Medicaments based on metronidazole or on a synergic mixture of m

Details Medicaments based on metronidazole or on a synergic mixture of m Medicaments based on metronidazole or on a synergic mixture of m

1997-03-25

1998-12-15

MacMillan, Keith D.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Having -c-, wherein x is chalcogen, bonded directly to...

514422, 514886, 514887, A61K 31415, A61K 3140

Patent

active

058497765

DESCRIPTION:

BRIEF SUMMARY
The present invention generally relates to the use of metronidazole, or more preferentially still of a combination of metronidazole and clindamycin, as active principle in the manufacture of pharmaceutical compositions, more particularly dermatological compositions, intended for a curative and/or prophylactic anti-inflammatory treatment, by the topical route.
Metronidazole, or 2-methyl-5-nitroimidazole-1-ethanol, is a product which is already known per se and which is widely used for the treatment, by the topical route, of rosacea (acne rosacea) as is, for example, described in U.S. Pat. No. 4,837,378. However, the exact mechanism(s) of action by which metronidazole treats this complaint still remain unknown or purely hypothetical today, some of the explanations advanced in this respect being in fact based at the very most only on simple speculative models of in vitro type.
Conversely, it is now well established that metronidazole constitutes a particularly active antimicrobial agent which is capable of acting in the systemic treatment of certain anaerobic and parasitic infections.
Thus, there exists, to the knowledge of the Applicant company, no published data to date regarding the in vivo anti-inflammatory potential of metronidazole applied by the topical route.
Now, work carried out by the Applicant company has made it possible to demonstrate that metronidazole has a good anti-inflammatory activity after in vivo topical application.
Moreover, an absolutely outstanding synergy, at the level of this anti-inflammatory activity, has been found in the specific case where the above metronidazole is additionally combined (new combination per se, especially as a medicament) with clindamycin. The latter result is all the more unexpected and surprising since clindamycin, which is an antibiotic which is already known and commonly used in the treatment of acne by the topical route, has per se no, or substantially no, anti-inflammatory activity.
All these discoveries are the basis of the present invention.
Thus, the subject of the present invention is the use of metronidazole for the manufacture of a pharmaceutical composition intended for an anti-inflammatory treatment.
Other characteristics, aspects, objectives and advantages of the invention will become still more clearly apparent on reading the description which follows and various concrete, but in no way limiting, examples intended to illustrate it.
Preferably, the pharmaceutical composition is intended for topical use.
More particularly, the pharmaceutical composition is thus a dermatological composition.
Advantageously, use is made of a combination based on the synergic mixture of metronidazole and clindamycin for the manufacture of a pharmaceutical composition intended for an anti-inflammatory treatment.
The dermatological composition is more particularly intended for the treatment, by the topical route, of skin diseases or complaints having at least one inflammatory component or, at the same time, one inflammatory and one infectious component.
More particularly, the skin diseases or complaints correspond to skin inflammations accompanying any type of dermatoses such as eczema, psoriasis, acne rosacea, acne vulgaris, ulcers, seborrhoeic dermatitides and irritations induced by chemical, physical or mechanical agents or others.
In what follows, topical route is understood to mean any technique for administration of a product by direct application of the latter to a surface (or external) part of the body, such as the skin, and systemic route is understood to mean any technique for administration of a product by a route other than the topical route, for example the oral and/or parenteral route.
Administration of the compositions according to the invention can thus be carried out by the enteral, parenteral, topical or ocular route. However, these compositions are preferably packaged in a form suitable for an application by the topical route.
By the enteral route, the medicaments can be provided in the form of tablets, gelatin capsules, dragees, syrups, suspension

REFERENCES:
patent: 4018918 (1977-04-01), Ayer et al.
Chemical Abstracts AN 1993: 503333, 1993.
Chemical Abstracts AN 1976: 145357, Busch et al, 1976.
Chemical Abstracts AN 1989: 502704, Borgman et al, 1988. (Corresponds to WO 8806888, Abstract only).

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