Starch-based release modifying excipients and pharmaceutical compositions derived therefrom
US11058773B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Oct 11, 2018 |
| Grant date | Jul 13, 2021 |
| Priority date | — |
| Expiry date | Oct 11, 2038 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K9/209
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
There is provide an extended release dosage form comprising a release modifying excipient comprising high amylose starch, cross-linked hydroxypropylated amylopectin, and a pre-gelatinized common starch; wherein the release modifying excipient is substantially free of crosslinks between amylose and amylopectin and substantially free of crosslinks between amylose and amylose. It has been found that the extended release properties of conventional cross-linked high amylose starches (e.g., Contramid®) can be reproduced by intimately mixing i) cross-linked chemically modified amylopectin; ii) a high amylose, non-chemically modified starch and; iii) a pre-gelatinized common starch. Producing a release modifying excipient in this way means that no chemical cross linking between (a) amylose and amylopectin or (b) amylose and amylose has occurred—properties heretofore considered vital for Contramid® function. The release modifying excipient blends overcome problems associated with use of Contramid, and provide a flexible platform for formulation of active pharmaceutical ingredients for controlled release applications.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.