MXPA00000570A - Bright white film coatings and film coating compositions therefor - Google Patents

Bright white film coatings and film coating compositions therefor

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Publication number
MXPA00000570A
MXPA00000570A MXPA/A/2000/000570A MXPA00000570A MXPA00000570A MX PA00000570 A MXPA00000570 A MX PA00000570A MX PA00000570 A MXPA00000570 A MX PA00000570A MX PA00000570 A MXPA00000570 A MX PA00000570A
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Mexico
Prior art keywords
composition
weight
range
dispersion
plasticizer
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Application number
MXPA/A/2000/000570A
Other languages
Spanish (es)
Inventor
Susan M Grillo
Brian Korchok
Bruce Kinsey
Melanie Hartman
Stuart C Porter
Rita Steffenino
George Reyes
Thomas J Burke
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Bpsi Holdings Inc
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Publication of MXPA00000570A publication Critical patent/MXPA00000570A/en

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Abstract

A dry film coating composition used to make a bright white film coating for nutritional supplements, pharmaceutical tablets, and the like, comprises dextrose, an auxiliary film-former, and titanium dioxide. Optionally, but advantageously, the coating composition also may include one or more of the following components:a plasticizer, a surfactant, a flow aid, and a preservative.

Description

BRILLIANT RECORDS AND COM POS FILMS FOR THEMSELVES BACKGROUND OF THE INVENTION 1. FIELD OF THE INVENTION This invention relates to the field of aqueous film coating of nutritional supplements and pharmaceutical tablets, and specifically concerned with providing bright white film coatings based on dextrose to coat nutritional supplements, such as vitamin tablets and calcium tablets. oyster shell, and pharmaceutical tablets, such as, acetaminophen (APAP), aspirin (ASA) and ibuprofen. 2. Description of the Prior Art Hydroxypropyl methylcellulose (H PMC) has been used in coatings for substrates such as pharmaceutical tablets. For example, such coatings, including white coatings (coatings containing titanium dioxide as the colorant), made from coating compositions manufactured by Colorcon and described in US Pat. 4,543, 370 and 4,683,256, such patents being incorporated herein by reference, have proven especially effective when used in pharmaceutical tablets. However, in the nutritional and pharmaceutical supplement industries, it is desired to provide some pharmaceuticals, such as, APAP and I buprofen, and some nutritional supplements with a white coating, which is brighter than the white coatings obtained using coating compositions based on HPMC.
BRIEF DESCRIPTION OF THE INVENTION "- An object of the invention is to provide a white film coating for vitamin tablets, calcium tablets / oyster shell, and pharmaceutical tablets which is brighter than the white film coatings obtained using compositions of coating based on H PMC. These and other objectives are achieved by our invention, which is described below.
DETAILED DISCLOSURE OF THE INVENTION In accordance with the invention, our dry film coatings compositions for use in the formation of coating dispersions for film coating nutptional supplements, pharmaceutical tablets and the like, comprise dextrose, an auxiliary film former. and titanium dioxide. Advantageously, the inventive dry film coating compositions may include one or more of the following components: a plasticizer, a surfactant, a flow aid and a preservative. According to the invention, a method for coating substrates such as nutritional supplements, pharmaceutical and similar tablets, comprises mixing dextrose, an auxiliary film former and titanium dioxide in water to form an aqueous aqueous coating dispersion, applying the dispersion fde inventive coating on said substrates to form a white film coating on said substrates, and drying the white film coating on said substrates. Optionally, but advantageously, the following components can be mixed in water with the dextrose, the auxiliary film former and the titanium dioxide, to form the inventive coating dispersion: a plasticizer, a surfactant, a flow aid and a conservative. The invention also includes coated substrates, such as coated vitamins, calcium tablets / oyster shell, and coated pharmaceutical tablets, the aqueous coating dispersion formed from the dry film coating composition or from the components of said composition, the method for making the dry film coating compositions and the method for making the dispersions of the invention. The primary film former of the inventive dry film coating composition and the inventive aqueous coating dispersion is dextrose. The preferred range for dextrose is about 20% to about 50% by weight of the inventive dry film coating composition and the non-aqueous ingredients of the inventive aqueous coating dispersion. More preferably, the range for dextrose is about 25% to about 35% by weight of the inventive dry film coating composition