Pharmaceutical formulation
US12083127B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Apr 4, 2023 |
| Grant date | Sep 10, 2024 |
| Priority date | — |
| Expiry date | Apr 4, 2043 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K31/5517
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The invention relates to a stable, peroxide-free pharmaceutical composition of 8-chloro-5-methyl-1-[4-(2-pyridyloxy)cyclohexyl]-4,6-dihydro-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine, and a process for the preparation thereof and its use in the treatment of diseases or conditions in which V1a inhibition plays a role or is implicated, such as autism spectrum disorder (ASD), and the core social and communication deficits of patients associated therewith. The formulation includes a compressed tablet kernel comprising: (a) compound of formula I, disintegrant, filler, glidant and lubricant; and (b) a film coating system comprising coating agent, colorant, plasticizer, anti-tacking agent, and coating vehicle. The process for making the formulation comprises combining the tablet kernel ingredients into a blend, sieving the blend, and compressing the blend to form a tablet kernel, and spraying the film coating system onto the tablet kernels.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.