Microencapsulated medicament in sweet matrix

• US 4,749,575 A
• Filed: 01/29/1986
• Issued: 06/07/1988
• Est. Priority Date: 10/03/1983
• Status: Expired due to Term

• Current Assignee: Bio-Dar Limited
• Original Assignee: Bio-Dar Limited
• Inventors: Rotman, Avner
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/823,798
• Time in Patent Office: 860 Days
• Field of Search: 426/616, 426/613, 426/631, 426/660, 426/572, 426/72, 426/74, 424/22, 424/48, 424/17, 424/440, 424/490, 424/457, 424/468, 424/441, 514/777
• US Class Current: 424/441
• CPC Class Codes: A23G 1/426 containing vitamins, antibiotics
• 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 9/2081 with microcapsules or coated microparticles according to A61K9/50

Abstract

Any orally administrable medicament is prepared into a dosage form which eliminates the unpleasant taste and mouth feel of the medicament and is easily and pleasantly ingested even by children, by microencapsulating the medicament into microcapsules of less than 300 microns diameter, and embedding the microcapsules into a soft, sweet, palatable matrix, such as chocolate.

Claims

1. A sustained release unit dosage form for oral administration to human patients of a large dosage designed for gradual release of a pharmaceutically active principle which could cause a serious overdose if released immediately if not in sustained release form, comprising:

a soft, sweet, palatable matrix which is sufficiently soft to allow mastication thereof without the necessity of substantial chewing, said matrix having substantially homogenously embedded therein macrocapsules of a large sustained release dosage of active principle, said microcapsules having a diameter below about 300 microns, and being present in said matrix in a quantity sufficient to provide a sustained release unit dose of said active principle in each bite-size unit of said matrix, said microcapsules being microencapsulated in gastric resistant sustained release material.

2. A dosage form in accordance with claim 1, wherein said matrix is selected from the group consisting of chocolate, fudge, marshmallow, peanut butter, carob or solid yogurt.

3. A dosage form in accordance with claim 1, wherein said matrix is one which has substantially the same consistency as chocolate.

4. A dosage form in accordance with claim 3, wherein said matrix is chocolate, carob or solid yoghurt.

5. A dosage form in accordance with claim 3, wherein said matrix is chocolate.

6. A dosage form in accordance with claim 5, wherein said matrix is sweet chocolate or milk chocolate.

7. A dosage form in accordance with claim 1, wherein said active principle is an anti-bacterial agent, analgesic, anti-histamine, decongestant, anti-inflammatory agent, anti-hypertensive agent, hypnotic, sedative, tranquilizer, alkaloid, diuretic, vasodilator, hormone or vitamin.

8. A dosage form in accordance with claim 1, wherein said microcapsules of active principle have a diameter of less than about 250 microns.

9. A dosage form in accordance with claim 1, wherein said microcapsules of active principle have a diameter of about 40-150 microns.

10. In the method of administering a unit dose of pharmaceutically active principle to a human patient in need of such active principle, comprising orally administering a unit dose of the active principle in a chewable administrative form, the improvement wherein said pharmaceutically active principle is in sustained release form in a large dosage designed for the gradual release thereof and comprises a sustained release unit dosage form in accordance with claim 1.