Methods of producing anamorelin hydrochloride having controlled chloride content
US-9403867-B2 · Aug 2, 2016 · US
Methods of producing anamorelin hydrochloride having controlled chloride content
US2016229889A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2016229889-A1 |
| Application number | US-201615135051-A |
| Country | US |
| Kind code | A1 |
| Filing date | Apr 21, 2016 |
| Priority date | Apr 20, 2012 |
| Publication date | Aug 11, 2016 |
| Grant date | — |
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Abstract
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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.
First claim
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1 - 23 . (canceled) 24 . Anamorelin monohydrochloride having a chloride content of from 5.6 to 6.3% and a residual solvent concentration less than 5000 ppm, wherein the residual solvent concentration excludes water. 25 . The anamorelin monohydrochloride of claim 24 , wherein the residual solvent is selected from methanol, butyl acetate, propyl acetate, ethyl acetate, isopropyl acetate, isobutyl acetate, methyl acetate, methylethyl ketone, methylisobutyl ketone, 2-methyltetrahydrofuran and combinations thereof. 26 . The anamorelin monohydrochloride of claim 24 , comprising less than 3% total impurities selected from by-products, contaminants, and degradation products. 27 . The anamorelin monohydrochloride of claim 24 , comprising less than 2% total impurities selected from by-products, contaminants, and degradation products. 28 . The anamorelin monohydrochloride of claim 24 , comprising less than 1% total impurities selected from by-products, contaminants, and degradation products. 29 . The anamorelin monohydrochloride of claim 24 , comprising less than 5% water. 30 . The anamorelin monohydrochloride of claim 24 , comprising less than 3% water. 31 . The anamorelin monohydrochloride of claim 24 , comprising less than 2% water. 32 . The anamorelin monohydrochloride of claim 24 , in an isolated state. 33 . The anamorelin monohydrochloride of claim 24 , in combination with one or more pharmaceutically acceptable excipients. 34 . The anamorelin monohydrochloride of claim 24 , in combination with one or more pharmaceutically acceptable excipients in the form a tablet or capsule or pellets or granules or powders. 35 . The anamorelin monohydrochloride of claim 24 , having a solubility in water greater than 100 mg/mL. 36 . The anamorelin monohydrochloride of claim 24 , having a solubility in water greater than 333 mg/mL. 37 . The anamorelin monohydrochloride of claim 24 , wherein the anamorelin monohydrochloride has a stability defined by a percentage increase in impurities of no more than 114% when stored at 25° C. and a relative humidity of 60% for two years. 38 . The anamorelin monohydrochloride of claim 24 , wherein the anamorelin monohydrochloride has a solubility in water greater than 333 mg/mL, and a stability defined by a percentage increase in impurities of no more than 114% when stored at 25° C. and a relative humidity of 60% for two years.
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Classifications
Anorexiants; Antiobesity agents · CPC title
Processes · CPC title
- C07D401/06Primary
linked by a carbon chain containing only aliphatic carbon atoms · CPC title
containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone · CPC title
- A61K38/05Primary
Dipeptides · CPC title
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- What does patent US2016229889A1 cover?
- 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.
- Who is the assignee on this patent?
- Helsinn Healthcare Sa, Ono Pharmaceutical Co
- What technology area does this patent fall under?
- Primary CPC classification C07D401/06. Mapped technology areas include Chemistry & Metallurgy.
- When was this patent published?
- Publication date Thu Aug 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time) (A1). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 1 related publication on this page (citations in our corpus or others sharing the same primary CPC).