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Details for Patent: 5,223,264

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Details for Patent: 5,223,264

Title: Pediatric effervescent dosage form
Abstract:The present invention relates to oral effervescent dosage forms for the administrations of an intended ingredient to children, and processes for their administration.
Inventor(s): Wehling; Fred (New Hope, MN), Schuehle; Steve (Minneapolis, MN), Madamala; Navayanarao (Plymouth, MN)
Assignee: Cima Labs, Inc. (Minneapolis, MN)
Filing Date:Aug 26, 1991
Application Number:07/750,883
Claims:1. An oral pediatric vitamin supplement comprising: a mixture of at least one effervescent disintegration agent, and a pediatrically effective amount of at least one intended ingredient selected from the group consisting of vitamins and minerals and mixtures thereof, wherein said mixture is present in the form of a compressed tablet of a size and shape adapted for direct oral administration to children and which will rapidly and completely disintegrate when administered; and wherein said effervescent disintegration agent is present in a amount which is effective to both aid in rapid disintegration of said tablet and to provide a positive organoleptic sensation to children.

2. The vitamin supplement of claim 1, wherein said effervescent disintegration agent is selected from a mixture of at least one acid selected from the group consisting of citric acid, tartaric acid, malic acid, fumaric acid, adipic acid, succinic acid, acid anhydrides of said acids and acid salts of said acids and mixtures thereof, and at least one carbonate source selected from the group consisting of carbonate salts, bicarbonate salts, sesequicarbonate salts and mixtures thereof.

3. The vitamin supplement of claim 1, wherein said vitamin is selected from the group consisting of: thiamine, riboflavin, nicotinic acid, pontotheniacacid, pyridoxine, biotin, folic acid, Vitamin B.sub.12, cholines carnitine, alpha, beta and gamma carotenes, lipoic acid, ascorbic acid, Vitamin A, Vitamin D, Vitamin E, Vitamin K, coenzymes containing said vitamins, and mixtures thereof.

4. The vitamin supplement of claim 1, further comprising at least one additional adjuvant selected from the group consisting of binders, lubricants, fillers, colors, flavors, and mixtures thereof.

5. The oral pediatric vitamin supplement of claim 1 wherein said mineral is selected from the group consisting of calcium, zinc, iron, selenium, copper, iodine, magnesium, phosphorous, chromium, and mixtures thereof.

6. A process of administering an intended ingredient to a child comprising the step of: providing a tablet including at least one effervescent disintegration agent, and a pediatrically effective amount of at least one intended ingredient; directly administering said tablet to a child so that said tablet disintegrates in the child's mouth, and promoting disintegration of said tablet and providing a positive organoleptic sensation in the mouth by operation of said effervescent disintegration agent, wherein said intended ingredient is selected from the group consisting of vitamins and minerals and mixtures thereof.

7. The process of claim 6, wherein said vitamin is selected from the group consisting of: thiamine, riboflavin, nicotinic acid, pontothenicacid, pyridoxine, biotin, folic acid, Vitamin B.sub.12, cholines, carnitine, alpha, beta and gamma carotenes, lipoic acid, ascorbic acid, Vitamin A, Vitamin D, Vitamin E, Vitamin K, coenzymes containing said vitamins, and mixtures thereof.

8. The process of claim 6, wherein said mineral is selected from the group consisting of calcium, zinc, iron, selenium, copper, iodine, magnesium, phosphorous, chromium and mixtures thereof.

9. The process of claim 6, wherein said effervescent disintegration agent is selected from a mixture of at least one acid selected from the group consisting of citric acid, tartaric acid, malic acid, fumaric acid, adipic acid, succinic acid, acid anhydrides of said acids and acid salts of said acids and mixtures thereof, and at least one carbonate source selected from the group consisting of carbonate salts, bicarbonate salts, sesequicarbonate salts and mixtures thereof.
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