Abstract: Emulsions of lipophiles such as glycerol monostearate which are compatible with acrylic copolymer emulsions are made stable by using an emulsion stabilizer such as polysorbate 80 in an amount by weight between 1% and 5% of the lipophile and homogenizing the emulsion wherein the emulsion micelles are less than 50 microns. The ability to make a stable emulsion of a lipophile is important in the coating process as it enables preparation and shipment of the lipophilic emulsion to the coater rather than the preparation of a lipophilic emulsion at the time of the coating process which involves a heating and cooling process.

Abstract: The field of the invention generally relates to a shellac-based enteric coating with a reliable and consistent dissolution profile in both acid and neutral environments based on the selective choice of coating excipients used with the shellac. The enteric coating formulation includes a shellac, a maltrin, sodium alginate, one or more plasticizers, and optionally talc. The shellac is present in a range of approximately 40% to 60% w/w % and has an acid number of between 71 and 73. The maltrin is present in a range of approximately 15% to 30% w/w %. The sodium alginate is present in a range of approximately 15% to 30% w/w %. The one or more plasticizers are present in a range of approximately 2% to 20% w/w %. The optional talc is present in a range of 0% to 10%.

Abstract: A coating composition for use in coating foods, confections, nutraceuticals and pharmaceuticals is comprised of shellac in aqueous solution, a hydrolyzed starch product having a dextrose equivalent of 10 or greater and an effective amount of a plasticizer. The coating composition provides a surprisingly high gloss coating. The edible film coating composition solution may be stabilized by adding an effective amount of ethylene diamine tetraacetic acid salt wherein the solution may remain stable for at least three months. The ethylene diamine tetraacetic acid salt may include disodium, trisodium and tetrasodium salts of ethylene diamine tetraacetic acid. Preferably, the concentration of ethylene diamine tetraacetic acid is about 0.5% to 2% of the solution.

Abstract: The invention generally relates to film coating compositions and processes for film coating pharmaceutical, nutraceutical, and food products. One film coating composition includes a shellac in an aqueous solution; a hydrolyzed starch product; an optional plasticizer; and a coating resin. The coating resin may be one or more of polyvinyl pyrrolidone, polyvinyl alcohol, and poly(vinyl pyrrolidone-vinyl acetate). The shellac, hydrolyzed starch product, plasticizer and coating resin comprise the solids in the composition.

Abstract: Emulsions of lipophiles such as glycerol monostearate which are compatible with acrylic copolymer emulsions are made stable by using an emulsion stabilizer such as polysorbate 80 in an amount by weight between 1 % and 5% of the lipophile and homogenizing the emulsion wherein the emulsion micelles are less than 50 microns. The ability to make a stable emulsion of a lipophile is important in the coating process as it enables preparation and shipment of the lipophilic emulsion to the coater rather than the preparation of a lipophilic emulsion at the time of the coating process which involves a heating and cooling process.

Abstract: A coating composition for use in coating foods, confections, nutraceuticals and pharmaceuticals is comprised of shellac in aqueous solution, a hydrolyzed starch product having a dextrose equivalent of 10 or greater and an effective amount of a plasticizer. The coating composition provides a surprisingly high gloss coating. The edible film coating composition solution may be stabilized by adding an effective amount of ethylene diamine tetraacetic acid salt wherein the solution may remain stable for at least three months. The ethylene diamine tetraacetic acid salt may include disodium, trisodium and tetrasodium salts of ethylene diamine tetraacetic acid. Preferably, the concentration of ethylene diamine tetraacetic acid is about 0.5% to 2% of the solution.

Abstract: Emulsions of lipophiles such as glycerol monostearate which are compatible with acrylic copolymer emulsions are made stable by using an emulsion stabilizer such as polysorbate 80 in an amount by weight between 1% and 5% of the lipophile and homogenizing the emulsion wherein the emulsion micelles are less than 50 microns. The ability to make a stable emulsion of a lipophile is important in the coating process as it enables preparation and shipment of the lipophilic emulsion to the coater rather than the preparation of a lipophilic emulsion at the time of the coating process which involves a heating and cooling process.

Abstract: A coating composition for use in coating foods, confections, nutraceuticals and pharmaceuticals is comprised of shellac in aqueous solution, a hydrolyzed starch product having a dextrose equivalent of 10 or greater and an effective amount of a plasticizer. The coating composition provides a surprisingly high gloss coating. The edible film coating composition solution may be stabilized by adding an effective amount of ethylene diamine tetraacetic acid salt wherein the solution may remain stable for at least three months. The ethylene diamine tetraacetic acid salt may include disodium, trisodium and tetrasodium salts of ethylene diamine tetraacetic acid. Preferably, the concentration of ethylene diamine tetraacetic acid is about 0.5% to 2% of the solution.

Abstract: Film coatings for enteric and colonic release at selected pH are provided by selecting and/or formulating a shellac of a predetermined acid number. The method includes the selection of the acid number to provide the release at the specified pH and a method of providing a shellac of a predetermined acid number by blending of shellacs of different acid numbers. In general, films that release or dissolve at or above pH 7.4 are based on the selection of shellac with an acid number below 74. Films that release or dissolve above pH 7.0 are comprised of shellac selected with an acid number below 80. Films that release or dissolve at below pH 7.0 are comprised of shellac selected to have an acid number above 80. The film coating may be modified with a water soluble resin and/or a plasticizer. Preferably the shellac will comprise 50% or more of the resin system, and is formed out of water, not alcohol.

