# US 8,541,018 B2 · Palatable suspending vehicle for pharmaceutical ingredients

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- Number: US 8,541,018 B2
- Document ID: US8541018B2
- Status: Granted
- Kind: B2
- Application number: 13/207,849
- Filed: 2011-08-11
- Published: 2012-05-24
- Granted: 2013-09-24
- Earliest claimed: 2004-08-13
- Assignees: Fagron, Inc.
- Applicants: Joshua Radke; Michael Jones; Martin Erickson
- Inventors: Joshua Radke; Michael Jones; Martin Erickson
- Web page: https://patentgrep.com/patent/US8541018B2

## CPC

- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/10: Dispersions; Emulsions
- A61K 31/166: having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/277: having a ring, e.g. verapamil
- A61K 31/325: Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof (thiurams A61K31/145)
- 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 47/34: 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: 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)

## Abstract

The invention relates to a liquid vehicle that can be used to create suspensions and/or solutions of liquid or powdered medications. The vehicle is thixotropic and has improved stability and rheologic characteristics. Vehicles of the invention include an aqueous medium and a suspending agent comprising a polysaccharide having at least 50% glucose repeating saccharide units and at least 90% alpha linkages. The polysaccharide can be a starch, modified starch, or glycogen. The aqueous medium and individual components of the vehicle provide a palatable and easily ingested drug preparation. The invention also provides a vehicle containing an aqueous medium, suspending agent comprising a polysaccharide having at least 50% glucose repeating saccharide units and at least 90% alpha linkages, buffer, and artificial sweetener, the combined suspending vehicle having a pH of about 3 to about 10 and an osmolality of 300 mOmsol or less.

## Claims

### Claim 1

A vehicle for preparing medicinal suspensions or solutions, comprising:
a) an aqueous medium;
b) about 1% to about 15% by weight of a suspending agent, wherein the suspending agent is a starch or glycogen;
c) an artificial sweetener;
d) a pH of about 3 to about 10;
e) a buffer comprising an organic acid, inorganic acid, salts thereof, or mixtures thereof; and
f) osmolality of about 300 mOsmol or less;
wherein the vehicle is thixotropic and a pseudoplastic power law fluid comprising a consistency index of at least 400 at a shear rate of about 1 sec−1.

### Claim 2 (depends on 1)

The vehicle of claim 1, wherein the starch is a modified starch.

### Claim 3 (depends on 1)

The vehicle of claim 1, wherein the starch comprises an amylose to amylopectin ratio of about 20%:80% to about 60%:40% by weight.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the vehicle comprises a yield value greater than 0.

### Claim 5 (depends on 4)

The vehicle of claim 4, wherein the vehicle comprises a flow index of less than about 0.8 at a shear rate of less than about 1 sec−1.

### Claim 6 (depends on 1)

The vehicle of claim 1, wherein the vehicle comprises a pH of about 3 to about 5.

### Claim 7 (depends on 1)

The vehicle of claim 1, further comprising:
a) a preservative;
b) an antimicrobial agent;
c) an anti-oxidant;
d) a flavoring agent;
e) a flavor enhancer;
f) a colorant;
g) a texture modifier;
h) a surfactant; or
i) a defoaming agent.

### Claim 8 (depends on 1)

The vehicle of claim 1, wherein the organic acid comprises malic acid, citric acid, ascorbic acid, tartaric acid, adipic acid, lactic acid, furmaric acid, maleic acid, acetic acid, phosphoric acid, a salt thereof, or mixtures thereof.

### Claim 9 (depends on 1)

The vehicle of claim 1, wherein the artificial sweetener comprises sucralose, aspartame, saccharin, stevia, acesulfame-K, or mixtures thereof.

### Claim 10 (depends on 1)

The vehicle of claim 1, wherein the vehicle comprises about 1% or less artificial sweetener by weight.

### Claim 11 (depends on 1)

The vehicle of claim 1, wherein the vehicle comprises osmolality of about 50 mOsmol or less.

### Claim 12 (depends on 1)

The vehicle of claim 1, wherein the vehicle comprises osmolality of about 30 mOsmol to about 40 mOsmol.

### Claim 13 (depends on 1)

The vehicle of claim 1, wherein high shear mixing is not required to uniformly distribute a drug within the vehicle.

### Claim 14 (depends on 1)

A composition comprising the vehicle of claim 1 in admixture with one or more drugs.

### Claim 15 (depends on 1)

The vehicle of claim 1, comprising a consistency index of about 400 to about 30,000 at a shear rate of about 1 sec−1.

### Claim 16 (depends on 1)

The vehicle of claim 1, wherein the starch comprises hydrated starch granules.

### Claim 17 (depends on 1)

The vehicle of claim 1, comprising at least about 70% by weight of the aqueous medium.

### Claim 18

A composition comprising:
a) a suspending agent selected from starch or glycogen;
b) an artificial sweetener; and
c) a buffer comprising an organic acid, inorganic acid, salts thereof, or mixtures thereof;
wherein the composition, upon addition of a volume of an aqueous medium, forms a vehicle that is thixotropic and a pseudoplastic power law fluid, the vehicle comprising
at least 70% aqueous medium by weight,
about 1% to about 15% by weight suspending agent,
pH of about 3 to about 10,
osmolality of about 300 mOsmol or less, and
a consistency index of at least 400.

### Claim 19 (depends on 18)

The composition of claim 18, wherein the starch comprises an amylose to amylopectin ratio of about 20%:80% to about 60%:40% by weight.

### Claim 20 (depends on 18)

The composition of claim 18, wherein the starch is a modified starch.

### Claim 21 (depends on 18)

The composition of claim 18, wherein the organic acid comprises malic acid, citric acid, ascorbic acid, tartaric acid, adipic acid, lactic acid, furmaric acid, maleic acid, acetic acid, phosphoric acid, or mixtures thereof.

### Claim 22 (depends on 18)

The composition of claim 18, wherein the artificial sweetener comprises sucralose, aspartame, saccharin, stevia, acesulfame-K, or mixtures thereof.

### Claim 23 (depends on 18)

The composition of claim 18, further comprising
a) a preservative;
b) an antimicrobial agent;
c) an anti-oxidant;
d) a flavoring agent;
e) a flavor enhancer;
f) a colorant;
g) a texture modifier;
h) a surfactant; or
i) a defoaming agent.

### Claim 24 (depends on 18)

A composition comprising the composition of claim 18 in admixture with one or more drugs.

### Claim 25 (depends on 4)

The vehicle of claim 4, wherein the vehicle comprises a yield value of about 0.01 dynes/cm2 to about 600 dynes/cm2.