and the non-aqueous ingredients of the inventive aqueous coating dispersion. The auxiliary film former may be polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methyl cellulose, hydroxypropyl cellulose (HPC), carboxymethyl sodium cellulose (sodium CMC), maltodextrin, polydextrose, modified food starch, modified food starch with corn syrup, starch (eg starch STARCH 1 500), tapioca dextrin, lactose, sodium alginate, PG alginate, gum arabic, polyvinyl alcohol (PVA), any of the film coating polymers declared in the U.S. Patent of Colorcon No. 4, 543, 370, which is incorporated herein by reference, and com binations thereof. The auxiliary film former (s) act as force intensifiers for the film coating. Its presence in the coatings helps prevent cracking of the film coating, as well as helping to prevent chipping / edge wear of the coated tablet. A preferred auxiliary film former is sodium CMC. The preferred and most preferred ranges for the auxiliary film-forming agent (s) of the inventive dry film-forming composition and by weight of the non-aqueous ingredients of the inventive aqueous coating dispersion are 1% to 50% (preferred) and 10% to 20% (most preferred). The preferred ranges and the most preferred ranges for the various exemplary auxiliary film formers are discussed below. The preferred range and the most preferred range for the tianium dioxide (TiO2) are 25% to 50% (preferred and 30% to 40% (most preferred) by weight of the inventive coating composition and by weight of the non-aqueous ingredients Examples of the plasticizer are mineral oil, polyethylene glycol having a molecular weight in the range of 200 to 8000, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, triethyl citrate (Citroflex A2), tributyl citrate. (Citroflex 4) and acetyl tributyl citrate (Citroflex A4), and preferred ranges for the plasticizer are discussed below, along with the preferred and most preferred ranges of several exemplary plasticizers Examples of the surfactant is Polysorbate 80, and the preferred ranges for the surfactant are set forth below, together with the preferred and most preferred ranges for an exemplary surfactant.Example of the flow auxiliary is the acid rich, and preferred and most preferred for the auxiliary flow ranges set forth below, together with preferred and more preferred ranges for stearic acid ranges. Example of the preservative is sodium citrate, and the preferred ranges for the preservative are discussed below, along with the preferred and most preferred ranges for sodium citrate.
FILM TRAINERS OR THE AUXI LIAR Preferred 1 -50% More preferred 1 0-20% Preferred PV 0-10% More preferred 3-6% Preferred RRP 0-1 0% More preferred 3-6% H PMC / Methylcellulose / H PC Preferred 0-50% More preferred 5-50% Even more preferred 1-20% Preferred Polydextrose 0-50% More preferred 5-50% Even more preferred 1-20% Lactose Preferred 0-20% More preferred 5-10% Na CMC Preferred 0-15% More preferred 1-15% Even more preferred 5-8% Modified food starch / modified food starch with corn syrup solids / Starch 1500 Preferred 0-15% More preferred 1-15% Even more preferred 5-8% Maltodextrin Preferred 0-50% More preferred 5-50% Even more preferred 10-20% Tapioca dextrin Preferred 0-50% More preferred 5-50% Even more preferred 10-20% Preferred PG alginate 0-5% More preferred 3-5% Preferred sodium alginate 0-5% More preferred 3-5% Preferred gum arabic 0-5% More preferred 3-5% SURFACTANT Preferred 0-5% Polysorbate 80 Preferred 0-5% More preferred 0.5-1% FLOW AUXILIARY Preferred 0-15% More preferred 5-10% Preferred stearic acid 0-15% More preferred 5-10% PLASTICIZER Preferred 0-20% Preferred mineral oil 0- 1 5% Most preferred 3-5% Polyethylene glycol 8000 Preferred 0-20% More preferred 5-1 0% Glycerin Preferred 0- 1 5% More preferred 5-1 0% CONSERVATIVE Preferred 0-5% More preferred 2-3% Sodium Citrate Preferred 0-5% Most preferred 2-3% The ranges set forth above are all by weight of the dry film coating composition of the invention and of the non-aqueous ingredients of the aqueous coating dispersion 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 together for five minutes in a PK Mixer (Paterson Kelly) to form a mixture. Then, the liquid components were added to the mixture of dry components via bar I of the mixer and combined therein upon mixing for an additional five minutes to form a dry film coating composition of the invention. Optionally, the composition can also be milled, such as, in a hammer mill (Apex Machinery, Dartford, England), for example. Optionally, the dry film coating composition can be granulated using a planetary mixer, such as a Hobart planetary mixer. To achieve this, the dry film coating composition is loaded into the mixer and the mixer is turned on, adding sufficient water slowly until the composition forms slightly adherent granules. These granules are then passed through a 1 -2 mm mesh and then dried in a 30 ° C oven until the moisture content is below 5%. The composition is then sieved again through a 1 -2 mm mesh and then it is ready for use in a gregular, non-dusty form.
