COLORANTS THE COSMETICS FOR THE PHARMACEUTICAL
International Journal of Pharmacy and Pharmaceutical SciencesISSN- 0975-1491Vol 3, Suppl 3, 2011Review ArticleCOLORANTS THE COSMETICS FOR THE PHARMACEUTICAL DOSAGE FORMSKRISHNA VAMSHI ALLAM1*, GANNU PRAVEEN KUMAR1Department of Pharmaceutics, Talla Padmavathi College of Pharmacy, Kareemabad, Warangal, 506002, Telangana, A.P., India.Email: kv.allam@gmail.comReceived: 20 Feb 2011, Revised and Accepted: 22 March 2011ABSTRACTColorants are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms. There are many types of pharmaceuticalformulations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments andsalves etc. The purpose of coloring varies with different formulations. Coloring may be required to increase the aesthetic appearance or to prolongthe stability or to produce standard preparations or for identification of a particular formulation. Color psychology says that, the color of theproduct may also influence the efficacy of therapy. Thus, the prime priority of colorants is to increase the aesthetic appearance of the product, so wecan say that the colorants are the cosmetics for the pharmaceutical formulations. The classification of various colorants including FD&C categories,the lists of colorants and their uses, the description about major colorants widely used in the formulations was discussed here in detail. In manyregions around the world there is a distinction between colors that may be used in drugs and those for food use. This review also discusses theStatus of color additives based on Code of Federal Regulations, The international regulatory status, Coloring systems for various dosage forms,Colorant blending, Handling precautions, Safety, Stability and Storage data of various colorants. Legislations, which govern the usage of colorants,include European Union Legislation and United States Legislation.Keywords: Colorants, Coloring agents, FD&C colors, Pharmaceutical Colorants and Coloring systems.INTRODUCTIONStandard preparationsColorants or coloring agents are mainly used to impart a distinctiveappearance to the pharmaceutical dosage forms. We can also saythat the colorants are the cosmetics for the pharmaceuticalpreparations, because the aesthetic appearance of dosage forms canbe enhanced by using suitable colorants. The main categories ofdosage form that are colored are: tablets (either the core itself or thecoating.), hard or soft gelatin capsules: (the capsule shell or coatedbeads), oral liquids, topical creams, toothpastes, ointments andsalves. The elegance and eye appeal of a colored product is valuable,especially for children whom it is often used to treat with syrups,tablets, or capsules, to avoid injections and allow treatment at home.Natural calamine is obsolete for pharmaceutical purposes, because itis not constant in color and has been replaced by artificiallyprepared material tinted with a form of ferric oxide. Differences inthe tint of green soft soap caused by variation in the quality of theoils used in its preparation are sometimes covered by a suitable dye.When lactose is used as the diluent for powdered opium it should becolored with Caramel to give a uniform appearance to the product3.Pharmaceutical preparations are colored mainly for followingreasons:Increases acceptabilityUnattractive medication can be made more acceptable to the patientby the use of color, and color can also be used to make a preparationmore uniform when an ingredient in the formulation has itself avariable appearance from batch to batch. Many patients rely on colorto recognize the prescribed drug and proper dosage. Theseattributes assist in improving patient compliance1.It is believed that brightly colored tonics, cherry red children’scough mixtures and flesh‐tinted powders and ointments are morelikely to be used because they are attractive.For identificationIt helps to identify a product in its manufacturing and distributionstages. Colors may be used for identifying similar‐looking productswithin a product line, or in cases where products of similarappearance exist in the lines of different manufacturers2. The use ofdifferent colors for different strengths of the same drug can also helpeliminate errors. A specific example is the anesthetic Trichloroethylene, which may be colored blue to distinguish it