Petrolatum-based delivery systems and for active ingredients
The present disclosure is broadly concerned with petrolatum-based compositions as a suspension matrix for the active ingredients. The disclosure is also concerned with processes for forming stable emulsions of active ingredients in petrolatum.
1. A stable petrolatum-based composition comprising:
greater than about 80% by weight petrolatum;
a polar solvent; and
an active ingredient soluble in the polar solvent,
wherein the composition contains no emulsifier.
2. The composition according to claim 1 , wherein the active ingredient is a water-soluble active ingredient.
3. The composition according to claim 2 , wherein the polar solvent comprises water.
4. The composition according to claim 1 , wherein the active ingredient comprises less than 1% by weight of the petrolatum-based composition.
5. The composition according to claim 1 , wherein the composition is greater than 90 % by weight petrolatum.
6. The composition according to claim 1 , wherein the polar solvent and active ingredient are dispersed in the petrolatum in the form of nanodroplets.
7. The composition according to claim 6 , wherein the nanodroplets range in size from about 10 nm to about 10,000 nm.
8. The composition according to claim 1 , wherein the composition further comprises one or more compounds selected from the group consisting of TGF-alpha, TGF-beta (TGFβ1, TGFβ2, TGFβ3), platelet-derived growth factor (PDGF), epidermal growth factor (EGF), fibroblast growth factor also referred to as keratinocyte growth factor (FGF1, FGF2, FGF4, FGF7), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), connective tissue growth factor (CTGF), activin, interleukin- 1 (IL1α, IL1β, TNFα, and GM-CSF.
9. A wound dressing comprising a therapeutically effective amount of the composition according to claim 1 .
10. A suture comprising a therapeutically effective amount of the composition according to claim 1 .
11. A stable petrolatum-based composition consisting essentially of a polar solvent, an active ingredient soluble in the polar solvent, and greater than about 80% by weight petrolatum.
12. The composition according to claim 11 , wherein the polar solvent is water, the active ingredient being a water-soluble active ingredient.
13. The composition according to claim 11 , wherein the polar solvent and active ingredient are dispersed in the petrolatum in the form of nanodroplets.
14. The composition according to claim 13 , wherein the nanodroplets range in size from about 10 nm to about 10,000 nm.
15. A wound dressing comprising a therapeutically effective amount of the composition according to claim 11 .
16. A suture comprising a therapeutically effective amount of the composition according to claim 11 .
17. A stable composition comprising an active ingredient solution dispersed in petrolatum, whereby the composition contains no emulsifier and the composition comprises greater than about 80% by weight petrolatum.
18. The composition according to claim 17 , wherein the active ingredient solution comprises an active ingredient and a polar solvent.
19. The composition according to claim 17 , wherein the active ingredient solution does not chemically react with the petrolatum.
20. The composition according to claim 17 , wherein the active ingredient comprises a preservative or a combination of preservatives.
21. The composition according to claim 17 , wherein the active ingredient maintains efficacy for at least 3 months when stored at 40° C.±2° C. and 75%±5% relative humidity.
22. The composition according to claim 18 , wherein the polar solvent is water.
23. The composition according to claim 22 , wherein water comprises between about 0.1% and about 6% of the total composition by weight.
24. The composition according to claim 17 , wherein the total amount of active ingredient is less than about 1% by weight of the total composition.
25. A wound dressing comprising a therapeutically effective amount of the composition according to claim 17 .
26. A suture comprising a therapeutically effective amount of the composition according to claim 17 .