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US 2016/0235804 A1Published application
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
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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.
Claims20
1-23. (canceled)
24) A method of making a pharmaceutical dosage form comprising:
- a) combining a therapeutically effective amount of anamorelin monohydrochloride with one or more pharmaceutically acceptable excipients to form a mixture;
- b) processing said mixture into a finished dosage form;
- and
- c) repeating steps (a) and (b) one or more additional times using anamorelin monohydrochloride from different batches, wherein the chloride content among the different batches varies by no more than 7%.
1 more element
Dependencies are inferred from the claim text.