Methods of producing anamorelin hydrochloride having controlled chloride content
AssigneesHelsinn Healthcare SA, Ono Pharmaceutical Co., Ltd.
InventorsShin-itsu Kuwabe, Takehiko Yanagimachi, Hideyuki Yoshiyama, Seemon Pines, Eleanor De Groot, Silvina Garcia Rubio, Peter Manini
Life of this patent
Estimating the term…
Abstract
The present invention relates to particulate forms of anamorelin monohydrochloride or a composition comprising anamorelin monohydrochloride having controlled chloride content, preferably isolated in an amorphous and/or fine particulate state, processes for making the particulate forms, and pharmaceutical compositions comprising the particulate forms.
Claims18
Anamorelin monohydrochloride comprising less than 3% total impurities selected from by-products, contaminants, and degradation products.
Anamorelin monohydrochloride comprising:
- a) less than 3% total impurities selected from by-products, contaminants, and degradation products;
- b) a residual solvent concentration excluding water of less than 5000 ppm;
- and
- c) a chloride content of from 5.6 to 6.2%.
Dependencies are inferred from the claim text.