Colorants The Cosmetics For The Pharmaceutical Dosage Forms-Books Pdf

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Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. Unaffected by light tropical temperatures hydrolysis and Readily available and inexpensive. micro organisms and therefore be stable on storage 7. Natural coloring matters are less satisfactory than coal tar colors in. Unaffected by oxidizing or reducing agents and pH changes. many of these respects, Compatible with medicaments and not interfere with them. Ready solubility in water is desirable in most cases but some Classification. oil soluble and spirit soluble colors are necessary. Does not interferes with the tests and assays to which the A Organic dyes and their lakes. preparations containing it are subject Should not be B Inorganic or mineral colors. appreciably adsorbed on to suspended matter, Free from objectionable taste and odour C Natural colors or vegetable and animal colors. Fig 1 Color wheel, Organic dyes and their lakes certified by the FDA Lakes unlike dyes are insoluble and color by. dispersion Consequently the particle size of lakes is very critical to. Dyes their coloring capacity or tinctorial strength Table 1 Generally the. Dyes are synthetic chemical compounds that exhibit their coloring smaller the particle size the higher the tinctorial strength of lakes. power or tinctorial strength when dissolved in a solvent 8 They are due to increased surface area for reflected light Lakes are formed. usually 80 to 93 rarely 94 to 99 pure colorant material Dyes by the precipitation and absorption of a dye on an insoluble base or. are also soluble in propylene glycol and glycerin They are available substrate The base for the FD C lakes is alumina hydrate The. in a wider range of shades or hues with higher coloring power than method of preparation of the alumina hydrate and the conditions. the natural pigments Dyes are usually cheaper in cost under which the dye is added or absorbed determines the shade. The physical properties of dyes particle size variation in the particle size dispersability as well as tinctorial strength Other. grinding and drying process different suppliers are usually not important variables are the temperature concentration of reactants. critical in terms of their ability to produce identically colored final pH and the speed and type of agitation The shade or hue of a. systems The tinctorial strength of a dye is directly proportional to lake varies with the pure dye content. its pure dye content Solutions of dyes should be made in stainless The use of insoluble certified lakes has several advantages namely. steel or glass lined tanks for minimization of dye container. incompatibility with moderate mixing and should routinely be The fact that they are insoluble enables the drying stages to be. filtered to remove any undissolved dye particles 9 Colors for clear performed more quickly. liquid preparations are limited to the dyes Examples include Mottling is reduced because the opacity of the system. Tartrazine Erythrosine Sunset Yellow and Patent Blue V minimizes the defect of tablet surface depressions. Lakes Over coloring is not a problem because the system is opaque. hence only one shade of color will result, Lakes have been defined by the FDA as the Aluminum salts of FD C Full color development can be achieved with a fewer number of.
water soluble dyes extended on a substratum of alumina Lakes application states This results in significant time savings. prepared by extending the calcium salts of the FD C dyes are also Raw material costs are also improved many of the problems. permitted but to date none has been made Lakes also must be associated with color reproducibility have been eliminated entirely. Table 1 Typical characteristic properties of Aluminum lakes. Average particle size 5 10 m,Moisture content 12 15. Oil absorption 40 45 a,Specific gravity 1 7 2 0 g cm3. pH stability range 4 0 8 0, a ASTM D281 31 expressed as grams of oil per 100 g of color Source Hand book of pharmaceutical excipients pg no 507. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. FD C lakes are available in six basic colors One yellow one orange Natural colors or vegetable and animal colors. two reds a pink red and an orange red two blues a green blue. and a royal blue 10 This is a chemically and physically diverse group of materials Some. of this colors are the products of chemical synthesis rather than. Blends are available to provide m ore lake colors as needed extraction from a natural source for example carotene of. including brown green orange red yellow and purple commerce I s regularly synthetic in origin The term frequently. applies to such materials is nature identical which in many ways is. Lakes are largely water insoluble forms of the common synthetic more descriptive Some would even make the case that any product. water soluble dyes They are prepared by adsorbing sodium or which is not a constituent of the normal diet should not be called. potassium salt of a dye onto a very fine substrate of hydrated natural This viewpoint would remove colors such as Cochineal and. alumina followed by treatment with a further soluble aluminum Annatto from consideration As a generalization natural colors are. salt The lake is then purified and dried11 not as stable to light as the other group of colors They do however. Some examples of Aluminum lakes Brilliant Blue Lake Sunset advantage in that they have a wide acceptability Few medicinally. active vegetable extracts have acceptable colors of their own. yellow lake Amaranth lake Allura red lake Indigo carmine lake. especially when diluted in a dispensed preparation a large number. Quinoline yellow lake, of vegetable coloring matters were used in the past The only three.