fromchloroform which it resembles in physical characteristics.Coloring may help a doctor to recognize a previous treatment.Specific colored products become known to doctors andpharmacists, and this can help sales3.Stability purposeSome of the insoluble colors or pigments have the additional benefitwhen used in tablet coatings or gelatin shells of providing usefulopacity, which can contribute to the stability of light‐sensitive activematerials in the tablet or capsule formulation. Pigments such as theiron oxides, titanium dioxide, and some of the aluminum lakes areespecially useful for this purpose4.COLOR PSYCHOLOGY THE PSYCHOLOGICAL EFFECTS OFCOLORThe study of color is complex, and made difficult by its variety ofsystems, which include the aesthetic, psychological, physiological,associative, and symbolic. This has led to discoveries of thepsychophysiological attributes of color5. Color psychology says thatthe color of the product may also influence the efficacy of therapy.Color effects have universal meaning.Colors in the red area of the color spectrum are known as “warmcolors” and include red, orange and yellow (Fig.1). These warmcolors evoke emotions ranging from feelings of warmth and comfortto feelings of anger and hostility. Colors on the blue side of thespectrum are known as “cool colors” and include blue, purple andgreen. These colors are often described as calm, but can also call tomind feelings of sadness or indifference6. The studies were alsoapplied to medications.Ideal properties of a colorant Nontoxic and have no physiological activity. Free from harmfulimpuritiesIs a definite chemical compound because then only its coloringpower will be reliable, its assay will be practicable and easier.Its Tinctorial (coloring) power should be high so that onlysmall quantities are required.
Allam et al.Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, 13 21 Unaffected by light, tropical temperatures, hydrolysis andmicro‐organisms and, therefore, be stable on storage 7.Unaffected by oxidizing or reducing agents and pH changes.Compatible with medicaments and not interfere with them.Ready solubility in water is desirable in most cases but someoil‐soluble and spirit‐soluble colors are necessary.Does not interferes with the tests and assays to which thepreparations containing it are subject. Should not beappreciably adsorbed on to suspended matter.Free from objectionable taste and odour. Readily available and inexpensive.Natural coloring matters are less satisfactory than coal tar colors inmany of these respects.ClassificationA. Organic dyes and their lakesB. Inorganic or mineral colorsC. Natural colors or vegetable and animal colorsFig. 1: Color wheelOrganic dyes and their lakesDyesDyes are synthetic, chemical compounds that exhibit their coloringpower or tinctorial strength when dissolved in a solvent 8. They areusually 80 to 93% (rarely 94 to 99%) pure colorant material. Dyesare also soluble in propylene glycol and glycerin. They are availablein a wider range of shades or hues with higher coloring power thanthe natural pigments. Dyes are usually cheaper in cost.The physical properties of dyes (particle size, variation in thegrinding and drying process, different suppliers) are usually notcritical in terms of their ability to produce identically coloredsystems. The tinctorial strength of a dye is directly proportional toits pure dye content. Solutions of dyes should be made in stainlesssteel or glass‐lined tanks (for minimization of dye‐ containerincompatibility) with moderate mixing and should routinely befiltered to remove any undissolved dye particles 9. Colors for clearliquid preparations are limited to the dyes. Examples includeTartrazine, Erythrosine, Sunset Yellow and Patent Blue V.LakesLakes have been defined by the FDA as the "Aluminum salts of FD&Cwater soluble dyes extended on a substratum of alumina". Lakesprepared by extending the calcium salts of the FD&C dyes are alsopermitted but to date none has been made. Lakes also must becertified by the FDA. Lakes, unlike dyes, are insoluble and color bydispersion. Consequently, the particle size of lakes is very critical totheir coloring capacity or tinctorial strength (Table 1). Generally, thesmaller the particle size, the higher the tinctorial strength of lakesdue to increased surface area for