Other granulation methods can also be used, such as spray granulation and roller compaction. 450 grams of the resulting film coating composition was dispersed in 1800 grams of distilled water (approximately 30 minutes) to form an inventive coating dispersion (20% solids), and all dispersion was atomized using a coater Accela Height of 60.96 cm (Thomas Engineering) on 1 5000 grams of vitamin tablets (Pharmavite) to form a nventive coating on them, having a theoretical weight gain of 3.0%. This produced a bright white film coating on the tablets.
Component Grams Percentages Dextrose (Staley) 32.0% 1600.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 1 0% 500.00 Polyethylene glycol 8000 (U nion Carbide) 8% 400.00 HPMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Titanium dioxide (water) (Kronos) 32% 1 600.00 Pol isorbate 80 (ICI Surfactants) 1% 50.00 1 00% 5000.00 EXAMPLE 2 Example 1 was repeated, except that the dispersion was atomized onto 15,000 grams of APAP tablets. This produced a bright white film coating on the APAP tablets.
EXAMPLE 3 Example 1 was repeated, except that the film coating composition had the following formulation: Component Grams Percentages Dextrose (Staley) 26.0% 1300.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 10% 500.00 Polyethylene glycol 400 (Union Carbide) 8% 400.00 HPMC / Pharmacoat E-15 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Stearic acid (Humeo) 6 & 300.00 Sodium citrate, anhydrous 3% 150.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 150.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polisorbate 80 (ICI Surfactants) 1% 50.00 100% 5000.00 This produced a bright white film coating on the tablets.
EXAMPLE 4 Example 2 was repeated, except that the film coating composition had the formulation of Example 3. This produced a bright white film coating on the APAP tablets.
EXAMPLE 5 The dry components of the following formulation were mixed together for five minutes in a food processor to form a mixture. Then, the liquid components of the formulation were agglomerated to the mixture of the dry components and combined there to mix for an additional five minutes to form a film coating composition of the invention. Optionally, the coating composition can be granulated or ground. 9.0 grams of the resulting film coating composition were dispersed in 36.0 grams of distilled water and stirred until dispersed to form an inventive coating dispersion (20% solids), and all dispersion was atomized using an Aeromatic Strea 1 coating (N iro) on 300 grams of concave white placebos of 0.952 cm, to form an inventive coating on them, having a theoretical weight gain of 3.0%. This produces a bright white film coating on the tablets.
Component Grams Percentages Dextrose (Staley) 26.0% 1 300.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 1 0% 500.00 Polyethylene glycol 400 (Union Carbide) 8% 400.00 H PMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Stearic acid (Humid) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polysorbate 80 (ICI Surfactants) 1% 50.00 1 00% 5000.00 Examples 6-1 9 further illustrate the invention, all percentages being by weight. In Examples 6-1 9, the components of each formulation are mixed together, formed into a coating dispersion and applied to concave white placebos of 0.952 cm, as in Example 5, to obtain glossy white film coatings.