Abstract: An improved dye composition for use in coating tablets and the like is constituted by a stable, aqueous suspension containing a water-soluble, nontoxic dye, an opacifying agent which may be titanium dioxide or iron oxide an immobilizing agent for immobilizing the dye and preventing it from migrating when applied to a tablet or the like, the immobilizing agent being constituted by a nontoxic metal salt present in an amount of from approximately 0.1 to 10 equivalents of metal per mole of dye, and water. The suspension may also contain a film-forming, water-soluble or water-dispersible edible polymer and a plasticizer. These compositions are used in lieu of lake compositions to produce tablets and the like with uniform, non-mottled coatings.

Abstract: An improved wet powder, edible, film-forming composition for use in coating tablets and capsules consists essentially of powdered pigment particles, a film-forming, water soluble or water-dispersible, edible polymer and up to approximately 30% by weight of water. Such compositions are formed by blending the pigment particles and the polymer and applying the water onto the pigment-polymer blend in atomized form. Similar wet powder, edible, clear, film-forming compositions for use in coating tablets and capsules with a clear coating consist essentially of a film-forming, water soluble or water-dispersible, clear, edible polymer and up to approximately 30% by weight of water and are formed by applying the water onto the polymer in atomized form. The application of water in this manner preconditions the polymer and permits the preparation of smooth stable coating suspensions upon dilution with additional water and without the formation of fish eyes.

Abstract: An improved wet powder, edible, film-forming composition for use in coating tablets and capsules consists essentially of powdered pigment particles, a film-forming, water soluble or water-dispersible, edible polymer and up to approximately 30% by weight of water. Such compositions are formed by blending the pigment particles and the polymer and applying the water onto the pigment-polymer blend in atomized form. Similar wet powder, edible, clear, film-forming compositions for use in coating tablets and capsules with a clear coating consist essentially of a film-forming, water soluble or water-dispersible, clear, edible polymer and up to approximately 30% by weight of water and are formed by applying the water onto the polymer in atomized form. The application of water in this manner preconditions the polymer and permits the preparation of smooth stable coating suspensions upon dilution with additional water and without the formation of fish eyes.

Abstract: An improved dye composition for use in coating tablets and the like is constituted by a stable, aqueous suspension containing a water-soluble, nontoxic dye, an opacifying agent which may be titanium dioxide or iron oxide all immobilizing agent for immobilizing the dye and preventing it from migrating when applied to a tablet or the like, the immobilizing agent being constituted by a nontoxic metal salt present in an amount of from approximately 0.1 to 10 equivalents of metal per mole of dye, and water. The suspension may also contain a film-forming, water-soluble or water-dispersible edible polymer and a plasticizer. These compositions are used in lieu of lake compositions to produce tablets and the like with uniform, non-mottled coatings.

Abstract: An improved wet powder, edible, film-forming composition for use in coating tablets and capsules consists essentially of powdered pigment particles, a film-forming, water soluble or water-dispersible, edible polymer and up to approximately 30% by weight of water. Such compositions are formed by blending the pigment particles and the polymer and applying the water onto the pigment-polymer blend in atomized form. Similar wet powder, edible, clear, film-forming compositions for use in coating tablets and capsules with a clear coating consist essentially of a film-forming, water soluble or water-dispersible, clear, edible polymer and up to approximately 30% by weight of water and are formed by applying the water onto the polymer in atomized form. The application of water in this manner preconditions the polymer and permits the preparation of smooth stable coating suspensions upon dilution with additional water and without the formation of fish eyes.

Abstract: An improved dye composition for use in coating tablets and the like is constituted by a stable, aqueous suspension containing a water-soluble, nontoxic dye, an opacifying agent which may be titanium dioxide or iron oxide an immobilizing agent for immobilizing the dye and preventing it from migrating when applied to a tablet or the like, the immobilizing agent being constituted by a nontoxic metal salt present in an amount of from approximately 0.1 to 10 equivalents of metal per mole of dye, and water. The suspension may also contain a film-forming, water-soluble or water-dispersible edible polymer and a plasticizer. These compositions are used in lieu of lake compositions to produce tablets and the like with uniform, non-mottled coatings.

Abstract: Improved stable, fluid, aqueous dispersion compositions comprise a pigment, an alkali metal, alkaline earth metal or ammonium salt of a linear aliphatic substituted glycine such as a salt of ethylene diamine tetraacetic acid or nitrilo triacetic acid as a stabilizing agent, and water. The dispersion composition may additionally contain a lower alkanol such as methanol and/or a water soluble plasticizer such as propylene glycol. Coating compositions for use as a film coating for tablets and the like contain the above-described stable, fluid, aqueous dispersion composition, a water soluble plasticizer, a film coating resin, and water. The described fluid, aqueous dispersion compositions have been found to remain stable for extended periods exceeding six months.

Abstract: A pigment suspension for a film coating for tablets and the like comprising a solvent, pigment particles dispersed in the solvent, and a low molecular weight alcohol soluble polymer which acts as a protective colloid coating the pigment particles and providing for a higher concentration of pigment particles in the pigment suspension. The method of making the pigment suspension comprises the steps of pouring a solvent into a container, stirring the pigment particles into the solvent to disperse the pigment particles evenly, stirring a protective colloid into the liquid in the container and dispersing it therethrough to make the liquid less viscous and more adaptable for accepting additional pigment particles, and stirring additional pigment particles into the container liquid to obtain the desired pigment suspension.A coating suspension for tablets and the like comprising the pigment suspension dispersed in a polymer solution.