Title:  Soft chewable tablet comprising separated active ingredients

United States Patent:  6,440,450

Issued:  August 27, 2002

Inventors:  Han; Yoon Dong (Seoul, KR); Park; Jong Bum (Anyang, KR)

Assignee:  Sam-Pharmaceutical Co., Ltd. (Kyunggi-do, KR)

Appl. No.:  314552

Filed:  May 19, 1999

The present invention provides an improved soft chewable multivitamin tablet in which vitamin C is separated from calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof in a core or multilaminate form and a process for preparing the same. The soft chewable multivitamin tablet of the present invention maintains its stability over a long-storage time in terms of the content and potency of vitamins while overcoming the problems of incompatibility, bad mouthfeel and palatability.

DETAILED DESCRIPTION OF THE INVENTION

A soft chewable multivitamin tablet of the present invention comprises active ingredients, sugars, fatty materials and emulsifiers, wherein an active ingredient of vitamin C is separated from calcium pantothenate, and/or minerals such as iron, copper, zinc and mixtures thereof.

The soft chewable multivitamin tablet of the invention is formulated by a process which comprises the steps of:

(i) dissolving and concentrating sugars in a concentrating tank at a temperature of 120 to 135^oC., cooling the concentrated sugars to a temperature of 80 to 100^oC., adding a molten mixture of fatty materials and emulsifiers, and kneading to a temperature of 60 to 80^oC., adding and thoroughly kneading an active ingredient of vitamin C and the other active ingredients except calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof, or calcium pantothenate and/or the said minerals, and cooling to obtain a kneaded mixture;

(ii) dissolving active ingredients which are different from those contained in the kneaded mixture, together with sugars and a stabilizer at a temperature of 40 to 60^oC. to obtain a dispersed material; and,

(iii) extruding, rope sizing and tabletting the kneaded mixture and the dispersed material in a separate manner to give a soft chewable multivitamin tablet.

A soft chewable multivitamin tablet of the invention is explained in more detail as below.

A soft chewable multivitamin tablet of the invention comprises active ingredients, sugars, fatty materials and emulsifiers, and may further comprise fondant, gums, flavors, stabilizers and the like to improve mouthfeel and palatability and to stabilize the active ingredients. The active ingredients are contained in a soft chewable multivitamin tablet in an amount of 0.1 to 50 wt %, preferably 0.1 to 25 wt %, which includes vitamins such as vitamin A, vitamin B₁, vitamin B₂, vitamin B₆, vitamin B₁2, vitamin C, vitamin D, vitamin E, vitamin K, nicotinamide, folic acid, calcium pantothenate, biotin and mixtures thereof; mineral supplements such as calcium, calcium carbonate, calcium phosphate, magnesium, magnesium carbonate, magnesium glycerophosphate, manganese, potassium, lecithin, iron, copper, zinc, phosphorus and mixtures thereof; and, herbal drugs such as hippophae rhamnoides ext., pollen, Garcinia, Echinaceae, ginsenoside ext., Ginkgo biloba ext., blueberry, hawthorn ext., acanthopanax ext., aloe ext., Cardus marianus ext. and mixtures thereof.

Further, the soft chewable multivitamin tablet may comprise citric acid or sodium citrate as a stabilizer for vitamin C in a level of 10 to 200 parts, preferably 20 to 80 parts, by weight of the vitamin C 100 parts, whereby vitamin C becomes stabilized to give synergic effect, where the stabilizer plays a dual role as a chelating agent and pH controller as well. In this connection, if the level of stabilizer is lower than the said range, the stabilization cannot be realized, or if it is higher than the said range, the chelation is not realized and pH will rise or fall as well.

In addition, the present invention includes a multivitamin tablet which further comprises sodium citrate for the stabilization of an active ingredient of calcium pantothenate, where calcium pantothenate is stabilized by forming a microenvironment of pH 6 to 7 to permit a long-term storage. Citric acid for stabilizing vitamin C should also be separated from calcium pantothenate.

In the soft chewable multivitamin tablet of present invention, sugars such as white sugar, corn syrup, sorbitol(solution), maltitol(syrup), oligosaccharide, isomaltooligosaccharide, fructose, lactose, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, polydextrose, dextrin and mixtures thereof are added to improve mouthfeel and palatability, in an amount of 50 to 90 wt %, preferably 75 to 85 wt % by weight of the whole tablet.