Inorganic colors or mineral colors left in the codex are caramel formerly called burnt sugar prepared. by heating water soluble carbohydrates with an accelerator until a. Stability towards light is an important characteristic displayed by black viscid mass is formed cochineal a dried insect and carmine. this materials some of which have a useful opacifying capacity e g the aluminum lake of the coloring matter of cochineal Other. Titanium dioxide Another great advantage of inorganic colors is examples for natural colorants include Riboflavin and Anthocyanins. their wide regulatory acceptance making them most useful for Paprika Oleoresin Beet Root Red Annatto Curcumin Turmeric. multinational companies wishing to standardize international The main disadvantages with the obsolete vegetable colors were. formulae On draw back to their use is that the range of colors that Apart from indigo a definite chemical compound most were used as. can be achieved is rather limited a crude drug or an extract with consequent variation in coloring. power and difficulty of standardization The tinctorial power was. Until the discovery of coal tar dyes mineral pigments were often very low and often these colors were fugitive in solution In addition. used to color foods and drugs but because many have toxic effects they are less readily available and more expensive than coal tar. they were quickly displaced when synthetic dyes became available colors12 13. Possibly the most important application of mineral coloring in a. Physical and chemical properties, present day medicament is the use of a mixture of red and yellow. ferric oxides to give calamine a flesh color Titanium dioxide is used Table 2 shows the detailed description about the physicochemical. to color and opacify hard gelatin capsules properties of some major colorants. Table 2 Physical and chemical properties of some certified colorants. FD C Chemical Stability to Tinctorial Hue Solubility g at. name class Light Oxidation pH strength 100ml 25 C,change Water 25. Red No 3 Xanthine Poor Fair Poor V good Bluish pink 9 8. Erythrosine, Red No 40 Monoazo V good Fair Good V good Yellowish red 22 9 5. Yellow No 6 Monoazo Moderate Fair Good Good Reddish 9 10. Sunset Yellow FCF, Yellow No 5 Pyrazolone Good Fair Good Good Lemon Yellow 20 12. Tartrazine, Green No 3 Fast TPM Fair Poor Good Excellent Bluish green 20 20.
Blue No 1 Brilliant TPM Fair Poor Good Excellent Greenish Blue 20 20. Blue No 2 Indigoid V Poor Poor Poor Poor Deep blue 1 6 0 5. Indigotine, TPM TriPhenyl Methane Source Mendes et al Pharmaceutical Dosage Forms Tablets Vol 1 second edition. Regulatory status Directive makes some specific references to food legislation from. 1962 that has subsequently been repealed, Coloring agents have an almost unique status as pharmaceutical. excipients in that most regulatory agencies of the world hold However the European Commission has provided guidance on cross. positive lists of colors that may be used in medicinal products The references to the current food color legislation as contained in. legislation also defines purity criteria for the individual coloring Council Directive 94 36 EC In addition the Scientific Committee on. agents In many regions around the world there is a distinction Medicinal Products and Medical Devices has delivered opinions on. between colors that may be used in drugs and those for food use14 the suitability and safety of amaranth erythrosine canthaxanthin. aluminum and silver as colors for medicines Silver was considered. European union legislation unsuitable15, The primary legislation that governs coloring matters that may be United states legislation. added to medicinal products is Council Directive 78 25 EEC of 12 The 1960 Color Additive Amendment to the Food Drug and Cosmetic. December 1977 This Directive links the pharmaceutical Act defines the responsibility of the Food and Drug Administration. requirements with those for foods in the EU Unfortunately the in the area of pharmaceutical colorants. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. Colors requiring certification are described as FD C Food Drug Color Index No CI 19140. and Cosmetic D C Drug and Cosmetic or External D C The. remaining colors are described as uncertified colors and are mainly Yellow or Orange yellow powder Aqueous solutions are yellow. of natural origin colored Tartrazine is a monoazo or pyrazolone dye It is used to. improve the appearance of a product and to impart a distinctive. Licensing authority approval coloring for identification purposes. In addition to national approvals and lists a pharmaceutical US regulations require that prescription drugs for human use. licensing authority can impose additional restrictions at the time of containing Tartrazine bear the warning statement This product. application review Within the EU this generally takes the form of. contains FD C yellow 5 Tartrazine which may cause allergic type. restricting colors such as Tartrazine and other azo colors in. reactions including bronchial asthma in certain susceptible. medicinal products for chronic administration and especially in. medicines for allergic conditions16 persons Although the overall incidence of sensitivity to Tartrazine. in the general population is low it is frequently seen in patients who. The food drug and cosmetic act are also hypersensitive to aspirin19 21. The Food Drug and Cosmetic Act of 1938 created three categories of. Brilliant Blue FCF Erioglaucine Eriosky blue Patent Blue. coal tar dyes of which only the first two are applicable to the. AR E133 Xylene Blue VSG Color Index No CI 42090,manufacture of chewable tablets.
