Process for preparing fat soluble beadlets

Details Process for preparing fat soluble beadlets Process for preparing fat soluble beadlets

2000-07-27

2002-09-03

Tate, Christopher R. (Department: 1651)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S484000, C424S490000, C514S458000, C514S725000

Reexamination Certificate

active

06444227

ABSTRACT:

FIELD OF THE INVENTION
The invention is related to a process for preparing beadlets containing fat soluble substances.
BACKGROUND OF THE INVENTION
U.S. Pat. No. 4,670,247 reportedly discloses the preparation of fat soluble beadlets by emulsifying a fat soluble substance selected from the group consisting of vitamin A, D, E, K and derivatives thereof, carotenoids, polyunsaturated fatty acids, the flavoring or aroma substances with water, gelatin and a sugar. The emulsion is then converted to droplets. The droplets are collected in a starchy collecting powder to form particles. The particles from the starchy collecting powder are then heat treated to form a water insoluble beadlet. The selected fat soluble substance is preferably vitamin A acetate or vitamin A palmitate. The sugar is a reducing sugar and can be selected from the group consisting of fructose, glucose, lactose, maltose, xylose, and mixtures thereof. The collecting powder used according to U.S. Pat. No. 4,670,247 is a starchy powder. However, other powders such as, e.g., calcium silicate (EP 0 867 177 A), calcium aluminum silicate, tri-calcium phosphate, silicic acid or celluloses can also be used. The heat treatment results in crosslinking of the gelatin matrix.
According to conventional heating methods, the crosslinking step was performed by heating on preheated stainless steel trays in an electric oven at a temperature of from about 90° C. for 2 hours to about 180° C. for less than a minute. These conventional crosslinking methods by heating have the disadvantage that the crosslinking is not uniform due to the non-uniformity of the heat treatment. Moreover, the previous processes are often less satisfactory because too much energy is expended in their performance and thus they are uneconomical.
It has now been found that these disadvantages can be overcome when the crosslinking step is performed by exposure to radiation or by using an enzyme.
SUMMARY OF THE INVENTION
The present invention relates to a process for preparing beadlets containing fat soluble substances having the steps of:
(1) forming an aqueous emulsion of a fat soluble substance, a gelatin, and a reducing agent and, optionally, an antioxidant and/or a humectant;
(2) optionally adding a crosslinking enzyme;
(3) converting the emulsion into a dry powder; and
(4) crosslinking the gelatin matrix in the coated particles by exposing the coated particles to radiation or, in the case of a crosslinking enzyme being present, by incubating the coated particles.


REFERENCES:
patent: 4670247 (1987-06-01), Scialpi
patent: 5126328 (1992-06-01), Bower et al.
patent: 5230969 (1993-07-01), Savant et al.
patent: 6030645 (2000-02-01), Tritsch et al.
patent: 6039901 (2000-03-01), Soper et al.
patent: 0 285 682 (1988-10-01), None
patent: 0 867 177 (1998-02-01), None
patent: 0 982 038 (2000-03-01), None
patent: 993138 (1965-05-01), None
Patent Abstracts of Japan, vol. 17, No. 382 of JP 05065457 (1993).
Patent Abstracts of Japan, vol. 7, No. 268 of JP 58149645 (1983).
Cortesi, et al., “Sugar cross-linked gelatin for controlled release: microspheres and disks,”Biomaterials,vol. 19, pp. 1641-1649 (1998).
Derwent English language abstract of EP 0 982 038 A1 (document B3).

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