Claims for Patent: 11,123,287

Summary for Patent: 11,123,287

Title:	Orodispersible films having quick dissolution times for therapeutic and food use
Abstract:	The present invention concerns an orodispersible self-supporting film free from hydrocolloids comprising: a) a film-forming substance consisting of a maltodextrin in an amount comprised between 40 and 80% by weight; b) a plasticizer in an amount comprised between 15 and 55% by weight; e) a surfactant System in an amount comprised between 0.5 and 6% by weight; d) an active ingredient for food or therapeutic use in an amount between 0.05 and 30% by weight, characterised in that it contains a homopolymer or a copolymer of vinyl acetate in a quantity comprised between 2 and 10% by weight where the percentages are calculated on the total weight of said film.
Inventor(s):	Francesco Cilurzo, Maurizio Di Grigoli, Paola Minghetti, Stefania Pagani
Assignee:	PHARMAFILM Srl
Application Number:	US14/430,255
Patent Claims:	1. An orodispersible self-supporting film free from hydrocolloids comprising: a) a film-forming substance consisting of a maltodextrin in an amount between 40 and 80% by weight; b) a plasticizer in an amount between 15 and 55% by weight; c) one or more surfactants in an amount comprised between 0.5 and 6% by weight and; d) an active ingredient for food or therapeutic use in an amount between 0.05 and 30% by weight, said orodispersible self-supporting film free from hydrocolloids further containing a homopolymer or a copolymer of vinyl acetate in a quantity between 1 and 20% by weight, where the percentages are based on the total weight of said film. 2. The orodispersible self-supporting film according to claim 1 wherein the homopolymer or copolymer of vinyl acetate is polyvinylpyrrolidone vinyl acetate or polyvinyl acetate in a quantity between 1 and 10% by weight. 3. The orodispersible self-supporting film according to claim 2, wherein the polyvinyl acetate has a weight molecular weight average between 5000 and 500000. 4. The orodispersible self-supporting film according to claim 3 wherein the polyvinyl acetate has a molecular weight average between 250000 and 450000. 5. The orodispersible self-supporting film according to claim 1, wherein the homopolymer or copolymer of vinyl acetate is contained in an amount between 2.5 and 10% by weight based on the film total weight. 6. The orodispersible self-supporting film according to claim 5, wherein the homopolymer or copolymer of vinyl acetate is contained in an amount between 3 and 10% by weight based on the film total weight. 7. The orodispersible self-supporting film according to claim 5, wherein the homopolymer or copolymer of vinyl acetate is contained in an amount between 3 and 6% by weight based on the film total weight. 8. The orodispersible self-supporting film according to claim 7, wherein the homopolymer or copolymer of vinyl acetate is contained in an amount between 3 and 5.5% by weight based on the film total weight. 9. The orodispersible self-supporting film according to claim 1, wherein the maltodextrin has a dextrose content, expressed in equivalents, of less than 50. 10. The orodispersible self-supporting film according to claim 9, wherein the dextrose content is between 11 and 40. 11. The orodispersible self-supporting film according to claim 1, wherein the plasticizer is selected from the group consisting of polyalcohols, citric acid esters, sebacic acid esters and mixtures thereof. 12. The orodispersible self-supporting film according to claim 11, wherein the plasticizer is selected from the group consisting of propylene glycol, glycerine, sorbitol, maltitol and mixtures thereof. 13. The orodispersible self-supporting film according to claim 1, wherein the one or more surfactants are selected from the group consisting of sorbitan derivatives, sorbitol derivatives, esters of sucrose, fatty acid esters and mixtures thereof. 14. The orodispersible self-supporting film according to claim 1, wherein the active ingredient for food use is an active ingredient with a breath freshening action or is indicated for oral hygiene or is a natural active ingredient suitable for nutritional supplementation. 15. The orodispersible self-supporting film according to claim 14, wherein said active ingredient for food use with a breath freshening action is selected from menthol and eugenol. 16. The orodispersible self-supporting film according to claim 14, wherein said natural active ingredient suitable for nutritional supplementation is chosen from mineral salts normally used for such purpose, and vitamins. 17. The orodispersible self-supporting film according to claim 16, wherein the vitamin is ascorbic acid. 18. The orodispersible self-supporting film according to claim 1, characterized in that the active ingredient for therapeutic use is chosen from active ingredients with essentially topical action. 19. The orodispersible self-supporting film according to claim 18, wherein the active ingredient for therapeutic use is chosen from antibacterial, antifungal, antiviral and disinfectants of the oral cavity. 20. The orodispersible self-supporting film according to claim 1, wherein the active ingredient for therapeutic use is selected from the group consisting of active ingredients with essentially systemic action. 21. The orodispersible self-supporting film according to claim 20, wherein the active ingredient with essentially systemic action is selected from the group consisting of anti-inflammatory, analgesic, antipsychotic, hypnotic, anxiolytic, muscle relaxant, antimigraine, antiparkinsonian, antihemetic, antihistaminic, beta blocker, anti-asthmatic, anti-hypertensive, and antitussive agent. 22. The orodispersible self-supporting film according to claim 21 wherein the active ingredient is selected from the group consisting of: Piroxicam, Ketoprofen, Diclofenac, Tramadol, Morphine, Nifedipine, Diazepam, Lorazepam, Alprazolam, Bromazepam, Triazolam, Lormetazolam, Zolpidem, Paracetamol, Selegiline, Atenolol, Salbutamol, Sumatriptan, Clozapine, Cetirizine, and their pharmaceutically acceptable salts. 23. The orodispersible self-supporting film according to claim 1, further containing one or more excipients selected from the group consisting of non-sticking agents, sweeteners, flavourings, colorants, preservatives, buffer systems and mixtures thereof. 24. The orodispersible self-supporting film according to claim 23, wherein the non-sticking agent is selected from the group consisting of colloidal silica and talc. 25. The orodispersible self-supporting film according to claim 1 for therapeutic or food use. 26. A process for the preparation of the self-supporting film according to claim 1, comprising the following steps: i) dispersing maltodextrin, plasticizer, one or more surfactants, homopolymer or copolymer of vinyl acetate, and active ingredient for therapeutic or food use in a polar solvent, ii) laminating on a silicone paper the mixture obtained in the previous step, iii) drying, iv) removing the silicone paper from the film obtained in the preceding step.