Antacid composition, substantially free of preservatives

• US 5,858,413 A
• Filed: 07/23/1996
• Issued: 01/12/1999
• Est. Priority Date: 08/14/1995
• Status: Expired due to Term

• Current Assignee: Rhone-Poulenc Rorer GmbH
• Original Assignee: Rhone-Poulenc Rorer GmbH
• Inventors: Durr, Manfred, Hager, Jorg-Christian, Jettka, Winfred
• Primary Examiner(s): Spivack, Phyllis G.
• Application Number:
  US08/685,377
• Time in Patent Office: 903 Days
• Field of Search: 424/604, 424/653, 424/682, 424/683, 424/686, 424/687, 424/688, 424/689, 424/690, 424/692, 424/715, 514/819, 514/574
• US Class Current: 424/682
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/08 Oxides; Hydroxides
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 9/0056 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 Class Codes: 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
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/12 Antidiarrhoeals

Abstract

A pharmaceutical, oral composition of a liquid to semisolid consistency is disclosed, wherein the composition, substantially free of preservatives, contains at least one antacid active substance as well as more than 45% by weight, a sugar and/or sugar alcohol, relative to the ready-to-use composition, and up to 40% by weight, a pharmaceutically harmless solvent, relative to the ready-to-use composition.

Claims

1. A pharmaceutical composition for oral use, comprising:

between 12% by weight and 30% by weight of at least one antacid active substance selected from the group consisting of aluminum hydroxide, magnesium hydroxide, magnesium trisilicate, magnesium carbonate, magnesium phosphate, calcium carbonate, calcium phosphate, sodium citrate, magnesium oxide, magaldrate, hydrotalcite, sodium hydrogencarbonate, bismuth subcarbonate, and mixtures thereof;

more than 45% by weight of a sugar or sugar alcohol; and

between 12% and 35% by weight of water,

wherein said composition has a liquid to semisolid consistency and is substantially free of preservatives.

2. The pharmaceutical composition of claim 1, wherein said composition has a solids content of up to 88% by weight.

3. The pharmaceutical composition of claim 1, comprising between 45% and 80% by weight of said sugar or sugar alcohol.

4. The pharmaceutical composition of claim 1, comprising between 48% by weight and 70% by weight of said sugar or sugar alcohol.

5. The pharmaceutical composition of claim 1, wherein said sugar alcohol is selected from the group consisting of sorbitol, maltitol, and mixtures thereof.

6. The pharmaceutical composition of claim 1, wherein said sugar comprises sucrose.

7. The pharmaceutical composition of claim 1, which has a gelatinous consistency.

8. The pharmaceutical composition of claim 1 further comprising pharmaceutically harmless excipients.

9. The pharmaceutical composition of claim 8, wherein said excipients comprise between 2% and 8% by weight of glycerol, between 0.2% by weight and 2% by weight of a thickening agent, and between 0.05% by weight and 0.7% by weight of an aromatic substance.

10. The pharmaceutical composition of claim 9 wherein said thickening agent is selected from the group consisting of xanthan gum, guar gum, cellulose, and mixtures thereof.

11. The pharmaceutical composition of claim 9 wherein said thickening agent comprises microcrystalline cellulose, methyl cellulose, hydroxyethyl cellulose, methylhydroxypropyl cellulose, hydroxypropyl cellulose or mixtures thereof.

12. The pharmaceutical composition of claim 1 comprising between 46% and 58% by weight of said sugar or sugar alcohol.