FD C colors These are colorants that are certifiable for use in It can be combined with Tartrazine E102 to produce various. foods drugs and cosmetics shades of green It is widely used in soaps shampoos mouth. D C colors These are dyes and pigments considered safe for washes22 and other hygiene and cosmetics applications It has the. use in drugs and cosmetics when in contact with mucous capacity for inducing an allergic reaction in individuals with pre. membranes or when ingested existing moderate asthma23. External D C colors These colorants due to their oral. toxicity are not certifiable for use in products intended for ingestion Titanium Dioxide TiO2 Anatase titanium dioxide brookite. but are considered safe for use in products applied externally 17 titanium dioxide E171 Kronos 1171 pigment white 6 rutile. Widely used colorants in pharmaceuticals titanium dioxide Tioxide TiPure titanic anhydride Tronox Color. Index No CI 77891,Beta carotene Beta carotene carotene carotene. E160a TiO2 is also an effective opacifier in powder form where it is. employed as a pigment to provide whiteness and opacity to products. Color Index No CI 75130 natural and CI 40800 synthetic such as paints coatings plastics papers inks foods medicines i e. pills tablets and also in topical pharmaceutical formulations as well. It occurs in the pure state as red crystals when recrystallized from as most toothpastes24. light petroleum It is capable of producing colors varying from pale. Owing to its high refractive index titanium dioxide has light. yellow to dark orange It can be used as a color for sugar coated. scattering properties that may be exploited in its use as a white. tablets prepared by the ladle process However Beta carotene is. very unstable to light and air and products containing this material pigment and opacifier The range of light that is scattered can be. should be securely packaged to minimize degradation It is altered by varying the particle size of the titanium dioxide powder. particularly unstable when used in spray coating processes It is used as a white pigment in film coating suspensions sugar. probably owing to atmospheric oxygen attacking the finely. coated tablets and gelatin capsules Titanium dioxide may also be. dispersed spray droplets,admixed with other pigments. Because of its poor water solubility beta carotene cannot be used to. color clear aqueous systems and cosolvents such as ethanol must be Quinoline Yellow SS Solvent Yellow 33 FD C Yellow 11. used Suppositories have been successfully colored with beta Quinoline Yellow A Yellow No 204. carotene in approximately 0 1 concentration Color Index No CI 47000. Indigo Carmine Indigotine sodium indigotin disulfonate. It is a bright yellow dye with green shade It is insoluble in water but. soluble Indigo blue E132 FD C blue 2, soluble in non polar organic solvents Quinoline Yellow SS is used in. Color Index No CI 73015 spirit lacquers polystyrene polycarbonates polyamides acrylic. resins and to color hydrocarbon solvents It is also used in. It is a dark blue powder Aqueous solutions are blue or bluish. externally applied drugs and cosmetics, purple The primary use of Indigo carmine is as a pH indicator. Indigo carmine is an indigoid dye used to color oral and topical Allura Red AC Allura Red Food Red 17 E129 FD C Red 40. pharmaceutical preparations and also used with yellow colors to. produce green colors Color Index No CI 16035, It is used as a dye in the manufacturing of capsules Indigo It has the appearance of a dark red powder It is approved by the US.
Carmine is also used to color nylon surgical sutures and is used FDA for use in cosmetics drugs and food This colorant may have. diagnostically as a 0 8 w v injection slightly less allergy or intolerance reaction by aspirin intolerant. people and asthmatics than most of the azo dyes although those. Sunset Yellow FCF Yellow orange S E110 FD C yellow 6. with skin sensitivities should be careful Allura Red has also been. Color Index No CI 15985 connected with cancer in mice Not recommended for consumption. by children It is banned in Denmark Belgium France Germany. It is a reddish yellow powder Aqueous solutions are bright orange. Switzerland Sweden Austria and Norway, colored Sunset yellow FCF is a monoazo dye and is often used in. conjunction with E123 Amaranth in order to produce a brown Quinizarine Green SS Solvent Green 3 Oil Green G D C. coloring in both chocolates and caramel At high concentrations Green 6. Sunset Yellow in solution with water undergoes a phase. change from anisotropic liquid to a nematic liquid crystal This Color Index No CI 61565. occurs between 0 8 M and 0 9 M at room temperature18. It is a green dye an anthraquinone derivative It has the appearance. Tartrazine Hydrazine yellow E102 FD C yellow 5 of a black powder with melting point of 220 221 C It is insoluble in. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. water It is used for adding greenish coloring to materials It is used Iron oxides are widely used in cosmetics foods and pharmaceutical. in cosmetics and medications25 applications as colorants and UV absorbers As inorganic colorants. they are becoming of increasing importance as a result of the. Iron Oxides limitations affecting some synthetic organic dyestuffs However iron. Iron oxide black CI 77499 Iron III oxide hydrated CI 77492 oxides also have restrictions in some countries on the quantities that. Iron oxide red and Iron oxide yellow monohydrate are the various may be consumed and technically their use is restricted because of. iron oxides used in pharmaceutical preparations their limited color range and their abrasiveness. They occur as yellow red black or brown powder The color Other than the above mentioned colorants there are many more. depends on the particle size and shape and the amount of combined colorants were under practice the status of these color additives. water was described in Table 3, Table 3 Status of color additives code of federal regulations 4 1 87. Color Used for, FD C Blue No 1 May be used for coloring drugs in amounts consistent with cGMP. FD C Blue No 2 May be used for coloring drugs in amounts consistent with cGMP. D C Blue No 4 May be used in externally applied drugs in amounts consistent with cGMP. D C Blue No 9 May be used for coloring cotton and silk surgical Sutures including sutures for. ophthalmic use in amounts not to exceed 2 5 by weight of the suture. FD C Green No 3 May be used for coloring drugs in amounts consistent with cGMP. D C Green No 5 May be used for coloring drugs in amounts consistent with cGMP. May be used in externally applied drugs in amounts not exceeding 0 01 by. D C Green NO 8 weight of the finished product, D C Orange No 4 May be used for coloring externally applied drugs in amounts consistent with.
