Coating processes – Medical or dental purpose product; parts; subcombinations;... – Particulate or unit-dosage-article base
Patent
1993-07-30
1995-04-11
Beck, Shrive
Coating processes
Medical or dental purpose product; parts; subcombinations;...
Particulate or unit-dosage-article base
424467, 424476, A61K 944
Patent
active
054056420
DESCRIPTION:
BRIEF SUMMARY
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is based upon PCT Application No. PCT/EP92/00358, filed Feb. 14, 1992, which claims priority from European Patent Application Ser. No. EP. 91.200.417.3, filed Feb. 27, 1991.
The present invention relates to a method of highlighting intagliations in tablets by selectively depositing and fixing in said intagliations a filling material having a different color than that of the tablet surface.
As more and more medicines become available, the risk of confusing look-alike or resembling medicines increases. Such poses a potential threat to patients, in particular to the elderly and to those patients taking more than one preparation. A significant aspect of improving drug safety therefore resides in avoiding and eliminating this risk of confusing different preparations.
Besides distinguishing medicines by means of color or shape, the use of inscriptions has become a method of choice for identifying preparations. Inscriptions are particularly attractive due to their versatility in conveying information such as, for example, the company name, product name, the dose and the like identifying marks.
The printing of marks on the surface of tablets is a first approach to identify preparations. Drawbacks associated with this technique are the necessity of using specialized machinery and the low quality of the printed marks due to smearing and smudging.
Another method involves the engraving or impressing of a figure, mark, character or any combination thereof, in a tablet by a punching procedure. Such impressed marks are generally termed `intagliations` and will henceforth be designated as such.
Unfortunately, said intagliations are not easily discerned as their legibility depends on the irregularities on the surface of the tablets and the quality of the outer coating film which may partially or completely fill up said intagliations. This problem is further aggravated by the increasing tendency towards smaller unit dosage forms.
EP-B-0,060,023 discloses a method of emphasizing intagliations in colored (i.e. not white) solid articles, in particular tablets, by coating the tablet surface and filling up the intagliations with a coating film comprising an optically anisotropic substance. An optical contrast between the tablet surface and the intagliations is obtained, presumably due to the different orientation of the optically anisotropic substance on the tablet surface and in the intagliations. The technique is limited to colored articles and only allows the use of optically anisotropic filling materials. The optical effect merely being based on a different contrast is not particularly clear.
EP-B-0.088,556 relates to a method of highlighting intagliations in white or colored tablets by contacting said tablets with a dry, powdery material having a different color than the tablet surface and then removing the excess powdery material not deposited in the intagliations. The powdery material is taught to adhere better to the intagliations of coated tablets than to those of uncoated tablets. Adherence can further be increased by using a mixture of a wax and a powdery material as the deposition material and heating the filled tablets to 40.degree.-90.degree. C. in order to melt the wax. Finally, an outer coating may be applied to the filled tablets.
The method disclosed in EP-B-0.088,556 has several problems. In the first place it has been found that the adhesion of the powdery material to the intagliations is not satisfactory as said material shows a tendency to loosen and fall out. This problem arises particularly when an outer coating film is applied to the filled tablet and the loosened material becomes fixed in said outer coating film, thus yielding speckled tablets. Addition of a wax to the powdery material in order to improve adhesion on the other hand, adversely affects the distribution of the powdery material in that more of it sticks to the surface of the tablet and is difficult to remove. Several more drawbacks are associated with the use of a wax in the dry powd
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De Conde Valentin F. V.
Gilis Paul M. V.
Beck Shrive
Cameron Erma
Janssen Pharmaceutica N.V.
Metz Charles J.
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