EXAMPLE 6 Component Percentages Grams Dextrose (Staley) 35.0% 1 750.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 1 0% 500.00 Glycerin 5% 250.00 HPMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polysorbate 80 (ICI Surfactants) 1% 50.00 1 00% 5000.00 EJ EM PLO 7 Component Percentages Grams Dextrose (Staley) 35.0% 1750.00 Methylcellulose 1 5% 750.00 Glycerin (DOW) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Titanium dioxide (water) (Kronos) 32% 1 600.00 Polysorbate 80 (ICI Surfactants) 1% 50.00 1 00% 5000.00 EJ EMPLOYMENT 8 Component Percentages Grams Dextrose (Staley) 20.0% 200.00 Methylcel ulosa 14% 140.00 Sodium CMC (Aqualon) 8% 80.00 Stearic acid (Humeo) 8% 80.00 Tapioca dextrin (Staley) 5% 50.00 Glycerin (DOW) 2% 20.00 Sodium citrate, anhydrous 3% 30.00 (ADM Corn Processing) Titanium dioxide (water) (Kronos) 40% 400.00 1 00% 1 000.00 EJ EM PLO 9 Component Percentages Grams Dextrose (Staley) 20.0% 200.00 Methylcellulose (DOW) 14% 140.00 Tapioca dextrin (Staley) 5% 50.00 Sodium CMC (Aqualon) 8% 80.00 Polydextrose (Pfizer) 8% 80.00 Glycerin (DOW) 2% 20.00 Sodium citrate, anhydrous 3% 30.00 (ADM Corn Processing) Titanium dioxide (water) (Kronos) 40% 400.00 1 00% 1 000.00 EXAMPLE 10 Component Percentages Grams Dextrose (Staley) 25.0% 250.00 Methylcellulose (DOW) 14% 140.00 Sodium CMC (Aqualon) 8 % 80.00 PU RITY 4 * (National Starch and Chemical 8% 80.00 Company) Glycerin (DOW) 2% 20.00 Sodium citrate, anhydrous 3% 30.00 (ADM Corn Processing) Titan dioxide io (water) (Kronos) 40% 400.00 1 00% 1000.00 * Purity 4 is a modified food starch with Tapioca as its source.
EXAMPLE 1 1 Component Percentages Grams Dextrose (Staley) 25.0% 250.00 Methylcellulose (DOW) 14% 140.00 Sodium CMC (Aqualon) 8% 80.00 PU RITY HO ** (National Starch and Chemical 8% 80.00 Company) Glycerin (DOW) 2% 20.00 Sodium citrate, anhydrous 3% 30.00 (ADM Corn Processing) Titanium dioxide (water) (Kronos) 40% 400.00 1 00% 1 000.00 ** Purity HO is a modified food starch and corn syrup dehydrated with waxy corn as its source.
EXAM PLO 12 Component Percentages Grams Dextrose (Staley) 25.0% 250.00 Methylcellulose (DOW) 14% 140.00 Sodium CMC (Aqualon) 8% 80.00 PU RITY GUM 59 *** (National Starch and 8% 80.00 Chemical Company) Glycerin (DOW) 2% 20.00 Sodium citrate, anhydrous 3% 30.00 (ADM Corn Processing) Titanium dioxide (water) (Kronos) 40% 400.00 1 00% 1 000.00 *** Purity GUM 59 is a food grade modified with waxy corn as its source EJ EMPLO 1 3 Component Percentages Grams Dextrose (Staley) 29.0% 1450.00 HPMC / Pharmacoat E-50 (DOW / Shin Etsu) 1 0% 500.00 Polyethylene glycol 8000 (Union Carbide) 8% 400.00 HPMC / Pharmacoat E-15 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 150.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 150.00 Gum arabic (Colloides Naturels, Inc.) 3% 150.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polisorbate 80 (ICI Surfactants) 1% 50.00 100% 5000.00 EXAMPLE 14 Component Percentages Grams Dextrose (Staley) 25.0% 250.00 Methylcellulose (Dow) 14.0% 140.00 Sodium CMC (Aqualon) 8.0% 80.00 Starch 1500 (Colorcon) 8.0% 80.00 Glycerin (Dow) 2.0% 20.00 Sodium citrate, anhydrous 3.0% 30.00 (ADM Corn Processing) Titanium dioxide (water) (Kronos) 40.0% 400.00 100.0% 1000.00 EJ EM PLO 1 5 Component Percentages Grams Dextrose (Staley) 29.0% 1450.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 1 0% 500.00 Polyethylene glycol 8000 (U nion Carbide) 8% 400.00 HPMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Alginate of PG (Kelco) 3% 1 50.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polysorbate 80 (ICI Surfactants) 1% 50.00 1 00% 5000.00 EXEM PLO 16 Component Percentages Grams Dextrose (Staley) 29.0% 1450.