D C Orange No 5 May be used in mouthwashes and dentifrices and for externally applied drugs. in amounts not to exceed 5 mg per daily dose of the drug. D C Orange No 10 May be used for coloring externally applied drugs in amounts consistent with. D C Orange No 11 May be used for coloring externally applied drugs in amounts consistent with. D C Orange No 17 May be used for coloring externally applied drugs in amounts consistent with. FD C Red No 3 May be used for coloring ingested drugs in amounts consistent with cGMP. FD C Red No 4 May be used for externally applied drugs in amounts consistent with cGMP. D C Red No 6 May be used for coloring drugs such that the combined total of D C Red No 6. and 7 does not exceed 5 mg per daily dose of the drug. D C Red No 7 May be used for coloring drugs such that the combined total of D C Red No 6. and 7 does not exceed 5 mg per daily dose of the drug. D C Red No 8 May be used for coloring ingested drugs in amounts not exceeding 0 1 by. weight of the finished product and for externally applied drugs in amounts. consistent with cGMP, D C Red No 9 May be used for externally applied drugs in amounts consistent with cGMP. D CRedNo 17 May be used for externally applied products in amounts consistent with. D C Red No 19 May be used for externally applied products in amounts consistent with. D C Red No 21 May be used for coloring drug product in amounts consistent with cGMP. D C Red No 22 May be used for coloring drug product in amounts consistent with cGMP. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. D C Red No 27 May be used for coloring drug product in amounts consistent with cGMP. D C Red No 28 May be used for coloring drug product in amounts consistent with cGMP. D C Red No 30 May be used for coloring drug product in amounts consistent with cGMP. D C Red No 31 May be used for externally applied drugs in amounts consistent with cGMP. D C Red No 34 May be used for coloring externally applied in amounts consistent with cGMP. D C Red No 39 May be used for external germicidal solutions not to exceed 0 1 by weight of. the finished drug product, FD C Red No 40 May be used in coloring drugs Subject to restrictions and in amounts. consistent with cGMP, D C Violet No 2 May be used for coloring externally applied drugs in amounts consistent with. FD C Yellow No 5 In general products containing FD C Yellow No 5 Tartrazine must be so. labeled The Code of Federal Regulations should be consulted for use. restrictions that may be added, FD C Yellow No 6 May be used for coloring drugs in amounts consistent with cGMP.
