Enhanced Pilocarpine Formulations with Improved Stability and Shelf Life
Legal Citation
Summary of the Inventive Concept
This inventive concept introduces a system, method, and composition for preparing and manufacturing stable pilocarpine formulations with improved shelf life, addressing the limitations of existing formulations in terms of pH control, buffer composition, and storage conditions.
Background and Problem Solved
The original patent disclosed pilocarpine formulations with reduced buffer content, but these formulations still faced challenges in maintaining stability and shelf life. The new inventive concept addresses these limitations by introducing a modified buffer solution, pH adjustment, and optimized storage conditions, ensuring improved stability and shelf life of the pilocarpine compositions.
Detailed Description of the Inventive Concept
The new inventive concept comprises a system for preparing stable pilocarpine formulations, including a mixing unit for combining pilocarpine compound(s) with a modified buffer solution, and a processing unit for adjusting the pH of the resulting mixture to between about 3 and about 6. The modified buffer solution comprises a combination of citrate and phosphate buffers, allowing for more precise pH control. The pH-adjusting agent, such as sodium hydroxide, ensures the desired pH range. The resulting composition maintains at least about 99% of the pilocarpine compound originally present when stored under conditions comprising a temperature of about 25°C±2°C and a relative humidity of about 60%±5%.
Novelty and Inventive Step
The new inventive concept introduces a novel combination of modified buffer solution, pH adjustment, and optimized storage conditions, which provides a significant improvement over the existing pilocarpine formulations. The use of a citrate and phosphate buffer combination and the precise pH control using a pH-adjusting agent are new and non-obvious features that address the limitations of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different buffer combinations, pH-adjusting agents, or storage conditions. Additionally, the system and method could be adapted for the preparation of other ophthalmic compositions or pharmaceuticals.
Potential Commercial Applications and Market
The enhanced pilocarpine formulations with improved stability and shelf life have significant commercial potential in the ophthalmic industry, particularly in the treatment of presbyopia and other age-related eye conditions. The target market includes pharmaceutical companies, ophthalmic manufacturers, and healthcare providers.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and ophthalmic drug delivery, specifically focusing on pilocarpine-based compositions for treating ocular conditions like presbyopia
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation scientist with expertise in ophthalmic drug development, possessing knowledge of buffer systems, pH control, and pharmaceutical stability testing, typically holding a PhD or equivalent industrial experience in pharmaceutical chemistry
Obviousness Rationale
A person of ordinary skill would recognize that the PTD's modifications to the source patent represent predictable variations in pharmaceutical formulation techniques. The core innovations involve minor adjustments to buffer composition and pH control that would be considered routine optimization for a skilled formulation scientist. The PTD's approach of combining citrate and phosphate buffers and using sodium hydroxide for pH adjustment represents a straightforward extension of known pharmaceutical formulation principles.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,538 |
|---|---|
| Title | Stable pilocarpine formulations with modified buffer characteristics and related methods |
| Assignee(s) | Somerset Therapeutics, LLC |