Claims for Patent: 12,280,146

Summary for Patent: 12,280,146

Title:	Nanoemulsion without propylene glycol
Abstract:	The present invention relates to oil in water nanoemulsions which are essentially free of propylene glycol. The nanovesicle formulations are particularly stable in regard to shelf life at different storage temperatures.
Inventor(s):	Montserrat FOGUET, Lars MÖLLMANN
Assignee:	Biofrontera Bioscience GmbH
Application Number:	US18/533,497
Patent Claims:	1. A formulation comprising: (a) a nanoemulsion comprising: (i) at least one aqueous component; (ii) a carrier component comprising: (1) at least one lipophilic component, (2) at least one surfactant, and (3) at least one alcohol; and (b) 5-aminolevulinic acid and/or a derivative, a precursor, a metabolite, and/or a pharmaceutically acceptable salt thereof, wherein the formulation comprises essentially no propylene glycol and essentially no sorbitol. 2. The formulation of claim 1, wherein the formulation further comprises less than 1% w/w of a non-cyclic polyol having 2 to 5 carbon atoms. 3. The formulation of claim 1, wherein the formulation further comprises less than 1% w/w of a non-cyclic polyol having 2 to 12 carbon atoms. 4. The formulation of claim 1, wherein the at least one alcohol comprises: 3, 4, or 5 carbon atoms; or 1-propanol, 2-propanol, or a mixture thereof. 5. The formulation of claim 1, comprising the at least one aqueous component in an amount from 50% to 99% (w/w), from 70% to 95% (w/w), from 75% to 95% (w/w), or from 80% to 90% (w/w). 6. The formulation of claim 4, comprising the at least one lipophilic component in an amount from 0.1% to 30% (w/w), from 0.25% to 15% (w/w), from 0.25% to 10% (w/w), from 2% to 10% (w/w), or 3% to 8% (w/w) based on total weight of the nanoemulsion. 7. The formulation of claim 1, wherein the formulation comprises no propylene glycol. 8. The formulation of claim 1, wherein the formulation further comprises less than or equal to 0.99%, 0.95%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, or 0.1% w/w of a non-cyclic polyol having 2 to 5 carbon atoms. 9. The formulation of claim 1, wherein the formulation further comprises essentially no non-cyclic polyol having 2 to 5 carbon atoms. 10. The formulation of claim 1, wherein the formulation further comprises no non-cyclic polyol having 2 to 5 carbon atoms. 11. The formulation of claim 1, wherein the formulation further comprises less than or equal to 0.99%, 0.95%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, or 0.1% w/w of a non-cyclic polyol having 2 to 12 carbon atoms. 12. The formulation of claim 1, wherein the formulation further comprises essentially no non-cyclic polyol having 2 to 12 carbon atoms. 13. The formulation of claim 1, wherein the formulation further comprises no non-cyclic polyol having 2 to 12 carbon atoms. 14. The formulation of claim 1, wherein the at least one lipophilic component comprises: triglycerides and/or mixtures thereof; or a caprylic triglyceride, a capric triglyceride, or a mixture thereof. 15. The formulation of claim 1, wherein the at least one surfactant comprises: a phospholipid, a phosphatidylcholine, a lysophospholipid, a ceramide, and/or a mixture thereof; and/or a polyoxyethylene-type surfactant. 16. The formulation of claim 4, wherein the at least one alcohol is in an amount from 0.1% to 10% (w/w), from 0.5% to 5% (w/w), from 1% to 5% (w/w), or from 1% to 3% based on total weight of the nanoemulsion. 17. The formulation of claim 1, wherein the formulation further comprises essentially no monosaccharides and disaccharides.