Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2000-07-24
2001-11-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S499000
Reexamination Certificate
active
06322818
ABSTRACT:
TECHNICAL FIELD
The present invention relates to agglomerated, substantially spherical starch particles made completely on the basis of starch and to a process for producing these particles. The process comprises the use of completely pregelatinised starch as binder for starch granules. The particles so obtained are useful for immobilisation of desired products, which include such divers products as enzymes, pharmaceuticals, colorants, flavours, carotenoids, vitamins, antifoams.
BACKGROUND OF THE INVENTION
There is a growing interest in the addition of specific ingredients or additives to food, feed, detergents, cosmetics, chemicals etc. The form wherein these ingredients or additives are added will depend on the physical and chemical characteristics. Some components are so active that they have to be added in diluted forms, others are prone to oxidation or are very hygroscopic so that they have to be packaged in one form or another.
One way of packaging the ingredients or additives is by enclosing them in capsules other possibilities include the enclosure or entrapment in a gel or gellifying agent or the binding to a carrier.
Different types of carrier materials are known, depending on the specific component and on the desired application a carrier is chosen. For some applications or components there are still no suitable carriers available. Starch-based carriers have been investigated for some time. In general when starch is used as a carrier the final, loaded particles are not strong or hard enough. Alternatively they do not degrade fast enough.
British Patent Application GB 2,311,534 A discloses starch particles comprising 30-95% starch and/or low-protein flour; 0.1-50% silicon dioxide; and 5-15% water. As indicated in the summary of the invention, bridging pages 1 and 2 the silicon dioxide is added to improve the flowability of starch granules.
European Patent Application EP 402 186 A discloses a process for preparing directly compressible starch. In this process a part of the starch is heated for some time to around 80° C. This temperature is however not enough to fully pregelatinise the starch.
Japanese patent application JP 56028606 relates to the preparation of granular potato starch. It discloses a process wherein potato starch is charged in a fluidising granulator and a solution of gelatinised potato starch is sprayed as a binder. The fluidised potato starch agglomerates and grows surrounding the binder nucleus to obtain fine granular potato starch.
PCT application WO 95/19376 relates to a porous particle aggregate and methods for the preparation thereof. It relates to substantially spherical porous aggregates of starch granules bound together with a binder at least at their points of contact and said starch granule aggregates having an average diameter of about 5 to about 250 microns. The porous particle aggregate is prepared by spray-drying.
There is a need for a carrier material consisting of substantially spherical particles with an improved hardness and composed of starch exclusively. Such a product can therefore easily be applied in food, feed and pharmaceutical applications.
SUMMARY OF THE INVENTION
The present invention discloses agglomerated, substantially spherical particles characterised in that the particle is comprising 100% starch (w/w) and said particle consists of successive layers comprising starch granules and pregelatinised starch and said particle has a diameter of from 50 &mgr;m to 3 mm, preferably of from 100 &mgr;m to 2 mm, more preferably of from 300 &mgr;m to 800 &mgr;m.
The starch used for making the particles can be any type of starch for example the starch is selected from the group consisting of rice, wheat, corn, potato, sago, bean and tapioca starch and mixtures thereof. It is possible to use mixtures of different types of starch. It is also possible to use chemically or physically modified starches or hydrolysed starch materials.
The present invention also discloses agglomerated particles containing in addition to starch, enzymes, pharmaceuticals, colorants, flavours, carotenoids, and/or vitamins.
A process for producing the agglomerated, substantially spherical starch particles of the present invention is also disclosed and comprises the following steps: Starch seeds are sprayed with a slurry of starch granules and pregelatinesed starch, and the seeds are layered with the slurry, the spraying and subsequent layering is repeated until the particles have reached a final diameter of from 50 &mgr;m to 3 mm.
The present invention further relates to a process wherein enzymes, pharmaceuticals, colorants, flavours, carotenoids, vitamins and/or antifoams are added to the slurry of starch granules and pregelatinised starch, or to the last layer when the particles are reaching the final diameter.
The present invention further relates to a process comprising the following steps:
a) Preparing agglomerated substantially spherical starch particles according to the process aforementioned, and
b) Covering the agglomerated substantially spherical starch particles with enzymes, pharmaceuticals, colorants, flavours, carotenoids, vitamins and/or antifoams.
The process is performed in a fluid bed reactor, fluid drum granulator or a blender.
DETAILED DESCRIPTION OF THE INVENTION
The present invention discloses agglomerated, substantially spherical particles characterised in that the particle is comprising 100% starch (w/w) and said particle consists of successive layers comprising starch granules and pregelatinised starch and said particle has a diameter of from 50 &mgr;m to 3 mm, preferably of from 100 &mgr;m to 2 mm, more preferably of from 300 &mgr;m to 800 &mgr;m.
Such particles are made completely from starch and can be used as such or can act as a carrier, which makes them suitable for a whole series of applications, including addition to food or feed.
It is recognised that the desired diameter of the particles will depend on their intended application. By the processes of the present invention particle wherein successive layers are formed, diameters of up to 3 mm can be reached.
The desired application and the diameter will also have an effect on the preferred type of starch. The starch granules themselves have a certain diameter so that it becomes difficult to make particles of for example less than 100 &mgr;m from potato starch knowing that potato starch granule diameters are in the range of from 10 &mgr;m to 100 &mgr;m. As a rough measure it should be kept in mind that the diameter of some of the useful starch granules are as follows: rice starch 1 &mgr;m to 5 &mgr;m, wheat starch 3 &mgr;m to 50 &mgr;m, corn starch 10 &mgr;m to 30 &mgr;m and potato starch 10 &mgr;m to 100 &mgr;m.
The processes of the present invention are equally applicable to all kinds of starches such as rice, wheat, corn, potato, sago, bean and tapioca starch or mixtures thereof. Although it may be most practical to use the same type of starch providing the starch granules and pregelatinised starch, it is of course possible to combine different types of starches. The pregelatinised starch and the starch granules may therefore be different. It is further possible to use different types of starch granules or use mixed starches for pregelatinisation. In such cases it may be useful to sieve the starch granules to obtain more or less the same granule diameter.
In addition to the native starches it is also possible to perform the granulation process on physically or chemically modified starches or on hydrolysed starch based products (i.e. maltodextrins, dextrose)
The starch particles are essentially onion-type agglomerates wherein starch seeds are layered or coated with a slurry of starch granules and pregelatinised starch. These particles may be obtained by different types of agglomeration or granulation processes, which allow layering or coating for obtaining a substantially spherical particle with a big diameter. The essence of the process for obtaining the agglomerates of the starch granules is that starch seeds are sprayed with a slurry of starch granules and pregelatinised st
Bennett Rachel M.
Cerestar Holding B.V.
Fitch Even Tabin & Flannery
Page Thurman K.
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