Tailored Liposomal Compositions for Specialized Environments
Legal Citation
Summary of the Inventive Concept
The present invention relates to adapted liposomal compositions of docetaxel for specific operational environments, including high-temperature storage, disaster relief, high-security needs, extreme weather conditions, and emergency medical kits.
Background and Problem Solved
The original patent provided a composition of docetaxel liposomal injection with high drug loading. However, it lacked adaptations for specialized environments, limiting its applicability. The present invention addresses this limitation by introducing tailored liposomal compositions to cater to unique operational requirements.
Detailed Description of the Inventive Concept
The new inventive concept comprises five specialized variations of liposomal compositions: (1) for high-temperature storage, featuring a lyoprotectant to maintain stability above 40°C; (2) for disaster relief, utilizing a solubilizer to facilitate rapid reconstitution; (3) for high-security needs, incorporating a pH adjusting agent to achieve a pH below 3.5; (4) for extreme weather conditions, employing a temperature-controlled container to preserve the composition; and (5) for emergency medical kits, ensuring stability for at least 6 months at room temperature. These adaptations enable the liposomal compositions to perform effectively in diverse environments.
Novelty and Inventive Step
The novelty of the present invention lies in the tailored liposomal compositions, which address specific operational requirements. The inventive step resides in the identification of these unique needs and the development of adapted compositions to cater to them.
Alternative Embodiments and Variations
Alternative embodiments may include variations in the ratio of docetaxel to phospholipids, cholesterol, and lyoprotectants, as well as the use of different solubilizers or pH adjusting agents. Additionally, the inventive concept could be expanded to include other operational environments, such as space exploration or high-altitude settings.
Potential Commercial Applications and Market
The present invention has significant commercial potential in the pharmaceutical industry, particularly in the development of targeted therapies for cancer treatment. The specialized liposomal compositions can cater to diverse market segments, including disaster relief organizations, high-security facilities, and emergency medical services.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/127 |
| A | A61 | A61K9/0019 |
| A | A61 | A61K9/1277 |
| A | A61 | A61K31/337 |
| A | A61 | A61K47/24 |
| A | A61 | A61K47/26 |
| A | A61 | A61K47/28 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical Formulation and Drug Delivery Systems, specifically liposomal drug compositions with a focus on antineoplastic agents like docetaxel, involving expertise in pharmaceutical chemistry, lipid formulation, and drug encapsulation technologies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with advanced degree (PhD/PharmD) specializing in drug delivery systems, having expertise in liposomal formulation techniques, stability testing, and understanding of pharmaceutical excipient interactions
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's core liposomal docetaxel composition by applying standard pharmaceutical formulation strategies to address specific environmental challenges. The disclosed adaptations leverage known techniques in lyoprotectant addition, pH modification, and solubilizer incorporation, which are routine problem-solving approaches in pharmaceutical development. These variations demonstrate incremental modifications that would be obvious to a skilled practitioner seeking to optimize drug delivery in diverse operational contexts.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,680 |
|---|---|
| Title | Composition of docetaxel liposomal injection with high drug loading |
| Assignee(s) | SHILPA MEDICARE LIMITED |