TH14569U - Pharmaceutical formulations for external body use products. - Google Patents

Abstract

Page 1 of 1. Abstract of the Invention. This invention relates to the composition of a pharmaceutical formulation for external use product consisting of: a) nanoparticles encapsulated with pharmaceutical active ingredients in amounts of 5-50 percent by weight; b) a gelling agent in amounts of 2.5-15 percent by weight; c) a neutralizing agent in amounts of 0.2-0.5 percent by weight; d) an additive in amounts of 0.5-15 percent by weight; and e) a pharmaceutically acceptable carrier to achieve 100 percent by weight. The specific characteristic is that these nanoparticles can encapsulate at least three active ingredients, and the formulation exhibits good stability and enhanced skin delivery of these active ingredients.

Claims (10)

------05/04/2018------(OCR) Page 1 of 2 pages. Claims 1. The pharmaceutical formulation for external use products shall consist of: - Nanoparticles encapsulated with at least 3 pharmaceutical active ingredients in amounts of 5-50 percent by weight; - Gelling agent in amounts of 2.5-15 percent by weight; - Neutralizing agent in amounts of 0.2-0.5 percent by weight; and - A pharmaceutically acceptable carrier to achieve 100 percent by weight. 2. The pharmaceutical formulation composition as per claim 1, where the appropriate encapsulated nanoparticles are those capable of encapsulating 5-10 active ingredients. 3. The pharmaceutical formulation composition. According to claim 1 or 2, where the pharmaceutical active ingredient means the pharmaceutical active ingredient for topical delivery; 4. The composition of the pharmaceutical formulation according to claim 1, where the nanoparticles encapsulated with the pharmaceutical active ingredient may be selected from nanoemulsion particles, lipid nanoparticles, solid lipid nanoparticles, polymer nanoparticles, or mixtures of such substances; 5. The composition of the pharmaceutical formulation according to claim 4, where the appropriate nanoparticles encapsulated with the pharmaceutical active ingredient are nanoemulsion particles; 6. The composition of the pharmaceutical formulation according to claim 1, where the gelling agent may be selected from the group of emulsifying-stabilizing polymers, synthetic acrylate polymers, modified synthetic starch, hydrogenated vegetable oil, synthetic carbomer polymers. or a mixture of such substances. 7. Components of the pharmaceutical formulation according to claim 1, where the neutralizing agent may be selected from triethanolamine, potassium hydroxide, sodium hydroxide, or a mixture of such substances. 8. Components of the pharmaceutical formulation according to claim 1, where the pharmaceutically acceptable carrier is additionally composed of additives in the amount of 0.5-15 percent by weight of the formulation components. Page 2 of 2 pages. 9. Components of the pharmaceutical formulation according to claim 8, where the additives may be selected from solvents, flavoring agents, preservatives, cooling agents, or a mixture of such substances. 10. Components of the pharmaceutical formulation according to claims 1-9, any one of which has the following steps: a. Dissolve the gelling agent. a) Prepare the solution from step a) using a pharmaceutically acceptable carrier, then stir at a speed of 250-450 rpm until a homogeneous solution is obtained. b) Adjust the pH of the solution from step a) with a neutralizing agent until the pH is in the range of 5-7. c) Add the nanoparticles containing the pharmaceutical active ingredient to the solution prepared in step b) and continuously stir at a speed of 250-450 rpm until well combined. 1. The formulation of a pharmaceutical product for external use shall consist of: a) nanoparticles encapsulated with pharmaceutical active ingredients in a quantity of 5-50 percent by weight; b) a gelling agent in a quantity of 2.5-15 percent by weight; c) a neutralizing agent in a quantity of 0.2-0.5 percent by weight; and d) a pharmaceutically acceptable carrier to achieve a total quantity of 100 percent by weight, with the specific characteristic that the nanoparticles are capable of encapsulating at least three different active ingredients. 2. Components of the pharmaceutical formulation as per claim 1, where the nanoparticles containing the active ingredients can retain 5-10 different active ingredients. 3. Components of the pharmaceutical formulation as per claim 1 or 2, where active pharmaceutical ingredient means the active pharmaceutical ingredient for topical delivery. 4. Composition of the pharmaceutical formulation according to claim 1, whereby nanoparticles encapsulated with the pharmaceutical active ingredient in clause (a) may be selected from nanoemulsion particles, lipid nanoparticles, solid lipid nanoparticles, polymer nanoparticles, or mixtures of such substances. 5. Components of the pharmaceutical formulation as per claim 4, where the nanoparticles encapsulated with the pharmaceutical active ingredient in clause (a) are nanoemulsion particles. 6. Components of the pharmaceutical formulation as per claim 1, whereby the gelling agent in clause b) is selected from emulsifying-stabilizing polymers, synthetic acrylate polymers, modified synthetic starch, hydrogenated vegetable oil, synthetic carbomer polymers, or mixtures of such agents. 7. Composition of the pharmaceutical formulation according to claim 1, whereby the neutralizing agent in clause c) may be selected from triethanolamine, potassium hydroxide, sodium hydroxide or a mixture of such agents. 8. Composition of the pharmaceutical formulation according to claim 1, whereby the pharmaceutically acceptable carrier in clause d) is further supplemented with additives in an amount of 0.5-15 percent by weight of the components of the formulation. 9. Components of the pharmaceutical formulation as per claim 8, where additives may be selected from solvents, flavorings, preservatives, cooling agents, or mixtures of such agents. 10. The components of the pharmaceutical formulation, as per one of the preceding claims, are prepared by following a procedure consisting of: i) a gelling solution and a pharmaceutically acceptable carrier, stirred at 250-450 rpm until a homogeneous solution is obtained; ii) the pH of the solution obtained from step i) is adjusted with a neutralizing agent until the pH is in the range of 5-7; iii) nanoparticles containing the pharmaceutical active ingredient are added to the solution prepared in step ii), and continuously stirred at 250-450 rpm until well combined.