Trientine tetrahydrochloride and a method of preparation and a pharmaceutical composition thereof
AssigneeYu-Jet Co., Ltd
InventorsCherng-Yih Perng, Ming-Ren Liang, Yu-Chen Lin, Tai-Yun Feng
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Abstract
A method of preparation of trientine tetrahydrochloride crystals in which an anti-solvent at a feeding temperature is added into a trientine tetrahydrochloride solution and stirred for crystallization wherein the feeding temperature ranges from 50° C. to 75° C. and the anti-solvent is an alcohol solvent. A novel trientine tetrahydrochloride featuring XRPD peaks detected at 21.9, 24.8, 25.2, 28.0 and 35.6±0.1° 2θ for stable storage of a pharmaceutical composition manufactured with the trientine tetrahydrochloride.
Claims17
A method of preparation of trientine tetrahydrochloride crystals, comprising:
- step 1:
- adding an anti-solvent at a feeding temperature into a trientine tetrahydrochloride solution and stirring for crystallization;
- wherein the feeding temperature ranges from 50° C. to 75° C. and the anti-solvent is an alcohol solvent,
- wherein the stirring is made for a duration of at least one hour at a temperature ranging from 5° C. to 25° C.,
- wherein the method does not require a use of seed crystals, and
- wherein the trientine tetrahydrochloride crystals feature X-Ray Powder Diffraction (XRPD) peaks detected at 21.9, 24.8, 25.2, 28.0 and 35.6±0.1° 2θ.
A pharmaceutical composition, comprising trientine tetrahydrochloride crystals, wherein the trientine tetrahydrochloride crystals feature X-Ray Powder Diffraction (XRPD) peaks detected at 21.9, 24.8, 25.2, 28.0 and 35.6±0.1° 2θ.
Dependencies are inferred from the claim text.