reflected light. Lakes are formedby the precipitation and absorption of a dye on an insoluble base orsubstrate. The base for the FD&C lakes is alumina hydrate. Themethod of preparation of the alumina hydrate and the conditionsunder which the dye is added or absorbed determines the shade,particle size, dispersability as well as tinctorial strength. Otherimportant variables are the temperature, concentration of reactants,final pH, and the speed and type of agitation. The shade or hue of alake varies with the pure dye content.The use of insoluble certified lakes has several advantages, namely: The fact that they are insoluble enables the drying stages to beperformed more quickly. Mottling is reduced because the opacity of the systemminimizes the defect of tablet surface depressions. Over coloring is not a problem because the system is opaque,hence, only one shade of color will result. Full color development can be achieved with a fewer number ofapplication states. This results in significant time savings. Raw material costs are also improved; many of the problemsassociated with color reproducibility have been eliminated entirely.Table 1: Typical characteristic properties of Aluminum lakesAverage particle sizeMoisture contentOil absorptionSpecific gravitypH stability range(a)5–10 μm12–15%40–45 (a)1.7–2.0 g/cm34.0–8.0ASTM D281‐31, expressed as grams of oil per 100 g of color. Source: Hand book of pharmaceutical excipients. pg.no: 507.14
Allam et al.Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, 13 21FD&C lakes are available in six basic colors: One yellow, one orange,two reds (a pink‐red and an orange‐red), two blues (a green‐blueand a royal blue)10.Blends are available to provide m ore lake colors as neededincluding brown, green, orange, red, yellow and purple.Lakes are largely water‐insoluble forms of the common syntheticwater‐soluble dyes. They are prepared by adsorbing sodium orpotassium salt of a dye onto a very fine substrate of hydratedalumina, followed by treatment with a further soluble aluminumsalt. The lake is then purified and dried11.Some examples of Aluminum lakes‐ Brilliant Blue Lake, Sunsetyellow lake, Amaranth lake, Allura red lake, Indigo carmine lake,Quinoline yellow lake.Inorganic colors or mineral colorsStability towards light is an important characteristic displayed bythis materials, some of which have a useful opacifying capacity, e,g.Titanium dioxide. Another great advantage of inorganic colors istheir wide regulatory acceptance, making them most useful formultinational companies wishing to standardize internationalformulae. On draw back to their use is that the range of colors thatcan be achieved is rather limited.Until the discovery of coal tar dyes, mineral pigments were oftenused to color foods and drugs but because many have toxic effectsthey were quickly displaced when synthetic dyes became available.Possibly the most important application of, mineral coloring in apresent‐day medicament is the use of a mixture of red and yellowferric oxides to give calamine a flesh color. Titanium dioxide is usedto color and opacify hard gelatin capsules.Natural colors or vegetable and animal colorsThis is a chemically and physically diverse group of materials. Someof this colors are the products of chemical synthesis rather thanextraction from a natural source, for example, β‐carotene ofcommerce I s regularly synthetic in origin. The term frequentlyapplies to such materials is ‘nature identical’, which in many ways ismore descriptive. Some would even make the case that any productwhich is not a constituent of the normal diet should not be called‘natural’. This viewpoint would remove colors such as Cochineal andAnnatto from consideration. As a generalization, natural colors arenot as stable to light as the other group of colors. They do, however,advantage in that they have a wide acceptability. Few medicinally –active vegetable extracts have acceptable colors of their own,especially when diluted in a dispensed preparation, a large numberof vegetable coloring matters were used in the past. The only threeleft in the codex are caramel, formerly called burnt sugar (preparedby heating water‐soluble carbohydrates with an accelerator until ablack viscid mass is formed), cochineal (a dried insect), and carmine(the aluminum lake of the