MXPA99006294A - Film coatings and film coating compositions based on dextrin - Google Patents

Abstract

A dry film coating composition for forming a coating suspension for film coating nutritional supplements, pharmaceutical tablets, and the like, comprising a dextrin and a detackifier.

Description

FILM CLADDINGS AND COMPOSITIONS OF FILM COATINGS BASED ON DEXTRINE Background of the invention 1. Field of the Invention This invention relates to an aqueous film coating field of nutritional supplements and pharmaceutical tablets, and especially relates to the provision of dextrin-based film coatings for coating nutritional supplements, such as vitamin tablets and herbal tablets. , and pharmaceutical tablets, such as acetaminophen (APAP), aspirin (ASA), and ibuprofen. 2. Description of the Prior Art Hydroxypropyl methylcellulose, maltodextrin and lactose have been used in coatings for substrates such as pharmaceutical tablets. For example, said coatings made of coating compositions manufactured by Colorcon and described in the Patents of E. U.A. Nos. 4, 543,370, 4,683,256, 4,643, 898, 4, 725,441, and 4, 828, 841, and in the U.S. Patent Application. allowed Series No. 08/400, 134, it has been proven that all such patents and the patent application, incorporated herein by reference, are especially effective when used in pharmaceutical tablets. However, the coatings based on hydroxypropyl methylcellulose, maltodextrin and lactose, especially transparent coatings (clear non-pigmented coatings, sometimes suffer from a "frosting" problem (the formation of a white frost-like appearance in the coating) when used Also, coatings based on hydroxypropyl methylcellulose, maltodextrin, and lactose sometimes suffer from a "frosting" problem when used to coat pharmaceutical tablets (eg, coded APAP tablets) to coat nutritional supplements such as vitamins and herbal tablets. In addition, coatings based on hydroxypropyl methylcellulose sometimes become very brittle and dried when used to coat herbal tablets, resulting in the shedding of herbal tablet coatings Also, coatings based on hydr oxypropylmethylcellulose, sometimes have an opaque matte finish, with low gloss, instead of a desirable glossy finish, when they were used to coat nutritional supplements such as vitamins and herbal tablets. Tapioca dextrin has been used as an ingredient in a sealant layer for chocolates, nuts, etc. in the food / candy field and the sealer layer containing tapioca dextrin is covered with a coating such as a sugar cover. It is recognized that tapioca dextrin is very fragile and very thick.

COMPE DIO DE LA INVENCIÓN It is an object of the invention to provide a film coating having durable gloss, good film adhesion and good film clarity. Another object of the invention is to provide a film coating that can be used as a glossy coating for vitamin tablets, herbal tablets and pharmaceutical tablets having durable gloss, which adhere well to difficult substrates such as calcium-oyster shell , and that are not frosted or transparent. Another object of the invention is to provide a film coating that facilitates the flow of the tablet in the bed of a coating tray. These and other objectives were achieved by our invention, which is described later. 3. Brief Description of the Drawings Figure 1 shows a coating tray containing 3. 5 kg of uncoated tablets. A line is drawn on the back wall of the coating tray which follows the edge of the plane and is parallel to the upper part of the tablet bed of the uncoated tablets. Figure 2 shows a coating tray containing 3.5 kg of tablets coated with a film coating made using formulation A. This figure illustrates the geometry of the bed for the uncoated tablets shown in Figure 1.

Figure 3 shows a coating tray containing 3. 5 kg of tablets coated with a film coating made using Formulation B. This figure illustrates that the geometry of the bed for the coated tablets is matched to the bed geometry of the uncoated tablets shown in Figure 1. Figure 4 shows a coating tray containing 3. 5 kg of tablets coated with a film coating made using Formulation C. This figure illustrates that the geometry of the bed for the coated tablets is matched to the bed geometry of the uncoated tablets shown in Figure 1. Figure 5 shows a coating tray containing 3. 5 kg of tablets coated with a film coating made using Formulation D. This figure illustrates that the geometry of the bed for the coated tablets is matched to the bed geometry of the uncoated tablets shown in Figure 1. Figure 6 shows a coating tray containing 3. 5 kg of tablets coated with a film coating made using Formulation E. This figure illustrates that the geometry of the bed for the coated tablets is matched to the bed geometry of the uncoated tablets shown in Figure 1. Figure 7 shows a coating tray containing 3. 5 kg of tablets coated with a film coating made using Formulation F. This figure illustrates that the geometry of the bed for the coated tablets is matched to the bed geometry of the uncoated tablets shown in Figure 1.

DETAILED DESCRIPTION OF THE INVENTION In accordance with the invention, in our dry film coating compositions for use in the formation of coating suspensions for nutritional film coating supplements, pharmaceutical tablets, and the like, comprise a dextrin and a antiespesante. Advantageously, the dry film coating compositions may include one or more of the following components: auxiliary film former (s), a plasticizer, a surfactant, colorant, a flow aid and a preservative. According to the invention, a method for coating substrates such as nutritional supplements, pharmaceutical tablets and the like, comprises mixing dextrin and an antiesping agent in water to form an aqueous coating suspension of the invention, applying the coating suspension of the invention to said substrates to form a film coating on said substrates and sect the film coating on said substrates. Optionally, but advantageously, the following components can be mixed in water with dextrin and anti-thickener to form the coating suspension of the invention: auxiliary film former (s), a plasticizer, a surfactant, a dye, a flow attendant and a conservator.

The invention also includes coated substrates, such as coated vitamins, coated herbal tablets, and coated pharmaceutical tablets, and the method for forming the dry film coating compositions and the method for forming the coating suspensions of the invention. Dextrin (CsH10? 5) n - * - H2O) is an incompletely hydrolysed starch. It was prepared by dry-heating corn, maize, waxy, waxy sorghum, potato, maranta, wheat, rice, tapioca, or sago starches, or by dry-heating the starches after treatment with alkalis, acids, or pH control agents. suitable, and drying the treated starch with acid or alkali. A preferred dextrin is tapioca dextrin. Preferably, the dextrin is from about 5% to about 97% by weight of the dry film coating composition of the invention and of the waterless ingredients of the aqueous coating suspension of the invention. For transparent coatings (coatings without coloring), a scale from about 35% to about 75% dextrin by weight of the dry film coating composition of the invention and the waterless ingredients of the aqueous coating suspension of the invention is preferred, and is still preferred plus a scale of about 65% to about 75% dextrin by weight of the dry film coating composition of the invention and of the waterless ingredients of the aqueous coating suspension of the invention.

