Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
View Patent ↗The present invention teaches a foamable pharmaceutical carrier comprising a benefit agent, selected from the group consisting of a dicarboxylic acid and a dicarboxylic acid ester; a stabilizer selected from the group consisting of at least one surface-active agent; at least one polymeric agent and mixtures thereof; a solvent selected from the group consisting of water, a hydrophilic solvent, a hydrophobic solvent, a potent solvent, a polar solvent, a silicone, an emollient, and mixtures thereof, wherein the benefit agent, stabilizer and solvent are selected to provide a composition that is substantially resistant to aging and to phase separation and or can substantially stabilize other active ingredients. The invention further relates to a foamable composition further containing a liquefied hydrocarbon gas propellant.
1. A foamable composition comprising a carrier and a liquefied or compressed gas propellant, wherein the carrier comprising:
(a) about 15% by weight of the carrier of azelaic acid;
(b) about 2% to about 50% by weight of the carrier of a hydrophobic solvent;
(c) a polar solvent;
(d) a surface-active agent;
(e) a polymeric agent; and
(f) water; and
wherein the surface-active agent comprises a combination of at least two surface-active agents and wherein there is a difference of about 4 or more units between the HLB values of the at least two surface-active agents;
wherein combined amount of the polymeric agent and the surface-active agent is about 0.05% to about 10% by weight of the carrier; and
wherein the liquefied or compressed gas propellant is present at about 3% to about 25% by weight of the composition.
2. The foamable composition of claim 1 , wherein the hydrophobic solvent comprises caprylic/capric triglyceride.
3. The foamable composition of claim 2 , wherein caprylic/capric triglyceride is present at about 11% by weight of the carrier.
4. The foamable composition of claim 1 , wherein the polar solvent comprises dimethyl isosorbide.
5. The foamable composition of claim 4 , wherein dimethyl isosorbide is present at about 5% by weight of the carrier.
6. The foamable composition of claim 4 , wherein the polar solvent further comprises propylene glycol.
7. The foamable composition of claim 1 , wherein the combination comprises at least one non-ionic surface-active agent having an HLB value of less than 9.
8. The foamable composition of claim 7 , wherein the at least one non-ionic surface-active agent comprises glyceryl stearate.
9. The foamable composition of claim 1 , wherein the combination comprises at least one non-ionic surface-active agent having an HLB value of more than 9.
10. The foamable composition of claim 9 , wherein the at least one non-ionic surface-active agent having an HLB value of more than 9 comprises PEG-40 stearate and/or Polysorbate 80.
11. The foamable composition of claim 1 , wherein the combination comprises at least one ionic surface-active agent.
12. The foamable composition of claim 1 , wherein the polymeric agent is present at about 0.01% to about 5% by weight of the carrier.
13. The foamable composition of claim 1 , wherein the polymeric agent comprises a naturally-occurring polymeric agent and/or a semi-synthetic polymeric agent.
14. The foamable composition of claim 13 , wherein the naturally-occurring polymeric agent comprises xanthan gum.
15. The foamable composition of claim 13 , wherein the semi-synthetic polymeric agent comprises methylcellulose.
16. The foamable composition of claim 11 , wherein the foamable composition further comprises a foam adjuvant.
17. The foamable composition of claim 16 , wherein the foam adjuvant comprises a fatty alcohol having 15 or more carbons in its carbon chain and/or a fatty acid having 16 or more carbons in its carbon chain.
18. The foamable composition of claim 17 , wherein the fatty alcohol comprises cetostearyl alcohol.
19. The foamable composition of claim 1 , wherein the foamable composition comprises less than about 5% by weight of the carrier of a short-chain alcohol.
20. The foamable composition of claim 1 , wherein the foamble composition further comprises an anti-perspirant, an anti-static agent, a buffering agent, a bulking agent, a chelating agent, a cleanser, a colorant, a conditioner, a deodorant, a diluent, a dye, an emollient, a fragrant, a hair conditioner, a humectant, a pearlescent acid, a perfuming agent, a permeation enhancer, a pH-adjusting agent, a preservative, a protectant, a skin penetrating enhancer, a softener, a solubilizer, a sunscreen, a sun blocking agent, a sunless tanning agent, a viscosity modifier, and/or a vitamin.
21. The foamable composition of claim 1 , the pH of the foamable composition is in the range from about 4.0 to about 6.0.
22. The foamable composition of claim 1 , wherein the foamable composition has a shelf-life of at least one year at ambient temperature.