Abiraterone-Niraparib Fixed-Dose Tablets for mCRPC Adherence
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Solution Overview
Problem
Current therapeutic options for metastatic castration-resistant prostate cancer (mCRPC) are limited, particularly for patients who do not respond initially or become refractory to existing treatments, and there is a need for improved therapies that address DNA-repair anomalies in prostate cancer.
Innovation Solution
A combination of abiraterone acetate and niraparib, formulated as fixed-dose combinations (FDCs) to enhance patient compliance, therapy adherence, and efficacy, with formulations ensuring homogeneous distribution, stability, and comparable or improved bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate drugs are administered to treat prostate cancer, then therapeutic efficacy can be achieved, but patient compliance and therapy adherence deteriorate due to increased tablet burden
Solution Approach 1:
The patent combines abiraterone acetate and niraparib into a single fixed-dose combination tablet, merging multiple separate medications into one unified dosage form. This reduces the number of tablets patients must take while maintaining the therapeutic efficacy of both drugs, thereby improving patient compliance and therapy adherence
2Reliability
If multiple separate drugs are administered to treat prostate cancer, then therapeutic efficacy can be achieved, but treatment complexity increases due to multiple dosing schedules
Solution Approach 1:
The fixed-dose combination tablet merges abiraterone acetate and niraparib into a single dosage unit with predetermined dosing ratios, eliminating the need for separate dosing schedules and administration instructions. This simplifies the treatment regimen while preserving the therapeutic benefits of both agents
3Ease of operation
If fixed-dose combinations are formulated, then patient compliance improves, but formulation complexity increases to ensure homogeneous distribution
Solution Approach 1:
The patent employs granulation technology to create homogeneous distribution of abiraterone acetate and niraparib within the tablet matrix. By controlling the local quality and distribution of each active ingredient at the granule level, the formulation ensures consistent dosing while simplifying patient administration
4Ease of operation
If fixed-dose combinations are formulated, then therapy adherence improves, but manufacturing precision requirements increase to ensure content uniformity
Solution Approach 1:
The granulation process creates uniformly distributed granules containing both active ingredients, ensuring that each tablet contains the precise intended dosage. This controlled local quality at the granule level translates to consistent content uniformity across all tablets, meeting stringent manufacturing precision requirements while improving therapy adherence
Data Source
AI summary
The present disclosure relates to a combination of abiraterone acetate and niraparib, free-dose and fixed-dose combinations of abiraterone acetate and niraparib, and methods of treatment of prostate cancer with said combinations.