For white coatings (coatings containing titanium dioxide as the dye), a scale from about 30% to about 50% dextrin by weight of the dry film coating composition of the invention and the ingredients without water of the aqueous coating suspension of the invention and still more preferred is a scale of about 35% to about 40% dextrin by weight of the dry film coating composition of the invention and of the ingredients without water of the suspension of aqueous coating of the invention. For color coatings (having lacquers, dyes and the like as a colorant), a scale from about 35% to about 75% dextrin by weight of the dry film coating composition of the invention and the water-free ingredients of the aqueous coating suspension of the invention, and a scale from about 45% to about 55% dextrin by weight of the dry film coating composition of the invention and the ingredients is even more preferred. without water of the aqueous coating suspension of the invention. Examples of antiespesante are mineral oil, carnauba wax, acetylated monoglycerides (Myvacet), lecithin (Alcolec), and magnesium stearate. For transparent coatings (coatings without colorant), a scale from about 1% to about 15% of the antisense by weight of the dry film coating composition of the invention of the waterless ingredients of the aqueous coating suspension of The invention, and more preferably a scale of about 7.5% to about 10% of the antisense by weight of the dry film coating composition of the invention and of the waterless ingredients of the aqueous coating suspension of the invention. For white coatings (coatings containing titanium dioxide as the dye), a scale of from about 1% to about 15% of the antisense by weight of the dry film of the invention and of the waterless ingredients of the suspension is preferred. aqueous coating of the invention, and more preferably a scale of from about 2% to about 5% of the antisweatant by weight of the dry film coating composition of the invention and of the waterless ingredients of the aqueous coating suspension of the invention For color coatings (those having lacquers, dyes, and the like as a colorant), a scale of from about 1% to about 10% of the anti-thickener by weight of the dry film coating composition of the invention is preferred and of the water-free ingredients of the aqueous coating suspension of the invention, and a scale of from about 2% to about 5% of the anti-thickener by weight of the dry film coating composition of the invention of the ingredients is preferably further preferred. water of the aqueous coating suspension of the invention. When mineral oil is used as the antisipping agent in color formulations, a scale of about 1% to about 7.5% of the mineral oil by weight of the dry film coating composition of the invention and of the waterless ingredients of the invention are preferred. aqueous coating suspension of the invention and a scale of from about 2% to about 4% mineral oil by weight of the dry film coating composition of the invention and of the waterless ingredients of the water suspension is further preferred. of the invention, in order to prevent the coating color from draining if the amount of titanium dioxide in the coating is low. The auxiliary film former (s) can be dextrose, polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (H PC), sodium carboxymethylcellulose (sodium CMC) maltodextrin, sodium alginate, PG alginate, polyvinyl alcohol (PVA) and their combinations. The auxiliary film former (s) (s) act as strength enhancers for the film coating. Their presence in the coatings helps cracking the film coating, as well as helping to prevent wear / tearing of the coated tablet. The preferred and most preferred scales of the auxiliary film former (s) is by weight of the dry film forming composition of the invention and by weight of the waterless ingredients of the aqueous coating suspension of the invention. they are from 0% to about 55% (preferred) and from 3.5 to 10% (more preferred) for transparent formulations, from 5% to 50% (preferred) and from 5% to 20% (most preferred) for the white formulations , and from 5% to 50% (preferred) and from 5% to 20% (more preferred) for the color formulations. Preferred scales and most preferred scales for various auxiliary film formers are shown below. When coating extremely friable tablets with a transparent coating made of a transparent formulation, a preferred auxiliary film former is Na CMC in an amount of up to 50% by weight of the dry film forming composition of the invention and by weight of the water-free ingredients of the aqueous coating suspension of the invention, and preferably in an amount of about 40% to about 45% by weight of the dry film-forming composition of the invention and by weight of the ingredients without water of the aqueous coating suspension of the invention. The Na CMC improves the film resistance of the coating of the invention, which results in the coated tablet being less friable than the uncoated tablet. Illustrative plasticizers are polyethylene glycol having a molecular weight on the scale of 200 to 8000, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, triethyl citrate (Citroflex A2), tributyl citrate (Cigtroflex 4) and citrate acetiltributyl (Citroflex A4) and the preferred scales for the plasticizer are shown below, along with the preferred and most preferred scales for various illustrative plasticizers. Illustrative surfactant people are Polysorbate 80 and preferred scales for the surfactant are shown below, along with the preferred and most preferred scales for an illustrative agent. A colorant can be any of approved colors, opacifiers or colorants. For example, the colorant can be FD &; C, D &C lacquers, titanium dioxide, magnesium carbonate, talc, fumed silica, iron oxides, channel black, riboflavin, carmine 40, "ponceau" 4R, patent blue V5, caramel, curcumin, " annatto ", dyes and combinations thereof. The preferred scale and the most preferred scale for the dye (Ti02) in the white formulations are 20% to 50%) (preferred) and 25% to 40% (more preferred) by weight of the coating composition of the invention and by weight of the water-free ingredients of the coating suspension of the invention. The preferred scale and the most preferred scale for the colorant in the color formulations are 0.1% to 40% (preferred) and 15% I 25% (more preferred) by weight of the coating composition of the invention and by weight of the water-free ingredients of the coating suspension of the invention. An exemplary flow aid is stearic acid, and preferred scales and most preferred scales for the flow aid are shown below, along with the preferred and most preferred scales for stearic acid. The illustrative preservative is