Fast dissolving orally consumable films

• US 6,923,981 B2
• Filed: 04/17/2003
• Issued: 08/02/2005
• Est. Priority Date: 09/25/1998
• Status: Expired due to Term

• Current Assignee: Johnson & Johnson Consumer Inc. (Johnson & Johnson)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Leone, Robert S., Leung, Sau-Hung Spence, Kulkarni, Neema, Kumar, Lori D., Sorg, Albert F.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Sheikh, Humera N.
• Application Number:
  US10/418,368
• Publication Number:
  US 20030206941A1
• Time in Patent Office: 838 Days
• Field of Search: 424/439, 424/400
• US Class Current: 424/439
• CPC Class Codes: A23G 3/50 characterised by shape, structure or physical form, e.g. products with supported structure
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/0216 Solid or semisolid forms
• CPC Class Codes: A61K 8/21 Fluorides; Derivatives thereof
• CPC Class Codes: A61K 8/34 Alcohols
• CPC Class Codes: A61K 8/347 Phenols
• CPC Class Codes: A61K 8/37 Esters of carboxylic acids
• CPC Class Codes: A61K 8/416 Quaternary ammonium compounds A61K8/35 takes precedence
• CPC Class Codes: A61K 8/43 Guanidines
• CPC Class Codes: A61K 8/44 Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
• CPC Class Codes: A61K 8/4973 with oxygen as the only hetero atom
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/645 Proteins of vegetable origin; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/65 Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/73 Polysaccharides
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/732 Starch; Amylose; Amylopectin; Derivatives thereof
• CPC Class Codes: A61K 8/733 Alginic acid; Salts thereof
• CPC Class Codes: A61K 8/736 Chitin; Chitosan; Derivatives thereof
• CPC Class Codes: A61K 8/8129 : Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers or esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers, e.g. polyvinylmethylether
• CPC Class Codes: A61K 8/8147 : Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/8152 : Homopolymers or copolymers of esters, e.g. (meth)acrylic acid esters; Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/8176 : Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/86 : Polyethers
• CPC Class Codes: A61K 8/922 : of vegetable origin
• CPC Class Codes: A61K 9/0056 : Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 : Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/2072 : characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/7007 : Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 : Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 : for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/12 : Antidiarrhoeals
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/10 : Expectorants
• CPC Class Codes: A61P 11/14 : Antitussive agents
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61Q 11/00 : Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

Physiologically acceptable films, including edible films, are disclosed. The films include a water soluble film-forming polymer such as pullulan. Edible films are disclosed that include pullulan and antimicrobially effective amounts of the essential oils thymol, methyl salicylate, eucalyptol and menthol. The edible films are effective at killing the plaque-producing germs that cause dental plaque, gingivitis and bad breath. The film can also contain pharmaceutically active agents. Methods for producing the films are also disclosed.

Claims

1. A consumable film that adheres to and dissolves in a mouth of a consumer, wherein said film is a single layer, non-self-adhering, non-brittle film comprising at least one water soluble polymer and an antimicrobial effective combination of at least two essential oils selected from the group consisting of (i) about 0.01 to about 4 wt % thymol, (ii) about 0.01 to about 4 wt % methyl salicylate, (iii) about 0.01 to about 4 wt % eucalyptol and (iv) about 0.01 to about 15 wt % menthol and wherein the oil content of the dry film is at least 10 wt %.

2. The consumable film according to claim 1, comprising at least three of said essential oils.

3. The consumable film according to according to claim 1, comprising thymol, methyl salicylate, eucalyptol and menthol.

4. The consumable film according to claim 3, further comprising a salt of gluconic acid.

5. The consumable film according to claim 3, further comprising copper gluconate.

6. The consumable film according to claim 1, wherein said water soluble polymer is 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.

7. The consumable film according to claim 6, wherein said water soluble polymer is pullulan.

8. The consumable film of claim 7, comprising:

about 40 to about 80 wt % pullulan;

about 0.01 to about 4 wt % thymol;

about 0.01 to about 4 wt % methyl salicylate;

about 0.01 to about 4 wt % eucalyptol; and

about 0.01 to about 15 wt % menthol.

9. The consumable film according to claim 6, further comprising:

about 0.01 to about 5 wt % of at least one stabilizing agent;

about 0.001 to about 0.1 wt % of at least one of at least one coloring agent;

about 0.1 to about 8 wt % of water;

about 0.1 to about 15 wt % of at least one sweetening agent;

about 0.1 to about 15 wt % of at least one flavoring agent;

about 0.1 to about 4 wt % of at least one cooling agent; and

about 0.1 to about 5 wt % of at least one surfactant.

10. The consumable film according to according to claim 9, wherein said least one stabilizing agent is selected from the group consisting of xanthan gum, locust bean gum and carrageenan, and said at least one sweetening agent is selected from the group consisting of saccharin, aspartame and acesulfame K.

11. The consumable film according to claim 1, wherein said film does not substantially adhere to itself.

12. The consumable film according to claim 1, wherein said film is free of glycerin and sorbitol.

13. The consumable film according to claim 1, wherein said film is free of humectants.

14. The consumable film according to claim 1, wherein the essential oils comprises at least about 10 wt % of the film.

15. The consumable film according to claim 14, wherein the essential oils comprises at least about 15 wt % of the film.

16. The consumable film according to claim 1, further comprising water in an amount from about 3 wt % to about 8 wt %.