Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Patent
1997-08-27
1999-04-06
Fay, Zohreh
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
514912, 514913, A61K 31195
Patent
active
058919139
DESCRIPTION:
BRIEF SUMMARY
This application claims priority to European Patent Application No. 95/03844, filed on Sep. 28, 1995.
The present invention describes an ophthalmic composition comprising diclofenac potassium, the use of said composition as a medicament for treating inflammatory conditions of the eye, for treating glaucoma or for treating ear inflammatory and/or painful conditions (otitis); as well as the use of diclofenac potassium in the preparation of a pharmaceutical composition for treating any inflammatory condition of the eye, for treating glaucoma or for treating ear inflammatory and/or painful conditions (otitis).
Hitherto, predominantly corticosteroids have been used for the treatment of relatively severe acute or chronically recurrent inflammatory symptoms in the eye. The immunosuppressant action of these substances, however, conceals the risk of a deterioration in the clinical picture as a result of a bacterial or viral infection. Therefore, considerable efforts are still made, to develop potent non-steroidal anti-inflammatory agents and to introduce them into ophthalmological therapy.
EP 242 328 describes for example a medicament for the treatment of inflammations of the eye, which medicament comprises sodium
Diclofenac-potassium, is chemically described as potassium non-steroidal anti-inflammatory drug (NSAID). A Norwegian publication, Cephalalgia 13, 117-123(1993), describes for example the use of diclofenac potassium in the acute treatment of migraine.
A stabilized aqueous solution of pharmaceutically acceptable salts of disclosed in U.S. Pat. No. 4,960,799. Diclofenac potassium is not specifically disclosed in said application. Accordingly, all claims and working examples of said application disclose either diclofenac sodium or its free acid as a pharmaceutically active ingredient. Hence, said application is clearly directed towards the provision of a stable aqueous solution of a pharmaceutically acceptable salt of amount of a pharmaceutically acceptable salt of ethylenediamine tetraacetic acid.
Surprisingly it was found, that the potassium salt of especially suitable to treat inflammatory ocular processes in general. It has been demonstrated that for example the ocular penetration of diclofenac potassium is much superior in comparison to the corresponding diclofenac sodium. In addition to said advantage, pharmacological studies show a much better topical tolerance, e.g. ocular tolerance, and efficacy of diclofenac potassium in comparison to diclofenac sodium and also a surprisingly short onset of action as well a long lasting duration of action e.g. in the eye.
Therefore the present invention relates to an ophthalmic composition for treating inflammatory ocular conditions, for treating glaucoma or for treating ear inflammatory and/or painful conditions (otitis), which composition comprises a therapeutically effective amount of diclofenac potassium and a carrier.
The present invention relates also to an ophthalmic composition for treating inflammatory conditions of the eye, which composition comprises a therapeutically effective amount of diclofenac potassium and a carrier.
The present invention relates also to an ophthalmic composition, which comprises a therapeutically effective amount of diclofenac potassium, a carrier and a stabilizer.
The present invention relates also to an ophthalmic composition, which comprises a therapeutically effective amount of diclofenac potassium, a carrier and a solubilizer.
The present invention relates also to an ophthalmic composition, which comprises a therapeutically effective amount of diclofenac potassium, a carrier, a stabilizer and a solubilizer.
The present invention relates also to an ophthalmic composition, which comprises a therapeutically effective amount of diclotenac potassium, a carrier, a solubilizer, a stabilizer and a complexing agent.
The present invention relates also to an ophthalmic composition, which comprises a therapeutically effective amount of diclofenac potassium, a carrier, a solubilizer, a stabilizer, a complexing agent and a tonicity enhancin
REFERENCES:
patent: 4960799 (1990-10-01), Nagy
Diclofenac-K (50 and 100)mg and placebo in the Acute Treatment of Migraine, C. Dahlof, et al., Cephalalgia 13, pp. 117-123, 1993.
Amoxicillin Comparative Double-Blind Study in Ent Infections Clinical Evaluation of Diclofenac Potassium vs. Placebo, Hospital Infantil Mexico, pp. 50-56, 1988. (English abstract).
The Treatment of Upper Respiratory Trace and Ear Inflammatory Non-Infectious Conditions with NSAID A Comparative Rndomized Trial with Nimesulide and Potassium Diclofenac, Oliveira, D.D., pp. 87-91, 1991. (English abstract).
Blum Wolfgang
Huxley Alica
Kis Gyorgy Lajos
Sallmann Alfred
Fay Zohreh
Lee Michael U.
Novartis Finance Corporation
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