Controlled release delivery system for nasal applications
AssigneeM & P Patent Aktiengesellschaft
InventorClaudia Mattern
Life of this patent
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Abstract
This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
Claims7
A testosterone gel formulation for nasal administration to a patient for controlled release of testosterone into systemic circulation of the patient following the nasal administration for treating the patient with testosterone therapy, the testosterone gel formulation comprising:
- (a) testosterone, wherein said testosterone is present within the testosterone gel formulation in an amount of from about 0.5% to about 10% by weight of the testosterone gel formulation:
- (b) at least one lipophilic or partly lipophilic carrier present in an amount of from about 60% to about 98% by weight of the testosterone gel formulation;
- (c) a compound or a mixture of compounds having surface tension decreasing activity present in an amount of from about 1% to about 20% by weight of the testosterone gel formulation;
- and
- (d) a viscosity regulating agent present in an amount of from about 0.5% to about 10% by weight of the testosterone gel formulation.
A testosterone gel formulation for nasal administration for controlled release of testosterone into systemic circulation of a patient following nasal administration to the patient, the testosterone gel formulation comprising:
- (a) testosterone, wherein said testosterone is present within the testosterone gel formulation in an amount of from about 0.5% to about 6% by weight of the testosterone gel formulation;
- (b) castor oil in an amount of from about 75% to about 95% by weight of the testosterone gel formulation;
- (c) oleoyl macrogolglycerides in an amount of from about 1% to about 5% by weight of the testosterone gel formulation;
- and
- (d) colloidal silicon dioxide in an amount of from about 0.5% to about 5% by weight of the testosterone gel formulation;
- wherein the testosterone serum level achieved following the nasal administration of the testosterone gel formulation to the patient is sustained above the patient's testosterone baseline for at least 6 hours.
Dependencies are inferred from the claim text.