Advanced Stable Oral Suspensions of Baclofen
Legal Citation
Summary of the Inventive Concept
The present invention provides novel improvements to stable oral suspensions of baclofen, enhancing their stability, efficiency, and user experience. The inventive concept introduces a system, method, and composition that address the limitations of existing baclofen suspensions, offering better control over pH, viscosity, and metal ion removal.
Background and Problem Solved
The original patent disclosed stable oral suspensions of baclofen, but it had limitations in terms of pH control, viscosity, and metal ion removal. The present inventive concept solves these problems by introducing a system for stabilizing oral suspensions, a method for preparing stable suspensions, and a composition with improved viscosity and metal ion removal properties.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for stabilizing oral suspensions of baclofen, which includes a container filled with a therapeutically effective amount of baclofen, a stabilizer dispenser that selectively releases at least one stabilizer, and a pH controller that adjusts the pH of the suspension to a predetermined range. The method for preparing a stable oral suspension involves mixing a therapeutically effective amount of baclofen with at least one stabilizer and adding a pH adjusting agent to achieve a pH between about 4 to about 8. The composition includes a therapeutically effective amount of baclofen, at least one stabilizer, and a viscosity modifier that maintains a predetermined viscosity over a range of temperatures.
Novelty and Inventive Step
The new claims introduce a novel system, method, and composition that overcome the limitations of the original patent. The inventive step lies in the integration of a stabilizer dispenser, pH controller, and viscosity modifier, which provides a more efficient, safer, and user-friendly solution for stable oral suspensions of baclofen.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different types of containers, stabilizers, and pH controllers. Variations of the method may involve different mixing protocols, temperatures, and pH ranges. The composition may also be modified to include additional excipients or different viscosity modifiers.
Potential Commercial Applications and Market
The advanced stable oral suspensions of baclofen have significant commercial potential in the pharmaceutical industry, particularly in the treatment of spasticity, muscle spasms, and other conditions. The target market includes patients, caregivers, and healthcare professionals seeking more efficient, safer, and user-friendly solutions for baclofen administration.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and drug delivery, specifically liquid pharmaceutical suspensions with a focus on neurological medication stabilization techniques
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation scientist with expertise in drug suspension preparation, stability testing, excipient selection, and pharmaceutical manufacturing processes, typically holding a PhD or equivalent industrial experience in pharmaceutical sciences
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable engineering solutions to known challenges in baclofen suspension stability. The disclosed system for selective stabilizer release, pH control, and viscosity modification are logical extensions of the source patent's core teachings about creating stable liquid baclofen formulations. These variations represent routine optimization techniques well within the ordinary skill of a pharmaceutical formulation expert.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,524 |
|---|---|
| Title | Stable oral suspensions of baclofen |
| Assignee(s) | ANI Pharmaceuticals, Inc. |