Process for preparing losartan potassium with improved flow ability
OwnerIgor Lifshitz, Ilan Kor +1inventors
InventorsIgor Lifshitz, Ilan Kor, Shalom Shabat
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Abstract
Provided is a method of improving the flowability of losartan potassium powder having an initial Hausner ratio of 1.45 or more, which method includes reslurrying the losatrtan potassium in a reslurry solvent.
Claims25
A method of increasing the flowability of losartan potassium powder initially having a Hausner ratio of about 1.45 or greater comprising the step of reslurrying the losartan potassium powder in a reslurry solvent selected from the group consisting of the hydrocarbons, the alkyl ethers, the alkyl esters, and mixtures of two or more of these.
The method of claim 7 wherein the protic solvent is an alcohol 10. The method of claim 9 wherein the alcohol is isopropanol.
A method of increasing the flowability of losartan potassium powder initially having a Hausner ratio of about 1.45 or greater, wherein the losartan potassium is made by neutralizing losartan free acid with a potassium base in the presence of an alcohol, comprising the steps of:
- a) reslurrying the losartan potassium in a reslurry solvent selected from:
- the hexanes, the heptanes, cyclohexane, methylcyclohexane, benzene, toluene, the xylenes, ethyl acetate, propyl acetate, butyl acetate, diethyl ether, dibutyl ether, and mixtures of two or more of them.
- b) isolating the losartan potassium after reslurrying, and
- c) drying the losartan potassium isolated after reslurry to obtain a powder, wherein the dried losartan potassium powder has a Hausner ratio less than 1.45.
A method of increasing the flowability of losartan potassium powder initially having a Hausner ratio of about 1.45 or greater, wherein the losartan potassium is made by neutralizing losartan free acid with potassium hydroxide in the presence of isopropanol, comprising the steps of:
- a) reslurrying the losartan potassium in a reslurry solvent selected from the heptanes, cyclohexane, and toluene, wherein the reslurrying is at about the boiling point of the reslurry solvent,
- b) isolating the losartan potassium after reslurrying,
- c) drying the losartan potassium isolated after reslurry to obtain a powder, and
- d) milling the dried losartan potassium powder to obtain losratan potassium powder having Hausner ratio ≦1.3.
Losartan potassium powder having Hausner ratio ≦1.3 obtained by a process comprising the steps of:
- a) reslurrying the losartan potassium in a reslurry solvent selected from the group consisting of the hexanes, the heptanes, cyclohexane, methylcyclohexane, benzene, toluene, the xylenes, ethyl acetate, propyl acetate, butyl acetate, diethyl ether, dibutyl ether, and mixtures of two or more of them, wherein the reslurrying is at about the boiling point of the reslurry solvent,
- b) isolating the losartan potassium after reslurrying,
- c) drying the losartan potassium isolated after reslurry to obtain a powder, and
- d) milling the dried losartan potassium powder to obtain losratan potassium powder having Hausner ratio ≦1.3.
A pharmaceutical composition comprising losartan potassium powder having Hausner ratio <1.45 and at least one pharmaceutically acceptable excipient.
Dependencies are inferred from the claim text.