Enhanced Hypertonic Pharmaceutical Compositions for Ototoxicity Protection
Legal Citation
Summary of the Inventive Concept
The present inventive concept provides improved hypertonic pharmaceutical compositions and delivery methods for protecting against platinum-induced ototoxicity, enhancing the safety and efficacy of chemotherapy treatments.
Background and Problem Solved
Platinum-based antineoplastic agents are widely used to treat cancers and tumors, but they induce hearing loss in patients. The original patent disclosed hypertonic pharmaceutical compositions containing an anti-platinum chemoprotectant agent, but these compositions have limitations in terms of delivery and bioavailability. The present inventive concept addresses these limitations by providing improved compositions and delivery methods that enhance the bioavailability and efficacy of the chemoprotectant agent.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for delivering a hypertonic pharmaceutical composition to a subject's round window, a method for treating platinum-induced ototoxicity using a hypertonic pharmaceutical composition with a tonicity agent, a composition with a calculated osmolarity of at least 2,500 mOsm/L and formulated for sustained release, a kit for treating platinum-induced ototoxicity, and a method for enhancing the bioavailability of an anti-platinum chemoprotectant agent. These improvements enable more efficient and effective protection against ototoxicity.
Novelty and Inventive Step
The inventive concept's novelty lies in the specific combination of components and delivery methods that enhance the bioavailability and efficacy of the chemoprotectant agent. The inventive step is the recognition of the need for improved delivery and bioavailability, and the provision of solutions that address these limitations.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different delivery devices, such as syringes or pumps, and various tonicity agents. The compositions may also be formulated for different routes of administration, such as intravenous or oral delivery.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the development of safer and more effective chemotherapy treatments. The target market includes pharmaceutical companies, hospitals, and research institutions focused on cancer treatment and ototoxicity prevention.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulations, specifically hypertonic compositions for chemotherapy otoprotection, involving pharmaceutical chemistry, drug delivery systems, and medical treatment protocols
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with expertise in drug formulation, medical chemistry, and medical device design, holding a PhD or equivalent advanced degree with 3-5 years of specialized research experience in chemotherapeutic agent delivery and protective pharmaceutical compositions
Obviousness Rationale
A PHOSITA would recognize that the PTD represents predictable variations on the source patent's core hypertonic pharmaceutical composition technology, with incremental modifications to delivery mechanisms, osmolarity ranges, and administration routes that would be considered routine optimization within the existing technological framework. The disclosed variations represent standard engineering approaches to enhancing drug delivery and bioavailability that would be apparent to a skilled practitioner familiar with pharmaceutical formulation techniques. The PTD's claims represent logical extensions of the source patent's fundamental compositional and methodological teachings.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,567 |
|---|---|
| Title | Hypertonic pharmaceutical compositions containing an anti-platinum chemoprotectant agent |
| Assignee(s) | Decibel Therapeutics, Inc. |