sodium citrate, and the most preferred scales for the preservative are shown below, along with the preferred scales and the most preferred scales of sodium citrate.TRANSPARENT WHITE PIGMENTED AUXILIARY FILM TRAINERS Preferred 0-55% 5-50% 5-50% Most Preferred 3.5-10% 5-20% 5-20% Dextrose Preferred 0-20% 25-50% 5-20% Most Preferred 7.5-10 % 30-35% 7.5-15% Preferred PVP 0-20% 0-10% 0-10% Most Preferred 3.5-7.5% 3.5-7.5% 3.5-7.5% HPMC / Methylcellulose / HPC Preferred 0-10% 5-50% 5-50% Most Preferred 3.5-7.5% 5-20% 5-20% Na / Alginate Alginate of PG Preferred 0-10% 1-10% 1-10% Most Preferred 3.5-7.5% 5-20% 3.5-7.5% CMC of Na Preferred 0-50% 1-105 1-10% More preferred 3.5-7.5% 3.5-7.5% 3.5-7.5% for tablets with high friability Most preferred for 50-45% 3.5-7.5% 3.5-7.5% tablets with high friability Preferred Maltodextrin 0-25% 5-50% 5-50% Most Preferred 15-20% 5-20% 5-20% TENSOACTIVE AGENT Preferred 0-15% 0-15% 0-15% Polysorbate 80 Preferred 0-2% 0-2% 0-2% Most Preferred 0.5-1% 0.5-1% 0.5-1% FLOW AUXILIARY Preferred 0-10% 0-10% 0-10% Most Preferred 2-5% 2-5% 2-5% Preferred Stearic Acid 0-10% 0-10% 0-10% Most Preferred 2-5% 2-5% 2-5% PLASTICIZING Preferred 0-15% 0-15% 0-15% Polyethylene glycol 8000 Preferred 0-15% 0-15% 0-15% Most Preferred 7.5-10% 7.5-10% 7.5-10% Preferred glycerin 0-10% 0-10% 0-10% More preferred 3.5-7.5% 3.5-7.5% 3.5-7.5% CONSERVATIVE Preferred 0-5% 0-5% 0-5% Sodium Citrate Preferred 0-4% 0-4% 0-4% Most Preferred 1 -2% 2-3% 2-3% The scales shown above are all by weight of the dry film coating composition of the invention and the waterless ingredients of the coating suspension of the invention. The following examples illustrate the invention, all ingredients being by weight. EXAMPLE 1 The dry components of the following formulation were mixed for five minutes in a food processor to form a mixture. Then, the liquid components were added to the mixture of the dry components and mixed therein by mixing for an additional two minutes. Optionally, the components of the formulation were granulated using a Planetary mixer such as a Hobart planetary mixer. After the dry film coating composition was charged into the mixer and the mixer was turned on, sufficient water was added slowly until the composition formed slightly adherent granules. These granules are then passed through a 1 -2 mm screen and then passed to an oven at 30 ° C until the moisture content is below 5%. The composition is then screened again through a 1-2 mm screen and then ready for use in a granular form that is not powdered. If not optionally granulated, the composition can be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example. Other granulation methods that can be used are spray granulation and roll compaction. 20 grams of the resulting film coating composition were dispersed in 180 grams of distilled water to form a coating solution / suspension of the invention (10% solids) and 30 grams of this solution / suspension were sprayed using a coater Aeromático Strea I in 1000 grams of placebos coated with color to form the coating of the invention on it, having a theoretical weight gain of 1.0%. This produced a film coating on the tablet that had an excellent durable glossy gloss, minimal thickening, good film adhesion, good film clarity without frosting. The coating process described above was repeated, except that a 15% solids coating solution / suspension was used, obtained by mixing 30 grams of the formulation of this example in 170 grams of distilled water to form the aqueous coating solution / suspension. and then spraying 20 grams of the solution / suspension in 1000 grams of color-coated placebos. Again, the resulting coating had an excellent durable glossy gloss, minimal thickening, good film adhesion and good non-frosted film clarity.

Component Grams Percentages Tapioca Dextrin (A. E. Staley) 70% 700.00 Dextrose (A. E. Staley) 10% 100.00 Mineral Oil (Eastech 10% 100.00 Chemical Inc.) Polyethylene glycol 8000 8% 80.00 (U nion Carbide) Sodium Anhydride Citrate (ADM Corn Processing) 2% 20.00 1 00% 1 00.00 Examples 2-20 further illustrate the invention, all percentages being by weight. In Examples 2-12, the components of each formulation were mixed, formed into a coating suspension and applied to tablets, as in Example 1, to obtain film coatings having durable gloss, good film adhesion and good clarity of film EXAMPLE 2 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 72% 720.00 Dextrose (A.E. Staley) 10% 100.00 Mineral Oil (Pennreco) 15% 150.00 Sodium Citrate 2% Anhydride 20.00 (ADM Corn Processing) Polysorbate 80 (ICI surfactants) 1% 10.00 100% 1000 EXAMPLE 3 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 72% 720.00 Dextrose (A.E. Staley) 10% 100.00 PVP (Pennreco) 5% 50.00 Mineral Oil (Pennreco) 10% 100.00 Sodium Citrate 2% Anhydride 20.00 (ADM Corn Processing) Polysorbate 80 (Surfactants I Cl) 1% 10.00 100% 1000 EXAMPLE 4 Component Percentages Grams Tapioca Dextrin (AE Staley) 69.5% 695.00 Dextrose (AE Staley) 10% 100.00 HPMC 3-15 (DOW) 7.5% 75.00 Mineral Oil (Pennreco) 10% 100.00 Sodium Citrate 2% Anhydride 20.00 (ADM Corn Processing) Polysorbate 80 (ICI surfactants) 1% 10.00 100% 1000 EXAMPLE 5 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 63.5% 635.00 Dextrose (A.E. Staley) 10% 100.00 PVP (Pennreco) 5% 50.00 Mineral Oil (Pennreco) 10% 100.00 Glycerin 8% 80.00 Sodium Citrate 2% Anhydride 20.00 (ADM Corn Processing) Wax of Caranuba (Ross) 1.5% 15.00 100% 1000 EXAMPLE 6 Component Porcentai es Gramos Tapioca Dextrin (AE Staley) 738% 380.00 Sodium CMC (Aqualon) 18% 180.00 Dextrose (AE Staley) 16% 160.00 Maltodextrin (AE Staley) 16% 160.00 Mineral Oil (Pennreco) 10% 100.00 Sodium Citrate Anhydride (ADM Corn Processing) 2% 20.00 100% 1000 EXAMPLE 7 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 95% 950.00 Mineral Oil (Pennreco) 5% 50.00 100% 1000 EXAMPLE 8 Component Percentages Grams Tapioca dextrin (A.E. Staley) 97% 970.00 Carnauba wax 3% 30.00 100% 1000 EXAMPLE 9 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 97% 970.00 Magnesium Stearate 3% 30.00 100% 1000 EXAMPLE 10 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 95% 950.00 Alcoleco 5% 50.00 100% 1000 EXAMPLE 11 Component Percentages Grams Tapioca Dextrin (A.E. Staley) 37.9% 379 Dextrose 10.1% 101 Alcoleco 10% 100 Na Citrate 2% 20 CMC of Na 40% 400 100% 1000 EXAMPLE 1 2 C orr iponen te P orcentai es G rams Dextrin of T¡ api oca (A., E. Sta law) 32.9% 329 Dextrose 10.1% 1 01 Alcoleco 10% 1 00 Na Citrate 2% 20 CMC from N to 45% 450 1 00% 1 000 EXAMPLE 13 The dry components of the following formulation were mixed for five minutes in a PK (Peterson Kelly) blender to form a mixture. Then, the liquid components of the formulation were added to the mixture of the dry components via the I-shaped bar of the mixer and mixed therein by mixing for an additional five minutes. 