Solid drug form of N-(2,6-bis(1-methylethyl)phenyl)-N′-((1-(4-(dimethylamino)phenyl)cyclopentyl)methyl)urea hydrochloride and compositions, methods and kits related thereto
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.
1. A solid drug form of N-(2,6-bis(1-methylethyl)phenyl)-N′-((1-(4-(dimethylamino)phenyl)cyclopentyl)methyl)urea hydrochloride having a purity in excess of 98% (w/w).
2. A solid drug form of claim 1 having a purity level in excess of 98.5% (w/w).
3. A solid drug form of claim 1 having a purity level in excess of 99% (w/w).
4. A solid pharmaceutical composition in a unit dosage form suitable for oral administration, comprising a solid drug form of claim 1 in combination with one or more pharmaceutically acceptable carriers or excipients.
5. A solid pharmaceutical composition in a unit dosage form suitable for oral administration, comprising a solid drug form of claim 2 in combination with one or more pharmaceutically acceptable carriers or excipients.
6. A solid pharmaceutical composition in a unit dosage form suitable for oral administration, comprising a solid drug form of claim 3 in combination with one or more pharmaceutically acceptable carriers or excipients.