D C Yellow No 7 May be used for externally applied drugs in amounts consistent with cGMP. D C Yellow No 10 May be used for coloring drugs in amounts consistent with cGMP. D C Yellow No 11 May be used for externally applied drugs in amounts consistent with cGMP. Source Peck Baley McCurdy and Banker Pharmaceutical Dosage Forms Tablets Vol 1 second edition. Coloring systems for various dosage forms 2 Tablet coating. In selecting a colorant for a given application prime consideration 2 1 Sugar coating. should be given to the type formulation in which the colorant is to. The coloring stage is one of the most critical parts of the operation It. be incorporated Whatever the form of colorant chosen it should. gives the tablet its color and in some cases its finished size Here. meet as many characteristics as the ideal colorant. the success measured in terms of the elegance of the final product. 1 Tablets Before the 1950s traditional color coating for solid dosage forms. was usually performed using soluble dyes as the prime colorant. 1 1 Wet granulation This system can produce the most elegant tablet However many. difficulties can arise usually related to the dye being soluble. Dissolving water soluble dyes in a binding solution for the. granulating process is the most common approach to coloring a Color migration readily occurs if the drying stage after each. tablet formulating However during drying of the granulation the application of color is not handled properly This results in non. solution the soluble colors may migrate and if more than one color uniform distribution of color or mottling Small depressions or. is used the dyes may migrate at different rates This results in an irregularities in the surface of the tablet may also cause non uniform. uneven coloring of the granulation which will have a mottled color Many smoothing coats are needed before any color can be. appearance after compression Some additives such as starches applied Care must be taken to ensure that the tablets do not become. clays and talc have been used to adsorb the dye there by reducing over colored Syrups of increasing dye concentrations usually are. but not completely eliminating the migration This entire problem used to achieve a color match and to control mottling This operation. can be avoided by using lakes or other pigments The colors will not may take from20 to 60 applications for the color to develop fully. migrate because they are insoluble In addition the light stability of Dye sugar coating is a very time consuming and delicate operation. the product will be improved, Late in the 1950s the pigment sugar coating process was developed. 1 2 Direct compression and subsequently patented by Arnold Nicholson and Stanley tucke26. The coloring composition of this invention essentially an aluminum. Mainly of the economic reason a growing interest in direct lake and a pacifier dispersed in a syrup solution This system. compression formulas has developed The number of processing produced brightly colored elegant tablets and eliminated many of. steps has been reduced Direct compression formulation requires the problems associated with the standard sugar coating techniques. blending only therefore lakes and other pigments are used because The dusty nature of pigments sometimes requires the use of air. the elimination of the wetting step prevents the effective us of filtration and dust collection systems to avoid contamination of. soluble colors other areas of the plant, The dry coloring of tablets with pigments is not without problems Today there are a number of manufacturers who offer color. Although there is little chance of color migration poor blending of matched pre dispersed pigment sugar coating concentrates These. the pigments into the power can result in color specking and hot concentrates are easily incorporated into the bulk of the syrup. spots This problem can be minimized by pre blending the pigment coating solution The convenience of these concentrates and easily. with a small part of one of the other ingredients before addition to incorporated into the bulk of the syrup coating solution The. the entire mixture to reduce pigment particle agglomeration The convenience of these concentrates and the ability of the. ease with which the pigment can be incorporated into the manufacturers to reproduce color batch after batch make these. formulation may depend on the components in the mixture products an attractive alternative to self preparation of dispersions. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. 2 2 Film coating the desired color should be used because higher concentrations can. results in a dull color Most liquid products have dye concentrations. It resolves many of the problems associated with sugar coating It of 0 001. involves the application of a film forming polymer onto the surface. of substrate such as tablets granules and capsules In addition to If the dye was added directly to the bulk mixing tank the presence of. the polymer it also contains plasticizers and colorants which are small amounts of undissolved material would be difficult to. needed to achieve the desired properties in the final dosage form determine and could cause additional problems later during the. The polymer and the plasticizer are usually dissolved in a solvent to compounding procedure30. form a coating solution in which the colorants can be dissolved or. dispersed The original film coating systems used organic solvents Pigments or dyes can be used for coloring opaque liquids such as. for polymer solution suspensions emulsions or imprinting inks In non aqueous systems. because of solubility restrictions the use of pigments is necessary If. Today aqueous systems have largely replaced the organic solvents pigments are chosen as the colorants it may be necessary to. for environmental reasons When using organic solvents water predispersed them before adding them to the final product. soluble days can be used as colorants However many of the same Concentrated dispersions in a wide variety of vehicles are. problems observed in sugar coating may exist relating to color commercially available. migration on drying of the films Additional because film coatings. are relatively thin small differences in film thickness on tablets may 5 Ointments and salves. result in significant color variation There has been some success in. using pacified dye systems however these systems have been Both dyes and pigments can be used for coloring ointments and. shown to have poorer light stability than pigmented coatings The salves depending on the vehicle Pigments are preferred because. colorants of choice of these applications are lakes and inorganic they will not migrate to the surface To incorporate the pigments. pigments In addition to providing color pigments have been into the system it may be necessary to blend the pigment and the. reported to reduce moisture diffusion through the film and improve product on a roll or ointment mill31. light stability as compared with dye27,6 Tooth pastes. Commercially available pre dispersed color mattered pigment. concentrates are recommended for use These concentrates are A major problem impacting the aesthetic appearance of striped. available both in liquid and in dry forms The dry forms may contain toothpaste is the bleeding or migration of color from one component. all of the components needed for a total film coating system that can into another This is especially severe if one colored component is. be dispersed in water or to her solvents directly at the coating pan applied to the surface of a white base For this reason a colorant that. exhibits substantially no visible bleeding is required. 3 Capsules, The high density polyethylene entrained colorants of the present.
