ATR-101 Solid Drug Form for Adrenocortical Carcinoma Treatment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current treatments for adrenocortical carcinoma (ACC) rely heavily on mitotane, which has limited efficacy and requires close patient monitoring, necessitating the development of new therapeutic agents for improved management of ACC and related conditions.
Innovation Solution
A novel solid drug form of N-(2,6-bis(1-methylethyl)phenyl)-N′-((1-(4-(dimethylamino)phenyl)cyclopentyl)methyl)urea hydrochloride (ATR-101) is formulated for oral administration, with specific particle size distribution and high purity, allowing for effective treatment of ACC and other disorders like Cushing's syndrome and congenital adrenal hyperplasia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mitotane is used for treatment of adrenocortical carcinoma, then therapeutic effect is achieved in only one-quarter to one-third of patients, but the treatment requires close patient monitoring and has numerous problems making its use difficult
Solution Approach 1:
The patent changes the chemical parameters of the therapeutic agent by developing ATR-101, a novel urea derivative with improved pharmacological properties compared to mitotane. This includes optimized molecular structure (C27H39N3O HCl) that provides better therapeutic efficacy while reducing adverse effects and monitoring requirements
Solution Approach 2:
The patent develops a new therapeutic agent that can be administered as a straightforward oral dosage form without the need for complex monitoring protocols or special administration conditions, making it more accessible and easier to use clinically
2Quantity of substance
If a novel solid drug form of ATR-101 is formulated for oral administration, then high loading capacity and purity are achieved, but specific particle size distribution control is required
Solution Approach 1:
The patent optimizes the physical parameters of the drug substance by controlling particle size distribution within specific ranges (d10: 2-10 μm, d50: 12-20 μm, d90: 40-60 μm) to achieve both high loading capacity in dosage forms and consistent manufacturing quality
Solution Approach 2:
The patent performs preliminary processing of the ATR-101 substance to establish the desired particle size distribution before final dosage form formulation, ensuring that the material is pre-conditioned for optimal loading capacity and manufacturing performance
Data Source
AI summary
A novel solid drug form of N-(2,6-bis(1-methylethyl)phenyl)-N′-((1-(4-(dimethylamino)phenyl)cyclopentyl)methyl)urea hydrochloride (also referred to “ATR-101”) suitable for oral dosing, and to compositions, methods and kits relating thereto. ATR-101 has particular utility in the treatment of, for example, aberrant adrenocortical cellular activity, including adrenocortical carcinoma (ACC), congenital adrenal hyperplasia (CAH) and Cushing's syndrome.