Back to results
US 10,300,063 B2Granted
Pharmaceutical composition not containing antioxidant and preparation method therefor
AssigneeSamyang Biopharmaceuticals Corporation
InventorsJoong-Woong Cho, Gyeong-Hae Kim, Min-Hyo Seo, Sa-Won Lee
Life of this patent
Estimating the term…
Abstract
Provided are a composition containing an unstable drug against oxidation like pemetrexed with improved stability and a preparation method thereof, by removing oxygen during the preparation without use of an antioxidant. The method is readily applicable for manufacturing by freezing and degassing in a sealed chamber, and can provide formulations with significantly increased stability for the unstable drug against oxidation.
Claims8
A method of preparing an antioxidant-free pharmaceutical composition, comprising:
- (a) preparing an antioxidant-free solution with dissolved oxygen comprising pemetrexed or a pharmaceutically acceptable salt thereof, and an aqueous solvent in a container;
- (b) freezing the antioxidant-free solution in the container to produce a frozen product;
- and
- (c) degassing the frozen product under a pressure of 2,000 mTorr or lower to obtain a degassed and frozen product,
- wherein the degassed and frozen product comprises 95 to 100 parts by weight of the solvent per 100 parts by weight of the solvent contained in the solution of step (a), and
- the steps of (b) and (c) are performed at a temperature of −20° C. or tower in a sealed chamber.
3 more elements
Dependencies are inferred from the claim text.