Fulvestrant formulations
AssigneeHaz Two, LLC
InventorNageswara R. Palepu
Life of this patent
Estimating the term…
Abstract
Fulvestrant formulations suitable for intramuscular injection at concentration in excess of 40 mg/ml in the absence of castor oil and castor oil derivatives are disclosed.
Claims22
A substantially non-aqueous fulvestrant formulation, comprising at least 40 mg/ml fulvestrant dissolved in a substantially non-aqueous solvent system which comprises glycofurol, said formulation being substantially free of castor oil and castor oil derivatives.
A solvent blend for fulvestrant having the ability to dissolve fulvestrant in excess of 40 mg/ml, comprising:
- (A) glycofurol alone or in conjunction with one or more members selected from the group consisting of polyethylene glycols, poloxamers, reverse poloxamers, propylene glycol, dihydrolipoic acid, and mixtures thereof;
- (B) dihydrolipoic acid alone or in conjunction with one or more members selected from the group consisting of polyethylene glycols, poloxamers, reverse poloxamers, and mixtures thereof;
- (C) polyethylene glycol in combination with at least one of a polxamer, a reverse poloxamer, or propylene glycol;
- and
- (D) optionally a compatible co-solvent compatible with fulvestrant;
- said solvent blend being substantially free of water, and substantially free of castor oil and castor oil derivatives.
A substantially non-aqueous fulvestrant formulation, comprising at least 40 mg/ml of fulvestrant dissolved in a substantially non-aqueous solvent system which comprises at least 20% glycofurol, said formulation having not more than 0.1% castor oil and castor oil derivatives.
Dependencies are inferred from the claim text.