USE OF pH SENSITIVE COMPOUNDS IN TASTE MASKING OF DRUG SUBSTANCES WITHIN ORAL THIN FILM STRIPS

• US 20110142942A1
• Filed: 12/10/2010
• Published: 06/16/2011
• Est. Priority Date: 12/10/2009
• Status: Abandoned Application

• Current Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Original Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Inventors: Hariharan, Madhu, Davidson, Kevin, Miloshoff, Laura, Schobel, A. Mark, Sanghvi, Pradeep
• Application Number:
  US12/965,196
• Publication Number:
  US 20110142942A1
• Time in Patent Office: Days
• US Class Current: 424/489
• 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

The present invention relates to an edible film dosage form that includes a film-forming polymer and a coated active composition capable of taste-masking an active contained therein. An edible film that includes an edible, water-soluble film forming polymer and an active with at least two coating layers is also disclosed.

Claims

1. A therapeutic film dosage comprising:

a film composition comprising;

(i) a film-forming polymer; and

(ii) a coated active composition comprising at least one particulate active and a coating composition comprising a taste-masking effective amount of a reverse-enteric polymer composition and a water-insoluble polymeric composition, wherein said reverse-enteric polymer composition and said water-insoluble polymeric composition are present in an amount of about 9;

1 to about 1;

9 by weight of the coating composition,

wherein said coating composition at least partially surrounds said active component and the at least partially coated active component is water-insoluble at a neutral pH.

2. The edible film dosage form of claim 1, wherein said coating composition prevents water from contacting said active component.

3. The edible film dosage form of claim 1, wherein said coating composition substantially prevents organoleptic detection of the active in the mouth.

4. The edible film dosage form of claim 1, wherein said coating composition is water-insoluble in the pH range of about 5 to about 9.

5. The edible film dosage form of claim 1, wherein said coating composition is water-soluble in the pH range of about 1 to about 4.5.

6. The edible film dosage form of claim 1, wherein said coating composition is substantially water-insoluble for about one minute to about two hours.

7. The edible film dosage form of claim 1, wherein said reverse-enteric polymer composition is selected from the group consisting of dimethylaminoethyl methacrylate, neutral methacrylic acid esters and combinations thereof.

8. The edible film dosage form of claim 7, wherein said water-insoluble polymeric composition is selected from the group consisting of cellulose acetate, ethylcellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, polyvinyl acetate phthalate and combinations thereof.

9. The edible film dosage form of claim 1, wherein said coating composition further comprises an acid-reactive component.

10. The edible film dosage form of claim 9, wherein said acid-reactive material is selected from the group consisting of calcium carbonate, calcium phosphate and combinations thereof.

11. The edible film dosage form of claim 10, wherein said calcium carbonate has a particle size range of from about 0.5 μ

m to about 25 μ

m.

12. The edible film dosage form of claim 1, further comprising non-pH dependent materials selected from the group consisting of sucrose, natural sweeteners, artificial sweeteners, and combinations thereof.

13. The dosage form of claim 1, further comprising insoluble, hydrophobic materials selected from the group consisting of magnesium stearate, stearic acid, sodium stearyl fumarate, and combinations thereof.

14. The therapeutic dosage form of claim 1, wherein said particle is granulated.

15. The therapeutic dosage form of claim 14, wherein said granulated particle further comprises an active adsorbate comprising magnesium trisilicate.

16. The edible film dosage form of claim 1, wherein said coating composition comprises an active adsorbate comprising magnesium trisilicate.

17. A therapeutic film for delivery of an active comprising:

an edible film dosage comprising;

(a) an edible, water-soluble film forming polymer; and

(b) an active composition comprising;

(i) an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof;

(ii) a first coating layer substantially surrounding said active component; and

(iii) a second coating layer substantially surrounding said first coating layer;

wherein said edible film dosage form is self-supporting.

18. The edible film of claim 17, wherein said first coating layer comprises ethylcellulose.

19. The edible film of claim 17, wherein said first coating layer is water-insoluble.

20. The edible film of claim 17, wherein said second coating layer is water-insoluble in the pH range of about 5 to about 9.

21. The edible film of claim 17, wherein said second coating layer comprises a compound selected from the group consisting of dimethyl aminoethyl methacrylate, neutral methacrylic acid esters, or combinations thereof and a water-insoluble, pH-independent base polymeric constituent.

22. The edible film dosage form of claim 17, wherein said first coating composition comprises an active adsorbate comprising magnesium trisilicate.

23. The edible film dosage form of claim 17, wherein said second coating composition comprises an active adsorbate comprising magnesium trisilicate.