Testosterone 2.5% in Isopropyl Myristate 5% Topical Gel

摘要

Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh and/or measure each ingredient. Dissolve the testosterone in the ethyl alcohol while mixing. Disperse the Carbopol 940 in the solution while mixing; this may take up to 30 minutes. Add the isopropyl myristate and mix well to form a thin gel. Bring the mixture to 90% of the total volume with purified water and mix well. Dropwise, add trolamine while mixing until the desired thickness of gel is achieved. Bring the mixture to final volume with purified water and mix well. Package and label. Use: Testosterone topical gels have been used in the treatment of low testosterone concentrations in men and low libido in women. Packaging: Package in tight, light-resistant containers. Labeling: Keep out of reach of children. Store in a cool place. Use only as directed. For external use. Discard after [time period]. Stability: A beyond-use date of 30 days may be used for this preparation. Quality Control: Quality-control assessment can include theoretical weight compared with actual weight, pH, specific gravity, active drug assay, color, texture-surface, texture-spatula spread, appearance, feel, rheologic properties, and physical observations.