Soft chewable dosage form

Patent metadata

Field	Value
Publication number	US-11141375-B2
Application number	US-201916654107-A
Country	US
Kind code	B2
Filing date	Oct 16, 2019
Priority date	Oct 18, 2018
Publication date	Oct 12, 2021
Grant date	Oct 12, 2021

Abstract

The invention relates to a soft chewable dosage form comprising a first active pharmaceutical ingredient encapsulated in a lipid material that is embedded in the soft chewable dosage form and wherein the soft chewable dosage form comprises at least a second active pharmaceutical ingredient as well as a method of treating a subject suffering from a disease or disorder in the gastro intestinal tract using the soft chewable dosage form.

First claim

The invention claimed is:

1. A soft chewable dosage form comprising a first active pharmaceutical ingredient encapsulated in a lipid material/matrix wherein the lipid encapsulated active pharmaceutical ingredient is embedded in the soft chewable dosage form and wherein the lipid material/matrix comprises a first lipid and a second lipid and the second lipid is plasticized to match the texture of the soft chewable dosage form, and wherein the soft chewable dosage form comprises at least a second active pharmaceutical ingredient.

2. The soft chewable dosage form according to claim 1 , wherein the lipid encapsulated active pharmaceutical ingredient comprises at least one histamine H2-receptor antagonist.

3. The soft chewable dosage form according to claim 2 , wherein the H2 receptor antagonist is selected from the group consisting of cimetidine, ranitidine, nizatidine, roxatidine and famotidine, their pharmaceutically acceptable salts, isomers and salts of isomers.

4. The soft chewable dosage form according to claim 3 , wherein the H2 receptor antagonist is famotidine and the second active pharmaceutical ingredient is at least one antacid.

5. The soft chewable dosage form according to claim 4 , wherein the particle size of the lipid encapsulated famotidine is from about 100 microns to about 5000 microns, such as from about 200 microns to about 2000 microns.

6. The soft chewable dosage form according to claim 4 wherein the at least one antacid is selected from the group consisting of calcium carbonate, sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, aluminum oxide, magnesium oxide, magnesium carbonate, aluminum phosphate, magaldrate and magnesium trisilicate.

7. The soft chewable dosage form according to claim 1 , wherein the lipid material is selected from the group consisting of Cetostearyl alcohol, Glyceryl dibehenate, mono/diglycerides, and hydrogenated vegetable oil.

8. The soft chewable dosage form according to claim 4 , wherein famotidine is a granulate, a bead, a compressed tablet, pellets or minitablettes.

9. The soft chewable dosage form according to claim 1 , wherein the second lipid is a plasticizer and is medium-chain triglycerides (MCT) oil ranging from about 5 to about 50% by weight of the total amount of lipid material in the lipid material/matrix.

10. The soft chewable dosage form according to claim 1 , further comprising a third active pharmaceutical ingredient, wherein the third active pharmaceutical ingredient comprises simethicone.

11. The soft chewable dosage form according to claim 1 , further comprising one or more ingredient(s) selected from the list consisting of colorings, flavors, sweeteners, thickeners, emulsifiers, antioxidants, preservatives, gelling agents and disintegrants.

12. The soft chewable dosage form according to claim 11 , wherein the flavor is selected from the group consisting of peppermint, spearmint, eucalyptus , licorice, vanilla, caramel, mixed berries, mixed fruits, black current, blue berry, cherry and lemon.

13. The soft chewable dosage form according to claim 1 , wherein the active pharmaceutical ingredient(s) are taste masked.

14. The soft chewable dosage form according to claim 3 , wherein famotidine is present in an amount of from about 2 to about 30 mg.

15. The soft chewable dosage form according to claim 4 , wherein the antacid is present in an amount of from about 200 to about 3000 mg.

Assignees

• Johnson & Johnson Consumer Inc

Inventors

• Koll Gregory E
• Mcnally Gerard P
• Dave Vipul

Classifications

• A61K9/0056 Primary

  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 title

• A61K9/0058 Primary

  Chewing gums (non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00) · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K31/426

  1,3-Thiazoles · CPC title

• A61K47/44

  Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) · CPC title