Enhanced Formulations of SN-38 with Poly(amino acid) Block Polymers for Cancer Treatment
Legal Citation
Summary of the Inventive Concept
This inventive concept relates to novel formulations and delivery systems of SN-38 with poly(amino acid) block polymers, designed to improve the efficacy, safety, and efficiency of cancer treatment.
Background and Problem Solved
The original patent disclosed formulations of SN-38 with poly(amino acid) copolymers, but these formulations have inherent limitations, such as limited biodegradability, non-specific targeting, and potential side effects. The new inventive concept addresses these limitations by introducing modified poly(amino acid) block copolymers with improved biodegradability, targeting moieties for enhanced tumor specificity, and novel solvent systems for improved stability.
Detailed Description of the Inventive Concept
The new claims introduce four key improvements: (1) a method for treating cancer using a composition with a modified poly(amino acid) block copolymer for improved biodegradability, (2) a system for delivering SN-38 with a poly(amino acid) block copolymer matrix designed for sustained release over at least 7 days, (3) a composition with a poly(amino acid) block copolymer conjugated to a targeting moiety for enhanced tumor specificity, and (4) a method for manufacturing a composition using a novel solvent system to improve stability. These improvements enable more efficient and targeted delivery of SN-38, reducing potential side effects and improving treatment outcomes.
Novelty and Inventive Step
The new claims introduce novel and non-obvious modifications to the original formulations, including the use of modified poly(amino acid) block copolymers, targeting moieties, and novel solvent systems. These modifications provide a significant improvement over the original patent, enabling more effective and efficient cancer treatment.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different poly(amino acid) block copolymer architectures, varying the ratio of SN-38 to poly(amino acid) block copolymer, or incorporating additional therapeutic agents into the formulation. These variations could provide further improvements in efficacy, safety, and efficiency.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the oncology market, with potential applications in treating various types of cancer. The improved formulations and delivery systems could provide a competitive advantage in the market, offering improved treatment outcomes and reduced side effects.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K47/34 |
| A | A61 | A61K9/08 |
| A | A61 | A61K9/19 |
| A | A61 | A61K31/4375 |
| A | A61 | A61K31/513 |
| A | A61 | A61K31/519 |
| A | A61 | A61K45/06 |
| A | A61 | A61K47/26 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulations, specifically cancer drug delivery systems involving camptothecin derivatives and polymeric carriers, requiring advanced knowledge in polymer chemistry, pharmacology, and drug delivery technologies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with a PhD in polymer chemistry or pharmaceutical sciences, experienced in drug formulation, polymer modification, and cancer treatment delivery mechanisms, familiar with polymer-drug conjugation techniques
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's core technology, involving standard polymer modification strategies and well-established drug delivery optimization techniques commonly employed in cancer therapeutic formulations. The disclosed improvements represent incremental advancements using known methodological approaches in polymer-drug systems. These modifications would be considered routine optimization within the existing technological framework of SN-38 delivery systems.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,630 |
|---|---|
| Title | Formulations of SN-38 with poly(amino acid) block polymers |
| Assignee(s) | TYNDALL FORMULATION SERVICES, LLC |