# US 11,026,886 B2 · Blend compositions for oral administration as a rapidly dissolving powder and/or suspension

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- Number: US 11,026,886 B2
- Document ID: US11026886B2
- Status: Granted
- Kind: B2
- Application number: 16/591,427
- Filed: 2019-10-02
- Published: 2020-06-04
- Granted: 2021-06-08
- Earliest claimed: 2017-07-06
- Assignees: Marenda Pharmaceuticals LLC
- Applicants: Marenda Pharmaceuticals LLC
- Inventors: Andrew Favara; Marc Karetny
- Web page: https://patentgrep.com/patent/US11026886B2

## CPC

- 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 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/009: {Sachets, pouches characterised by the material or function of the envelope (with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin}
- A61K 9/2068: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/2013)}
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed is a dry powder oral formulation that includes an active pharmaceutical ingredient (API), a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation. Also disclosed are an excipient composition in absence of an API and methods of making and using the formulations and compositions. Also disclosed is a chewable, swallowable, and/or orally disintegrating tablet comprising an active pharmaceutical ingredient (API), a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation.

## Claims

### Claim 1

A free flowing dry powder oral formulation suitable for administration in each of an aqueous solution, aqueous dispersion, tablet, and powder dosage form,
wherein the formulation comprises an active pharmaceutical ingredient (API) in an amount from about 3% w/w to about 15% w/w, a surfactant or emulsifier in an amount from 0.1% w/w to 1% w/w, a galactomannan in an amount from about 0.05% w/w to about 0.5% w/w, one or more sweetening agents in an amount up to about 1.0% w/w, one or more diluents in an amount up to about 90% w/w, one or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w and an organic acid in an amount from about 0.05% w/w to about 0.5% w/w, in a pharmaceutically acceptable preparation.

### Claim 2 (depends on 1)

The formulation of claim 1, wherein the API is a non-steroidal anti-inflammatory drug (NSAID).

### Claim 3 (depends on 1)

The formulation of claim 1, wherein the surfactant is an amphiphilic surfactant or emulsifier.

### Claim 4 (depends on 1)

The formulation of claim 1, wherein the galactomannan comprises fenugreek gum, guar gum, tara gum, locust bean gum, or any combination thereof.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein the one or more diluents comprise isomalt, a dextrin, a maltodextrin, fructose, or any combination thereof.

### Claim 6 (depends on 1)

The formulation of claim 1, wherein the one or more flavoring agents comprise fruity or mint flavoring agents.

### Claim 7

A free flowing dry powder oral formulation suitable for administration in each of an aqueous solution, aqueous dispersion, tablet, and powder dosage form,
wherein the formulation comprises an active pharmaceutical ingredient (API) in an amount from about 3% w/w to about 15% w/w, a galactomannan in an amount from about 0.05% w/w to about 0.5% w/w, one or more sweetening agents in an amount up to about 90% w/w, two or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w and an organic acid in an amount from about 0.05% w/w to about 0.5% w/w, in a pharmaceutically acceptable preparation.

### Claim 8 (depends on 7)

The formulation of claim 7, wherein the API is a non-steroidal anti-inflammatory drug (NSAID).

### Claim 9 (depends on 7)

The formulation of claim 7, wherein the galactomannan comprises fenugreek gum, guar gum, tara gum, locust bean gum, or any combination thereof.

### Claim 10 (depends on 7)

The formulation of claim 7, wherein the galactomannan has a mannose to galactose ratio of from about 1:1 to about 4:1.

### Claim 11 (depends on 7)

The formulation of claim 7, wherein the sweeting agent comprises isomalt.

### Claim 12 (depends on 7)

The formulation of claim 7, wherein the two or more flavoring agents comprise fruity or mint flavoring agents.

### Claim 13 (depends on 12)

The formulation of claim 12, wherein the fruity or mint flavoring agents are selected from cherry, strawberry, and raspberry.

### Claim 14 (depends on 13)

The formulation of claim 13, wherein the surfactant or emulsifier is amphiphilic.

### Claim 15 (depends on 7)

The formulation of claim 7, wherein the formulation solubility or dispersability in water is no more than about 0.5 w/v.

### Claim 16 (depends on 7)

The formulation of claim 7, wherein the formulation is in a unit dosage container selected from the group consisting of a blister foil pack, stick pack, sachet, pouch, and bottle.

### Claim 17

A free flowing dry powder oral formulation suitable for administration in each of an aqueous solution, aqueous dispersion, tablet, and powder dosage form,
wherein the formulation comprises a non-steroidal anti-inflammatory drug (NSAID) in an amount from about 6% w/w to about 10% w/w, a galactomannan in an amount from about 0.2% w/w to about 0.4% w/w, one or more sweetening agents in an amount up to about 90% w/w, one or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w and an organic acid in an amount from about 0.1% w/w to about 0.2% w/w, in a pharmaceutically acceptable preparation.

### Claim 18 (depends on 17)

The formulation of claim 17, wherein the NSAID comprises ibuprofen, the galactomannan comprises guar gum, the one or more sweetening agents comprise isomalt, and the organic acid comprises citric acid.

### Claim 19 (depends on 18)

The formulation of claim 18, further comprising a surfactant or emulsifier in an amount from about 0.2% w/w to about 0.8% w/w.

### Claim 20 (depends on 17)

The composition of claim 17, wherein the formulation solubility or dispersability in water is no more than about 0.5 w/v.