3 1 Hard gelatin capsules invention unexpectedly are substantially non bleeding when present. The capsules are colored primarily using FD C or D C colorants in conventional toothpaste or gel formations particularly when. and sometimes an opacifying agent such as Titanium dioxide The contrasted with similar colorants entrained in wax and synthetic. clear type of capsule is colored using water soluble dyes Solution of polymeric resins including paraffin wax and low density. these colors is simply added to the gelatin melt28 polyethylene For example the colorant may be entrained in the. High Density Polyethylene HDPE matrix using methods of. The pH of the gelatin is important because it can alter the shade of encapsulation32. the color It is also important to control the tackiness of the capsule. wall because variations can change color intensity If the active Blending of colorants. ingredient is photosensitive it is advisable to use an opaque capsule. Color combinations can attract or distract So while blending the. Opaque capsules can contain pigments or dyes and an opacifier The. colorants to produce different shades thorough knowledge about. colorants are usually dissolved or dispersed in water glycerin or. the individual colorant is the prime requirement33. combination of these vehicles before addition to the gelatin mixture. Wall thickness is rarely a factor in determining the shade of an The permitted colors do not always give satisfactory shades when. opaque capsule used alone but most popular tints and shades can be obtained by. blending For example Green S gives a greenish blue solution in. Recent technological advances in the area of spin printing have. distilled water and a more satisfactory green is produced by mixing. allowed some manufacturers to color identify capsules by printing. it with Tartrazine as in Green S and Tartrazine Solution B P C. bands of varying widths and colors on the capsule bodies through. Another example Brilliant Blue FCF can be combined. the use of colored imprinting inks, with Tartrazine E102 to produce various shades of green. 3 2 Soft gelatin capsules or soft gels, The National Formulary of the United States gives information on. Soft Gelatin capsules soft gels are one piece hermetically sealed the proportion of various water soluble and oil soluble dyes. soft gelatin shells containing a liquid a suspension or a semisolid necessary to give particular hues to liquid preparations and drug. Color used in shell has to be darker than color of encapsulating powders. material colors may be natural or synthetic29, Generally Spectral imaging can be used to identify and quantify the. Opacifier usually Titanium dioxide may be added to produce an colorant in tablets Combining colorant information with other. opaque shell when the fill formulation is a suspension or to prevent physical and chemical characteristics can provide a powerful. photo degradation of light sensitive fill ingredients Concentration of comparison of tablets34. opacifier may be up to 0 5, Colorants should be protected during processing use and. 4 Liquid products storage against, Dyes should be used that are completely soluble in the particular Oxidizing agents especially chlorine and hypo chlorites.
solvent and at the required concentration Many times dyes that Reducing agents especially invert sugars some flavors. correspond to the flavor of the product for example red for cherry metallic ions especially aluminum zinc tin and iron and. or yellow for lemon will be chosen Factors influencing the shade ascorbic acid. and stability of dyes in the liquid system must be carefully Microorganisms especially mold and reducing bacteria. considered as well These properties are pH microbiological activity Extreme pH levels especially FD C Red 3 which is insoluble. light exposure in the final product package and the compatibility of in acid media and Should not be used below pH 5 O Also. the dye with other ingredients When formulating liquid products effects of fading agents such as metals are greatly enhanced by. with dyes the lowest possible concentration of dye needed to give either very high or low pH values. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. The negative activity of reducing and oxidizing agents is suppliers to develop and test Non absorbable dyes which are. greatly enhanced by elevated temperatures considered safer by virtue of their non absorption from the. Exposure to direct sunlight FD C Red 40 and FD C Yellow gastrointestinal tract. 5 have moderate stability to light while FD C Blue 2 and. FD C Red 3 have poor light stability It is important to Stability and storage conditions. minimize the exposure of products to direct sunlight. especially products containing dye blends35 Pharmaceutical coloring agents form a chemically diverse group of. materials that have widely varying stability properties36 Specific. Concerns still persist about the safety of absorbable dyes despite information for selected colors is shown in Table 4. Completed studies done so far This has led dye manufacturers and. Table 4 Stability properties of some major colorants. Color Heat Light Acid Base Oxidizing agents Reducing agents. Brilliant blue FCF Good Moderate Very Good Moderate Moderate Poor. Indigo Carmine Good Very Poor Moderate Poor Poor Good. FD C green 3 Good Fair Good Poor Poor Very Poor, Erythrosine Good Poor Insoluble Good Fair Very Poor. Allura red AC Good Moderate Good Moderate Fair Fair. Tartrazine Good Good Good Moderate Fair Fair, Sunset Yellow Good Moderate Good Moderate Fair Fair. D C yellow 10 Good Fair Good Moderate Poor Good, Source Raymond C Rowe Paul J Sheskey and Sian C Owen Hand book of Pharmaceutical excipients. While some colors notably the inorganic pigments show excellent Tartrazine FD C yellow 5 has also been the subject of. stability other coloring agents such as some organic colors have controversy over its safety and restrictions are imposed on its use. poor stability properties but are used in formulations because of in some countries In general concerns over the safety of coloring. their low toxicity37 Lakes inorganic dyes and synthetic dyes should agents in pharmaceuticals and foods are associated with reports of. be stored in well closed light resistant containers at a temperature hypersensitivity42 44 and hyperkinetic activity especially among. below 30 C children45 In the USA specific labeling requirements are in place for. prescription drugs that contain Tartrazin as this color was found to. For most natural and nature identical colors the storage conditions be the potential cause of hives in fewer than one in 10 000 people In. are more stringent and a manufacturer s recommendations for a the EU medicinal products containing Tartrazine Sunset yellow. particular coloring agent should be followed To extend their shelf Carmoisine Amaranth Ponceau 4R or brilliant black BN must carry. life some natural colors are supplied as gelatin encapsulated or a warning on the label concerning possible allergic reactions The. similarly encapsulated powders and may be sealed in containers use of Tartrazine is banned in Norway. under Nitrogen,Handling precautions, To compensate for losses due to fading and other dye loss during.
