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US 11,142,603 B2Granted
Process for preparation of patiromer
AssigneeSolara Active Pharma Sciences Limited
InventorsSivadas Anand, Sarita Mohan Pavaskar, Bheemashankar Kulkarni
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Abstract
The present application relates to a commercially viable process for the preparation of Patiromer, a crosslinked polymer. More particularly the present application relates to a commercially viable process for the preparation of Patiromer sorbitex calcium, an active ingredient useful in the treatment of hyperkalemia.
Claims18
A process for preparing Patiromer of formula IA,
- wherein,
- m is the number of 2-fluoro-2-propenoate groups, and m is equal to 0.91,
- n and p are the number of crosslinking groups, and n+p is equal to 0.09, and
- * is an extended polymeric network,
- the process comprising:
- forming a reaction mixture comprising a polymer of formula V,
- wherein,
- R is C1-6 alkyl, and
- m, n, p and * are as defined hereinbefore,
- and a base in a solvent to provide a polymer of formula VI,
- wherein,
- M is selected from the group consisting of hydrogen, lithium, sodium, potassium, rubidium, caesium, calcium, magnesium, strontium, barium, and a combination thereof, and
- m, n, p and * are as defined hereinbefore,
- wherein the solvent is an ether solvent, and
- converting the compound of formula VI to Patiromer of formula IA.
12 more elements
A process for preparing Patiromer of formula IA,
- wherein,
- m is the number of 2-fluoro-2-propenoate groups, and m is equal to 0.91,
- n and p are the number of crosslinking groups, and n+p is equal to 0.09, and
- * is an extended polymeric network,
- the process comprising:
- a. reacting a polymerization mixture comprising the compounds of formulae II, III and IV,
- wherein R is C1-6 alkyl,
- in presence of a free radical initiator and optionally a stabilizer, in a solvent to obtain a polymer of formula V,
- wherein, R, m, n, p and * are as defined hereinbefore;
- b. converting the polymer of formula V to a polymer of formula VI, in presence of a base in a solvent,
- wherein,
- M is selected from the group consisting of hydrogen, lithium, sodium, potassium, rubidium, caesium, calcium, magnesium, strontium, barium, and a combination thereof;
- m, n, p and * are as defined hereinbefore, wherein the said organic solvent is ether;
- wherein, the solvent is an ether solvent,
- c. converting the compound of formula VI to Patiromer of formula IA, and
- d. optionally slurrying the Patiromer of formula IA with a polyol to obtain Patiromer sorbitex calcium of formula I:
- wherein, H2O is associated water and m, n, p, and * are as defined hereinbefore.
14 more elements
Dependencies are inferred from the claim text.