Enhanced Oral Dissolvable Film for Vitamin D3 Delivery
Legal Citation
Summary of the Inventive Concept
An improved oral dissolvable film (ODF) containing vitamin D3, featuring enhanced stability, bioavailability, and controlled release, addressing limitations of existing ODFs.
Background and Problem Solved
The original patent for oral dissolvable films containing vitamin D3 has limitations, such as degradation due to moisture, heat, light, or oxygen, and variable bioavailability. The new inventive concept addresses these issues by introducing protective layers, desiccant materials, surfactants, pH-sensitive polymers, and rate-controlling materials to create a more efficient and reliable ODF system.
Detailed Description of the Inventive Concept
The enhanced ODF system comprises a film encapsulated with a protective layer to prevent degradation, incorporating a desiccant material to maintain a humidity level below 20%. The film may also include a surfactant material to facilitate dissolution and absorption, and a pH-sensitive polymer designed to release vitamin D3 at a specific pH range. Additionally, a layer of rate-controlling material regulates the release of vitamin D3 over a predetermined period. These features ensure improved stability, bioavailability, and controlled release of vitamin D3.
Novelty and Inventive Step
The new claims introduce novel elements, such as the protective layer, desiccant material, surfactant material, pH-sensitive polymer, and rate-controlling material, which provide a significant improvement over the original patent. These elements, individually and in combination, create a more efficient and reliable ODF system that addresses the limitations of existing ODFs.
Alternative Embodiments and Variations
Alternative embodiments may include using different types of protective layers, desiccant materials, surfactants, pH-sensitive polymers, and rate-controlling materials. Variations may also include adjusting the composition and structure of the ODF system to accommodate different active ingredients or administration routes.
Potential Commercial Applications and Market
The enhanced ODF system has significant commercial potential in the pharmaceutical and nutraceutical industries, particularly for vitamin D3 supplementation. The improved stability, bioavailability, and controlled release of vitamin D3 make it an attractive solution for addressing vitamin D deficiency and related health issues.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and drug delivery systems, specifically oral dissolvable films (ODF) for vitamin and nutrient delivery, requiring expertise in pharmaceutical chemistry, polymer science, and drug stability engineering
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation scientist with advanced degree, experience in drug delivery technologies, knowledge of polymer chemistry, understanding of stability challenges for sensitive compounds like vitamin D3, and familiarity with oral film manufacturing techniques
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable engineering solutions to known stability challenges in oral dissolvable films. The proposed modifications of protective layers, desiccant materials, and controlled release mechanisms are standard problem-solving approaches in pharmaceutical formulation when addressing compound degradation and absorption limitations. These variations represent incremental improvements using known techniques that would be obvious to implement given the source patent's foundational ODF technology.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,557 |
|---|---|
| Title | Oral dissolvable film containing vitamin D3 |