Self-supporting films for pharmaceutical and food use

Abstract

Rapidly dissolving self-supporting films for food or pharmaceutical use comprising: a) a filmogenic substance consisting of a maltodextrin; b) a plasticiser; c) an active principle for food or pharmaceutical use, characterised in that said films are free of hydrocolloids.

1 . Self-supporting films comprising:
 a) a filmogenic substance consisting of a maltodextrin,   b) a plasticiser,   c) an active ingredient for food or pharmaceutical use, wherein said films are free from hydrocolloids.   
   
   
       2 . Self-supporting films as claimed in  claim 1 , wherein the maltodextrin (a) has a dextrose content of less than 50 expressed in equivalents. 
   
   
       3 . Self-supporting films as claimed in  claim 2  wherein said 1o dextrose content is between 11 and 40. 
   
   
       4 . Self-supporting films as claimed in  claims 1 , wherein the plasticiser is selected from the group consisting of polyalcohols, citric acid esters, sebacic acid esters or their mixtures. 
   
   
       5 . Self-supporting films as claimed in  claims 1 , wherein the plasticiser is selected from the group consisting of propylene glycol, glycerine, sorbitol, maltitol and their relative mixtures. 
   
   
       6 . Self-supporting films as claimed in  claims 1 , wherein the active principle for food use is an active principle with a breath freshening action and/or indicated for oral hygiene or an active principle suitable for nutritional supplementation. 
   
   
       7 . Self-supporting films as claimed in  claim 6 , wherein said active principle for food use is selected from the group consisting of menthol and eugenol. 
   
   
       8 . Self-supporting films as claimed in  claim 6  wherein said active principle suitable for nutritional supplementation is selected from the group consisting of mineral salts normally used for such purpose and vitamins. 
   
   
       9 . Self-supporting films as claimed in  claim 8  wherein the vitamin is ascorbic acid. 
   
   
       10 . Self-supporting films as claimed in  claims 1 , wherein said active principle for therapeutic use is selected from the group consisting of active principles with essentially lo topical activity. 
   
   
       11 . Self-supporting films as claimed in  claim 10 , wherein said active principle is selected from the group consisting of antibacterial, antimycotic, antiviral agents and disinfectants of the oral cavity. 
   
   
       12 . Self-supporting films as claimed in  claims 1  wherein the active principle for therapeutic use is selected from the group consisting of active principles with essentially systemic activity. 
   
   
       13 . Self-supporting films as claimed in  claim 12 , wherein said active principle with essentially systemic activity is selected from the group consisting of anti-inflammatory, analgesic, antipsychotic, hypnotic, anxiolytic, antihypertensive, myorelaxant, antimigraine, antiparkinsonian, antiemetic, antihistaminic, beta blocking and antiasthmatic agents. 
   
   
       14 . Self-supporting films as claimed in  claim 1 , wherein said principle is selected from the group consisting of: Piroxicam, Ketoprofen, Sodium diclofenac, Tramadol hydrochloride, Morphine, Nifedipine, Diazepam, Lorazepam, Alprazolam, Bromazepam, Triazolam, Lormetazepam, Zolpidem, Paracetamol, Selegiline, Atenolol, Salbutamol, Sumatriptan, Clozapine, Cetirizine, Ondansetron, Fentanyl and their pharmaceutically acceptable salts. 
   
   
       15 . Self-supporting films as claimed in  claim 14 , containing maltodextrin at concentrations between 40 and 80% by weight, plasticiser in concentrations between 15 and 55% by weight and the active principle for food or pharmaceutical use in a quantity between 0.05% and 30% by weight on the total weight of said film. 
   
   
       16 . Self-supporting films as claimed in  claims 1 , containing other excipients selected from the group consisting of anticaking agents, sweeteners, flavourings, colouring agents, preservatives, acidity regulating systems and mixtures thereof. 
   
   
       17 . Self-supporting films as claimed in  claim 16 , wherein said antisticking agents are selected from the group consisting of microcrystalline cellulose, colloidal silica and talc. 
   
   
       18 . Process for preparing self-supporting films claimed in  claim 1 , comprising the following steps:
 i) mixing the maltodextrin, plasticiser and active principle for food or therapeutic use,   ii) extruding the mixture coming from the preceding step .   
   
   
       19 . Process as claimed in  claim 18 , wherein the extrusion step (ii) is preferably conducted at a temperature between 60 and 120° C. 
   
   
       20 . Process as claimed in  claim 18 , conducted in a single screw extruder. 
   
   
       21 . Process for preparing self-supporting films claimed in  claim 1 , comprising the following steps:
 i) dispersing the maltodextrin, plasticiser and the active principle for therapeutic or food use in a polar solvent at a temperature between 60 and 105° C.,   ii) rolling the mixture obtained in the preceding step onto a silicone paper and drying it,   iii) removing the silicone paper from the film obtained in the preceding step.   
   
   
       22 . The process as claimed in  claim 21 , wherein the polar solvent used in step (i) is selected from the group consisting of water, a water miscible solvent and mixtures thereof. 
   
   
       23 . Process as claimed in  claim 22 , wherein said solvent consists of water and a water-ethanol mixture. 
   
   
       24 . Process as claimed in  claim 23 , wherein the temperature of steps (i) and (ii) is between 60 and 105° C. 
   
   
       25 . Process for preparing self-supporting films claimed in  claim 1 , comprising the following steps:
 i) mixing the maltodextrin, plasticiser and active ingredient for food or therapeutic use,   ii) granulating and sieving the mixture and mixing it with an anti sticking agent,   iii) storing the granules at least for 12 h,   iv) extruding the granules coming from the preceding step thereby obtaining the edible film.   
   
   
       26 . Process as claimed in  claim 25 , wherein the extrusion step (ii) is conducted at a temperature between 70 and 140° C. 
   
   
       27 . (canceled)