Enhanced Oral Dissolvable Film for Vitamin D3 Delivery
Legal Citation
Summary of the Inventive Concept
The present invention provides novel enhancements to oral dissolvable films containing vitamin D3, addressing limitations of existing films by incorporating moisture-absorbing layers, heat-resistant polymer matrices, synergistic antioxidant blends, novel drying processes, and light-blocking layers to improve stability, shelf life, and delivery efficiency.
Background and Problem Solved
The original patent disclosed an oral dissolvable film containing vitamin D3, but this invention had inherent limitations, including degradation due to moisture, heat, light, and oxygen exposure. The present inventive concept solves these problems by introducing novel components and processes that enhance the stability and delivery of vitamin D3.
Detailed Description of the Inventive Concept
The enhanced oral dissolvable film comprises a novel moisture-absorbing layer that reduces degradation of vitamin D3 due to moisture exposure. Additionally, a heat-resistant polymer matrix is incorporated to prevent degradation of the vitamin D3 at elevated temperatures. A synergistic blend of antioxidants enhances the shelf life of the vitamin D3. A novel drying process minimizes exposure of the vitamin D3 to oxygen, and a light-blocking layer prevents degradation due to UV light exposure. These enhancements improve the stability, shelf life, and delivery efficiency of the vitamin D3.
Novelty and Inventive Step
The present inventive concept is novel and non-obvious compared to the original patent, as it introduces new components and processes that address the inherent limitations of existing oral dissolvable films containing vitamin D3. The combination of these enhancements provides a significant improvement over the prior art.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include varying the composition of the moisture-absorbing layer, heat-resistant polymer matrix, antioxidant blend, and light-blocking layer. Additionally, different drying processes and manufacturing techniques could be employed to further optimize the oral dissolvable film.
Potential Commercial Applications and Market
The enhanced oral dissolvable film has significant commercial potential in the pharmaceutical and nutraceutical industries, particularly in the areas of vitamin D supplementation and treatment of vitamin D deficiency. The improved stability, shelf life, and delivery efficiency of the vitamin D3 make it an attractive solution for healthcare providers and consumers.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical drug delivery systems, specifically oral dissolvable films (ODF) for unstable active pharmaceutical ingredients, with expertise in polymer science, formulation chemistry, and drug stability engineering
Person of Ordinary Skill (PHOSITA) Profile
A professional with a PhD or Masters in pharmaceutical sciences or chemical engineering, with 3-5 years experience in drug delivery system design, familiar with polymer matrices, stabilization techniques, and pharmaceutical manufacturing processes
Obviousness Rationale
A PHOSITA would recognize that the PTD's enhancements represent predictable solutions to known stability challenges in vitamin D3 delivery, using standard pharmaceutical engineering techniques to address moisture, heat, light, and oxygen degradation mechanisms inherent in the original patent's design. The variations represent logical extensions of existing pharmaceutical formulation strategies applied to the specific context of oral dissolvable films containing unstable active ingredients.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,557 |
|---|---|
| Title | Oral dissolvable film containing vitamin D3 |