140 grams of the resulting film composition were dispersed in 1260 grams of distilled water and stirred until dispersed (approximately 20 minutes) to form a coating solution of the invention (10% solids), and all the solution was sprayed spraying using a 60.96 cm Accela Cota coater (Thomas Engineering) in 15 Kg. of herbal tablets (black walnut tablet from B &C utritional Products) to form the coating of the invention having a theoretical weight gain of 1.0. %. This produced a film coating on the tablets that had a lasting shine, good film adhesion and good film clarity. The coating process described above was repeated, except that a 15% solids coating solution was used, obtained by mixing 140 grams of the formulation of this example in 793.33 grams of distilled water to form an aqueous coating solution. Again, the resulting coating had a durable gloss, good film adhesion and good film clarity. Component Percentages Grapes Tapioca Dextrin (AE Staley) 70% 3500.00 Dextrose (AE Staley) 10% 500.00 Mineral Oil (Eastech Chemical Inc.) 1 0% 500.00 Polyethylene Glycol 8000 (Union Carbide) 8% 400.00 Sodium Citrate Anhydride (ADM) Corn Processing) 2% 100.00 100% 5000 EXAMPLE 14 In this example, the components of the formulation of! Example 13 was mixed, formed into a coating suspension and applied to tablets, as in Example 13, to obtain film coatings having durable gloss, good film adhesion and good film clarity, except that the tablets are vitamins (Pharmavite) instead of the herbaceous ones. EXAMPLE 15 In this example, the components of the Example formulation were mixed, formed in a coating suspension and applied to tablets, as in Example 13, to obtain the film coatings having durable gloss, good film adhesion and good film clarity, except that the tablets are oyster shells (Delavau) instead of the herbaceous ones. EXAMPLE 16 In this example, the components of the formulation of Example 13 were mixed, formed into a coating suspension and applied to tablets, as in Example 13, to obtain film coating having durable gloss, good film adhesion and good film clarity, except that the tablets are APAP instead of herbaceous. EXAMPLE 17 (WHITE PEARL) In this example, the components of the formulation of this example were mixed, formed into a suspension and applied to tablets as in Example 13, to obtain uniform, non-thickening film coatings having very high gloss. glossy, durable, good film adhesion and good film clarity, except that 450 grams of the coating composition of this example was dispersed in 1800 grams of distilled water and stirred until dispersed (approximately 30 minutes) to form the dispersion of the invention and all the dispersion was sprayed in 15 kg. of vitamins (Pharmavite), instead of 14 kg. of herbaceous tablets, to obtain a theoretical weight gain of 3.0% (20% solids). Component Percentages Grades Tapioca Dextrin (AE Staley) 39% 1950.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 10% 500.00 Polyethylene glycol 8000 (Union Carbide) 8% 400.00 HPMC / Pharmacoat E-15 (DOW / ShinEtsu) 5 % 250.00 Sodium citrate, anhydride (ADM Corn Processing) 3% 150.00 Mineral oil (Pennreco) 3% 150.00 Titanium dioxide (water) (Kronos) 32% 1600.00 100% 5000 EXAMPLE 18 (Orange) In this example, the components of The formulation of this example was mixed, formed into a coating suspension and applied to the tablets, as in Example 17, to obtain film coatings having durable gloss, good film adhesion and good film clarity, except that the coated tablets were provided with a clear coating made of the 37.5 gram dispersion of the formulation of Example 1 in 212.5 grams of distilled water and applying into said clear topcoat solution as in Example 1 on the tablet s coated from this example for a theoretical gain of 0.25% to 15% solids. This resulted in a transparent top cover over the color coating of the invention having a fairly good gloss. Component Percentages Grades Tapioca Dextrin (AE Staley) 43.55% 2177.50 Polyethylene Glycol 8000 (Union Carbide) 8% 400.00 H PMC / Pharmacoat E-50 (DOW / Shin Etsu) 10% 500.00 H PMC / Pharmacoat E-15 (DOW / ShinEtsu) 5.31% 265.50 Mineral Oil (Pennreco) 3% FD &C Yellow NO. 6, 150.00 HT 15-18% 0.62% 31 .00 Titanium dioxide (water) (Kronos) 29.52% 1576.00 100% 5000 EXAMPLE 19 (Red) The components of the formulation of this example were mixed, formed into a coating suspension and applied to tablets, as in Example 17 to obtain film coatings containing durable gloss, good film adhesion and good film clarity, except that 450 grams of the coating composition of this example were dispersed in 2550 grams of distilled water to form the coating dispersion of the invention. As in Example 18, a clear coat was applied to the coated tablets of this example following the procedures set forth in Example 18, resulting in a clear top coat on the color coating of the invention on the tablets having a very high gloss. good. Component Grams Percentages Tapioca Dextrin (A. E. Staley) 50% 2500.00 Polyethylene glycol 8000 (Union Carbide) 10% 500.00 H PMC / Pharmacoat E-50 (DOW / ShinEtsu) 8% 400.00 Stearic acid (Witco) 4% 200.00 Alcoleco F-100 (American Lecithin) 3% 150.00 Sodium Alginate (Kelco) 5% 250.00 Titanium dioxide (water) (Kronos) 5.05% 252.50 FD &C Red No. 40, HT, 38-42% 13.53% 676.50 FD &C Blue NO. 2, HT, 3-5% 1.42% 71.00 100% 5000 EXAMPLE 20 (Brown) In this example, the components of the formulation of this example were mixed, formed into a suspension and applied to tablets as in Example 13, to obtain film coatings having durable gloss, good film adhesion and good film clarity. Component Percentages Grams Tapioca Dextrin 29% 1450.00 Dextrose 10% 500.00 PEG 800 10% 500.00 Stearic Acid 4% 200.00 HPMC E-50 8% 400.00 Alcoleco F-100 3% 150.00 Sodium Alginate XL 5% 250.00 FD &C Red NO. 40, HT, 38-42% 24.56% 1228.00 Titanium dioxide 4.43% 221 .50 FD &C Blue No. 2, HT, 1 1 - 15% 2.01% 100.50 100% 5000"Sliding" Phenomenon The film coating of the invention causes a unique phenomenon, the reduction of the coefficient of friction of the tablet, which we refer to as the "slip factor" or "slip". The film coating reduces the coefficient of friction of the tablets, thus reducing the friction between the tablets, lasting and then applying the coating on the tablets, so that the tablets slide or slip or run past one of the tablets. another as they roll into the liner tray during the film coating application and as it is poured during the packaging procedures after being coated. In other words, the film coating of the invention imparts a sliding quality on the tablet and allows the tablets to flow more easily one on the other. We