Ingestible pharmaceutical compositions for treating upper gastrointestinal tract distress

• US 5,244,670 A
• Filed: 05/20/1992
• Issued: 09/14/1993
• Est. Priority Date: 04/04/1991
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Russell, Carmelita M., Upson, James G.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Bawa, Raj
• Application Number:
  US07/887,128
• Time in Patent Office: 482 Days
• Field of Search: 424/439
• US Class Current: 424/439
• 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 9/2013 Organic compounds, e.g. phospholipids, fats

Abstract

Ingestible pharmaceutical compositions comprising pharmaceutical actives useful for treating upper gastrointestinal tract distress (e.g., antacid agents) and 3-1-menthoxy propane 1,2-diol in amounts effective for providing a cooling sensation to the throat.

Claims

1. Ingestible pharmaceutical compositions comprising:

(a) from about 1% to about 99% of at least one pharmaceutical active useful for treating upper gastrointestinal tract distress selected from the group consisting of antacid agents, acid secretion prevention agents, bismuth-containing agents, and mixtures thereof; and

(b) from about 1% to about 99% of at least one excipient comprising 3-1-menthoxy propane 1,2-diol.

2. Ingestible pharmaceutical compositions according to claim 1 wherein the pharmaceutical active is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy-carbonate, dihydroxy aluminum sodium carbonate, aluminum magnesium glycinate, dihydroxy aluminum amino acetate, dihydroxy aluminum aminoacetic acid, calcium carbonate, calcium phosphate, aluminum magnesium hydrated sulfates, magnesium aluminate, magnesium alumino silicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, sucralfate, cimetidine, ranitidine, famotidine, omeprazole, bismuth subsalicylate, bismuth aluminate, bismuth citrate, bismuth subcitrate, bismuth nitrate, bismuth subcarbonate, bismuth subgalate, and mixtures thereof.

3. Ingestible pharmaceutical compositions according to claim 2 wherein the excipient further comprises one or more excipients selected from the group consisting of wetting agents, lubricants, tableting agents, flavoring agents, sweetening agents, coloring agents, stabilizers, antioxidants, cooling agents, preservatives, and mixtures thereof.

4. Ingestible pharmaceutical compositions according to claim 3 wherein the excipients comprise at least one cooling agent selected from menthol, menthol-like compounds, and mixtures thereof.

5. Compositions according to claim 4 wherein the cooling agent comprises N-ethyl-p-menthane-3-carboxamide.

12. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 1 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

13. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 2 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

14. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 5 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

6. Ingestible pharmaceutical compositions comprising:

(a) from about 25% to about 60% of at least one pharmaceutical agent useful for treating upper gastrointestinal tract distress selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy-carbonate, dihydroxy aluminum sodium carbonate, aluminum magnesium glycinate, dihydroxy aluminum amino acetate, dihydroxy aluminum aminoacetic acid, calcium carbonate, calcium phosphate, aluminum magnesium hydrated sulfates, magnesium aluminate, magnesium alumino silicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, sucralfate, cimetidine, ranitidine, famotidine, omeprazole, bismuth subsalicylate, bismuth aluminate, bismuth citrate, bismuth subcitrate, bismuth nitrate, bismuth subcarbonate, bismuth subgalate, and mixtures thereof;

(b) from about 40% to about 75% of excipients comprising 3-1-menthoxy propane 1,2-diol and at least one other excipient selected from the group consisting of wetting agents, lubricants, coloring agents, flavoring agent, sweetening agents, tableting agents, stabilizers, antioxidants, cooling agents, preservatives, and mixtures thereof.

7. Ingestible pharmaceutical compositions according to claim 6 wherein the pharmaceutical active is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy-carbonate, dihydroxy aluminum sodium carbonate, aluminum magnesium glycinate, dihydroxy aluminum amino acetate, dihydroxy aluminum aminoacetic acid, calcium carbonate, calcium phosphate, aluminum magnesium hydrated sulfates, magnesium aluminate, magnesium alumino silicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, sucralfate, and mixtures thereof, and wherein further the 3-1-menthoxy propane 1,2-diol comprises from about 0.01% to about 0.50% by weight of the composition.

8. Ingestible pharmaceutical compositions according to claim 7 wherein the pharmaceutical active comprises from about 1% to about 99% calcium carbonate.

9. Ingestible pharmaceutical compositions according to claim 8 wherein the 3-1-menthoxy propane 1,2-diol comprises from about 0.02% to about 0.20% by weight of the composition.

10. Ingestible pharmaceutical compositions according to claim 9 wherein the excipients further comprise at least one cooling agent selected from menthol, N-ethyl-p-menthane-3-carboxamide, and mixtures thereof.

11. Ingestible pharmaceutical compositions according to claim 10 in unit dose form.

15. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 6 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

16. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 7 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

17. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 8 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.

18. A method for treating upper gastrointestinal tract distress in humans, said method comprises orally administering to a human patient in need of such treatment a composition according to claim 9 in an amount safe for human oral consumption and effective for treating said upper gastrointestinal tract distress.