Octreotide-based Acromegaly Treatment for Specialized Environments
Legal Citation
Summary of the Inventive Concept
A system and method for treating acromegaly in unique operational environments, including high-security settings, disaster relief situations, extreme weather conditions, remote areas, and search and rescue operations.
Background and Problem Solved
The original patent disclosed a method of treating acromegaly using oral drug delivery of octreotide. However, this approach has limitations in terms of adaptability to specialized environments, where security, logistics, and environmental factors pose significant challenges. The present inventive concept addresses these limitations by providing novel, adaptive solutions for treating acromegaly in these unique settings.
Detailed Description of the Inventive Concept
The inventive concept comprises a range of specialized systems and methods for treating acromegaly, each tailored to a specific operational environment. For high-security environments, the system includes tamper-evident containers to prevent unauthorized access. For disaster relief situations, the method involves formulating the octreotide dosage form to withstand extreme temperatures and humidity. For extreme weather conditions, a portable kit is designed with a water-resistant container and temperature-controlled storage unit. For remote areas, a satellite-enabled communication device enables remote monitoring of IGF-1 levels and clinical symptoms, while an oral dosage form of octreotide is formulated for extended shelf life. Finally, for search and rescue operations, the method involves packaging the octreotide dosage form in a lightweight, compact container for ease of transport.
Novelty and Inventive Step
The inventive concept's novelty lies in its adaptability to specialized environments, which is not addressed by the original patent. The inventive step is the provision of unique, environment-specific solutions that ensure effective treatment of acromegaly in these challenging settings.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include using different formulations of octreotide, varying the dosage forms, or incorporating additional components to enhance treatment efficacy. Variations could also involve adapting the system and method for use in other specialized environments, such as military operations or space exploration.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the niches of high-security healthcare, disaster relief, and remote medical services. The target market includes government agencies, NGOs, and private companies operating in these specialized environments.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K38/08 |
| A | A61 | A61K9/0053 |
| A | A61 | A61K9/4858 |
| A | A61 | A61K38/31 |
| A | A61 | A61P5/06 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical drug delivery, specifically oral formulations for peptide-based treatments of endocrine disorders, requiring expertise in pharmaceutical chemistry, drug formulation, and medical device design
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or clinical researcher with advanced degrees in pharmacy, biochemistry, or medical sciences, experienced in developing oral drug delivery systems for peptide medications, familiar with formulation techniques, stability challenges, and environmental adaptation strategies
Obviousness Rationale
A PHOSITA would recognize that the PTD's environment-specific adaptations represent predictable engineering solutions to known challenges in drug delivery, particularly for sensitive peptide medications like octreotide. The variations demonstrate standard problem-solving approaches in pharmaceutical design, applying known techniques for container design, formulation stability, and monitoring technologies to the existing octreotide treatment method. These adaptations represent incremental improvements that would be obvious to a skilled practitioner seeking to extend the original patent's treatment methodology.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,595 |
|---|---|
| Title | Method of treating diseases |
| Assignee(s) | Amryt Endo, Inc. |