Wax foamable vehicle and pharmaceutical compositions thereof
Inventors
Tamarkin, Dov • KEYNAN, Rita • Schuz, David • Berman, Tal
Assignees
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Publication Number
US-11103454-B2
Publication Date
2021-08-31
Expiration Date
Abstract
Unique foamable vehicles or carriers comprising at least one wax, waxy substance, counterpart or derivative, a stabilizer, water, and a propellant are provided. In some embodiments, the wax is a liquid wax. In some embodiments, the wax includes a solid wax and a liquid wax. The compositions are substantially free of crystals. The components are selected to provide a composition that is substantially resistant to aging and to phase separation, and/or can substantially solubilize and or stabilize active ingredients. Pharmaceutical and cosmetic compositions with potentially enhanced skin delivery and their uses are also provided.
Core Innovation
The invention relates to a foam obtained from a foamable composition comprising a carrier and a liquefied hydrocarbon gas propellant, where the carrier comprises one or more liquid wax that mimics sebum, comprising at least one fatty acid and/or at least one fatty alcohol, a non-ionic surface-active agent, and water. Upon release of the foamable composition from a pressurized container, a breakable foam is formed. The foam comprises a micro or nanoemulsion and does not comprise a bioadhesive agent, a gelling agent, a film forming agent, or a polymeric phase change agent.
The disclosed approach further defines the liquid wax that mimics sebum using jojoba oil and selections of fatty acids and/or fatty alcohols. The foam formulation is described as being provided within systems that include fatty-acid and fatty-alcohol wax combinations and related wax/emulsion combinations. Foam performance is evaluated using shakability scoring, foaming breakability, collapse time, pH, density, and microscopic crystal observations.
The invention additionally addresses intra-canister uniformity by using an intra-canister uniformity sampling method and evaluates foam aging/creaming stress using a centrifugation-based aging/creaming test. The formulation is characterized as resistant to aging and phase separation/phase reversal resistance, and as substantially free of crystals and/or insoluble phases.
Claims Coverage
The independent claim set includes three independent claims. Across the independent claims, the core claim coverage is a breakable aerosol foam comprising a micro or nanoemulsion formed by releasing a foamable composition from a pressurized container, where the carrier uses sebum-mimicking liquid wax, a non-ionic surface-active agent, and water, while excluding bioadhesive, gelling, film forming, and polymeric phase change agents.
Sebum-mimicking liquid wax carrier with non-ionic surface-active agent and water
A foam obtained from a foamable composition comprising a carrier and a liquefied hydrocarbon gas propellant, wherein the carrier comprises one or more liquid wax that mimics sebum, comprising at least one fatty acid and/or at least one fatty alcohol, a non-ionic surface-active agent, and water.
Breakable foam upon release from a pressurized container forming a micro or nanoemulsion
Upon release of the foamable composition from a pressurized container, a breakable foam is formed, wherein the foam comprises a micro or nanoemulsion.
Exclusion of specific additive categories from the foam
The foam does not comprise a bioadhesive agent, a gelling agent, a film forming agent, or a polymeric phase change agent.
Jojoba oil sebum-mimicking liquid wax embodiment
A foam obtained from a foamable composition wherein the carrier comprises one or more liquid wax that mimics sebum, comprising jojoba oil, together with a non-ionic surface-active agent and water.
Across the independent claims, the core claim coverage centers on a wax-based carrier using sebum-mimicking liquid wax, or specifically jojoba oil, combined with a non-ionic surface-active agent and water, together with a liquefied hydrocarbon gas propellant to form a breakable foam upon release from a pressurized container. The foam comprises a micro or nanoemulsion in two of the independent claims, and all identified independent claims require exclusion of bioadhesive, gelling, film forming, and polymeric phase change agent categories.
Stated Advantages
Resistant to aging and phase separation/phase reversal resistance.
Foam does not comprise crystals and/or insoluble phases (substantially free from crystals and insoluble phases).
Documented Applications
Topical treatment/use for skin, mucosal surfaces, and body cavity disorders (including, for example, disorders treated with imiquimod/resiquimod/gardiquimod and other referenced therapeutic classes).
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