Polyethylene oxide-based films and drug delivery systems made therefrom

• US 8,017,150 B2
• Filed: 04/22/2008
• Issued: 09/13/2011
• Est. Priority Date: 04/11/2002
• Status: Expired due to Term

• Current Assignee: Aquestive Therapeutics, Inc.
• Original Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Inventors: Yang, Robert K., Fuisz, Joseph M., Fuisz, Richard C., Myers, Garry L.
• Primary Examiner(s): JUSTICE, GINA CHIEUN YU
• Application Number:
  US12/107,389
• Publication Number:
  US 20080260809A1
• Time in Patent Office: 1,239 Days
• Field of Search: 424/434, 424/435, 424/436, 424/443, 424/484
• US Class Current: 424/484
• CPC Class Codes: A61K 2800/92 Oral administration
• CPC Class Codes: A61K 8/0216 Solid or semisolid forms
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/86 Polyethers
• 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
• CPC Class Codes: A61K 9/7015 Drug-containing film-forming compositions, e.g. spray-on
• 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
• CPC Class Codes: C08J 2371/02 Polyalkylene oxides
• CPC Class Codes: C08J 5/18 Manufacture of films or sheets
• CPC Class Codes: F26B 13/104 supported by fluid jets only; Fluid blowing arrangements for flotation dryers, e.g. coanda nozzles

Abstract

The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

Claims

1. A mucosally-adhesive water-soluble film product comprising:

an analgesic opiate pharmaceutical active; and

at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer;

wherein;

the water-soluble polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;

the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100,000 to 300,000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600,000 to 900,000; and

the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component.

2. The film product according to claim 1, wherein said film product has a viscosity of about 1,000 cps to about 40,000 cps.

3. The film product according to claim 1, wherein said film product has a thickness of about 3 mils to about 6 mils.

4. The film product according to claim 1, further comprising an additional pharmaceutical active.

5. The film product according to claim 1, further comprising one or more sweeteners.

6. The film product according to claim 5, wherein said one or more sweeteners comprise a hydrogenated starch hydrolysate.

7. The film product according to claim 5, wherein said one or more sweeteners comprise the potassium salt of 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide.

8. The film product according to claim 1, further comprising one or more flavors.

9. The film product according to claim 1, further comprising one or more buffers.

10. A mucosally-adhesive water-soluble film product comprising:

an analgesic opiate pharmaceutical active; and

at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer;

wherein;

the water-soluble polymer component comprises the hydrophilic cellulosic polymer in a ratio of up to about 4;

1 with the polyethylene oxide;

the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100,000 to 300,000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600,000 to 900,000; and

the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component.

11. The film product according to claim 10, wherein said film product has a viscosity of about 1,000 cps to about 40,000 cps.

12. The film product according to claim 10, wherein said film product has a thickness of about 3 mils to about 6 mils.

13. The film product according to claim 10, further comprising an additional pharmaceutical active.

14. The film product according to claim 10, further comprising one or more sweeteners.

15. The film product according to claim 14, wherein said one or more sweeteners comprise a hydrogenated starch hydrolysate.

16. The film product according to claim 14, wherein said one or more sweeteners comprise the potassium salt of 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide.

17. The film product according to claim 10, further comprising one or more flavors.

18. The film product according to claim 10, further comprising one or more buffers.