Coating processes – Medical or dental purpose product; parts; subcombinations;... – Particulate or unit-dosage-article base
Patent
1987-06-09
1989-07-18
Lusignan, Michael
Coating processes
Medical or dental purpose product; parts; subcombinations;...
Particulate or unit-dosage-article base
424478, 424479, 427 3, A01W 102, A61K 900, A61K 1500, A61K 2100
Patent
active
048492469
DESCRIPTION:
BRIEF SUMMARY
Drugs or pharmaceuticals can be orally administered in the form of powders, dropping solutions or juices. As precise dosing is difficult with such administration forms, preference is generally given to manufacturer-dosed administration forms such as tablets, dragees or capsules. Reagents and other active ingredients, e.g. sweeteners or flavouring agents are frequently also tableted for a precisely dosed administration. The production procedure for tablets, dragees, capsules, etc. has largely been completely developed, but it is not possible to overlook a number of system-related disadvantages.
For low-dosed active ingredients, a large proportion of adjuvants must be added in order to obtain a handlable size of the individual dose. It is also substantially impossible to precisely mark individual tablets or dragees. Therefore blister packs have been adopted, which contain a large number of tablets, dragees and also capsules and which are printed with the necessary information and in particular the product name. The manufacture of such packs naturally involves an additional operation and pack transfers in the form of folding boxes are required, which have a considerable empty volume and therefore take up additional storage space. Another serious disadvantage of dragees and capsules is that splitting up is not possible, so that the minimum dose is predetermined. An accurate breaking up is also difficult in the case of tablets and only larger tablets provided with a notch as a predetermined breaking point can be split, but frequently fragments of unequal size are obtained.
Attempts have already been made to find a new administration form for the oral administration of drugs in the form of active ingredient-containing films or foils. Belgian Pat. No. 637,363 discloses a paper-like support material of insoluble cellulose fibres impregnated with an active ingredient solution or coated by application or sprinkling, dosing being achieved by perforating the support film in the manner of a sheet of postage stamps. The dosing of the active ingredient is necessarily extremely imprecise. DE-OS No. 24 32 925 and DE-OS No. 24 49 865 disclose the incorporation of drug active ingredients into film forming agents, which are preferably in the form of water-soluble compounds, such as methyl and ethyl cellulose, but in particular hydroxypropyl cellulose, hydroxyethyl cellulose or methylhydroxypropyl cellulose. The films can also contain fillers and parting agents. The thus obtained active ingredient-containing films can also be subdivided into individual portions by perforation for dosing purposes.
However, these proposals have not led to practical adoption and in the latest text book "Arzneiformenlehre" by P.H. List, fourth edition, Stuttgart 1985, no mention is made thereof. This is clearly based on the fact that the hitherto known proposals do not make it possible to obtain the requisite constant weight and uniform active ingredient distribution, such as are nowadays required. The Pharmakopoea Europae e.g. sets criteria for the uniformity of the weight of individually dosed drugs, which are graded according to the maximum permitted variations in per cent corresponding to the particular average weight. This requirement is generally.+-.5 to max. 10%. Corresponding values exist for solid drugs with respect to other parameters, such as the disintegration time and dissolving rate.
The aforementioned prior art proposals lead to products with an inadequate acceptance by the patient (e.g. it is difficult to ingest paper portions) and do not permit an accurate dosing per surface unit, as is an absolute requirement. When incorporating the active ingredient into a film, difficulties are caused not only by the precise dosing, but also it is necessary to produce a separate film for each active ingredient, so that the production process is not economic.
The problem of the present invention is to provide a "two-dimensional" administration and dosage form, which does not suffer from the aforementioned disadvantages, which can be easily produ
REFERENCES:
patent: 3444858 (1969-05-01), Russell
Chemical Abstracts, vol. 85, 1976, p. 364.
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