US2014371174A1PendingUtilityA1

Effervescent Dosage Form

Assignee: PROCTER & GAMBLEPriority: Jun 12, 2013Filed: Jun 12, 2013Published: Dec 18, 2014
Est. expiryJun 12, 2033(~6.9 yrs left)· nominal 20-yr term from priority
A61K 9/0007A61K 9/2036A61K 33/10A61K 9/2018A61K 9/2059A61K 9/2013A61K 31/7016A61K 9/2009A61K 31/695A61K 31/80A61K 9/0056A61K 47/12A61K 31/194A61K 31/19
65
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An effervescent chewable dosage form comprising:
 a. from about 26% to about 40% of a pH neutralization agent;   b. from about 3% to about 10% of an acid; and   c. from about 3% to about 10% of an effervescent agent.   
     
     
         2 . The effervescent chewable dosage form of  claim 1  wherein the pH neutralization agent is calcium carbonate. 
     
     
         3 . The effervescent chewable dosage form of  claim 1  wherein the acid is citric acid. 
     
     
         4 . The effervescent chewable dosage form of  claim 1  where the effervescent is sodium bicarbonate. 
     
     
         5 . The effervescent chewable dosage form of  claim 1  further comprising from about 0.3% to about 1% of a lubricant. 
     
     
         6 . The effervescent chewable dosage form of  claim 1  further comprising simethicone. 
     
     
         7 . The effervescent chewable dosage form of  claim 1  further comprising from about 35% to about 50% of a sweetener. 
     
     
         8 . The effervescent chewable dosage form of  claim 1  wherein the tablet breaking force is about 4 kp to about 8.5 kp. 
     
     
         9 . The effervescent chewable dosage form of  claim 1  wherein the pH at equilibrium is from about 6.5 to about 9.5. 
     
     
         10 . The effervescent chewable dosage form of  claim 1  wherein the pH after 2 minutes is from about 3 to about 6. 
     
     
         11 . The effervescent chewable dosage form of  claim 1  wherein the ratio of water solubility of the effervescent agent to the pH neutralization agent is greater than about 10,000:1. 
     
     
         12 . The effervescent chewable dosage form of  claim 1  wherein the molar ratio of the effervescent agent to the acid is from about 1:1 to about 5:1. 
     
     
         13 . An effervescent chewable dosage form comprising:
 a. from about 28% to about 34% calcium carbonate;   b. from about 4% to about 6% citric acid;   c. from about 5% to about 7% sodium bicarbonate; and   d. from about 35% to about 50% sweetener.   
     
     
         14 . The effervescent chewable dosage form of  claim 13  wherein the sweetener comprises sucrose. 
     
     
         15 . The effervescent chewable dosage form of  claim 13  further comprising a flavor selected from the group consisting of cherry, orange, lemon, and combinations thereof. 
     
     
         16 . The effervescent chewable dosage form of  claim 14  further comprises sucralose. 
     
     
         17 . The effervescent chewable dosage form of  claim 13  further comprising from about 3% to about 6% simethicone. 
     
     
         18 . The effervescent chewable dosage form of  claim 8  wherein the calcium carbonate particles are not larger than about 500 μm in diameter prior to tableting. 
     
     
         19 . The effervescent chewable dosage form of  claim 13  wherein the chewable tablet is a bi-layer tablet with a first layer and a second layer. 
     
     
         20 . The effervescent chewable dosage form of  claim 13  wherein the first layer and the second layer are different colors.

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