Process for making amlodipine maleate
OwnerFranciscus B. G. Benneker, Pavel Slanina +1inventors
InventorsFranciscus B. G. Benneker, Pavel Slanina, Frantisek Picha
Life of this patent
Estimating the term…
Abstract
A process for making amlodipine maleate comprises reacting amlodipine or an acid addition salt thereof with maleic acid under an acidic environment to form an amlodipine maleate product. The process allows for the formation of amlodipine maleate substantially free from amlodipine aspartate.
Claims26
A process, which comprises reacting amlodipine or an acid addition salt thereof with maleic acid under an acidic environment to form an amlodipine maleate product.
A process for the manufacture of an amlodipine maleate salt substantially free of amlodipine aspartate, which comprises the steps of:
- a) adding, continuously or portionwise, a source of amlodipine into a solution or suspension of maleic acid to form a solution, wherein the relative molar amount of maleic acid to amlodipine being added is at least 1.01:1;
- and
- b) separating amlodipine maleate in a solid form from the solution.
A process for the manufacture of an amlodipine maleate salt substantially free of amlodipine aspartate, which comprises the steps of:
- a) contacting, continuously or portionwise, a source of amlodipine with a solution or suspension of maleic acid under pH control to form a solution whereby the pH of the solution does not exceed 6.5;
- and
- b) separating amlodipine maleate in a solid form from the solution.
A process of purification, which comprises crystallizing or precipitating amlodipine maleate from a solution thereof wherein said solution comprises an excess of maleic acid.
Amlodipine maleate substantially free from amlodipine aspartate.
A pharmaceutical composition for treating or preventing hypertension, angina, or heart failure, that comprises an effective amount of amlodipine maleate substantially free from amlodipine aspartate and a pharmaceutically acceptable excipient.
A method for treating hypertension, angina, or heart failure, which comprises administering an effective amount of amlodipine maleate substantially free from amlodipine aspartate.
Dependencies are inferred from the claim text.