Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1987-05-19
1989-05-23
Lusignan, Michael
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424479, 424480, 424482, 424468, 427 3, A61K 946
Patent
active
048329568
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a tablet which contains at least one slowly dissolving or sparingly soluble pharmaceutical active compound and at least one disintegrating agent, and to a particular form of the tablet, and finally to a process for its preparation. A tablet of this type is disclosed in, for example, EP-A-No. 52,076 or GB-C-No. 825,892.
Compacts compressed to form solid articles, as are usual in powder technology, should be hard and mechanically stable in many cases but nevertheless disintegrate into the tablet components within a short time in water in order to release the active compounds and to permit them to come into contact with water or with body fluid.
Since the existence of compressed tablets, a very wide variety of substances have been incorporated for this purpose, in order to cause the disintegration of such substances. The substance first used, and the traditional one, was starch. Today, there are a large number of substances which are used for the disintegration of tablets, such as, for example, finely disperse silica, microcellulose or, in particular, polyvinylpyrrolidone, which undoubtedly has the best disintegrating effect. However, the mechanical efficiency of all these disintegrating agents depends to a great extent on the water solubility of the ingredients of the compressed tablet. Paradoxically, the higher the water solubility of the ingredients or accompanying substances, the more difficult becomes the choice of a suitable disintegrating agent and the slower and more unreliable becomes the disintegration of such compressed tablets. This may be due to the fact that the concentrated and therefore often highly viscous (e.g. sugar) solution of such substances which forms at the surface of the compressed tablet immediately closes and blocks the capillaries of the disintegrating agent.
Although the mode of action of such disintegrating agents was previously attributed to their swelling action, the more prevalent opinion today is that capillary forces acting on the particles of the disintegrating agent reduce the binding forces at certain points in the tablet and cause disintegration. Nevertheless, it is probable that, in addition to the capillary action, an increase in volume is necessary for tablet disintegration, so that a plurality of concurrent factors is involved. However, the capillary activity, which is scarcely measurable, is adversely affected by a very large number of factors during production of the preparations or pressing of the tablets. These are, in particular, high compressive pressures, granulation assistants, etc., which close the capillaries and thus reduce the disintegrating effect.
For this reason and other reasons, it has been virtually impossible to date to effect rapid disintegration of tablets containing large amounts of water-soluble carbohydrates. On the other hand, modern pharmaceutical technology requires tablets which both are pleasant to take orally and disintegrate rapidly in water, their constituents either dissolving or at least remaining dispersed and giving a drink. However, the tablets according to the two prior art Patents mentioned at the outset do not meet this requirement. It has in fact been virtually impossible to date to find, as an administration form, an intermediate product between the normal tablet or capsule, which either is swallowed or merely disintegrates in water, and an effervescent tablet which dissolves and gives a pleasant-tasting drink. It is therefore the object of the present invention to provide a novel tablet which, when taken as such, can be chewed or sucked and also disintegrates in water in the course of 30 to 60 seconds and gives a pleasant-tasting suspension or solution. A further object of the invention is to make the tablet glucose-free and sucrose-free and, if necessary, to be able to dispense with the use of effervescent additives.
As a rule, all substances are divided into readily soluble substances and substances which are difficult to dissolve; this phraseology is inexact because what is actually meant by this
REFERENCES:
patent: 4127645 (1978-11-01), Witzel et al.
patent: 4289751 (1981-09-01), Windheuser
patent: 4539198 (1985-09-01), Powell et al.
patent: 4678661 (1987-07-01), Gargely et al.
patent: 4687662 (1987-08-01), Schobel
patent: 4728513 (1988-03-01), Ventouras
Gergely Gerhard
Gergely Irmgard
Gergely Thomas
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