Back to results
US 7,740,884 B2Granted
Freeze-dried FSH/LH formulations
AssigneeAres Trading S.A.
InventorsFabrizio Samaritani, Piergiorgio Donati
Life of this patent
Estimating the term…
Abstract
The invention relates to the field of pharmaceutical formulations of a mixture of follicle stimulating hormone (FSH) and luteinising hormone (LH), and to methods of producing such formulations.
Claims12
A freeze-dried formulation consisting of:
- a follicle-stimulating hormone or a variant thereof, a luteinising hormone or a variant thereof, at least one surfactant selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, and polyoxyethylene (20) sorbitan monooleate, a stabilizer and tonicity agent selected from the group consisting of monosaccharides, disaccharides and sugar alcohols, methionine, and a phosphate buffer.
An article of manufacture comprising:
- a first container filled with a freeze-dried formulation consisting of a recombinant, human follicle-stimulating hormone or a variant thereof, a recombinant, human luteinising hormone or a variant thereof, polyoxyethylene (20) sorbitan monolaurate, sucrose, methionine;
- and a phosphate buffer;
- and
- a second container that comprises a solvent for reconstitution.
1 more element
A method for manufacturing a freeze-dried formulation comprising:
- forming a mixture consisting of a follicle-stimulating hormone or a variant thereof, a luteinising hormone or a variant thereof, at least one surfactant selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, and polyoxyethylene (20) sorbitan monooleate, a stabilizer and tonicity agent selected from the group consisting of monosaccharides, disaccharides and sugar alcohols, methionine, and a phosphate buffer;
- and
- subjecting the mixture to lyophilization.
Dependencies are inferred from the claim text.