Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
US12350372B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 17, 2023 |
| Grant date | Jul 8, 2025 |
| Priority date | — |
| Expiry date | Oct 11, 2043 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K31/192
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85% w/w API particles; 15-30% w/w coating material coating the API particles; and 3-15% w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60% relative humidity.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.