Controlled antacid delivery form and method of treatment therewith

• US 4,163,777 A
• Filed: 04/29/1977
• Issued: 08/07/1979
• Est. Priority Date: 04/29/1977
• Status: Expired due to Term

• Current Assignee: Lewis/Howe Company
• Original Assignee: Lewis/Howe Company
• Inventors: Mitra, Arun K.
• Primary Examiner(s): Waddell, Frederick E.
• Application Number:
  US05/792,101
• Time in Patent Office: 830 Days
• Field of Search: 424/19, 424/157, 424/21
• US Class Current: 424/468
• 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 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

A controlled antacid delivery form having an acid neutralizing component in a matrix including a gel-forming, swelling agent and a water insoluble lipid material. These materials are mixed with the antacid component, together with a large amount of sweet excipient, and compressed at high pressure to provide an antacid lozenge which dissolves very slowly in the mouth.

A method for controlled antacid delivery wherein the controlled antacid delivery form is slowly dissolved in the mouth and neutralizes the stomach acid over a long period of time with surprising little antacid, while bathing the esophageal lining with antacid. When the controlled antacid delivery form includes a mixture of antacids having different reactivities towards acid, said method provides for substantially complete utilization of each component.

Claims

1. A noncariogenic controlled antacid delivery composition compressed into lozenges having a hardness of at least 15 kg/in², including a mixture of a magnesium antacid salt and an aluminum antacid salt, said salts having different rates of reaction with hydrochloric acid, in a matrix including in combination mannitol, a gel-forming swelling agent selected from the group consisting of sodium carboxymethyl cellulose and xanthum gum, and a hydrophobic magnesium, calcium or aluminum salt of a fatty acid selected from the group consisting of stearic, palmitic, oleic and lauric acids, the mannitol being present in an amount from about 25 to 60 percent by weight, the gel forming agent being present in an amount from about 3 to 10 percent by weight, and the hydrophobic magnesium, calcium or aluminum salt of a fatty acid being present in an amount from about 1 to 5 percent by weight, to provide a lozenge which dissolves in about 15 to 60 minutes in a user'"'"'s mouth, each of said lozenges containing an effective amount of antacid salts to maintain the pH of the user'"'"'s gastric juice above 3.5.

2. A delivery system according to claim 1 wherein the lozenge weighs from about 1 to 3 grams.

3. A delivery system according to claim 2 wherein the lozenge is comprised of at least two layers, each having a different dissolution rate.

4. A delivery system according to claim 3 wherein the lozenge has a neutralizing capacity of about 15 to 40 meq.