FSH Formulation
OwnerJames Arthur Hoffmann, Jirong Luinventors
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Abstract
This invention relates to FSH or a FSH variant containing an alpha and beta subunit contained in formulations, and articles of manufacture. The invention provides advantageous new proteins and nucleic acids, multi-use pharmaceutical solutions, formulations and products of said proteins and nucleic acids where none approved for commercial use had previously existed having such extended use indications. These products are particularly useful in therapeutic regimens for increasing serum levels of FSH or a FSH variant over a period of treatment. Thus, inter alia, the invention fills the need for convenient products of FSH or from a FSH variant.
Claims61
A formulation comprising a non-gaseous preparation of FSH or a FSH variant, containing an alpha and beta subunit, with a preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, alkylparaben (methyl, ethyl, propyl, butyl and the like), benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, or mixtures thereof in an aqueous diluent.
A formulation comprising a non-gaseous preparation of FSH or a FSH variant lyophilized in a first vial, and a second vial containing a preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, alkylparaben (methyl, ethyl, propyl, butyl and the like), benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, or mixtures thereof in an aqueous diluent.
A process for preparing a preserved solution formulation of a non-gaseous preparation of FSH or a FSH variant, containing an alpha and beta subunit, which comprises admixing said FSH or a FSH variant and a preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, alkylparaben (methyl, ethyl, propyl, butyl and the like), benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, or mixtures thereof, in an aqueous diluent.
An article of manufacture for human pharmaceutical use, comprising packaging material and a vial comprising a solution of a non-gaseous preparation of FSH or a FSH variant, containing an alpha and beta subunit, and a preservative solution, wherein said packaging material comprises a label which indicates that said solution may be held over a period of 24 hours or greater.
An article of manufacture, comprising packaging material, a first vial comprising lyophilized FSH or a FSH variant, containing an alpha and beta subunit, and a second vial comprising a preservative solution, wherein said packaging material comprises a label which instructs a patient to reconstitute the said lyophilized FSH or a FSH variant in the preservative solution for use over a period of of 24 hours or greater.
A method of treating infertility in a patient, which comprises administering to a patient in need thereof a preserved solution of a non-gaseous preparation of FSH or a FSH variant, containing an alpha and beta subunit, said solution being suitable for administration over a period of 24 hours or greater.
A method of using a stable solution of FSH or a FSH variant, containing an alpha and beta subunit to treat infertility in a patient, which comprises administering to a patient in need thereof a solution of FSH or a FSH variant in a stable solution, said solution being suitable for administration over a period of 24 hours or greater.
The use of at least one alpha or beta polypeptide of a FSH or a FSH variant in the preparation of a preserved formulation adapted for administration over a period of 24 hours or greater.
A stable formulation comprising at least one FSH or a FSH variant, containing an alpha and beta subunit, and phosphate buffer containing saline or a salt, wherein said FSH or a FSH variant comprises at least 90% FSH or a FSH variant dimers after 60 days at 23° C.
A formulation comprising a first vial containing a nongaseous preparation of FSH or a FSH variant containing an alpha and beta subunit, and a second vial containing phosphate buffer containing saline or a salt.
A process for preparing a stable solution formulation of FSH or a FSH variant, containing an alpha and beta subunit, which comprises admixing a non-gaseous preparation of FSH or a FSH variant with a phosphate buffer containing saline or a salt.
An article of manufacture for pharmaceutical use, comprising packaging material and a vial comprising a stable solution of FSH or a FSH variant, containing an alpha and beta subunit, in an aqueous diluent, wherein said packaging material comprises a label which indicates that such solution is suitable for use over a period of 24 hours or greater.
An article of manufacture, comprising packaging material, a first vial comprising a lyophilized FSH or a FSH variant containing, an alpha and beta subunit, and a second vial comprising a stable aqueous diluent, wherein said packaging material comprises a label which instructs a patient to reconstitute said FSH or a FSH variant in the aqueous diluent to form a solution that is suitable for use over a period of 24 hours or greater.
A method of treating infertility in a patient, which comprises administering to a patient in need thereof a stable solution of FSH or a FSH variant, containing an alpha and beta subunit, in an aqueous phosphate buffered diluent, said solution being suitable for administration over a period of 24 hours or greater.
A method of using a solution FSH or a FSH variant, containing an alpha and beta subunit, to treat infertility in a patient, which comprises administering to a patient in need thereof a stable solution of FSH or a FSH variant in an aqueous diluent suitable for use over a period of 24 hours or greater.
The use of at least one polypeptide of a FSH or a FSH variant in the preparation of a stable formulation adapted for administration over a period of 24 hours or greater.
A formulation as described herein.
An article of manufacture as described herein
A process as described herein.
A use as described herein.
A method as described herein.
Use of a preserved solution of FSH or a FSH variant, containing an alpha and beta subunit, to treat infertility in a patient in need thereof, said solution being suitable for administration over a period of 24 hours or greater.
Use of a stable solution of FSH or a FSH variant, containing an alpha and beta subunit, to treat infertility in a patient, which comprises administering to a patient in need thereof a solution of said FSH or a FSH variant in a phosphate buffer, containing saline or a salt, over a period of 24 hours or greater.
Use of stable stable solution of purified FSH or a FSH variant, containing an alpha and beta subunit, in a phosphate buffer containing saline or a salt suitable for administration over a period of 24 hours or greater for treating infertility in a patient in need thereof.
Use of a stable solution FSH or a FSH variant, containing an alpha and beta subunit, to treat infertility in a patient in need thereof, wherein said stable solution of said FSH or a FSH variant in phosphate buffer containing saline or a salt is suitable for use over a period of 24 hours or greater.
A process of producing a formulation comprising admixing a non-gasesous preparation of FSH or a FSH variant, containing an alpha and beta subunit, and a preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, alkylparaben (methyl, ethyl, propyl, butyl and the like), benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, or mixtures thereof in an aqueous diluent.
A process of producing a stable formulation comprising admixing at least a non-gaseous preparation of FSH or a FSH variant, containing an alpha and beta subunit, and a phosphate buffer containing saline or a salt, wherein said FSH or a FSH variant comprises at least 90% FSH or a FSH variant dimers after 60 days at 23° C.
A process comprising preparing a a non-gasesous preparation FSH or a FSH variant lyophilized in a first vial, and preparing a second vial containing a preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, alkylparaben (methyl, ethyl, propyl, butyl and the like), benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, or mixtures thereof in an aqueous diluent.
Dependencies are inferred from the claim text.