MEDICINAL COMPOSITION AND ITS PROCESS OF PREPARATION

Abstract: The invention relates to a pharmaceutical formulation for cryotherapeutic treatments and to the process of preparing this formulation, which is desired to present a revulsive and anti-flammatory topical analgesic effect, mainly in inflammatory cases from traumatic origin. The product, which contains, methyl salicylate, camphor and menthol as analgesic and anti-inflammatory agents, can be presented under form of ice due to the presence, in the formulation, of the surfactants polisorbate 80 and laurilsulphate of sodium. The product comprises, by weight, 3.75 % to 6.25 % of methyl salicylate, 0.25 % to 0.75 % of camphor, 0.25 % to 0.75 % of menthol, 0.25 % to 0.75 % of polisorbate 80, 0.25 % to 0.75 % of laurilsulphate of sodium and distilled water q.s.p. The process of preparing the product includes mixing up the components of the analgesic and those of the surfactant phase, mixing up these two phases, adding distilled water q.s.p., cooling the product in order to obtain a "Medicinal Ice", triturating and packaging it.

Description: "MEDICINAL COMPOSITION AND ITS PROCESS OF PREPARATION" The present invention relates to a pharmaceutical formulation and also to the process of preparing it, taking account that the product has for purpose to reduce pain processes, mainly these ones derived from traumatisms and from intense inflammatory processes of several origins, wherein there is not any presence of exposed fractures. The present pharmaceutical formulation, therefore, has deniable application in Physiotherapy clinics and in the immediate assistance of traumatisms cases, with special emphasis in the sports practices. The product is also applicable in cases of abdominal colic from several origins. Other than the treatment with conventional ice, it is well known the topical use of pharmaceutical formulations, in various forms, such lotions, ointments, creams, gels, pomades and solid sticks, in which the main active principle is methyl salicylate, external peripheric analgesic with anti- inflammatory property. The use of methyl salicylate associated to menthol and camphor is also well known, as described in U. S. Patent No. 4,892,890 and French Patent No. 2,742,991, published in January 09, 1990 and July 04, 1997, respectively. Such formulations, however effective, do not have a immediate resolution, mainly in the sense of analgesic effect, fact that can be explained by the inertia of the employed vehicle. intending to present a product which can result in the amelioration of the attained place in a very short interval of time, the claimed formulation, hereinafter designated as "Medicinal Ice", has been developed, which includes methyl salicylate as main analgesic agent, which, interacting with specific surfactants, becomes more efficient on the cutaneous apparatus, besides providing a bigger action of mentol and camphor, which, when applied through water in the solid stage, have their analgesic topical effects potenciahzed. The present formulation, therefore, allows the association of known topical analgesic components with anti-inflammatory action, methyl salicylate, camphor and menthol, with water, through the use of specific surfactants, polisorbate 80 and laurilsulphate of sodium, which do not interfere with the activities of the analgesic active principles. Such combination, in adequade proportions, as well as its form of presentation, water in solid stage - ice - makes that it reaches the summit of the topical analgesic characteristics of each analgesic component, providing the pain relief in a speedy and efficient way. The treatment with the "Medicinal Ice", therefore, provides, with the use of a unique product, the advantages from the treatment with the conventional ice and those that result from the treatment with the topical analgesic and anti-inflammatory agents, besides maximising the effects of those agents. The "Medicinal Ice" presents the following composition, being the percentages by weight: Methyl salicylate 3,75 to 6,25 % Camphor 0,25 to 0,75 % Menthol 0,25 to 0,75 % Polisorbate 80 0,25 to 0,75 % Laurilsulphate of Sodium 0,25 to 0,75 % Destilled Water Q.S.P. Within the ranges hereabove mentioned, a more prefered embodiment of the invention comprises: Methyl salicylate 5 % Camphor 1 % Menthol 1 % Polisorbate 80 1 % Laurilsulpate of Sodium 1 % Destilled Water Q. S. P. For preparing the "Medicinal Ice", after checking up the weights of the components, it is necessary to mix up, the components of the analgesic phase, that is, methyl salicylate, camphor and menthol, and, separatelly, to mix up the surfactants, polisorbate 80 and laurilsulphate of sodium. After the complete solubuli-zation of each one of those two phases, the blend of these materials must be carried out, very carefully, and in small portions. After that, it is necessary to add that mixture to the destilled water q. s. p., shaking it very vigorously. Finally, the obtained product is disposed in shapes and submitted to cooling at 21 °C negatives, getting the "Medicinal Ice". After trituration in appropriated machines, the "Medicinal Ice" must be stored in cold chambers at 15 °C negatives. The "Medicinal Ice" is dispensed in plastic packages with thickness of 0,10 mm and capacity of 250 g, being the packages provided of orifices with diameter of about 1,0 mm, to allow the product extravase during liquefaction. The "Medicinal Ice" shall be apllied by means of compresses or by specific techniques employed in cryotheraphy, avoiding its application close to the eyes and the mucous membrane. The use of this medicine is counterindicated in cases of allergies to any of its formulating components.

Claims: CLAIMS 1) "MEDICINAL COMPOSITION" characterized by comprising, being the percentages by weight, 3,75 % to 6,25 % of methyl sahcylate; 0,25 % to 0,75 % of camphor; 0,25% to 0,75 % of menthol; 0,25 % to 0,75 % of pohsorbate 80; 0,25 % to 0,75 % of laurilsulphate of sodium and destilled water q.s.p.. 2) "MEDICINAL COMPOSITION" according to claim 1, characterized by 5% of methyl salicylate, 1 % of camphor, 1 % of menthol, 1 % of polisorbate80 and Id % of laurilsulphate of sodium; 3) "MEDICINAL COMPOSITION" according to claims 1 and 2, characterized by presenting form of ice. 4) "PROCESS FOR PREPARING THE MEDICINAL CO-MPOSrπON" as refered in claims 1, 2 and 3, characterised by a) Weighting the components: methyl salicylate, camphor, menthol, pohsorbate 80 and laurilsulphate; b) Mixing up die components of the analgesic phase: methyl salicylate, camphor and menthol; separately, mixing up the surfactants components: polisorbate 80 and laurilsulphate of sodium; c) -Mixing up the analgesic and the surfactant phases; d) Adding destilled water q.s.p., shaking vigorously the mixture; e) Disposing the mixture in shapes and cooling at 21° negatives; f) Triturating the product; g) Packaging the product in .packges provided with orifices.

Inventors: COELHO WANDERLEI, COELHO, WANDERLEI
Applicants: BJ FARMACEUTICA LTDA, COELHO WANDERLEI, BJ FARMACEUTICA LTDA., COELHO, WANDERLEI
Application year: 2000
Main classification: A01N37
IPC codes: A61K9, A61K31