Intranasal lower dosage strength testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder
A technology of gel preparation, testosterone gel, applied in diseases, endocrine system diseases, organic active ingredients, etc.
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Embodiment 1
[0278] Description and Composition of Testosterone Gel Preparations of the Invention
[0279] The composition of the three different concentrations of the drug product to be administered in this clinical trial is provided in the table below.
[0280] Dosage description
[0281] The testosterone gel formulations of the present invention are viscous thixotropic oil-based formulations containing dissolved testosterone, intended for intranasal application. The drug product is formulated with the following pharmacopeia inactive ingredients: castor oil, oleoyl polyoxy-glycerides and colloidal silicon dioxide.
[0282] Three different doses of testosterone gel formulations according to the invention were administered intranasally: 0.15% w / w, 0.45% w / w and 0.6% w / w. An overage was added to each syringe to form a gel that remained in the syringe after dosing. Regardless of the amount of gel in the syringe, this excess was kept constant at 23 μl.
[0283] Lower Dose Strength I...
Embodiment 2
[0293] Intranasal Testosterone Gel Preparations
[0294] The testosterone gel formulation of the present invention, which is a testosterone formulation in an intranasal gel, is proposed to evaluate the drug metabolism and pharmacodynamics of three different doses of the testosterone gel formulation of the present invention in patients with hypoactive sexual desire disorder (HSDD) compared with women with secondary anorgasmia (SA) And placebo and testosterone gel preparation of the present invention.
[0295] The active ingredient testosterone originates from Bayer Schering.
[0296] Nasal delivery challenges include:
[0297] Larger particles than are required for pulmonary administration (i.e., only particles >10 μm are heavy enough to avoid entering the respiratory tract);
[0298] The concentration must be higher due to the lower amount that can be applied;
[0299] Rapid clearance of the therapeutic agent from the site of deposition, resulting in less time available...
Embodiment 3
[0305] excess
[0306] [testosterone gel preparation of the present invention]
[0307] No excess was added to the formulation. An excess is added to each syringe to form a gel that remains in the syringe after dosing. Regardless of the amount of gel in the syringe, this excess was kept constant at 23 μl. Theoretical fill and dispense volumes for the testosterone gel formulations of the present invention are given below.
[0308]
[0309]
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Abstract
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