coloring matter of cochineal). Otherexamples for natural colorants include Riboflavin and Anthocyanins,Paprika Oleoresin, Beet Root Red, Annatto, Curcumin [Turmeric].The main disadvantages with the obsolete vegetable colors were‐Apart from indigo, a definite chemical compound, most were used asa crude drug or an extract with consequent variation in coloringpower and difficulty of standardization. The tinctorial power wasvery low and often these colors were fugitive in solution. In addition,they are less readily available and more expensive than coal tarcolors12‐13.Physical and chemical propertiesTable 2 shows the detailed description about the physicochemicalproperties of some major colorants.Table 2: Physical and chemical properties of some certified colorantsFD&CnameChemicalclassLightStability toOxidationRed No. 3(Erythrosine)XanthinePoorFairRed No. 40Yellow No. 6(Sunset Yellow FCF)Yellow No. 5(Tartrazine)Green No. 3 (FastGreen FCF)Blue No. 1 (BrilliantBlue FCF)Blue No. 2(Indigotine)MonoazoMonoazoV. ity(g/100ml)WaterPoorV. goodBluish pink9at25 C25%Et.OH8FairFairGoodGoodV. goodGoodYellowish redReddish2299.510GoodFairGoodGoodLemon Yellow2012TPM*FairPoorGoodExcellentBluish green2020TPM*FairPoorGoodExcellentGreenish Blue2020IndigoidV. PoorPoorPoorPoorDeep blue1.60.5pHchange(TPM * TriPhenyl Methane), Source: Mendes et al., Pharmaceutical Dosage Forms Tablets, Vol.1, second edition.Regulatory statusColoring agents have an almost unique status as pharmaceuticalexcipients in that most regulatory agencies of the world holdpositive lists of colors that may be used in medicinal products. Thelegislation also defines purity criteria for the individual coloringagents. In many regions around the world there is a distinctionbetween colors that may be used in drugs and those for food use14.¾European union legislationThe primary legislation that governs coloring matters that may beadded to medicinal products is Council Directive 78/25/EEC of 12December 1977. This Directive links the pharmaceuticalrequirements with those for foods in the EU. Unfortunately, theDirective makes some specific references to food legislation from1962 that has subsequently been repealed.However the European Commission has provided guidance on crossreferences to the current food color legislation as contained inCouncil Directive 94/36/EC. In addition, the Scientific Committee onMedicinal Products and Medical Devices has delivered opinions onthe suitability and safety of amaranth, erythrosine, canthaxanthin,aluminum, and silver as colors for medicines. Silver was consideredunsuitable15.¾United states legislationThe 1960 Color Additive Amendment to the Food Drug and CosmeticAct defines the responsibility of the Food and Drug Administrationin the area of pharmaceutical colorants.15
Allam et al.Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, 13 21Colors requiring certification are described as FD&C (Food Drugand Cosmetic); D&C (Drug and Cosmetic) or External D&C. Theremaining colors are described as uncertified colors and are mainlyof natural origin.¾Licensing authority approvalIn addition to national approvals and lists, a pharmaceuticallicensing authority can impose additional restrictions at the time ofapplication review. Within the EU this generally takes the form ofrestricting colors, such as Tartrazine and other azo colors, inmedicinal products for chronic administration, and especially inmedicines for allergic conditions16.The food, drug, and cosmetic actThe Food Drug and Cosmetic Act of 1938 created three categories ofcoal tar dyes, of which only the first two are applicable to themanufacture of chewable tablets. FD&C colors: These are colorants that are certifiable for use infoods, drugs, and cosmetics. D&C colors: These are dyes and pigments considered safe foruse in drugs and cosmetics when in contact with mucousmembranes or when ingested. External D&C colors: These colorants, due to their oraltoxicity, are not certifiable for use in products intended for ingestionbut are considered safe for use in products applied externally 17.Widely used colorants in pharmaceuticals¾ Beta carotene:E160a)Color Index No.:(Beta‐carotene; β‐carotene; β,β‐carotene;CI 75130 (natural)and CI 40800 (synthetic).It occurs in the pure state as red crystals when recrystallized fromlight petroleum. It is