have discovered that the coating of the film of the invention causes a reduction in the coefficient of tablet friction. With a reduced friction coefficient of tablets, the tablets flow better in the bed of a coating tray creating space for more tablets to be placed in the coating tray to be coated with the coating of the invention. To maintain the optimum bed geometry and bed flow desired to coat the tablets in the liner tray, a larger tablet load (10-20% increase in tray loading) is used when coated with the liner of the invention. Consequently, an increase in productivity is achieved since more tablets are coated at the same time. In addition, tablets provided with "slip" (i.e., tablets having a reduced coefficient of friction of tablets) slide / slide past one another, which is particularly advantageous when coating bulky tablets and tablets having edges. friables that have a tendency to shed as the trays roll into the liner tray The "slide" tablets also increase productivity by decreasing the time needed to process the coated tablets from the liner tray to the package of the coated tablets given that the tablets with the film coating of the invention flow better than the tablets coated with other film coatings The following Tests 1, 2 and 3 were carried out to compare the "slip" obtained from the film coating of the invention with the "slip" (if any) obtained from other film coatings The film coatings (3% weight gain) having the following formulations and coatings were used in each test: Formulation A (One OPADRY Coating Composition) Component Weight portion H PMC 6-CPS-Metocel E-6 31 .720 H PMC 3 CPS-Metocel E-3 31 .720 Titanium dioxide (water) 26,410 Peg 400 NF 8,000 FD &C Yellow NO. 6 HT 15% -18% 1 .150 Polysorbate 80 N F 1 .000 100.000 Formulation B (One OPADRY Coating Composition ll) Component Weight portion H PMC 3 CPS-Metocel E-3 30,330 Titanium dioxide (water) 29,450 Maltodextrin (Star-Dri 5) 18.00 H PMC 6 CPS-Metocel E-6 9.340 Triacetin US / EP / J PE-Eastman 7,500 Peg 8000 NF 2,500 H PMC-Metocel E50-LV Premium 2,330 FD &C Yellow NO. 6 HT 15% -18% .550 100,000 Formulation C (A Coating Composition OPADRY ll) Component Weight portion Titanium dioxide (water) 31,200 Polydextrose powder 23,600 HPMC 3 CPS-Metocel E-3 15,200 HPMC 6-CPS-Metocel E-6 15,200 Triacetin USP / EP / JPE-Eastman 6,000 HPMC-Metocel E50-LV Premium 5,000 Peg 8000 NF 2,000 FD &C Yellow No. 6 HT 15% -18% 1,800 100,000 Formulation D (A Coating Composition OPADRY ll) Component Weight portion Lactose monohydrate # 315, NF; FF 40,000 HPMC 15 CP-Pharmacoat 615 28,000 Titanium dioxide (water) 22,500 Triacetine USP / EP / JPE-Eastman 8,000 FD &C Yellow No. 6 HT 15% -18% 1,500 100,000 Formulation E (One Coating Composition OPADRY XD) Component Weight portion Titanium dioxide (water) 30,860 Dextrose 28,084 Maltodextrin (Star-Dri 1) 21 .216 Sodium alginate Kelgin-XL 5.440 H PMC 15 CPS-Metocel E-15 5.100 Triacetin USP / EP / J PE / Eastman 4.760 FD &C Yellow NO. 6 HT 15% -18% 1 .140 Alcoleco F-100 .680 100,000 Formulation F (One Coating Composition OPADRY NS) Component Weight portion Titanium dioxide (water) 36,516 Tapioca Dextrin 955 SR 30.670 H PMC-Metocel E50-LV Premium 10,000 Peg 8000 N F 7.000 PB-15Y-Y6-17 4,768 H PMC 16 CPS-Metocel E-15 4,046 Alcoleco F-100 4,000 Peg 400 N F 3,000 100,000 Formulation F is an illustrative formulation for the film coating of the invention. Test 1 - Measurement of Flow Regime A first set of vitamins was coated with a film coating using Formulation A, a second group of vitamins was coated with a film coating using Formulation B, a third group of vitamins was coated with a film coating using Formulation C, a fourth group of vitamins was coated with a film coating using formulation D, a fifth group of vitamins was coated with a film coating using Formulation E and a sixth group of vitamins was coated with a film coating using Formulation F. The flow rate for each group of vitamins was then measured using the following procedure to determine which coated film provided the higher flow rate. For each group of vitamins, the chamber of a Flodex Tester flow meter (manufactured by Hanson Research) was filled with the coated vitamins, but without packing the tablets in the chamber. Then the Flodex Tester flow measurement release door lever was pulled to release the tablets from the chamber through a 46 mm hole and the time was measured from a start of the tablet flow at the end of the flow of the tablet. This procedure was followed 5 times for each group of vitamins and the average length of flow time and normal deviation were determined. A constant weight (in this test 173 grams of vitamin tablets) of the vitamins was used during the test. The vitamin tablets coated with the film coatings made using Formulations A, B, and D did not flow from the Flowdex Tester chamber, unassisted, but instead, it was necessary to restrict the flow by throwing it on the side of the chamber. Flodex Tester. The results of this test are shown in Table 1 (a) and Graph 1 (a) Table 1 (a) Formulation Time (seconds) Normal deviation A 1,674 1.0735 B * 2.082 0.6543 C 1.302 0.1572 D 1.824 1.0211 E 1.36 0.1325 F 1.04 0.1736 Graph 1 (a) FORMULATION A seventh group of vitamins (gain of 3%) was coated with a film coating using an illustrative formulation (Formulation G) for the film coating of the invention. After, a first subgroup of these vitamins coated with Formulation G was coated, with a bright cover (weight gain of 0.25%) using Formulation H and the second subgroup of vitamin tablets coated with Formulation G, coated with a transparent gloss coating. The flow regime for the coated vitamins provided with a clear gloss coating based on Formulation H and the flow rate for the coated vitamins provided with a glossy coating based on Formulation I, were measured using the Test 1 procedure exhibited. before to determine which vitamins have the higher flow rate. The results are shown in Table 1 (b) and Graph 1 (b). Formulation G (One Coating Composition of OPADRY NS) Component Portion by weight Dextrin from Tapioca 31,500 Dextrose 7,500 HPMC E-50 12,000 HPMC E-16 10,000 Alcoleco F-100 4,000 PEG 800 7,000 PEG 400 3,000 T0O2 3,720 FD & C Red No. 40 HT 38-42% 19,190 FD &C Blue No. 4 HT 11-14% 2.090 100.00 Formulation H (One Clear Coating Composition of OPADRY) Component Weight portion H PMC 6 CPS-Pharmacoat 606 90,900 PEG 400 N F 4,550 PEG 8000 N F 4,550 1 00,000 Formulation I (One Coating Composition of OPADRY NS) Component Portion by weight Tapioca Dextrin 72,900 Dextrose 10,100 Alcoleco F-100 10,000 Sodium CMC 5,000 Sodium Citrate, FCC, USP 2,000,000 Table 1 (b) Formulation Time (sec.) H 1 .36 I 1 .26 Measurement of Flow Regime As shown by the results of the