processing and storage some formulators add a slight excess of dye Pharmaceutical coloring agents form a diverse group of materials. at the beginning This approach should be cautiously employed since and manufacturers data sheets should be consulted for safety and. one can obtain unattractive shades when too much color is added at handling data for specific colors. the beginning in an attempt to provide for time dependent or. processing color loss Regulations covering all aspects of colorants In general inorganic pigments and lakes are of low hazard and. including their procedures for use provisionally and permanently standard chemical handling precautions should be observed. certified and uncertified color additives and use levels and depending upon the circumstances and quantity of material handled. restrictions for each coloring additive are covered in the Code of Special care should be taken to prevent excessive dust generation. Federal Regulations 21 CFR parts 70 through 82 and inhalation of dust. Safety The organic dyes natural colors and nature identical colors present. a greater hazard and appropriate precautions should accordingly be. Toxicology studies are routinely conducted on an ongoing basis by taken46. organizations such as the World Health Organization WHO the US. Food and Drug Administration FDA and the European Commission CONCLUSION. EC The outcome of this continuous review is that the various The colorants works as the cosmetics for the pharmaceutical. regulatory bodies around the world have developed lists of formulations thus selection of appropriate colorant for a specific. permitted colors that are generally regarded as being free from pharmaceutical dosage form plays an important role in. serious adverse toxicological effects However owing to the manufacturing of the pharmaceutical dosage forms Since most of. widespread and relatively large use of colors in food a number of the colorants are extremely effective only minute amounts are. coloring agents in current use have been associated with adverse necessary to produce the desired color The Color consistency is. effects although in a relatively small number of people 38 39 important as it allows easy identification of a medication and. Allura Red AC is not recommended for consumption by children It is responsible for the dosage form s aesthetic appearance. banned in Denmark Belgium France Switzerland and Sweden40. As we can see selection of colorants for use in global drug. The lake of erythrosine FD C red 3 for example has been development can be very complicated and time consuming With the. delisted in the USA since 1990 following studies in rats that differences in colorant regulations worldwide and the need for. suggested that it was carcinogenic This delisting was as a result of various performance attributes based on the dosage form there are. the Delaney Clause which restricts the use of any color shown to numerous considerations that must be assessed Restrictions or. induce cancer in humans or animals in any amount However bans on the use of some coloring agents have been imposed in some. erythrosine was not regarded as being an immediate hazard to countries while the same colors may be permitted for use in a. health and products containing it were permitted to be used until different country As a result the same color may have a different. supplies were exhausted41 regulatory status in different territories of the world. Allam et al,Int J Pharm Pharm Sci Vol 3 Suppl 3 2011 13 21. Therefore it is important that appropriate expertise be consulted 24 Titanium dioxide Wikipedia the free encyclopedia. before finalizing colorant selection to help prevent future 25 http en wikipedia org wiki Titanium dioxide. development or registration problem 26 Quinizarine Green SS Wikipedia the free encyclopedia. 27 http en wikipedia org wiki Quinizarine Green SS. REFERENCES 28 Nicholson A E Tucker S J Coloring Solid Pharmaceutical Forms. 1 David R Schoneker Coloring Agents for Use in Pharmaceuticals and Compositions US Patent 2 925 365 February 16 1960. Color con Inc West Point Pennsylvania U S A 29 Porter S C Effect of additives on properties of an aqueous film. 2 Peck Baley McCurdy and Banker Pharmaceutical Dosage coating Pharm Technol 1980 4 3 66. Forms Tablets Vol 1 second edition 116 117 30 Encyclopedia of Pharmaceutical Technology Third Edition Vol 1. 