Effervescent dosage form

Patent metadata

Field	Value
Publication number	US-10028977-B2
Application number	US-201715482937-A
Country	US
Kind code	B2
Filing date	Apr 10, 2017
Priority date	Jun 12, 2012
Publication date	Jul 24, 2018
Grant date	Jul 24, 2018

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 comprising:
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% of a nutritive sweetener;
wherein the effervescent chewable dosage form is a tablet.

2. The effervescent chewable dosage form of claim 1 further comprising a synthetic sweetener.

3. The effervescent chewable dosage form of claim 2 wherein the synthetic sweetener is sucralose.

4. The effervescent chewable dosage form of claim 1 further comprising from about 0.05% to about 5% sucralose.

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

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

7. The effervescent chewable dosage form of claim 6 comprising about 3.47% starch.

8. The effervescent chewable dosage form of claim 1 further comprising a lubricant.

9. The effervescent chewable dosage form of claim 1 wherein the tablet comprises a tablet breaking force of about 4 kp to about 8.5 kp.

10. The effervescent chewable dosage form of claim 1 wherein the ratio of the effervescent agent to the citric acid is from 80% to 120% of the stoichiometric relationship.

11. A dose of an effervescent chewable dosage form comprising:
a. from about 300 mg to about 600 mg calcium carbonate;
b. about 100 mg sodium bicarbonate;
c. from about 72 mg to about 88 mg of an acid; wherein the acid is citric acid;
d. from about 50 mg to about 160 mg of a gas reducer, wherein the gas reducer is simethicone; and
e. from about 720.60 mg to about 723.80 mg of a nutritive sweetener;
wherein the effervescent chewable dosage form is a tablet.

12. The effervescent chewable dosage form of claim 11 comprising about 495 mg calcium carbonate, about 123 mg simethicone, and about 80 mg citric acid.

13. The effervescent chewable dosage form of claim 11 wherein the gas evolution of the dosage form is greater than about 25 mL.

14. The effervescent chewable dosage form of claim 11 further comprising a synthetic sweetener.

15. The effervescent chewable dosage form of claim 11 wherein the synthetic sweetener is sucralose.

Assignees

• Procter & Gamble

Inventors

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

Classifications

• A61K9/2036

  Silicones; Polysiloxanes · CPC title

• A61K31/80

  Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795 · CPC title

• A61K31/7016

  Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032) · CPC title

• A61K9/0056

  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 · CPC title

• A61K9/2009

  Inorganic compounds · CPC title