Methods for modulating dissolution, bioavailability, bioequivalence and drug delivery profile of thin film drug delivery systems, controlled-release thin film dosage formats, and methods for their manufacture and use

• US 20060210610A1
• Filed: 03/07/2006
• Published: 09/21/2006
• Est. Priority Date: 11/14/2002
• Status: Active Grant

• Current Assignee: CURE Pharmaceutical Incorporated
• Original Assignee: Cura Pharmaceutical Company Incorporated
• Inventors: Davidson, Robert S., Kehoe, Gary
• Granted Patent: US 8,999,372 B2
• Time in Patent Office: Days
• US Class Current: 424/439
• CPC Class Codes: A61K 31/451 having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
• CPC Class Codes: A61K 31/4545 containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/53 having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• 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 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence

Abstract

Methods for modulating dissolution, bioavailability, bioequivalence and drug delivery profile of thin film drug delivery systems, controlled-release thin film dosage formats, and methods for their manufacture and use are disclosed.

Claims

1. A composition for the oral administration of an active ingredient comprising a film layer and a powder matrix applied as a coating to said film layer, wherein the film layer is made from an edible composition having an effective dissolution rate in the oral cavity and wherein the powder matrix comprises one or more controlled-release active ingredients.

2. The composition of claim 1 wherein a controlled-release active ingredient is selected from the group consisting of slow-, medium-, fast- and delayed release, or a combination thereof.

3. The composition of claim 1 wherein a controlled-release active ingredient comprises a microencapsulated active ingredient.

4. The composition of claim 3 wherein an active ingredient is microencapsulated by a process selected from the group consisting of simple or complex coacervation, interfacial cross-linking, interfacial polymerization, polymer dispersion, matrix encapsulation, solvent evaporation, solvent extraction, spray drying, hot melt microencapsulation and supercritical fluid.

5. A composition for the oral administration of an active ingredient comprising an edible film comprising one or more controlled-release active ingredients, wherein the edible film is made from an edible composition having an effective dissolution rate in the oral cavity.

6. The composition of claim 5 wherein the controlled-release active ingredient is selected from the group consisting of slow-, medium-, fast- and delayed release, or a combination thereof.

7. The composition of claim 5 wherein the controlled-release active ingredient comprises a microencapsulated active ingredient.

8. The composition of claim 7 wherein an active ingredient is microencapsulated by a process selected from the group consisting of simple or complex coacervation, interfacial cross-linking, interfacial polymerization, polymer dispersion, matrix encapsulation, solvent evaporation, solvent extraction, spray drying, hot melt microencapsulation and supercritical fluid.

9. The composition of claim 5 wherein the composition further comprises a powder matrix applied as a coating to said edible film.

10. The composition of claim 9 wherein the powder matrix applied as a coating to said edible film comprises an active ingredient.

11. (cancelled)

12. (cancelled)

13. (cancelled)

14. A method of making a composition for the oral administration of a controlled-release active ingredient comprising forming an edible film wherein the edible film comprises a controlled-release active ingredient.

15. The method of claim 14 wherein the method comprises the steps of (a) forming an edible film;

(b) applying a coating to said edible film, wherein the coating includes a powder matrix comprising one or more controlled-release active ingredients.