above tests, the vitamin tablets coated with the film coating of the invention (Formulation F and Formulation I) flowed better than the vitamin tablets coated with other film coatings, illustrating the slip factor provided by the film coating of the invention. Test 2 - Response Angle A first group of vitamins coated with a film coating using Formulation A, a second group of vitamins coated with a film coating using Formulation B, a third group of vitamins coated with a film coating using Formulation C, a fourth group of vitamins was coated with a film coating using Formulation D, a fifth group of vitamins was coated with a film coating using Formulation E and a sixth group of vitamins was coated with the coating of film using Formulation F. The response angle of each group of coated vitamins was then measured using the following procedure. For each group of vitamins, 1.0 kg was placed. of vitamins in a funnel having a hole with a diameter of 2.75 cm, which was initially capped. The funnel was supported on a support ring mounted on a pallet so that the bottom of the funnel was 1 1 .43 cm above the back cover. With the vitamins in place in the funnel, the retainer was removed from the hole to allow the tablets to flow from the funnel through the hole to form a stack of tablets on the backsheet. The angle of the pile (the angle of repose) was measured. This procedure was followed three times for each group of vitamins and the angle of repose was determined for each group of vitamins. The group of tablets coated with the film coating of the invention (Formulation F) was the only group of tablets that flowed uninhibited through the funnel. The results of this group are shown in Table 2 and Graph 2. Table 2 Formulation Angle of Rest (degrees) A 44.33 B 41 .33 C 41 .67 D 40.67 E 29 F 20 Graph 2 As shown in the above test results, the vitamin tablets coated with the film coating of the invention (Formulation F) created the smallest resting angle by illustrating the slip factor provided by the film coating of the invention. Test 3 - Measurement of Differential in Grades A first group of vitamins was coated with a film coating using Formulation A, a second group of vitamins was coated with a film coating using Formulation B, a third group of vitamins was coated with a film coating using Formulation C, a fourth group of vitamins was coated with a film coating using Formulation D, a fifth group of vitamins was coated with a film coating using formulation E and a sixth group of vitamins was coated with a film coating using formulation F. A seventh group of vitamins was coated (weight gain of 3%) with a film coating using an illustrative formulation (Formulation G) for the film coating of the invention. Then, a first subgroup of these vitamins coated with Formulation G was coated with a gloss coating (gain in weight of 0.25%) using Formulation H and a second subset of these vitamins coated with Formulation G was coated with a gloss coating (gain 0.25% by weight) using Formulation I, which is an illustrative formulation of the film coating of the invention. The differential degree of each group (groups 1-6 and subgroups 1 and 2 of group 7) of the coated vitamins was measured using the following procedure to establish the numerical data on the slip. The differential degree is the degree of fall between the top of a tablet bed of uncoated tablets and the top of a tablet bed of coated tablets. 3.5 kg. of the uncoated vitamins were placed in an O'Hara Labcoat I coating pan (a 38.1 cm tray) and the uncoated tablets were rolled in a coating pan at two revolutions at a pan speed of three revolutions per minute. As shown in Figure 1, a first line was treated on the back wall of the coating tray after the plane of the edge and in parallel with the upper part of the tablet bed of the uncoated tablets. The uncoated tablets were then removed from the coating pan. Then, for each group (groups 1-6 and subgroups 1 and 2 of group 7) of the coated vitamin tablets, 3.5 of the coated vitamins were placed in the coating tray and the coated tablets were rolled on the coating tray to two revolutions at a pan speed of three revolutions per minute. A second line was treated on the back wall of the coating tray after the plane of the edge and parallel to the upper part of the tablet bed of the coated tablets if the bed geometry was not equal to the geometry of the bed of the tablets. uncoated tablets marked by the first line. To determine the differential degree (the degree of fall in the level of the high end of the bed of tablets) between uncoated tablets and coated tablets, we measured the angle formed between 1) a horizontal line along the posterior wall of the tray of coating that is intercepted with the extreme end portion of the bed of uncoated tablets and 2) a line from the end portion from the high end of the bed of coated tablets to the point on the rear wall of the coating tray where the line horizontal above is intercepted with a vertical line along the rear wall of the lining tray that divides the lining tray in two. The test procedure shown above was followed for each test (groups 1-6 and subgroups 1 and 2 of group 7) of vitamins and the results of this test are shown in Table 3, and are illustrated in Figures 1-7. Referring to the data in Table 3 and Figures 1-7, the film coatings based on Formulations A, B, C and D did not reduce the coefficient of friction of the tablets, and consequently, the bed geometry for the tablets. coated tablets based on Formulations A, B, C and D is equal to the bed geometry of the uncoated tablets, as shown in Figures 1-5. The film coatings based on Formulations E and H only slightly reduced the coefficient of friction of the tablets and, consequently, there is only a slight drop in the bed geometry of the tablets (Differential Grade of only 7 degrees) for coated tablets. based on the Formulations E (see Figure 6) and H compared to the tablet bed geometry for the uncoated tablets. The film coatings based on Formulations F and I, made in accordance with the invention, significantly reduced the coefficient of friction of the tablets and, consequently, there is a significant drop in the geometry of the bed of the tablets (Differential Grade of 19 degrees for Formulation F (see Fig. 7) and 20 degrees for Formulation I) of the coated tablets based on Formulations F and I compared to the geometry of the tablet bed for uncoated tablets. Table 3 Formulation Differential Grade (degrees) A 0 B 0 C 0 D 0 E 7 F 19 H 7 I 20 As shown in the results of the above tests, the tablets coated with the film coating of the invention (Formulations F and I) gave the highest degree differential, illustrating the degree of slip provided thereby.

