Enhanced Oral Drug Delivery for Acromegaly Treatment
Legal Citation
Summary of the Inventive Concept
An improved method and system for treating acromegaly through oral administration of octreotide, addressing the limitations of existing treatments by enhancing bioavailability, patient compliance, and monitoring capabilities.
Background and Problem Solved
The original patent disclosed a method of treating acromegaly using oral octreotide administration. However, the existing method has limitations, including suboptimal bioavailability, inadequate patient compliance, and insufficient monitoring capabilities. The new inventive concept addresses these limitations by introducing a combination of an H2-receptor antagonist and an antacid, delayed or targeted release formulations, and advanced monitoring devices.
Detailed Description of the Inventive Concept
The new inventive concept comprises a method and system for treating acromegaly through oral administration of octreotide. The method involves administering a combination of an H2-receptor antagonist and an antacid to enhance bioavailability, and monitoring IGF-1 and clinical symptoms using advanced devices. The system includes a dosage form with octreotide, an H2-receptor antagonist, an antacid, and a monitoring device. The dosage form can be formulated to have a delayed release profile or a targeted release profile in the small intestine. Additionally, the monitoring device can be a portable, handheld device, enabling patients to track their treatment progress more conveniently.
Novelty and Inventive Step
The new claims introduce the combination of an H2-receptor antagonist and an antacid, delayed or targeted release formulations, and advanced monitoring devices, which are not obvious from the original patent. These features enhance bioavailability, patient compliance, and monitoring capabilities, providing a significant improvement over existing treatments.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include different formulations of octreotide, such as nanoparticles or liposomes, or the use of other bioactive agents in combination with octreotide. Variations of the monitoring device could include wearable devices or mobile applications, enabling patients to track their treatment progress remotely.
Potential Commercial Applications and Market
The enhanced oral drug delivery system for acromegaly treatment has significant commercial potential in the pharmaceutical industry, particularly in the area of endocrinology. The target market includes patients with acromegaly, as well as healthcare providers and researchers seeking more effective and convenient treatments.
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 drug formulations for treating endocrine disorders like acromegaly, involving pharmacokinetic optimization and patient monitoring technologies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with expertise in drug formulation, bioavailability enhancement, dosage form design, and clinical monitoring technologies, holding advanced degrees in pharmaceutical sciences or related biomedical engineering disciplines
Obviousness Rationale
A person having ordinary skill in the art would recognize that the published technical disclosure represents predictable variations of the source patent's core method, utilizing known pharmaceutical techniques to enhance oral drug delivery and patient monitoring. The proposed modifications represent standard engineering approaches to improving drug bioavailability and treatment tracking that would be apparent to a skilled practitioner in pharmaceutical development. The combinations of known elements produce no unexpected results beyond the anticipated incremental improvements in drug delivery and patient management.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,595 |
|---|---|
| Title | Method of treating diseases |
| Assignee(s) | Amryt Endo, Inc. |