Enhanced Venglustat Pharmaceutical Compositions and Manufacturing Processes
Legal Citation
Summary of the Inventive Concept
The present inventive concept relates to novel pharmaceutical compositions and manufacturing processes of venglustat, providing improved bioavailability, reduced dosing frequency, and enhanced patient compliance.
Background and Problem Solved
The original patent disclosed pharmaceutical compositions comprising venglustat, but it had limitations in terms of bioavailability and patient compliance. The present inventive concept addresses these limitations by introducing controlled release oral dosage forms, taste-masking agents, and wearable devices for monitoring patient compliance.
Detailed Description of the Inventive Concept
The inventive concept comprises five key aspects: (1) a controlled release oral dosage form using a pH-dependent coating and a matrix forming excipient, (2) a chewable tablet with a taste-masking agent, (3) a system for monitoring patient compliance using a wearable device, (4) a novel granulation step in the manufacturing process, and (5) a pharmaceutical composition with a bioavailability enhancer. These aspects work together to provide improved bioavailability, reduced dosing frequency, and enhanced patient compliance.
Novelty and Inventive Step
The present inventive concept introduces a novel combination of a pH-dependent coating and a matrix forming excipient, a wearable device for monitoring patient compliance, and a bioavailability enhancer, which are not disclosed in the original patent. These features provide a non-obvious solution to the limitations of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include different types of controlled release mechanisms, such as osmotic pumps or diffusion-controlled systems. Additionally, the wearable device could be replaced with a mobile application or a web-based platform for monitoring patient compliance.
Potential Commercial Applications and Market
The inventive concept has potential commercial applications in the treatment of Fabry disease and other lysosomal storage disorders. The market for venglustat is expected to grow significantly in the coming years, and the present inventive concept could capture a significant share of this market.
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 dosage forms of enzyme inhibitor compounds like venglustat, with expertise in pharmaceutical manufacturing, drug formulation, and patient compliance technologies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or formulation engineer with advanced degree (PhD/PharmD), 5-10 years experience in drug delivery, knowledge of controlled release technologies, excipient interactions, and patient-centric drug design strategies
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's pharmaceutical composition teachings, utilizing standard pharmaceutical engineering techniques to incrementally improve drug delivery, bioavailability, and patient compliance through known methodological approaches in oral dosage form design.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,512 |
|---|---|
| Title | Pharmaceutical compositions comprising venglustat |
| Assignee(s) | Genzyme Corporation |