A soft chewable multivitamin tablet of the invention also comprises fatty materials in an amount of 3 to 15 wt %, preferably 5 to 7 wt %, by weight of the whole tablet, to prevent separation phenomenon and improve mouthfeel. The fatty materials include vegetable oil such as palm oil, palm hydrogenated oil, corn germ hydrogenated oil, castor hydrogenated oil, cotton-seed oil, olive oil, peanut oil, palm olein oil, Cacao fat, margarine, butter, shortening and palm stearin oil, or animal oil such as refined oil and refined lard whose melting point ranges from 30 to 42^oC.

To prevent the separation phenomenon and stickiness appearing in the conventional soft chewable tablets and to facilitate conversion of the active ingredients to emulsion or suspension upon taking, the soft chewable multivitamin tablet further comprises emulsifiers such as glycerin fatty acid ester, sorbitan monostearate, sucrose fatty acid ester, lecithin and mixtures thereof, in an amount of 0.01 to 5.0 wt %, preferably 0.05 to 2.0 wt % by weight of the whole tablet. If the level of emulsifier is lower or higher than the said range, the emulsification cannot be realized, or wax value will rise.

To improve the chewiness of the tablet, the soft chewable multivitamin tablet may comprise fondant in an amount of 3 to 20 wt %, preferably 5 to 15 wt %, or gums such as gelatin, agar, arabic gum, guar gum, and carrageenan in an amount of 0.1 to 5 wt %, by weight of the whole tablet. In addition, flavors such as strawberry flavor, tutti fruity flavor, orange flavor, banana flavor and mint flavor may be further included to improve flavorance of the multivitamin tablet.

A process for preparing a soft chewable multivitamin tablet of the present invention is further illustrated as below, where the present inventors separated an active ingredient of vitamin C from the others in a core or multilaminate form, since the contact between one component of vitamin C and the other component of calcium pantothenate, iron, copper, zinc and mixtures thereof, may bring about incompatibility and loss of content and potency of some vitamins.

Preparation of a Soft Chewable Multivitamin Tablet Having a Core

Sugars and water are mixed, dissolved, and concentrated by heating to a temperature of 120 to 135^oC. under a reduced pressure of -100 to -500 mmHg in a concentrating tank and cooled to a temperature of 90 to 100^oC., where concentration at a high temperature over 135^oC. is undesirable because sugars become degraded, conversed, browned or hardened. To the concentrate are added a molten mixture of fatty materials with emulsifier, and kneaded to a temperature 60 to 80^oC. and an active ingredient of vitamin C and the other active ingredients except calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof, or calcium pantothenate and/or the said minerals, are added and thoroughly kneaded, and then tempered to a temperature of 40 to 50^oC. to obtain a kneaded mixture for outer shell.

On the other hand, sugars, stabilizers and an active ingredient of vitamin C, or the other active ingredients of calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof, which are different from the components contained in the outer shell, are dissolved at a temperature of 40 to 60^oC. to obtain a dispersion for core part.

Finally, extruding, rope sizing and tabletting the kneaded mixture for outer shell and the dispersion for core part are carried out to give a soft chewable multivitamin tablet in a core form(see: FIG. 1).

Preparation of a Multilaminated Soft Chewable Multivitamin Tablet

Sugars and water are mixed, dissolved and concentrated by heating to a temperature of 120 to 135^oC. under a reduced pressure of -100 to -500 mmHg in a concentrating tank, and cooled to a temperature of 90 to 100^oC. To the concentrate are added a molten mixture of fat with emulsifier, and kneaded to a temperature of 60 to 80^oC., and gums, flavors, stabilizers and an active ingredient of vitamin C and the other active ingredients except calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof, are added and thoroughly kneaded, and then tempered to a temperature of 40 to 50^oC. to obtain a kneaded mixture of vitamin C layer.

Then, a kneaded mixture for multivitamins-minerals layer is prepared in a similar manner as in the layer of vitamin C.

Finally, the kneaded mixture for vitamin C layer and multivitamins-minerals layer are subjected to an extruder with two inlets (one for the kneaded mixture for the vitamin C layer and the other for the kneaded mixture for the multivitamins-minerals layer), extruded and cooled to give a soft chewable multivitamin tablet in a multilaminate form.

Claim 1 of 23 Claims

What is claimed is:

1. A soft chewable multivitamin tablet comprising active ingredients, sugars, fatty materials and emulsifiers comprising:

a first layer wherein the active ingredient comprises vitamin C and not calcium pantothenate, iron, copper, zinc or mixtures thereof; and

a second layer wherein the active ingredient comprises calcium pantothenate, iron, copper, zinc or mixtures thereof and not vitamin C.
 

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