capable of producing colors varying from paleyellow to dark orange. It can be used as a color for sugar‐coatedtablets prepared by the ladle process. However, Beta‐ carotene isvery unstable to light and air, and products containing this materialshould be securely packaged to minimize degradation. It isparticularly unstable when used in spray‐coating processes,probably owing to atmospheric oxygen attacking the finelydispersed spray droplets.Because of its poor water solubility, beta‐carotene cannot be used tocolor clear aqueous systems, and cosolvents such as ethanol must beused. Suppositories have been successfully colored with beta‐carotene in approximately 0.1% concentration.¾ Indigo Carmine: (Indigotine; sodium indigotin disulfonate;soluble Indigo blue; E132; FD&C blue #2)Color Index No.: CI 73015It is a dark blue powder. Aqueous solutions are blue or bluish‐purple. The primary use of Indigo carmine is as a pH indicator.Indigo carmine is an indigoid dye used to color oral and topicalpharmaceutical preparations and also used with yellow colors toproduce green colors.It is used as a dye in the manufacturing of capsules. IndigoCarmine is also used to color nylon surgical sutures and is useddiagnostically as a 0.8% w/v injection.¾Sunset Yellow FCF: (Yellow orange S., E110; FD&C yellow #6)Color Index No.: CI 15985It is a reddish yellow powder. Aqueous solutions are bright orangecolored. Sunset yellow FCF is a monoazo dye and is often used inconjunction with E123, Amaranth, in order to produce a browncoloring in both chocolates and caramel. At high concentrations,SunsetYellowin solution with water undergoesa phasechange from anisotropic liquid to a nematic liquid crystal. Thisoccurs between 0.8 M and 0.9 M at room temperature18.¾Tartrazine: (Hydrazine yellow; E102; FD&C yellow #5)Color Index No.: CI 19140Yellow or Orange yellow powder. Aqueous solutions are yellow‐colored. Tartrazine is a monoazo, or pyrazolone, dye. It is used toimprove the appearance of a product and to impart a distinctivecoloring for identification purposes.US regulations require that prescription drugs for human usecontaining Tartrazine bear the warning statement: This productcontains FD&C yellow #5 (Tartrazine) which may cause allergic‐typereactions (including bronchial asthma) in certain susceptiblepersons. Although the overall incidence of sensitivity to Tartrazinein the general population is low, it is frequently seen in patients whoare also hypersensitive to aspirin19‐21.¾ Brilliant Blue FCF: (Erioglaucine; Eriosky blue; Patent BlueAR; E133; Xylene Blue VSG) Color Index No.: CI 42090It can be combined with Tartrazine (E102) to produce variousshades of green. It is widely used in soaps, shampoos, mouthwashes22, and other hygiene and cosmetics applications. It has thecapacity for inducing an allergic reaction in individuals with pre‐existing moderate asthma23.¾ Titanium Dioxide(TiO2): (Anatase titanium dioxide; brookitetitanium dioxide; E171; Kronos 1171; pigment white 6; rutiletitanium dioxide; Tioxide; TiPure; titanic anhydride; Tronox.) ColorIndex No.: CI 77891TiO2 is also an effective opacifier in powder form, where it isemployed as a pigment to provide whiteness and opacity to productssuch as paints, coatings, plastics, papers, inks, foods, medicines (i.e.pills, tablets and also in topical pharmaceutical formulations) as wellas most toothpastes24.Owing to its high refractive index, titanium dioxide has light‐scattering properties that may be exploited in its use as a whitepigment and opacifier. The range of light that is scattered can bealtered by varying the particle size of the titanium dioxide powder.It is used as a white pigment in film‐coating suspensions, sugar‐coated tablets, and gelatin capsules. Titanium dioxide may also beadmixed with other pigments.¾ Quinoline Yellow SS: (Solvent Yellow 33; FD&C Yellow #11;Quinoline Yellow A; Yellow No. 204)Color Index No.: CI 47000It is a bright yellow dye with green shade. It is insoluble in water, butsoluble in non polar organic solvents. Quinoline Yellow SS is used inspirit lacquers, polystyrene, polycarbonates, polyamides, acrylicresins, and to color hydrocarbon solvents. It is also used inexternally applied drugs and cosmetics.