Self-adhesive patches made of fibres for the controlled release of bioactives

Claims

PATENT REQUESTS 1. Self-adhesive patch as a platform for controlled release of bioactive substances containing at least: i) the first block A which is in contact with the body mucosa or skin to which it adheres, characterized by the fact that it is made at least one layer made of hydrophilic polymers and having a surface density of at least 0.2 g / m2, wherein the hydrophilic polymers of block A form an emulsified mixture of polyethylene oxide and polyvinylpyrrolidone; ii) second block B placed on block A obtained by electrohydrodynamic processing, aerodynamic processing or by a combination of the two, which contains encapsulated bioactive substance(s), characterized by the fact that it is formed from at least one layer of fibers made of at least one hydrophobic polymer, and having a surface a density of at least 0.2 g / m2, preferably block B is formed by a combination of hydrophilic and hydrophobic polymers; iii) a third block C placed on block B, wherein block C is formed of at least one layer, characterized in that is obtained by electrohydrodynamic processing, aerodynamic processing or a combination of the two and is composed of one or more hydrophobic polymers selected from poly-ε-caprolactone, poly ε-caprolactone copolymer, polylactic acid and its copolymers and polyhydroxyalkanoates, or any of their mixtures, and in that it has a surface density of at least 0.2 g / m2.

2. A patch according to the preceding claims, wherein the hydrophilic polymers are independently selected from polyethylene oxide and its derivatives such as water-soluble nonionic resins, polyvinylpyrrolidone and its copolymers, polyvinyl alcohols and their copolymers with ethylene, polyacrylates, polyacrylic acid, water-soluble polyacrylonitriles, lignin and derivatives, polymers of acrylic and methacrylic esters, polysaccharides and derivatives, hyaluronic acid, pullulan, alginate, tragacanth, carrageenan, chitin and derivatives, cellulose, glycogen, starch and polymers derived from it, pectin, guar gum, xanthan gum, fructose, gellan, collagen, gelatin, soy protein, whey protein, zein, gluten, casein, lectins, thiolated polymers, polyanhydrides and copolymers of polyethylene glycol PAA, as well as mixtures thereof and / or wherein the hydrophobic polymers are independently selected from water-insoluble proteins, polyhydroxyalkanoates, medium chain length polyhydroxyalkanoates and all their possible copolymers, poly-ε-caprolactone and all its copolymers, polylactide acid and all its copolymers, polyphosphazenes, polyorthoesters, polyesters derived from natural precursors, silicones, polyesters, polyurethanes, polysulfones, halogenated polymers, polycarbonates, acrylonitrile butadiene styrene, latex and polyamides, as well as their mixtures, preferably hydrophilic polymers independently selected from among polyvinylpyrrolidone, polyethylene oxide, polyvinyl alcohol, polyacrylate, zein, gluten derivatives and cellulose materials or combinations thereof and / or the hydrophilic polymer is polyethylene oxide.

3. A patch according to any one of the preceding claims, wherein block A further comprises at least one other a polymer selected from acrylates, zein, gluten derivatives, ethylcellulose or mixtures thereof.

4. A patch according to any one of the preceding claims, wherein block C also contains the same or a different bioactive substance as that contained in block B and / or block C further contains other components such as aromas or flavor enhancers if applies orally, cavity, or aromatic substances or flavor enhancers.

5. A patch according to any one of the preceding claims, wherein at least one layer (B') is embedded between blocks B and C, which is formed from at least one hydrophilic polymer.

6. A patch according to any one of the preceding claims, wherein block A comprises at least one adhesive material, it is desirable that the adhesive material is hypoallergenic and / or porous.

7. The patch according to claim 6, wherein the adhesive material is permeable to the bioactive substance.

8. A patch according to any one of the preceding claims, wherein the bioactive substance is an active pharmaceutical ingredient.

9. Method for obtaining a self-adhesive patch obtained by electrospinning as a platform for controlled release of bioactive substances according to any one of claims 1 to 8, characterized in that it consists of the following steps: a) preparation of block A starting from a solution of hydrophilic polymer or polymers at a concentration between 0.01 and 98% weight, where the voltage of the used emitter is between 0.01 and 500 kV and the voltage in the collector is between 0 kV and -500 kV, with with a flow rate between 0.0001 to 1,000,000 ml / h, at a temperature between 1 °C and 100 °C and a relative humidity between 0% and 100%; b) preparation of block B starting from a solution of hydrophobic polymer or polymers at a concentration between 0.01 and 98% weight, and at least one bioactive agent in a concentration between 0 and 98% by weight, where the emitter voltage is used between 0.01 kV and 500 kV, and the collector voltage between 0 kV and -500 kV, with a flow rate between 0.0001 to 1,000,000 ml / h at a temperature between 1 °C and 100 °C and a relative humidity between 0% and 100%; c) preparation of block C starting from a solution of hydrophobic polymer or polymers at a concentration between 0.01 and 98% weight, and optionally one or more bioactive substances in a concentration between 0 and 98% by weight, wherein the voltage of the emitter used is between 0.01kV and 500kV, and the collector voltage between 0.01kV and - 500kV, with a flow between 0.0001 to 1,000,000 ml / h at temperature between 1 °C and 100 °C and relative humidity between 0% and 100%; d) processing of blocks produced continuously or separately in steps (a), (b) and (c), joined by means of lamination, whereby the lamination is carried out by calendering at a low temperature, preferably by calendering of produced layers is performed so that the last layer of block C that is in contact with the roller is at low temperature.

10. The method according to claim 9, characterized in that controlled output, multiple outputs or injectors with multiple broadcasters.

11. The method according to claim 9 or 10, wherein the resulting variation in fiber diameter is less than 35%.

12. The method according to any one of claims 9 to 11, characterized in that the variation in fiber diameter for given a multi-port injector system at least 5% smaller, preferably at least 15% smaller, than what would be produced with uncontrolled output. syringes.

13. The method according to any one of claims 9 to 12 for obtaining a self-adhesive patch as a platform for controlled release of bioactive substances according to any one of claims 1 to 8, characterized in that the adhesive material of block A not produced by electrohydrodynamic or aerohydrodynamic processing techniques.

14. Pharmaceutical use of the patch according to any one of claims 1 to 8, characterized in that it is used for controlled release of one or more bioactive substances.

15. Nutraceutical or cosmetic use of a patch according to any one of claims 1 to 8 for the controlled release of a single or more bioactive substances.