Process for producing individually dosed administration forms

Details Process for producing individually dosed administration forms Process for producing individually dosed administration forms

1990-04-30

1993-07-20

Nozick, Bernard

Coating processes

Fraud or tamper detecting

264 5, 264264, A61K 900

Patent

active

052291642

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The invention relates to a process for producing individually dosed administration forms, in which a formulation material containing active agents which are plastic at elevated temperature and conventional additives is placed on a stationary or moving substrate or in blisters or cavities produced from films and as a result the formulation material is transferred, accompanied by cooling, into an administration form, as well as to the administration forms obtainable by this process.


PRIOR ART

The conventional, widely used, solid administration forms for the administration of medicaments, dietetics and the like are essentially tablets, dragees, soft and hard gelatin capsules. These administration forms all require in a first stage shaping and in a second stage product packaging, which must meet the requirements of the product (e.g. stability) and the wishes of the consumer (e.g. attractiveness).
This stepwise production of a product up to the final packaging is disadvantageous from the cost standpoint when it is possible to obtain usable products no longer requiring separate shaping and instead are given their particular shape by the packaging or as a result of the consistency thereof through simple, dosing application to a substrate "run" to the desired shape and are then solidified. If simpler ways are possible, two-stage procedures must be looked upon as disadvantageous.
It could be assumed that processes for filling forms are known and widely used and no longer have any novelty value. As will be shown hereinafter, the patent literature contains information on this subject, which also applies to the pharmaceutical field.
DE-AS 1 017 322 describes a process in which use is made of a combined mould and pack for moulding and despatching ready for sale and use blanks of medicaments and similar materials, such as suppositories, pastilles and the like. However, two or more hinged-interconnected mould parts are required, each of which must have more than half the thickness of the subsequent moulded part to be effective in the sense of the known proposal. It is not possible to separate a packed individual dose.
The entire length of the sliding cover must be removed from the pack to permit the requisite folding apart of the mould parts for removing the shaped blanks. This necessarily leads to a contamination of the fragments which have remained in the pack due to dirt and microorganisms. DE-AS 1 017 322 also mentions the filling of the mould parts with the aid of a moulding frame, which is intended to permit a filling of the mould up to the edge. Material which projects and then solidifies after moulding can be scraped off and reused. This filling process cannot be pharmaceutically relevant as a result of its dosing inaccuracy, because the medicaments resulting therefrom would not meet present day demands.
The same applies with regards to the proposal for producing packaged administration forms according to German patent 1 947 684. This proposal constitutes a further development of the prior art of DE-AS 1 017 322, in that the aforementioned moulding frame is replaced by a perforated film, which is intended to ensure cleaner filling of the individual moulds. Here again it is a complex, discontinuous and hygenically dubious procedure, which cannot therefore be satisfactory.
The procedure of moulding fat-containing materials has been further developed in the meantime. Thus, for some time, separatable hollow forms or cavities preshaped from films have been filled with melted suppository material. After passing through a cooling tunnel, the previously open form is sealed. Approximately 25,000 suppositories per hour can be produced by using costly, automated machines. It is a disadvantageous of this process, which is limited to fats with melting points below 40.degree. C., that solid substances may sediment during the moulding and cooling process due to the low viscosity of the melted fat. Another danger is constituted by the change to the physical parameters of the fats used due to melting and recoo

REFERENCES:
patent: 2345917 (1944-04-01), Coffman
patent: 2790201 (1957-04-01), Eilbracht et al.
patent: 2796033 (1957-06-01), Feinstein
patent: 3341087 (1967-09-01), Rosin et al.
patent: 3608150 (1971-09-01), Laufer et al.
patent: 3832252 (1974-08-01), Higuchi

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