¾Allura Red AC: ( Allura Red; Food Red 17; E129: FD&C Red 40)Color Index No.: CI 16035It has the appearance of a dark red powder. It is approved by the USFDA for use in cosmetics, drugs, and food. This colorant may haveslightly less allergy or intolerance reaction by aspirin intolerantpeople and asthmatics than most of the azo dyes, although thosewith skin sensitivities should be careful. Allura Red has also beenconnected with cancer in mice. Not recommended for consumptionby children. It is banned in Denmark, Belgium, France, Germany,Switzerland, Sweden, Austria and Norway.¾ Quinizarine Green SS: (Solvent Green 3; Oil Green G; D&CGreen #6)Color Index No.: CI 61565It is a green dye, an anthraquinone derivative. It has the appearanceof a black powder with melting point of 220‐221 C. It is insoluble in16
Allam et al.Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, 13 21water. It is used for adding greenish coloring to materials. It is usedin cosmetics and medications25.Iron oxide black (CI 77499); Iron (III) oxide hydrated(CI 77492);Iron oxide red and Iron oxide yellow monohydrate are the variousiron oxides used in pharmaceutical preparations.Iron oxides are widely used in cosmetics, foods, and pharmaceuticalapplications as colorants and UV absorbers. As inorganic colorantsthey are becoming of increasing importance as a result of thelimitations affecting some synthetic organic dyestuffs. However, ironoxides also have restrictions in some countries on the quantities thatmay be consumed and technically their use is restricted because oftheir limited color range and their abrasiveness.They occur as yellow, red, black, or brown powder. The colordepends on the particle size and shape, and the amount of combinedwater.Other than the above mentioned colorants, there are many morecolorants were under practice; the status of these color additiveswas described in Table 3.¾Iron Oxides:Table 3: Status of color additives: code of federal regulations (4 1 87)ColorUsed forFD&C Blue No. 1May be used for coloring drugs in amounts consistent with cGMPFD&C Blue No.2May be used for coloring drugs in amounts consistent with cGMP.D&C Blue No.4May be used in externally applied drugs in amounts consistent with cGMP.D&C Blue No.9May be used for coloring cotton and silk surgical Sutures including sutures forophthalmic use in amounts not to exceed 2.5% by weight of the suture.FD &C Green No. 3May be used for coloring drugs in amounts consistent with cGMP.D&C Green No.5May be used for coloring drugs in amounts consistent with cGMP.D&C Green NO. 8May be used in externally applied drugs in amounts not exceeding 0.01% byweight of the finished product.D&C Orange No.4May be used for coloring externally applied drugs in amounts consistent withcGMP.D&C Orange No.5May be used in mouthwashes and dentifrices and for externally applied drugsin amounts not to exceed 5 mg per daily dose of the drug.D&C Orange No. 10May be used for coloring externally applied drugs in amounts consistent withcGMPD&C Orange No. 11May be used for coloring externally applied drugs in amounts consistent withcGMPD&C Orange No. 17May be used for coloring externally applied drugs in amounts consistent withcGMPFD&C Red No.3May be used for coloring ingested drugs in amounts consistent with cGMP.FD&C Red No. 4May be used for externally applied drugs in amounts consistent with cGMP.D&C Red No. 6May be used for coloring drugs such that the combined total of D&C Red No.6and 7 does not exceed 5 mg per daily dose of the drug.D&C Red No.7May be used for coloring drugs such that the combined total of D&C Red No.6and 7 does not exceed 5 mg per daily dose of the drug.D&C Red No.8May be used for coloring ingested drugs in amounts not exceeding 0.1% byweight of the finished product and for externally applied drugs in amountsconsistent with cGMP.D&C Red No.9May be used for externally applied drugs in amounts consistent with cGMP.D&CRedNo.17May be used for externally applied products in amounts consistent withcGMP.D&C Red No. 19May be used for externally applied products in amounts consistent withcGMP.D&C Red No. 21May be used for coloring drug product in amounts consistent with cGMP.D&C Red No. 22May be used for coloring drug product in amounts consistent with cGMP.17
