Claims for Patent: 11,077,068

Summary for Patent: 11,077,068

Title:	Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Abstract:	The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.
Inventor(s):	Myers; Garry L. (Kingsport, TN), Sanghvi; Pradeep (North Brunswick, NJ), Verrall; Andrew Philip (Indianapolis, IN), Francis; Vimala (Fremont, CA), Brooks; Laura (Sheboygan, WI)
Assignee:	Aquestive Therapeutics, Inc. (Warren, NJ)
Application Number:	16/717,041
Patent Claims:	1. An oral film for delivery of a desired amount of an active component comprising: an ingestible, water-soluble, polymer matrix; at least one anti-tacking agent selected from the group consisting of stearates; stearic acid; waxes; a blend of magnesium stearate and sodium lauryl sulfate; boric acid; surfactants; sodium benzoate; sodium acetate; sodium chloride; DL-Leucine; polyethylene glycol; sodium oleate; sodium lauryl sulfate; magnesium lauryl sulfate; talc; corn starch; amorphous silicon dioxide; syloid; metallic stearates, Vitamin E, Vitamin E TPGS, silica and combinations thereof; and a substantially uniform distribution of said desired amount of said active component within said polymer matrix, wherein said active component is selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof, said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix and maintain said substantially uniform distribution; wherein said film is self-supporting and the active component is substantially uniformly distributed, whereby said substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component. 2. The film of claim 1, wherein said anti-tacking agent comprises magnesium stearate. 3. The film of claim 2, wherein said anti-tacking agent further comprises silica. 4. The film of claim 1, wherein said anti-tacking agent is present in amounts of about 0.01% to about 20% by weight of said delivery system. 5. The film of claim 1, wherein said anti-tacking agent comprises: magnesium stearate present in amounts of about 0.1% to about 2.5% by weight of said delivery system; and silica present in amounts of about 0.1% to about 1.5% by weight of said delivery system. 6. The film of claim 1, wherein said water-soluble polymer matrix comprises polyethylene oxide and a cellulosic polymer. 7. The film of claim 6, wherein said cellulosic polymer comprises hydroxypropyl cellulose. 8. The film of claim 6, wherein said cellulosic polymer comprises hydroxypropylmethyl cellulose. 9. The film of claim 1, wherein said active component comprises dextromethorphan. 10. The film of claim 1, further comprising polydextrose. 11. The film of claim 1, wherein said film is applied to an oral cavity of a mammal. 12. The film of claim 11, wherein said film adheres to the tongue or the buccal cavity of the mammal. 13. The film of claim 1, wherein the anti-tacking agent is present in an amount sufficient to impart reduced film-to-film coefficient of friction. 14. The film of claim 1, wherein said film has a coefficient of friction which is low enough to reduce adhesion of said film to the roof of a mouth of a user of said film upon placement into the user's mouth. 15. The film of claim 1 further comprising a flavoring agent. 16. The film of claim 1 further comprising a coloring agent. 17. The film of claim 1 wherein the anti-tacking agent comprises sodium benzoate. 18. The film of claim 1, wherein the active component comprises an opiate, opiate derivative, an analgesic and combinations thereof. 19. The film of claim 1, further comprising a preservative. 20. The film of claim 1, wherein the film is sufficient to impart reduced film-to-film coefficient of friction.