
|---|---|
| Title | Stable oral suspensions of baclofen |
| Assignee(s) | ANI Pharmaceuticals, Inc. |