Allam et al.Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, 13 21D&C Red No. 27May be used for coloring drug product in amounts consistent with cGMP.D&C Red No. 28May be used for coloring drug product in amounts consistent with cGMP.D&C Red No. 30May be used for coloring drug product in amounts consistent with cGMP.D&C Red No. 31May be used for externally applied drugs in amounts consistent with cGMP.D&C Red No. 34May be used for coloring externally applied in amounts consistent with cGMPD&C Red No. 39May be used for external germicidal solutions not to exceed 0.1% by weight ofthe finished drug product.FD&C Red No. 40May be used in coloring drugs Subject to restrictions and in amountsconsistent with cGMPD&C Violet No.2May be used for coloring externally applied drugs in amounts consistent withcGMPFD&C Yellow No.5FD&C Yellow No.6In general products containing FD&C Yellow No.5 (Tartrazine) must be solabeled. The Code of Federal Regulations should be consulted for userestrictions that may be added.May be used for coloring drugs in amounts consistent with cGMP.D&C Yellow No. 7May be used for externally applied drugs in amounts consistent with cGMP.D&C Yellow No. 10May be used for coloring drugs in amounts consistent with cGMP.D&C Yellow No. 11May be used for externally applied drugs in amounts consistent with cGMPSource: Peck. Baley. McCurdy. and Banker, Pharmaceutical Dosage Forms Tablets, Vol.1, second edition.Coloring systems for various dosage forms2.In selecting a colorant for a given application, prime considerationshould be given to the type formulation in which the colorant is tobe incorporated. Whatever the form of colorant chosen, it shouldmeet as many characteristics as the ideal colorant.2.1. Sugar coating1.Tablets1.1. Wet granulationDissolving water‐soluble dyes in a binding solution for thegranulating process is the most common approach to coloring atablet formulating. However, during drying of the granulation, thesolution, the soluble colors may migrate and if more than one coloris used, the dyes may migrate at different rates. This results in anuneven coloring of the granulation, which will have a mottledappearance after compression. Some additives, such as starches,clays, and talc, have been used to adsorb the dye, there by reducingbut not completely eliminating the migration. This entire problemcan be avoided by using lakes or other pigments. The colors will notmigrate because they are insoluble. In addition, the light stability ofthe product will be improved.Tablet coatingThe coloring stage is one of the most critical parts of the operation. Itgives the tablet its color and, in some cases, its finished size. Herethe success measured in terms of the elegance of the final product.Before the 1950s, traditional color coating for solid dosage formswas usually performed using soluble dyes as the prime colorant.This system can produce the most elegant tablet. However, manydifficulties can arise usually related to the dye being soluble.Color migration readily occurs if the drying stage after eachapplication of color is not handled properly. This results in non‐uniform distribution of color or mottling. Small depressions orirregularities in the surface of the tablet may also cause non‐uniformcolor. Many smoothing coats are needed before any color can beapplied. Care must be taken to ensure that the tablets do not becomeover colored. Syrups of increasing dye concentrations usually areused to achieve a color match and to control mottling. This operationmay take from20 to 60 applications for the color to develop fully.Dye sugar‐coating is a very time‐consuming and delicate operation.Mainly of the economic reason, a growing interest in directcompression formulas has developed. The number of processingsteps has been reduced. Direct compression formulation requiresblending only; therefore, lakes and other pigments are used becausethe elimination of the wetting step prevents the effective us ofsoluble colors.Late in the 1950s, the pigment sugar‐coating process was developedand subsequently patented by Arnold
can say that the colorants are the cosmetics for the pharmaceutical formulations. The classification of various colorants including FD&C categories, the lists of colorants and their uses, the description about major colorants widely used in the formulations was discussed here in detail. . ASTM D281‐31, expressed as grams of oil per 100 g of .
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