Claims for Patent: 9,339,548

Summary for Patent: 9,339,548

Title:	Thermo-sensitive, mucoadhesive or dermoadhesive, and penetration-enhancing formulations for topical delivery of therapeutics
Abstract:	The present invention provides thermo-sensitive, mucoadhesive biopolymer formulations that enhance the penetration of therapeutics across the skin or mucosal surfaces. In a preferred embodiment, the biopolymer formulation comprises co-polymer of poloxamer 188 and propylene glycol, laurocapram and, optionally, one or more therapeutic agents. Also provided are uses of the biopolymer formulations for topical therapy of cancer including cervical cancer.
Inventor(s):	Hsu; Stephen I-Hong (Gainesville, FL)
Assignee:	UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INCORPORATED (Gainesville, FL)
Application Number:	14/739,334
Patent Claims:	1. A composition for topical delivery of therapeutics across the skin or mucosal surfaces comprising poloxamer 188, propylene glycol, laurocapram and a vaccine antigen selected from the group consisting of: tumor antigens, viral antigens, bacterial antigens, fungal antigens, parasite antigens and allergens. 2. A composition for topical delivery of therapeutics across the skin or mucosal surfaces comprising poloxamer 188, propylene glycol, laurocapram and a therapeutic agent, wherein the therapeutic agent is insulin, an insulin analog, a biguanide, a thiazolidinedione, a sulfonylurea, a nonsulfonylurea secretagogue, an alpha-glucosidase inhibitor or a combination thereof. 3. The composition for topical delivery of therapeutics across the skin or mucosal surfaces according to claim 2, wherein said insulin analog is Lispro (Humalog), Humulin (Isophane and Regular), Novolog (Aspart), Levemir (Detemir), or Lantus (glargine). 4. A composition for topical delivery of therapeutics across the skin or mucosal surfaces comprising poloxamer 188, propylene glycol, laurocapram and a therapeutic agent, wherein the therapeutic agent is metformin, rosiglitazone, pioglitazone, troglitazone, tolbutamide, acetohexamide, tolazamide, chlorpropamide, glipizide, glyburide, glimepiride, gliclazide, repaglinide, nateglinide miglitol, acarabose or a combination thereof. 5. A method of treating diabetes comprising the topical or mucosal administration of the composition according to claim 2 to a subject having diabetes in an amount effective to treat diabetes. 6. A method of inducing an immune response in a subject comprising the topical or mucosal administration of the composition according to claim 1 to a subject in an amount effective to induce an immune response to an vaccine antigen contained within said formulation, wherein said vaccine antigen is selected from the group consisting of: tumor antigens, viral antigens, bacterial antigens, fungal antigens, parasite antigens and allergens. 7. A method of treating diabetes comprising the topical or mucosal administration of the composition according to claim 4 to a subject having diabetes in an amount effective to treat diabetes.

Details for Patent 9,339,548

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	06/14/1996		2031-04-01
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	08/06/1998		2031-04-01
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	09/06/2007		2031-04-01
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	06/06/2017		2031-04-01