3 Grace Frimpong MRS Investigating the suitability of HIBISCUS 421. SABDARIFFA CALYX extract as Coloring agent for Pediatric 31 Yousry Naguib Soft Gel Capsules An Elegant Versatile. syrups July 2008 44 Dosage Form SIE Supplement Industry Executive. 4 Rowe RC The opacity of tablet film coatings J Pharm 32 Jagdish Parasrampuria Stephen William Pitt Liquid Oral. Pharmacol 1984 36 569 572 PubMed Preparation Johnson Johnson Skillman New Jersey U S A. 5 Aspects of Color Frank Vodvarka Associate Professor of Fine 33 David R Schoneker Coloring Agents for Use in. Arts Loyola University Chicago Pharmaceuticals Colorcon Inc West Point Pennsylvania. 6 Kendra Cherry About com Guide Color Psychology How Colors U S A. Impact Moods Feelings and Behaviors 34 Wong Mike North Brunswick NJ Prencipe Michael West. 7 Grace Frimpong MRS Investigating the suitability of HIBISCUS Windsor NJ Striped toothpaste stable to color bleeding United. SABDARIFFA CALYX extract as Coloring agent for Pediatric States Patent 5876701. syrups July 2008 45 46 35 http www wilsonhurst com grap 4200 lectures 06 20Col. 8 All about lake pigments Technical Bulletin Warner Jenkinson or 20Psychology pdf. Company St Louis MO 36 Gerda Edelman Martin Lopatka Maurice Aalders. 9 Mendes et al Pharmaceutical Dosage Forms Tablets Vol 1 Identification and quantification of colorants in ecstasy tablets. second edition 392 394 by hyper spectral imaging FTC. 10 Pharmaceutical Dosage Forms Tablets Vol 1 second http iasim s3 amazonaws com Thursday. edition 394 395 pm O10 Edelmann ecstasy pdf, 11 Marmion DM Handbook of US Colorants for Foods Drugs and 37 Mendes et al Pharmaceutical Dosage Forms Tablets Vol 1. Cosmetics 3rd edn New York Wiley Interscience 1991 second edition 393. 12 Loyd V Allen Nicholas G Popovich Howard C Ansel Ansel s 38 Woznicki EJ Schoneker DR Coloring agents for use in. pharmaceutical dosage forms and drug delivery systems pharmaceuticals In Swarbrick J Boylan JC eds Encyclopedia of. Edition 8 2005 Pharmaceutical Technology New York Marcel Dekker vol 3. 13 Cooper and Gunn s Dispensing for pharmaceutical students 1990 65 100. 12th edition 47 50 39 Delonca H Laget J P Saunal H Ahmed K Stability of principal. 14 Raymond C Rowe Paul J Sheskey and Si n C Owen tablet coating colors II effect of adjuvants on color stability in. Pharmaceutical excipients 507 French Pharm Acta Helv 1983 58 332 337. 15 European Commission Opinion on toxicological data colouring 40 Weiner M Bernstein IL Adverse Reactions to Drug Formulation. agents for medicinal products adopted by the Scientific Agents a Handbook of Excipients New York Marcel Dekker. Committee on Medicinal Products and Medical Devices 1998 1989 159 165. 16 Raymond C Rowe Paul J Sheskey and Si n C Owen 41 Smolinske SC Handbook of Food Drug and Cosmetic Excipients. Pharmaceutical excipients 508 509 Boca Raton FL CRC Press 1992. 17 Mendes et al Pharmaceutical Dosage Forms Tablets Vol 1 42 E129 UK Food Guide a British food additives website Last. second edition 392 retrieved 20 May 2007, 18 Raymond C Rowe Paul J Sheskey and Si n C Owen 43 Blumenthal D Red No 3 and other colorful controversies FDA. Pharmaceutical excipients 510 520 Consumer 1990 21 18. 19 Chaffee FH Settipane GA Asthma caused by FD C approved 44 Bell T Colourants and drug reactions letter Lancet 1991. dyes J Allergy 1967 40 65 72 338 55 56 PubMed, 20 Bernstein IL Gallagher JS Johnson H et al Immunologic and 45 L vesque H Moore N Courtois H Reporting adverse drug. nonimmunologic factors in adverse reactions to tartrazine In reactions by proprietary name letter Lancet 1991 338 393. Asher IM eds Proceedings 4th FDA Science Sympposium U S PubMed. Govt Printing Office Washington DC 1980 258 260 46 Dietemann Molard A Braun JJ Sohier B Pauli G Extrinsic. 21 Spector SL Wangaard CH Farr RS Aspirin and concomitant allergic alveolitis secondary to carmine letter Lancet 1991. idiosyncrasies in adult asthmatic patients J Allergy Clin 338 460 PubMed. Immunol 1979 64 500 506 47 Pollock I Young E Stoneham M et al Survey of colourings and. 22 LISTERINE Antiseptic Mouthwash SMART RINSE preservatives in drugs Br Med J 1989 299 649 651. WHITENING ADVANCED Fluoride Rinse and Tartar 48 Raymond C Rowe Paul J Sheskey and Si n C Owen Coloring. Protection Products Listerine com Retrieved 2009 07 31 Agents Pharmaceutical Excipients 508. 23 J Allergy Clin Immunol VOL 64 ISS Jul 1979 32 37.

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