Abstract:
The present invention relates to consumable film products and a method for producing same. More particularly, one aspect of the invention provides a method of making a consumable film by forming a composition into a ribbon, feeding the ribbon to one or more dies, cutting the ribbon into sections, and drying the sections. One or more ribbons may be simultaneously treated. The dies of the invention may be configured to produce an array of variously shaped products having a thickness of less than about ⅛″. Another aspect of the invention provides single-layer films and multiple-layer films produced according to the disclosed methods.

Description:
[0001]     This application claims priority to Provisional Patent Application 60/563,610, filed Apr. 20, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to fast-dissolving, orally consumable films, which may be used to deliver pharmaceutical agents, breath deodorizing agents, antimicrobial agents and salivary stimulants to the oral cavity. In general, the invention relates to a process of making and providing consumable films.  
       DESCRIPTION OF RELATED ART  
       [0003]     Consumable films and methods to produce these films are generally known. These existing processes require extensive, dedicated equipment including mixing, casting, and drying devices.  
       SUMMARY OF THE INVENTION  
       [0004]     Various aspects of the present invention are directed to providing a flexible, innovative process for manufacturing consumable films. In one aspect, the invention provides a method of making a consumable film by forming a composition into a ribbon, feeding the ribbon to one or more dies, cutting the ribbon into sections, and drying the sections. In various aspects, the ribbon includes gelatin, starch, active ingredients, and/or various other effective materials. Additionally, the dies may be rotary or flat and may include a series of rollers and dies. The rollers may have alternating cutting surfaces. In another aspect, the invention provides a method of making a consumable film by forming a composition into two or more ribbons, and feeding the ribbons to a rotating die or dies to produce multiple-layer sections using a conventional soft gel encapsulation device. In yet another aspect, one or more of the dies are modified such that molds are not cut into the dies and, thus, thin, square or rectangular shaped pieces of ribbon are produced. The dies of the invention may be configured to produce an array of variously shaped products. The invention also includes single-layer films and multiple-layer films produced according to the disclosed methods. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIG. 1  is a view of a system for making a consumable film.  
         [0006]      FIG. 2  is a view of an alternative system for making a consumable film.  
         [0007]      FIG. 3  is a view of a pair of rollers according to one aspect of the invention.  
         [0008]      FIG. 4  is a view of a pair of rollers according to another aspect of the invention.  
         [0009]      FIG. 5  is a view of a pair of rollers according to a further aspect of the invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0010]     In a conventional soft-gel manufacturing process, the gelatin mass and the center-fill medicinal mass are prepared separately. The gelatin mass may consist of a variety of materials including, for example, gelatin powder, glycerine, flavors, colors, and water. On the other hand, the center-fill, medicinal mass may include such compounds as oils, fats, waxes, excipients, and active ingredients. After the gelatin and medicinal masses are produced, they are transferred to a soft-gel encapsulator. In a typical encapsulation operation, molten gelatin is pumped to the encapsulator and two thin ribbons are formed on opposing sides of the encapsulator. These two ribbons then pass over a series of rollers and over a set of dies that determine the size and shape of the capsules. The medicinal mass, or fill, is fed to a positive displacement pump, which accurately transfers a predetermined amount of the fill and injects it between the two gelatin ribbons prior to the ribbons being sealed together by the application of heat and pressure. Thereafter, the capsules are dried.  
         [0011]     According to the principles of the invention, a consumable film may be produced using the encapsulating device described above, which is normally used to prepare liquid center-filled, gelatin capsules or soft-gels. It has been found that the materials contained in the gelatin mass and medicinal mass, discussed above, may be blended together prior to being shaped. In one aspect, one or more active ingredients may be added. Of course, a starch mass or another material may be substituted for or combined with the gelatin mass and active ingredients may or may not be employed according to the principles of the invention. Thereafter, the composition may be fed to an encapsulator. It may be formed into one or more thin ribbons, which, in one embodiment, are located on opposing sides of the encapsulator, and then passed over a set of dies and rollers and formed into capsules without the injection of other material. In one aspect, the dies may be constructed such that the ribbons form thin, square or rectangular pieces of ribbon. Any particular shaped or textured product including, but not limited to, circles, semicircles, triangles, parallelograms, fruit shapes, flower shapes, and the like, may be produced according to the principles of the invention by configuring the shape or texture of one or more of the dies. Thereafter, the products of the encapsulation machine are dried and packaged as desired.  
