Chewable tablet and process for preparation thereof

• US 6,060,078 A
• Filed: 09/28/1998
• Issued: 05/09/2000
• Est. Priority Date: 09/28/1998
• Status: Expired due to Term

• Current Assignee: SAE HAN Pharm Company Limited
• Original Assignee: SAE HAN Pharm Company Limited
• Inventors: Lee, Young Won
• Primary Examiner(s): Spear, James M.
• Application Number:
  US09/161,904
• Time in Patent Office: 589 Days
• Field of Search: 424/440, 424/441, 424/439, 424/464, 424/465, 424/474, 424/475, 424/481
• US Class Current: 424/440
• 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 9/0058 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 Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

The present invention relates to a chewable tablet containing a medicament in a core and a process for preparation thereof. In particular, the present invention relates to a chewable tablet comprising a core containing a medicament in the center of the tablet in a state of jelly or chewable base and an outer layer wrapping the core which is made up of chewable base such as a gum, a soft candy or a caramel. The chewable tablet is easy to take and has a good taste and nice chewing property due to the unique tablet form. In addition, the tablet has an advantage in bioavailability resulting from increased absorption rate and excellent stability due to unique preparation process. Therefore, the chewable tablet and the preparation process of the present invention can be used in pharmaceutical industry usefully.

Claims

1. A chewable tablet comprising a core containing a medicament in a state of jelly or chewable base;

and an outer layer of chewable base wrapping the core, wherein the said chewable base contains an enhancing agent of chewing property selected from the group consisting of isomalt and liquid maltitol and a keeping agent of hardness and extension property being a gum including gelatin or arabic gum.

2. The chewable tablet of claim 1 wherein said jelly base of the core is selected from the group consisting of pectin, sorbitol, maltitol, isomalt, liquid glucose, sugar, citric acid and flavoring agent.

3. The chewable tablet of claim 1 wherein said chewable base of the core or the outer layer is selected from the group consisting of gum, soft gum, soft nougat, soft candy, hard candy and caramel.

4. The chewable tablet of claim 3 wherein the tablet additionally contains excipients selected from the group consisting of sugars;

a protecting agent of adhesion to oral cavity and crystallization of sugars;

a flavoring agent;

a souring agent;

a coloring agent; and

combinations thereof, according to the chewable base.

5. The chewable tablet of claim 4 wherein said sugar is selected from the group consisting of white sugar, liquid glucose, sorbitol, dextrose, isomalt, liquid maltitol, aspartame and lactose.

6. The chewable tablet of claim 4 wherein said protecting agent of adhesion to oral cavity and crystallization of sugars is selected from the group consisting of glycerin, lecithin, hydrogenated palm oil and glyceryl monostearate.

7. The chewable tablet of claim 1 wherein said keeping agent of hardness and extension property comprises 0.1-2.0 weight % by total weight of the ingredients.

8. The chewable tablet of claim 1 wherein said enhancing agent of chewing property is prepared at temperatures of 135-140°

C. and under vapor pressure of 5.5 bar.

9. The chewable tablet of claim 1 wherein said medicament, which is contained in the core, is vitamins selected from the group consisting of vitamin A, vitamin B, vitamin B₁, vitamin B₂, vitamin B₆, vitamin C, vitamin E and vitamin K;

natural plant extracts selected from the group consisting of Sohgunjung-tang extracts, Sipchundaebo-tang extracts and Eleutherococcus senticosus extracts;

organic compounds selected from the group consisting of dimenhydrinate, meclazine.HCl, acetaminophen, aspirin, phenylpropanolamine.HCl and cetylpyridinium chloride;

or gastrointestinal agents selected from the group consisting of aluminum hydroxide gel dried, domperidone, soluble azulene, L-glutamine and hydrotalcite.

10. The chewable tablet of claim 4 wherein said sugar comprises 50-90 weight % by total weight of the ingredients.

11. The chewable tablet of claim 4 wherein said protecting agent of adhesion to oral cavity and crystallization of sugars comprises 0.04-2.0 weight % by total weight of the ingredients.