ADVANTAGES The invention provides a film coating having durable gloss, good film adhesion and good film clarity. O ur nvención also provides a film coating that may be used as a glossy coating for vitamin tablets, herbal tablets, and pharmaceutical tablets having lasting gloss, adhere well to difficult substrates such as calcium-oyster shell, and that no They are frosty and transparent. The coatings produced according to the invention mask the odor of the substrates coated therewith, which is particularly advantageous when treated with vitamins and herbaceous tablets which do not have a pleasant odor. The coating of the invention provides an elegant, glossy finish over pharmaceutical tablets without the need to apply a transparent outer coating over the colored coated tablets. However, the application of a transparent outer cover on the colored tablets coated with the coating of the invention also improves the finish on the tablets. The coating of the invention promotes a very fine logo definition on pharmaceutical tablets. The solution / suspension / aqueous coating dispersion of the invention has a viscosity that is notoriously lower than the viscosities of coating suspensions based on hydroxypropyl methylcellulose and maltodextrin. For example, the viscosity of the formulation of Example 1 at a level of 30% solids is 18.5 cP, at 40% solids it is 87.5 cP and at 50% solids it is 381 cP. Consequently, the gain in weight of the tablet because the coating can be reduced to 0.5% to 0.75%, which is substantially lower than the gain in weight of the tablet associated with the coating systems of the prior art, and still obtains a coated tablet that has excellent gloss. Also, due to the lower viscosity of the coating solutions / suspensions / dispersions of the invention, there is a lower likelihood that the spray equipment will be covered during the coating process, and the ability to use the higher solids content in the coating process. the coating suspension of the invention than could be anticipated with the use of the prior art systems. The film coating of the invention also causes a reduction in the coefficient of friction of the tablets and as a result of this, the tablets flow better in the bed of a coating tray. Due to this better flow of the tablets, the tray can be increased by 10-20% while maintaining the optimal bed geometry and the desired bed flow to coat the tablets. Consequently, an increase in productivity is achieved since more tablets can be coated at the same time.

Furthermore, reducing the coefficient of friction of tablets obtained by the film coating of the invention, tablets flow better in the bed of a coating pan which results in a reduction in spalling of the banks / wear shores during the coating process. Tablets provided with "slip" of the invention also increase productivity by decreasing the time required for the process of coating tablets from the coating pan to packaging of the coated tablets since the tablets with the coating film of the invention flow better than tablets coated with other film coatings.

Claims (10)

1. CLAIMS 1. A dry film coating composition for forming a coating suspension for nutritional supplements of peiicule coating, pharmaceutical tablets and the like, comprising a dry mixture of a dextrin; the dextrin being from 5% to 97% by weight of the composition, and an antiespesant, the antiespesant being from 1% to 15% by weight of the composition.
2. 2. The composition of claim 1, the dextrins being tapioca dextrin.
3. 3. The composition of claim 1, the antisipping agent being mineral oil, carnauba wax, acetylated monoglyceride, lecithin, magnesium stearate or a combination thereof.
4. 4. The composition of claim 1, the dextrin being from 35% to 75% by weight of the composition.
5. 5. The composition of claim 1, dextrin being from 65% to 75% by weight of the composition.
