Medicament form for the delivery of collagenase to wounds and pr

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

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514953, A61L 1538

Patent

active

060746645

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

In wound treatment, active substances to cleanse the wound and promote healing thereof, for example, the enzyme mixture recovered from the culture filtrate Clostridium histolyticum and consisting of different collagenases, clostripain, and neutral proteases (in the following referred to as collagenase for reasons of simplicity), which must come into direct contact with the bottom of the wound to develop their action. Typically, these wound treatments are administered by means of administration forms which, owing to their consistency, may be applied without interruptions, even to very uneven surfaces. These administration forms include solutions, powders, dusts, and sprays, or semisolid preparations, such as ointments, creams, and gels.
Since the individual dosage is carried out by the user, the main disadvantage of these administration forms lies in the fact that an accurate, reproducible and even dosage of collagenase across the whole application surface is not possible, in particular if the application must be repeated. Moreover, the known administration forms entail further shortcomings. Solutions, powders, dusts, or sprays permit high utilization of the applied collagenase, i.e., the main portion of the administered collagenase takes effect in the wound, but they have the disadvantage that the collagenase can be controlled to an only very limited extent by the administration form. If, for example, a certain collagenase concentration is to be kept constant in the wound over a given period of time, a time-consuming treatment is required involving many quick-releasing single doses to be applied within relatively short intervals. Ointments and creams, however, offer much more possibilities of controlling the collagenase release and of prolonging the action, but, owing to their lipophilla, they have the disadvantage that the collagenase introduced into the wound is utilized to a comparatively small extent because large portions of the collagenase fail to diffuse to the interface to the wound within the application period, so that they cannot be released. With washing the ointment or cream out, this collagenase portion is removed without having taken effect at all.
The use of modern active substance carrier systems and active substance release systems, such as application systems in the form of a patch, which are not introduced into the wound, but are applied on the wound overlapping its edges, is out of the question for collagenase, because this enzyme mixture has a proteolytic action so that it may only get into the wound, but must not reach the wound edge or the intact skin around the wound.
It is accordingly the object of the present invention to find an administration form that has the advantages, but avoids the disadvantages of conventional administration forms in a wound treatment with collagenase, and which makes it possible to release collagenase to the bottom of the wound in an exactly, evenly and reproducibly dosed manner, even in case of repeated application.
Most surprisingly, this object has been found in a deformable, flat-shaped, collagenase-releasing administration form that is characterised by a combination of the following properties: wound surface to be treated; form;


DETAILED DESCRIPTION OF THE INVENTION

According to technical terminology, conventional, deformable, active substance-releasing administration forms, which form flat-shaped structures after application in the wound, such as gels, ointments, creams, or liquid multicomponent systems which react with one another under solidification when joined in the wound, belong to the so-called multiple-dose administration forms. This means that one container comprises a certain quantity of said drug which is designed for a variety of applications involving corresponding dosage procedures. Dosage itself is carried out individually by the user. The user can only give details about the dosed collagenase amount, if he weighs the respective dose prior to application. In case of repeated use, reproducible applicati

REFERENCES:
patent: 5206026 (1993-04-01), Sharik
patent: 5227157 (1993-07-01), McGinity et al.
patent: 5656286 (1997-08-01), Miranda et al.

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