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 1 0% 500.00 Polyethylene glycol 8000 (U nion Carbide) 8% 400.00 HPMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5% 250.00 Sodium CMC (Aqualon) 6% 300.00 Sodium citrate, anhydrous 3% 1 50.00 (ADM Corn Processing) Mineral oil (Pennreco) 3% 1 50.00 Sodium alginate (Kelco) 3% 150.00 Titanium dioxide (water) (Kronos) 32% 1600.00 Polysorbate 80 (ICI Surfactants) 1% 50.00 100% 5000.00 EXAMPLE 17 Component Percentages Grams Dextrose (Staley) 40% 400.00 HPMC / Pharmacoat E-15 (DOW / ShinEtsu) 28% 280.00 Titanium dioxide (water) (Kronos) 32% 320.00 100% 1000.00 EXAMPLE 18 Component Percentages Grams Dextrose (Staley) 40% 400.00 HPMC / Pharmacoat E-15 (DOW / ShinEtsu) 18% 180.00 PEG 8000 10% 100.00 Titanium dioxide (water) (Kronos) 3% 320.00 100% 5000.00 EXAMPLE 19 Component Percentages Grams Dextrose (Staley) 29.9% 299.00 HPMC / Pharmacoat E-50 (DOW / ShinEtsu) 10.0% 100.00 Polyethylene glycol 8000 (Union Carbide) 8.0% 80.00 H PMC / Pharmacoat E-1 5 (DOW / ShinEtsu) 5.0% 50.00 Sodium CMC (Aqualon) 8.0% 80.00 Mineral oil (Pennreco) 3.0% 30.00 Sodium citrate, anhydrous 3.0% 30.00 (ADM Corn Processing) Tapioca dextrin (Staley) 0. 1% 1.00 Titanium dioxide (water) (Kronos) 32.0% 320.00 Polisorbate 80 (ICI Surfactants) 1 .0% 1 0.00 1 00.0% 1 000.00 EXAMPLE 20 Example 1 was repeated, except that the dispersion was atomized on 1 5000 grams of oyster shell substrates. This produced a bright white film coating on the oyster shell substrates.
Although it is preferred to make the coating dispersions of the invention from the inventive dry film coating compositions, the inventive coating dispersions can be made by adding the individual components of the inventive dry film coating composition to water to form the inventive coating dispersions.
ADVANTAGES The invention provides a film coating having good film adhesion and a smooth surface. Moreover, the invention produces a glossy white film coating that is noticeably brighter than the white film coatings produced using HPMC-based coating compositions.

Claims (9)

1. A composition for forming a coating dispersion for nutritional film coating supplements, pharmaceutical tablets and the like, comprising dextrose, an auxiliary film former, and titanium dioxide.
2. The composition of claim 1, wherein the dextrose is 20% to 50% by weight of the composition.
3. The composition of claim 1, wherein the dextrose is 25% to 35% by weight of the composition.
The composition of claim 1, the auxiliary film former being polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (sodium CMC), polydextrose, starch, modified food starch, food starch modified with solids of corn syrup, tapioca dextrin, lactose, maltodextrin, sodium alginate, PG alginate, gum arabic, polyvinyl alcohol (PVA) and combinations thereof.
The composition of claim 1, the auxiliary film former being in the range of 1% to about 50% by weight of the composition.
The composition of claim 1, the auxiliary film former being in a range of 10% to about 20% by weight of the composition.
7. The composition of claim 1, the titanium dioxide being in the range of about 25% to about 50% by weight of the composition. The composition of claim 1, the titanium dioxide being in a range from about 30% to about 40% by weight of the composition. 9. The composition of claim 1, further including a plasticizer. The composition of claim 9, the plasticizer being mineral oil, polyethylene glycol, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, triethyl citrate, triebutyl citrate or acetyl tributyl citrate. eleven . The composition of claim 9, the plasticizer being in a range of more than 0% to about 20% by weight of the composition. The composition of claim 9, the plasticizer being in a range of 5% to 10% by weight of the composition. The composition of claim 9, the plasticizer being in a range of 3% to 5% by weight of the composition. 14. The composition of claim 1, further including a surfactant. The composition of claim 14, wherein the surfactant is polysorbate 80. The composition of claim 14, wherein the surfactant is in a range of greater than 0% to about 5% by weight of the composition. The composition of claim 14, the surfactant being in a range of greater than 0.5% to about 1% by weight of the composition.
