Claims for Patent: 10,709,691

Summary for Patent: 10,709,691

Title:	Pharmaceutical dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms for oral administration comprising the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof and to processes of making said solid pharmaceutical dosage forms.
Inventor(s):	Beato; Stefania (Basel, CH), Quinton; Peggy (Waldighoffen, FR)
Assignee:	RECORDATI AG (Baar, CH)
Application Number:	16/175,082
Patent Claims:	1. A method of treating Cushing's disease or Cushing's syndrome with a pharmaceutical dosage form for oral administration comprising: (a) a drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]3-fluorobenz- onitrile as defined by formula (1) ##STR00003## or any pharmaceutically acceptable salt thereof, and (b) 70% to 95% by weight of microcrystalline cellulose based on the total weight of said pharmaceutical dosage form. 2. The method according to claim 1, wherein the drug substance is present as phosphate salt. 3. The method according to claim 2, wherein the drug substance is present as a mono-phosphate sa it. 4. The method according to claim 1, wherein the drug substance, calculated based on its free base, is present from 0.5 to 20% by weight based on the total weight of said pharmaceutical dosage form. 5. The method according to claim 1, wherein 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof is combined with 70% to 95% by weight of microcrystalline cellulose based on the total weight of said pharmaceutical dosage form into a pharmaceutically processable material to provide the pharmaceutical dosage form for oral administration.