Fast dissolving orally consumable films containing a taste masking agent

• US 7,648,712 B2
• Filed: 05/05/2006
• Issued: 01/19/2010
• Est. Priority Date: 03/23/2000
• Status: Expired due to Fees

• Current Assignee: Johnson & Johnson Consumer Inc. (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Ramsay, Michael P., Bess, William S., Ambike, Suhas H., Kulkarni, Neema
• Primary Examiner(s): Peselev; Elli
• Application Number:
  US11/429,547
• Publication Number:
  US 20060204559A1
• Time in Patent Office: 1,355 Days
• Field of Search: None
• US Class Current: 424/407
• CPC Class Codes: A61K 47/585 Ion exchange resins, e.g. polystyrene sulfonic acid resin
• 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 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence

Abstract

Physiologically acceptable films, including edible films, are disclosed. The films include a water soluble film-forming polymer, such as pullulan, and a taste masked pharmaceutically active agent, such as dextromethorphan. The taste masking agent is preferably a sulfonated polymer ion exchange resin comprising polystyrene cross-linked with divinylbenzene, such as AMBERLITE. Methods for producing the films are also disclosed.

Claims

1. An orally consumable single layer film that is adapted to adhere to and to dissolve fast in a mouth of a consumer, comprising:

a.) 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

b.) at least one pharmaceutically active agent; and

c.) a taste masking agent, which is ethyl cellulose

wherein the pharmaceutically active agent is coated with the taste masking agent and suspended in the film.

2. The consumable film according to claim 1, wherein said at least one water soluble polymer is pullulan.

3. The consumable film according to claim 1, wherein said at least one pharmaceutically active agent is a member selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory agents, antitussives, decongestants, anti-histamines, expectorants, anti-diaherrals, H2-antagonists, proton pump inhibitors, central nervous system agents, analgesics and mixtures thereof.

4. The consumable film according to claim 3, wherein the antimicrobial agent is a member selected from the group consisting of triclosan, cetyl pyridium chloride, domiphen bromide, quaternary ammonium salts, zinc compounds, sanguinarine, fluorides, alexidine, octonidine, EDTA and mixtures thereof.

5. The consumable film according to claim 3, wherein the non-steroidal anti-inflammatory agent is a member selected from the group consisting of aspirin, acetaminophen, ibuprofen, diflunisal, fenoprofen calcium, naproxen, tolmetin sodium, indomethacin, and mixtures thereof.

6. The consumable film according to claim 3, wherein the antitussive is a member selected from the group consisting of benzonatate, caramiphen edisylate, dextromethorphan, chlophedianol, diphenhydramine, salts thereof and mixtures thereof.

7. The consumable film according to claim 3, wherein the decongestant is selected from the group consisting of pseudoephedrine, phenylepherine, phenylpropanolamine, salts thereof and mixtures thereof.

8. The consumable film according to claim 3, wherein the antihistamine is selected from the group consisting of brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate, diphenhydramine hydrochloride, diphenhydramine citrate, diphenylpyraline hydrochloride, doxylamine succinate, promethazine hydrochloride, pyrilamine maleate, tripelennamine citrate, triprolidine hydrochloride and mixtures thereof.

9. The consumable film according to claim 3, wherein the expectorant is selected from the group consisting of guaifenesin, ipecac, potassium iodide, terpin hydrate and mixtures thereof.

10. The consumable film according to claim 3, wherein the antidiarrheal is loperamide.

11. The consumable film according to claim 3, wherein the H2-antagonist is selected from the group consisting of famotidine, ranitidine and mixtures thereof.

12. The consumable film according to claim 3, wherein the proton pump inhibitor is selected from the group consisting of omeprazole, lansoprazole, and mixtures thereof.

13. The consumable film according to claim 3, 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 70 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;

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

about 0.1 to about 12 wt % of a triglyceride;

about 0.001 to about 5 wt % of a preservative;

about 0.1 to about 5 wt % of a polyethylene oxide compound; and

about 1 to about 20 wt % of propylene glycol.

14. A method for preparing the consumable film of claim 1, said method comprising:

dissolving water-soluble ingredients in water to provide an aqueous solution;

mixing 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 at least one stabilizing agent to provide a film-forming mixture;

combining said film-forming mixture and said aqueous solution to provide a hydrated polymer gel;

providing a pharmaceutical agent coated with ethyl cellulose;

adding said pharmaceutical agent coated with ethyl cellulose to said hydrated polymer gel and mixing to provide a uniform gel;

casting the uniform gel on a substrate; and

drying the cast gel to provide said film.