# US 11,077,068 B2 · Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions

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- Number: US 11,077,068 B2
- Document ID: US11077068B2
- Status: Granted
- Kind: B2
- Application number: 16/717,041
- Filed: 2019-12-17
- Published: 2020-10-08
- Granted: 2021-08-03
- Earliest claimed: 2001-10-12
- Assignees: Aquestive Therapeutics, Inc.
- Applicants: Aquestive Therapeutics, Inc.
- Inventors: Garry L. Myers; Pradeep Sanghvi; Andrew Philip Verrall; Vimala Francis; Laura Brooks
- Web page: https://patentgrep.com/patent/US11077068B2

## CPC

- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/15: Vitamins
- A23L 33/16: Inorganic salts, minerals or trace elements
- A23P 20/20: Making of laminated, multi-layered, stuffed or hollow foodstuffs, e.g. by wrapping in preformed edible dough sheets or in edible food containers
- A23P 30/10: Moulding
- 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}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/38: Cellulose; Derivatives thereof
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

The film of claim 1, wherein said anti-tacking agent comprises magnesium stearate.

### Claim 3 (depends on 2)

The film of claim 2, wherein said anti-tacking agent further comprises silica.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

The film of claim 1, wherein said water-soluble polymer matrix comprises polyethylene oxide and a cellulosic polymer.

### Claim 7 (depends on 6)

The film of claim 6, wherein said cellulosic polymer comprises hydroxypropyl cellulose.

### Claim 8 (depends on 6)

The film of claim 6, wherein said cellulosic polymer comprises hydroxypropylmethyl cellulose.

### Claim 9 (depends on 1)

The film of claim 1, wherein said active component comprises dextromethorphan.

### Claim 10 (depends on 1)

The film of claim 1, further comprising polydextrose.

### Claim 11 (depends on 1)

The film of claim 1, wherein said film is applied to an oral cavity of a mammal.

### Claim 12 (depends on 11)

The film of claim 11, wherein said film adheres to the tongue or the buccal cavity of the mammal.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

The film of claim 1 further comprising a flavoring agent.

### Claim 16 (depends on 1)

The film of claim 1 further comprising a coloring agent.

### Claim 17 (depends on 1)

The film of claim 1 wherein the anti-tacking agent comprises sodium benzoate.

### Claim 18 (depends on 1)

The film of claim 1, wherein the active component comprises an opiate, opiate derivative, an analgesic and combinations thereof.

### Claim 19 (depends on 1)

The film of claim 1, further comprising a preservative.

### Claim 20 (depends on 1)

The film of claim 1, wherein the film is sufficient to impart reduced film-to-film coefficient of friction.