         [0012]     In one aspect, a consumable film may be produced by forming a composition into a ribbon, cutting the ribbon into sections, and drying the sections. In another aspect, multiple ribbons may be formed and cut into sections. Of course, both single-layer and multiple-layer films may be produced. Preferably, the sections may be sized to render individual dosage units. The ribbon may be cut using one or more dies, which may be flat or rotary dies. In another aspect, the dies include a series of rollers and dies.  
         [0013]      FIG. 1  provides a device  10  that is useful for producing a consumable film. In this example, ribbon  1  may be cast on a moving surface  20 , and transferred over roller  30  to a pair of cutting rollers  40 , and then collected and dried. In another aspect depicted in connection with  FIG. 2 , two ribbons  1  may be cast on moving surfaces  20 , and transferred over rollers  30  to a pair of cutting rollers  40 , and then collected and dried. Of course, more than two ribbons may be cast, transferred, combined/cut, collected and dried. The equipment illustrated in  FIG. 1  may also be employed to produce a multiple-layer film by passing a previously cast film through cutting rollers  40  simultaneously with a ribbon  1  from roller  30 .  
         [0014]      FIG. 3  illustrates a pair of rollers according to one aspect of the invention where cutting surfaces are disposed on roller  41  that engage roller  42 . In another aspect, rollers  43  are equipped with alternating cutting and non-cutting regions. As such, the rollers  43  may be arranged such that ribbon sections are cut using alternating cutting surfaces disposed on the rollers  43  as shown in  FIG. 4 . As described above, the dies disposed on the rollers  40  may be of any desired shape. For example,  FIG. 5  depicts rectangular shaped dies arranged on roller  44  that mate with roller  45 . While the products of the invention may be any shape, the depth of the dies may be restricted to be no more than about ⅛″. In another aspect the depth of the dies is limited to about 3/32″, and in yet another aspect the maximum depth of the dies is about 1/16″.  
         [0015]     The film produced by the inventive method may be made from any of a wide variety of materials, including water-soluble polymers, that provide a viscous solution that is flowable at normal operating conditions. The material may have a viscosity in the range of about 5,000 to about 25,000 cps at approximately 140° F. In another aspect the viscosity range is about 5,000 to about 12,000 cps at approximately 140° F. The materials that are useful for carrying out the invention include gelatins such as hydrolysed gelatin, acylated gelatin, and fish gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein, starch, maltitol, maltitol syrup, glucose syrups, hydrogenated starch hydrolysate, saccharides, agar, acacia gum, sodium alginate, alginates, carrageenans, gellan, guar gum, karaya, locust bean gum, pectin, pullulan, polyethylene glycol, tragacanth gum, xanthan gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, polyvinyl pyrrolidone, polyvinyl alcohol, polystyrene sulphonate, dextran sulphate, chitosan derivatives, cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, cellulose derivatives, bentonite and diatomaceous earths, sorbitols, soribitans, polyhydric alcohols, mannitol, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, plasticizers such as glycerin, propylene glycol, and sorbital, coloring agents, preservative materials such as potassium sorbate and ethyl, methyl and propyl parabens, and water. The film may include one or more active ingredients, which may be added to the ribbon material during processing. Typical ingredients include analgesics and anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, anti-bacterial agents, anti-coagulants, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents and immunosuppressants, anti-parkinsonian agents, anti-protazoal agents, anti-thyroid agents, anxiolytic, sedatives, hypnotics and neuroleptics, β-blockers, breath freshening agents, cardiac inotropic agents, corticosteroids, diuretics, enzymes, gastro-intestinal agents, histamine h,-receptor antagonists, lipid regulating agents, local anaesthetics, neuro-muscular agents, nitrates and other anti-anginal agents, nutritional agents, opioid analgesics, vaccines, sex hormones, spermicides, and stimulants. The active ingredients also include essential oils as antimicrobial agents, flavoring agents, sulfur precipitating agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, binding agents, coloring agents, sweeteners, fragrances, and the like. The film may also include, for example, materials identified in U.S. Pat. Nos. 5,614,217, 5,817,323, and 6,596,298, and U.S. Provisional Patent Application Ser. No. 60/467,339, the disclosures of which are incorporated by reference in their entireties.  
         [0016]     While the invention has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.