8. The composition of claim 1, further including a flow aid.
9. The composition of claim 18, wherein the flow aid is stearic acid. The composition of claim 1 8, the flow aid being in a range of more than 0% to about 15% by weight of the composition. twenty-one . The composition of claim 1 8, the flow aid being in a range of more than 5% to about 10% by weight of the composition. 22. The composition of claim 1, further including a conservator. 23. The composition of claim 22, the preservative being sodium citrate. 24. The composition of claim 22, wherein the preservative is in a range of greater than 0% to about 5% by weight of the composition. The composition of claim 22, the preservative being in a range of about 2% to about 3% by weight of the composition. 26. The composition of claim 1, further comprising a plasticizer, the plasticizer being mineral oil, polyethylene glycol, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, triethyl citrate, tirbuyl citrate or acetyl tributyl citrate and the plasticizer being in a range of more than 0% to about 20% by weight of the composition, the dextrose being 20% up to 50% by weight of the composition, the auxiliary film former being polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (sodium CMC), polydextrose, starch, altered modified starch, food starch modified with corn syrup solids, tapioca dextrin, lactose, maltodextrin, sodium alginate, PG alginate, gum arabic, polyvinyl alcohol (PVA) and combinations thereof , being in auxiliary film former in a range of 1% to about 50% by weight of the composition, and the titanium dioxide being in a range of about 25% to about 50% by weight of the composition. The composition of claim 26, further including a surfactant, the surfactant being polysorbate 80, and the surfactant being in a range of greater than 0% to about 5% by weight of the composition, a flow aid, the auxiliary being of stearic acid flow, and the flow aid being in a range of more than 0% to about 15% by weight of the composition, and a conservative, the sodium citrate being conservative, and the conservative being in a range of more than from 0% to about 5% by weight of the composition. 28. A method for coating substrates, such as food supplements, pharmaceutical tablets and the like, with a white film coating, comprising the steps of mixing dextrose, an auxiliary film former, and titanium dioxide in water to form a dispersion of aqueous coating, applying an effective amount of said coating dispersion on said substrates to form a white film coating on said substrates, and drying the white film coating on said substrates. 29. The method of claim 28, including dispersing a plasticizer in the aqueous coating dispersion. 30. The method of claim 28, including dispersing a surfactant in the aqueous coating dispersion. 31 The method of claim 28, including dispersing a flow aid in the aqueous coating dispersion. 32. The method of claim 28, including dispersing a preservative in the aqueous coating dispersion. 33. The method of claim 28, wherein the dextrose is in a range of about 20% to about 50% by weight of the nonaqueous ingredients of the dispersion, the auxiliary film former being in a range of about 1% to about 50% by weight of the non-aqueous ingredients of the dispersion, and the titanium dioxide being in a range of about 25% to about 50% by weight of the non-aqueous ingredients of the dispersion. 34. The method of claim 28, the dextrose being in a range of about 25% to about 35% by weight of the non-aqueous ingredients of the dispersion, the auxiliary film former being in a range of about 10% up to about 20% by weight of the non-aqueous ingredients of the dispersion, and the titanium dioxide being in a range of about 30% to about 40% by weight of the non-aqueous ingredients of the dispersion. 35. The method of claim 33, further comprising a plasticizer, the plasticizer being mineral oil, polyethylene glycol, propylene glycol, glycerin, triacetin, acetyltriethyl citrate, triethyl citrate, tributyl citrate, or acetyl tributyl citrate, and the plasticizer in a range of more than 0% up to about 20% by weight of the non-aqueous ingredients of the dispersion. 36. The method of claim 35, further including a surfactant, the surfactant being polysorbate 80, and the surfactant being in a range of greater than 0% to about 5% by weight of the nonaqueous ingredients of the dispersion, a flow aid, the stearic acid flow assistant being, and the flow aid being in a range of more than 0% to about 15% by weight of the non-aqueous ingredients of the dispersion, and a preservative, the sodium citrate preservative, and the preservative being in a range of more than 0% up to about 5% by weight of the non-aqueous ingredients of the dispersion. SUMMARY A dry film coating composition used to make a glossy white film coating for nutritional supplements, pharmaceutical tablets and the like, comprises dextrose, an auxiliary film former, and titanium dioxide. Optionally, but advantageously, the coating composition may also include one or more of the following components: a plasticizer, a surfactant, a flow aid and a preservative.
MXPA/A/2000/000570A 1997-07-16 2000-01-14 Bright white film coatings and film coating compositions therefor MXPA00000570A (en)

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US08895484 1997-07-16

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