Process for preparing dispensable testosterone cream
AssigneeLawley Pharmaceuticals Pty Ltd.
InventorMichael Buckley
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Abstract
This invention relates to a process of preparing an oil-in-water emulsion comprising testosterone for use in a pump-action dispensing device. It further relates to the oil-in-water emulsion produced by the process of the invention, and the combination of the emulsion with a pump-action dispensing device.
Claims15
A process for preparing an oil-in-water emulsion of testosterone, the method comprising:
- (i) providing an oil-in-water emulsion comprising a water phase, an oil phase, an emulsifying agent and testosterone;
- and
- (ii) stirring the emulsion provided in step (i) under vacuum to remove air bubbles to achieve a viscosity of 20,000 to 50,000 mPa·s when measured at 25° C.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein the vacuum is applied at a pressure of −4 to −9 kPa.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein an oil-in-water emulsion is prepared in step (i) by combination of the oil phase, the water phase and the emulsifying agent followed by subsequent addition of testosterone.
A process for preparing an oil-in-water emulsion of testosterone as claimed in claim 6, wherein the oil phase and the water phase are combined at a temperature of 75 to 80° C., followed by cooling to a temperature of 25 to 30° C. prior to the addition of testosterone.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein the emulsion comprises testosterone in a concentration of 1 to 100 mg/g.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein the emulsion further comprises a thickening agent, a stabiliser, a preservative, an anti-oxidant, an acidifying agent and/or a neutralising agent.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein the emulsion consists of a water phase, an oil phase, an emulsifying agent, a thickening agent, a stabiliser, a preservative, an anti-oxidant, an acidifying agent, a neutralising agent and testosterone.
A process for preparing an oil-in-water emulsion of testosterone as claimed in any preceding claim, wherein the pH of the emulsion is 5 to 7.
An oil-in-water emulsion of testosterone, obtainable by the process of any preceding claim.
An oil-in-waler emulsion of testosterone comprising:
- 10 mg/g or 50 mg/g testosterone;
- 20 mg/g polyethylene glycol hexadecyl ether;
- 10 mg/g cetostearyl alcohol;
- 0.5 mg/g butylated hydroxytoluene;
- 40 mg/g almond oil;
- 12 mg/g of a preservative mixture comprising phenoxyethanol and at least one paraben;
- 1 mg/g citric acid;
- 12 mg/g triethanolamine;
- 8 mg/g carbomer;
- 25 mg/g dl-α-tocopheryl acetate;
- and
- water as solvent,
- wherein the emulsion has viscosity of 20,000 to 50,000 mPa·s when measured at 25° C.
Dependencies are inferred from the claim text.