Topical erythropoietin formulations and methods for improving wound healing with and cosmetic use of the formulations
Inventors
Assignees
Publication Number
US-11213569-B2
Publication Date
2022-01-04
Expiration Date
2036-09-01
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Abstract
Topical formulations containing erythropoietin (EPO), and also preferably fibronectin (FN), especially gel formulations, are used to accelerate wound healing, e.g., from a burn, compared to the healing process without such a formulation being applied. Methods of preparing the formulations are also provided.
Core Innovation
The invention relates to topical formulations containing erythropoietin (EPO) and preferably fibronectin (FN), especially gel formulations. These formulations are used to accelerate wound healing, for example from burns, compared to wound healing processes without such treatments. The invention also includes methods of preparing these topical formulations.
The problem addressed by the invention is delayed wound healing particularly associated with diabetes mellitus (DM). People with diabetes often suffer from non-healing wounds such as diabetic skin ulcers (DSUs) due to impaired angiogenesis, decreased blood flow, increased inflammation, diminished fibroblast proliferation, and reduced keratinocyte reepithelialization. Prior art indicates EPO has beneficial effects in wound healing including stimulating angiogenesis and collagen deposition, and FN facilitates provisional wound matrix formation and prevents its dissociation, complementing EPO's effects.
The invention demonstrates that topical EPO treatment accelerates wound healing in diabetic subjects through a mechanism involving stimulation of aquaporin-3 (AQP3), which facilitates cell migration, proliferation, and reepithelialization. The effect of EPO on wound healing is potentiated by fibronectin, which enhances the salutary action of EPO when co-formulated. The compositions preferably contain a gel base with excipients such as glycerol, carbomer 940, benzyl alcohol, triethanolamine, methylparaben, and propylparaben, and can be formulated as hydrogels using fibrin, collagen or hyaluronic acid.
Claims Coverage
The patent contains two independent claims covering a specific composition and its therapeutic use for wound treatment.
Composition containing erythropoietin and fibronectin in a gel formulation
A composition comprising 5% w/w erythropoietin, 30% w/w fibronectin, and excipients including glycerol (5% w/w), Carbomer 940 (1% w/w), benzyl alcohol (2% w/w), triethanolamine (0.9% w/w), methylparaben (0.2% w/w), propylparaben (0.05% w/w), and water to 100% w/w, formulated as a gel.
Method of treating wounds by topical application of said composition
A method of treating a wound by topically applying a therapeutically effective amount of the gel composition containing erythropoietin and fibronectin as described above to the wound for treatment.
The independent claims cover a gel composition with defined percentages of erythropoietin and fibronectin along with other specified excipients, and a method of treating wounds by topical application of this gel formulation.
Stated Advantages
Accelerates wound healing, particularly in diabetic wounds, by stimulating angiogenesis, collagen and hyaluronic acid synthesis, and reepithelialization.
Potentiation of erythropoietin's wound healing effects by fibronectin, leading to enhanced therapeutic efficacy.
Formulations maintain erythropoietin and fibronectin stability in a gel format suitable for topical application.
Effective in promoting healing of chronic diabetic ulcers with clinical evidence demonstrating complete wound closure.
Documented Applications
Topical treatment of partial thickness and chronic wounds including diabetic ulcers and burns.
Accelerating healing of skin wounds in subjects diagnosed with diabetes, high blood sugar, insulin resistance, or insulin production deficits.
Applying the compositions cosmetically for treatment of scratched skin, soft skin fissures, and acne.
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