Effervescent dosage form

Patent metadata

Field	Value
Publication number	US-9649274-B2
Application number	US-201514715628-A
Country	US
Kind code	B2
Filing date	May 19, 2015
Priority date	Jun 12, 2012
Publication date	May 16, 2017
Grant date	May 16, 2017

Abstract

An effervescent chewable dosage form that comprises a pH neutralization agent, an acid, and an effervescent agent. The chewable dosage form can also further comprise simethicone, a sweetener, and a lubricant. The pH neutralization agent can be calcium carbonate, the acid can be citric acid and the effervescent agent can be sodium bicarbonate.

First claim

What is claimed is:

1. An effervescent chewable dosage form consisting essentially of:
a. from about 28% to about 34% of a pH neutralization agent; wherein the pH neutralization agent is calcium carbonate;
b. from about 4% to about 6% of citric acid;
c. from about 5% to about 7% of an effervescent agent; wherein the effervescent agent is sodium bicarbonate;
d. from about 2% to about 9% of a gas reducer; wherein the gas reducer is simethicone; and
e. from about 35% to about 50% sweetener;
wherein the ratio of the effervescent agent to the acid is from 90% to 110% of the stoichiometric relationship;
wherein the effervescent chewable dosage form is a tablet.

2. The effervescent chewable dosage form of claim 1 wherein the tablet breaking force is about 4 kp to about 8.5 kp.

3. The effervescent chewable dosage form of claim 1 wherein the ratio of the water solubility of the effervescent agent to the pH neutralization agent is greater than about 1000:1.

4. The effervescent chewable dosage form of claim 1 wherein the dosage form has a gas evolution of from about 24 mL to 32 mL.

5. The effervescent chewable dosage form of claim 1 wherein the pH at equilibrium is from about 7.5 to about 9.0.

6. The effervescent chewable dosage form of claim 1 wherein the pH after two minutes is from about 3 to about 5.5.

7. The effervescent chewable dosage form of claim 1 further comprising starch.

8. The effervescent chewable dosage form of claim 7 comprising about 3.47% starch.

9. The effervescent chewable dosage form of claim 1 wherein the sweetener is sucrose.

Assignees

• Procter & Gamble

Inventors

• Stella Mark Edward
• Entwisle John Richard
• Newlon Jason William
• Naykki Christine Louis

Classifications

• A61K9/2013

  Organic compounds, e.g. phospholipids, fats · CPC title

• A61K33/10 Primary

  Carbonates; Bicarbonates · CPC title

• A61K9/2018

  Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates · CPC title

• A61K9/2036

  Silicones; Polysiloxanes · CPC title

• A61K9/2059

  Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin · CPC title