Personalized Pemafibrate Dosing Regimens with OATP1B Inhibitor Co-administration Consideration
Legal Citation
Summary of the Inventive Concept
The present invention provides an innovative approach to optimize pemafibrate dosing regimens by integrating OATP1B inhibitor co-administration status, ensuring safer and more efficient treatment of dyslipidemia.
Background and Problem Solved
The original pemafibrate dosing regimens patent (Patent Literature 1) has limitations in addressing the impact of OATP1B inhibitors on pemafibrate pharmacokinetics, leading to potential adverse effects and suboptimal treatment outcomes. The present invention addresses this limitation by incorporating OATP1B inhibitor co-administration status into the dosing regimen optimization process.
Detailed Description of the Inventive Concept
The inventive concept comprises a system and method for optimizing pemafibrate dosing regimens, which takes into account the patient's original daily dose and OATP1B inhibitor co-administration status. The system utilizes a dosing calculator module, a database of OATP1B inhibitors, and a patient data input module to determine an adjusted daily dose of pemafibrate. The method involves identifying the patient's OATP1B inhibitor co-administration status and adjusting the pemafibrate dosing regimen accordingly, using a pharmacokinetic model to minimize the risk of adverse effects.
Novelty and Inventive Step
The new claims introduce the novel concept of integrating OATP1B inhibitor co-administration status into pemafibrate dosing regimen optimization, which is not disclosed in the original patent. This inventive step provides a more personalized and efficient approach to treating dyslipidemia, distinguishing the present invention from the prior art.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different types of OATP1B inhibitors, various pharmacokinetic models, and diverse patient data input modules. Additionally, the system and method could be adapted for use with other medications affected by OATP1B inhibitors, expanding the scope of the inventive concept.
Potential Commercial Applications and Market
The present invention has significant commercial potential in the pharmaceutical industry, particularly in the treatment of dyslipidemia. The innovative approach to pemafibrate dosing regimen optimization could lead to improved treatment outcomes, reduced adverse effects, and enhanced patient safety, ultimately increasing market share and revenue for pharmaceutical companies.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical dosing optimization, specifically clinical pharmacology focusing on drug metabolism, pharmacokinetics, and personalized medicine approaches for lipid-modifying therapies
Person of Ordinary Skill (PHOSITA) Profile
A clinical pharmacologist or pharmaceutical researcher with expertise in drug dosing strategies, pharmacogenomics, drug-drug interactions, and quantitative pharmacokinetic modeling, holding an advanced degree with 3-5 years of specialized experience in lipid-modifying therapeutics
Obviousness Rationale
A PHOSITA would recognize that integrating OATP1B inhibitor co-administration status into pemafibrate dosing represents a predictable extension of existing dosing optimization strategies, leveraging known pharmacokinetic principles to personalize drug therapy and mitigate potential adverse interactions through systematic dose adjustment based on well-understood metabolic pathways.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,540 |
|---|---|
| Title | Pemafibrate dosing regimens |
| Assignee(s) | KOWA COMPANY, LTD. |