Method and system for preventing sore throat in humans

• US 10,085,938 B2
• Filed: 12/20/2016
• Issued: 10/02/2018
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Seed Health, Inc.
• Original Assignee: Joseph E. Kovarik, Katherine Rose Kovarik
• Inventors: Kovarik, Joseph E., Kovarik, Katherine Rose
• Primary Examiner(s): Yu, Hong
• Application Number:
  US15/385,278
• Publication Number:
  US 20170100330A1
• Time in Patent Office: 651 Days
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 49/0045 the fluorescent agent being a peptide or protein used for imaging or diagnosis in vivo
• CPC Class Codes: A61K 49/0069 the agent being in a particular physical galenical form
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence

Abstract

A method and system to prevent sore throat infections in humans includes the administration of an active ingredient to a site on the mucus membranes of the throat of a human that inhibits adherence and promotes desorption of S. pyogenes to soft tissue surfaces, such as the pharyngeal and oral mucosa of a human. A mucoadhesive strip having a surface topography that resists bioadhesion of undesired bacteria that are typically present in a human'"'"'s mouth is preferably employed and that has one or more encapsulated agents selected from the group consisting of an antibiotic; lactic acid bacteria; S. pyogenes modified by a CRISPR-Cas system to reduce one or more virulence factors; and a breath mint solution.

Claims

1. A buccal bioadhesive strip for treating sore throat in a human being, comprising:

a solid strip having a first and second side, said first side having a surface comprising a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 microns in at least a portion of said surface, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip is sized to extend over a majority of the soft palate, and wherein said strip includes xylitol and at least one encapsulated feature containing one of an analgesic and a lactic acid bacteria that coaggregates with S. pyogenes.

2. The strip of claim 1, wherein said strip includes at least one polymer selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof.

3. The strip of claim 1 wherein said strip comprises bioluminescent material.

4. The strip of claim 1 wherein said strip is non-dissolvable in a person'"'"'s mouth.

5. The strip of claim 1 wherein said strip is dissolvable in a person'"'"'s mouth within a period of 3 hours.

6. The strip of claim 1, wherein the strip comprises at least one encapsulated feature that contains S. pyogenes modified by a CRISPR-Cas system to reduce one or more virulence factors.

7. The strip of claim 1 wherein said strip includes at least 200 mg of xylitol.

8. The strip as set forth in claim 1, wherein said strip comprises Prevotella bacteria.

20. The strip of claim 1, wherein said strip includes at least 0.2% xylitol by weight.

21. The strip of claim 1, wherein said strip reduces the adhesion of S. pyogenes to an epithelial tissue of a person.

22. The strip of claim 1 wherein said strip includes at least 200 mg of xylitol.

23. The strip of claim 1 wherein said strip has at least one active ingredient encapsulated inside a frangible capsule that may be broken by a person pressing against said strip with the person'"'"'s tongue.

25. The film as set forth in claim 23, wherein said strip includes one of bacterial and helminth components.

9. A buccal bioadhesive solid strip for treating sore throat in a human being, comprising:

at least one surface of said strip having a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 microns in at least a portion of said at least one surface, said strip having a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip is sized to extend over a majority of the soft palate, said strip including between 0.2 and 0.9% xylitol by weight and having a length dimension of between 0.5 and 2 cm;

a surface area of 0.25-1.5 inches; and

a weight of at least 30 mg.

10. The strip of claim 9, wherein the strip comprises at least one encapsulated feature that contains S. pyogenes modified by a CRISPR-Cas system to reduce one or more virulence factors.

11. The strip of claim 9, wherein the strip comprises S. pyogenes that have been modified to render ineffective virulence factors in a manner effective to avoid sore throat progression.

12. The strip of claim 9, wherein the strip comprises lactic acid bacteria that populate the strip and that are specifically able to coaggregate with S. pyogenes.

13. The strip of claim 9, wherein the strip is dissolvable in a person'"'"'s mouth after one hour.

14. The strip of claim 9, wherein the strip comprises S. pyogenes that have been modified to remove or disable one or more virulence factors and wherein the S. pyogenes is encapsulated on the strip within a pouch or pocket.

15. A buccal bioadhesive solid strip for treating sore throat in a human being, comprising:

at least one surface of said strip having a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 microns in at least a portion of said at least one surface, said strip having a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip is sized to extend over a majority of the soft palate, said strip including at least 0.2% xylitol by weight and having a length dimension of between 0.5 and 2 cm;

a surface area of between 0.25-1.5 square inches;

a weight of at least 30 mg; and

includes bacteria modified by a CRISPR-Cas or Cfp1 system.

16. The strip of claim 15, wherein the strip includes S. pyogenes that have been modified to render ineffective virulence factors in a manner effective to avoid sore throat progression.

17. The strip of claim 15, wherein the lactic acid bacteria populate the strip that are specifically able to coaggregate with S. pyogenes.

18. The strip of claim 15, wherein the strip is dissolvable and has a rectangular shape.

19. The strip of claim 15, wherein the strip has a thickness of between 100-400 microns thick.

24. A buccal bioadhesive strip, comprising:

a strip having at least one surface having a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature wherein an average spacing between adjacent ones of said features is between 0.5 and 5 microns, said strip having a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip extends over a majority of the soft palate, and wherein said strip includes at least one polymer selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof; and

wherein said strip includes between 0.2 and 0.9% xylitol by weight.