Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-12-21
2001-03-27
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S451000, C424S489000, C424S490000
Reexamination Certificate
active
06207189
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns a procedure for the production of tablets and capsules of natural substances of vegetable origin, without the use of technologic excipients or adjuvants, in the field of herbal medicine and pharmaceutical products.
2. Description of Related Art
At present it is possible to produce tablets, containing natural substances of vegetable origin, through the compression of a mixture of dry extracts and/or herbal powders with the addition of a number of excipients, also called technologic adjuvants. The latter are normally synthetic or semi-synthetic substances and, according to their functions, they are divided into:
binders: their function is to tie the powder particles together to obtain the tablet;
lubricants: their function is to reduce the adhesion of the powders to the machines and, in particular, to the matrix and punch with which the tablets are produced, as well as to increase the flowability of the mixture of powders during the compression phase.
Therefore, the tablets and capsules obtained through the known technologies normally contain 30%-60% of their weight in excipients that must be used only and exclusively for technological reasons. Therefore it is impossible to produce, at the state of the art, 100% natural tablets which contain only dry extracts and/or herbal powders.
On the other hand it could be theoretically possible to eliminate the need of technologic adjuvants by prior granulation of the mixture to be pressed. The hypothetically produced granulate could in fact lose its characteristics of low flowability and binding power or excessive adhesiveness and it could be correctly pressed.
But, even with the state of the art machines and methods for granulation (wet, dry, fluid bed), it is not possible to granulate without the use of excipients and more specifically of binding agents.
This invention rises from the observation that dry extracts and herbal powders, but in particular their mixtures, usually possess good binding properties, but have very little flowability. It would therefore be possible to produce tablets and/or capsules simply by modifying this last characteristic, that is by increasing the flowability of the mixture. Using the granulation process, the flowability of mixture is considerably improved, but to obtain granules this process requires the use of binding agents or the use of liquids (water or solvents) which, after having caused the aggregation of particles into granules, must be evaporated and therefore taken away from the granule.
The latter solution would be the only one possible to obtain a granulate and therefore a tablet or a capsule without excipients, but in this specific case, since the dry extracts are extremely hygroscopic, due to their low humidity content (<5%), it is technically impossible to have a wet granulation of the product.
SUMMARY OF THE INVENTION
The aim of the present invention is to overcome the obstacles that exist in the present state of the art, and to identify a procedure to make the production of tablets and capsules possible without using technologic excipients and adjuvants. This will allow the production of tablets and capsules that are 100% natural and contain only 100% of dry extract and/or herbal powders, single or mixed together in the ratio required for the effect expected after their ingestion. In this way, we can reduce at least the number or weight of the tablets or capsules that must be ingested to obtain, for example, a specific pharmacological effect.
The procedure, which has made these results possible, is embodied in the mixing of the dry extracts and of the micronized powders, of one or more medicinal herbs, blended in the appropriate ratio. Then the mixture undergoes a granulation process with the aid of steam at atmospheric pressure, for a time interval of some fractions of a second, followed by the introduction of dry air, in the first place to eliminate the steam and in the second to effect a drying process with which to consolidate the granules that are produced, before they are introduced into the machine that forms the tablets and capsules, without the use of technological excipients or adjuvants.
The said procedure is particularly effective since it gives rise to granules that are extremely flowing and with the adhesive characteristic that do not require the addition of technologic excipients neither in the granulation step nor in the compression one. The substantial novelty, in respect to the other known techniques, is represented by the fact that the procedure uses steam at atmospheric pressure as moisting agent which, after its contact with the powders to generate the granulation, is quickly removed by dry air, immediately after humidifying section where the granules are formed, in a section in which the product is dried after having reached the granule stage.
REFERENCES:
patent: 3622677 (1971-11-01), Short
patent: 4384005 (1983-05-01), McSweeney
patent: 3712058 (1988-10-01), None
patent: 0457075 (1991-11-01), None
patent: 0800860 (1997-10-01), None
patent: 2285117 (1976-04-01), None
Encyclopedia Brittanica (Acessed Mar. 3, 2000) www.search.eb.com/bol/topic?eu.
Aboca di Mercati Valentino & C. Societa Semplice
Dennison, Scheiner Schultz & Wakeman
Patten Patricia
Weber Jon P.
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