BE886486A - PHARMACEUTICAL FORM "GEL" CONTAINING 2- (3-BENZOYL-PHENYL) -PROPIONIC ACID AND ITS USE IN THERAPEUTICS FOR LOCAL USE - Google Patents

Description

       

  "Pharmaceutical form" gel "containing 2- (3-benzoylphenyl) -propionic acid and its

  
therapeutic use for local use "

  
The invention relates to the use of the pharmaceutical form "gel" containing 2- (3-benzoylphenyl) -propionic acid
(Ketoprofen), for a more rational use

  
for local applications.

  
The invention also relates to the compositions below.

  
above, their preparation as well as a method for the therapy of inflammatory and algic syndromes, with local use of the above-mentioned compositions.

  
More particularly, and as has been said more

  
top, the present invention relates to the use of the pharmaceutical form "gel" for compositions containing 2- (3-benzoylphenyl) -propionic acid (Ketoprofen), broad-

  
 <EMI ID = 1.1>

  
recognized anti-inflammatory and analgesic, which allows local percutaneous treatment of painful, inflammatory and traumatic affections of the joints, tendons, ligaments and muscles.

  
The pharmaceutical form to which reference is made in the present invention has the characteristic of being constituted by a solution of Ketoprofen in an aqueous-alcoholic solvent, made sufficiently viscous with the aid of suitable excipients, so that it can be spread over the part reached. This pharmaceutical form therefore differs from the common topical pharmaceutical forms applicable for the active ingredient mentioned above, forms which are constituted by a suspension or by a solution in an oily vehicle (ointment) or by a suspension in the oil-in-water phase. or the water in oil phase (cream or ointment).

  
Compared to the oily form (ointment), the "gel" form of Ketoprofen according to the invention is more compatible with skin lesions and with exudates and can therefore be more easily spread over the affected part, which it allows to perspire, which does not take place in the case where the local oil-based form is used, whereas, unlike the latter, the "gel" form can be easily removed with water or an aqueous solution.

  
Unlike the pharmaceutical form consisting of oily suspensions (ointments) in the oil in water phase or in the water in oil phase (cream or ointment), the pharmaceutical form gel with Ketoprofen guarantees rapid absorption of the drug, given that it- it is in the state of solute and not of dispersed phase.

  
We will give below, by way of nonlimiting example,

  
 <EMI ID = 2.1>

  

 <EMI ID = 3.1>


  
Regarding clinical experiences, the gel

  
based on Ketoprofen according to the example cited, demonstrated optimal tolerance, both local and general, and optimal therapeutic activity.

  
Clinical experiences.

  
Clinical trials were carried out, using the “gel” of the composition according to the example cited above, on 100 patients suffering from muscular and synovial lesions of the knee, fractures or arthritis of the foot, periarthritis sc apulo -humeral and / or elbow, bone lesions or arthritis of the hand. The gel was applied to these patients at a local level, in doses of 2-6 g, twice a day, depending on the region of the skin to be treated, for a period of between 5 and 15 days.

  
As clinical evaluation criteria, we considered: spontaneous pain or pain on palpation; signs of inflammation; passive and active joint motility. As a biological criterion, the sedimentation rate was considered.

  
To assess possible side effects, not only the subjective and objective symptomatology was taken into account, but also the following haematological criteria:
blood sugar, plasma urea, hematocrit, hemoglobin, white blood cells, total protein, transaminases.

  
2- (3-Benzoylphenyl) -propionic acid in the pharmaceutical form "gel" according to the example cited has been shown to be therapeutically active in inflammatory conditions of the joints, tendons, ligaments and muscles, where he determined a decrease in the dou-

  
 <EMI ID = 4.1>

  
pain on palpation in 60% of cases, alleviation

  
 <EMI ID = 5.1>

  
tion of passive joint motility in 94% of cases and of active joint motility in 98% of cases, a reduction in the speed of sedimentation.

  
In addition, the product has been shown to be perfectly tolerable both "in loco" and systemically.

CLAIMS

  
1.- Process for the preparation of pharmaceutical forms containing 2- (3-benzoylphenyl) -propionic acid, for local use, which consists in preparing the latter in the form of a "gel" using a hydroalcoholic solution.

  
2.- Use of pharmaceutical forms "gel" containing 2- (3-benzoylphenyl) -propionic acid (Ketoprofen) applicable in therapy for local use.

  
3.- Compositions for pharmaceutical use in a topical form of a "gel" comprising 2- (3-benzoylphenyl) propionic acid.


    

Claims (1)

4.- Compositions according to claim 3 in the form and in centesimal dosages. 5.- Method for the therapy of inflammatory and algic syndromes at a local level, using the composition according to the preceding claims.