6. 6. The composition of claim 1, the anti-thickener being from 7.5% to 10% by weight of the composition. The composition of claim 1, further including an auxiliary film former. The composition of claim 7, the auxiliary film former being dextrose, polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (H PC), sodium carboxymethylcellulose (sodium CMC), maltodextrin, sodium alginate, alginate of PG, polyvinyl alcohol (PVA) and their combinations. 9. The composition of claim 7, the former. of auxiliary film being on a scale greater than 0% to about 55% by weight of the composition. 10. The composition of claim 7, the auxiliary film former being on a scale greater than 3.5% to about 10% by weight of the composition. eleven . The composition of claim 9, the auxiliary film former being sodium carboxymethylcellulose (Sodium CMC) on a scale of about 40-45% by weight of the composition. 12. The composition of claim 1, further including a plasticizer. The composition of claim 12, the plasticizer being polyethylene glycol, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, tiethyl citrate, tributyl citrate or acetyltributyl citrate. 14. The composition of claim 12, the plasticizer being on a scale of 7.5% to 10% by weight of the composition. 16. The composition of claim 12, the plasticizer being on a scale of 3.5% to 7.5% by weight of the composition. 17. The composition of claim 1, further including a surfactant. 18. The composition of claim 17, the surfactant being polysorbate 80. 19. The composition of claim 17, the surfactant being in the scale greater than 0% to about 2% by weight of the composition. The composition of claim 17, the surfactant being on the scale greater than 0.5% to about 1% by weight of the composition. twenty-one . The composition of claim 1, further including a flow aid. 22. The composition of claim 21, the flow aid being stearic acid. 23. The composition of claim 21, the flow aid being on the scale greater than 0 to about 10% by weight of the composition. 24. The composition of claim 21 the flow aid being on the scale greater than 2% to about 5% by weight of the composition. 25. The composition of claim 1, further including a preservative. 26. The composition of claim 25, the preservative being sodium citrate. 27. The composition of claim 25, the preservative being on a scale greater than 0% to about 5% by weight of the composition. 28. The composition of claim 25, the preservative being on a scale greater than 1% to about 2% by weight of the composition. 29. The composition of claim 1, further comprising an auxiliary film former and titanium dioxide. 30. The composition of claim 29, the dextrin being on a scale of about 30% to about 50% by weight of the dry film coating composition, the thickener being on the scale of about 1% to about 15% by weight of the coating composition of dry film, the auxiliary film former being on a scale from about 5% to about 50% by weight of the dry film coating composition, the titanium dioxide being on a scale from about 20% to about 50% by weight weight of the dry film coating composition. 31 The composition of claim 29, dextrin being on a scale of about 35% to about 40% by weight of the dry film coating composition, the thickener being on the scale of about 2% to about 5% by weight of the dry film coating composition, the auxiliary film former being on a scale from about 5% to about 20% by weight of the dry film coating composition, the titanium dioxide being on a scale of about 25% to about 40% by weight of the dry film coating composition. 32. The composition of claim 29, further including a plasticizer. 33. The composition of claim 29, which further includes a surfactant people. 34. The composition of claim 29, further including a flow aid. 35. The composition of claim 29, which further includes a preservative. 36. The composition of claim 30, further compng a plasticizer, a surfactant, a flow aid and a preservative, the plasticizer being on the scale from about 1% to about 15% by weight of the composition, the agent surfactant being on the scale from about 1% to about 2% by weight of the composition, the flow assistant being on a scale greater than 0% to about 10% by weight of the composition, and the conservative being on a scale from about 1% to about 4% by weight of the composition. 37. The composition of claim 31, further compng a plasticizer, a surfactant, a flow aid and a preservative, plasticizer being on the scale from about 7.5% to about 10% by weight of the composition, the surfactant being on the scale from about 0.5% to about 1% by weight of the composition, the flow assistant being on a scale greater than 2% to about 5% by weight of the composition, and the conservative being on a scale of about 2% to about 3% by weight of the composition. 38. The composition of claim 1, further compng an auxiliary film former and a colorant. 39. The composition of claim 40, dextrin being on a scale from about 35% to about 75% by weight of the dry coating film composition, the thickener being on the scale of about 1% to about 10% by weight of the dry film coating composition, the auxiliary film former being on a scale from about 5% to about 50% by weight of the dry film coating composition, the dye being on a scale of about 0.1% to about 40% by weight of the dry film coating composition. 40. The composition of claim 38, dextrin being on a scale from about 4% to about 55% by weight of the dry film coating composition, the thickener being on the scale of about 2% to about 5%. by weight of the dry film coating composition, the auxiliary film former being on a scale from about 5% to about 20% by weight of the dry film coating composition, the dye being on a scale of about 15% to about 25% by weight of the dry film coating composition. 41. The composition of claim 38, which also includes a plasticizer. 42. The composition of claim 38, which further includes a surfactant. 43. The composition of claim 38, further including a flow aid. 44. The composition of claim 38, which further includes a preservative. 45. The composition of claim 39, further comprising: a plasticizer, a surfactant, a flow aid and a preservative. plasticizer being on a scale greater than 0% to about 15% by weight of the composition, the surfactant being on a scale greater than 0% to about 2% by weight of the composition, the flow assistant being on a scale greater than 0% to about 2% by weight of the composition, and the preservative being on a scale greater than 0% to about 5% by weight of the composition. 46. The composition of claim 40, further comprising a plasticizer, a surfactant, a flow aid and a plasticizer preservative being on the scale from about 7.5% to about 10% by weight of the composition, the surfactant being on the scale from about 0.5% to about 1% by weight of the composition, the flow assistant being on a scale greater than 2% to about 5% by weight of the composition, and the conservative being on a scale of about 2% to about 3% by weight of the composition. 47. A method for coating substrates such as nutritional supplements, pharmaceutical tablets and the like, with a film coating comprising the steps of mixing a dextrin and an antiesping agent in water to form an aqueous coating suspension, the dextrin being from 5% to 97% by weight of the waterless components of the suspension and the anti-thickener being from 1% to 15% by weight of the water-free components of the suspension, by applying an effective amount of said coating suspension on said substrates to form a film coating on said substrates and drying the film coating on said substrates. 48. The method of claim 47, which includes dispersing an auxiliary film former in the aqueous coating suspension. 49. The method of claim 47, which includes dispersing a plasticizer in the aqueous coating suspension. 50. The method of claim 47, including dispersing a surfactant in the aqueous coating suspension. 51 The method of claim 47, including dispersing a flow aid in the aqueous coating suspension. 52. The method of claim 47, including dispersing a preservative in the aqueous coating suspension. 53. The method of claim 47, including dispersing a film former and titanium dioxide in the aqueous coating suspension. 54. The method of claim 53, the dextrin being on the scale of about 30% to about 50% by weight of the dry film composition, the antiespesant being on the scale of about 1% to about 15% by weight of the dry film coating composition, the auxiliary film former being on a scale from about 5% to about 50% by weight of the dry film coating composition, the titanium dioxide being on a scale of about 20% at about 50% by weight of the dry film coating composition. 55. The method of claim 47, further including an auxiliary film former and a colorant. 56. The method of claim 55, the dextrin being on the scale of from about 75% to about 75% by weight of the dry film composition, the anti-thickener being on the scale of about 1% to about 10% by weight of the dry film coating composition, the auxiliary film former being on a scale from about 5% to about 50% by weight of the dry film coating composition, the dye being on a scale of about 0.1% at about of 40% by weight of the dry film coating composition. RESU MEN A dry film coating composition for forming a coating suspension to coat films with nutritional supplements, pharmaceutical tablets and the like, comprising a dextrin and an antiscatter.