Enhanced Venglustat-Based Pharmaceutical Compositions for Improved Efficacy and Patient Compliance
Legal Citation
Summary of the Inventive Concept
The present disclosure relates to novel venglustat-based pharmaceutical compositions and systems that address the limitations of existing formulations, providing improved physical and chemical stability, enhanced bioavailability, and better patient compliance.
Background and Problem Solved
The original patent disclosed pharmaceutical compositions comprising venglustat, but these compositions have inherent limitations, such as poor physical and chemical stability, low bioavailability, and unpleasant taste. The present inventive concept solves these problems by introducing novel formulations, excipients, and delivery systems that improve the overall performance of venglustat-based pharmaceuticals.
Detailed Description of the Inventive Concept
The new inventive concept comprises five distinct aspects. Firstly, a chewable tablet formulation with improved physical and chemical stability and reduced chewing difficulty index. Secondly, a novel excipient blend that enhances the dissolution rate of venglustat. Thirdly, a pH-dependent coating that facilitates targeted release of the active ingredient in the gastrointestinal tract. Fourthly, a novel taste-masking agent that reduces the bitterness of venglustat. Lastly, a system for monitoring and controlling the release of venglustat from an oral pharmaceutical composition, comprising a sensor that detects the pH of the gastrointestinal tract and adjusts the release rate of the active ingredient accordingly.
Novelty and Inventive Step
The present inventive concept introduces novel and non-obvious solutions to the limitations of existing venglustat-based pharmaceutical compositions. The combination of a chewable tablet formulation, novel excipient blend, pH-dependent coating, taste-masking agent, and pH-sensing release control system provides a unique and innovative approach to improving the efficacy and patient compliance of venglustat-based treatments.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different excipient blends, coating materials, or taste-masking agents. Additionally, the pH-sensing release control system could be adapted for use with other oral pharmaceutical compositions. Variations of the chewable tablet formulation may include different shapes, sizes, or flavors to improve patient compliance.
Potential Commercial Applications and Market
The present inventive concept has significant commercial potential in the treatment of Fabry disease and other lysosomal storage disorders. The improved efficacy, safety, and patient compliance of the novel venglustat-based pharmaceutical compositions could lead to increased market share and revenue growth in the pharmaceutical industry.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K31/439 |
| A | A61 | A61K9/0053 |
| A | A61 | A61K9/2009 |
| A | A61 | A61K9/2013 |
| A | A61 | A61K9/2018 |
| A | A61 | A61K9/2095 |
| A | A61 | A61K9/485 |
| A | A61 | A61K9/4833 |
| A | A61 | A61K9/4858 |
| A | A61 | A61K9/4866 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and drug delivery systems, specifically focusing on oral pharmaceutical compositions for enzyme inhibitors like venglustat, with expertise in tablet design, excipient selection, and controlled release technologies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation scientist with advanced degree (PhD or equivalent) in pharmaceutical sciences, experienced in drug delivery system design, tablet manufacturing, and excipient optimization, with knowledge of oral drug formulation techniques and patient compliance strategies
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent standard pharmaceutical formulation optimization techniques applied to the venglustat composition disclosed in the source patent. The proposed modifications such as chewable tablet design, excipient blend optimization, pH-dependent coating, and taste-masking are well-established pharmaceutical engineering approaches for improving drug delivery and patient acceptability. These variations would be considered predictable extensions of known pharmaceutical formulation strategies within the existing technological framework.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,512 |
|---|---|
| Title | Pharmaceutical compositions comprising venglustat |
| Assignee(s) | Genzyme Corporation |