COSMETICS, PREPARATION AND IT'S EVALUATION.

FORMULATIVE PHARMACY

1. Cosmetics 1

2. 2 Cosmetics Cosmetics are substances or products used to enhance or alter the appearance or fragrance of the body. Many cosmetics are designed for use of applying to the face and hair .

3. 3 U.S. FDA The U.S. FDA defines cosmetics as: "intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions”

4. 7 Cosmetics: Formulation and preparation of the following cosmetic preparations: Lipsticks Shampoos cold cream vanishing cream tooth pastes Hair dyes sunscreens

5. 8 LIPSTICKS Lipstick is a cosmetic product containing pigments , oils , waxes and emollients that apply color, texture and protection to lips . some lipsticks are also lip balms , to add color and hydration . These preparation do not damage the skin and are non tacky. They typically involve a color change but also increases shine and smooth out appearance of wrinkles and folds on lips . They are a solid product housed in a molded packaging.

6. 9 HOW LIPSTICKS WORK Lipsticks are made from hydrophobic materials. When the solid formula is applied to lip surface, friction melts it briefly and allow for transfer. The materials cools and reforms creating that sticks to surface due to hydrophobic interactions. Color is a key ingredient of lipsticks. It gives an impression on lip surface. Silicones and oily materials are also added to reflect light and provide shine.

7. COMPOSITION INGREDIENTS STAINING DYES OIL SOLUBLE PIGMENTS INSOLUBLE PIGMENTS TITANIUM DIOXIDE - 0.5-3 (%) - 2 (%) - 8-10(%) - 1-4 (%) 10

8. 11 WAX MIXTURE: gloss and hardness of lipsticks are hardly dependent on characteristics and the quantity of waxes used. So composition of wax is of prime importance. Wax mixture include s White beeswax , Candelilla wax , Carnauba wax, Ozokerite wax, Ceresin wax, Cetyl alcohol and cetostearyl alcohol OILS MIXTURE : the oil mixtures are required to blend properly with waxes to provide a suitable film on lips . It also acts as dispersing agent for insoluble pigments. Ideal mixture is one which enables the product to spread easily. Castor oil, Tetrahydrofurfuryl alcohol and its esters Fatty acids alkyl amides, Paraffin oil, Isopropyl myristate, isopropyl palmitate and butyl stearate.

9. 12 SOLVENTS used are Tetrahydrofurfuryl alcohol and esters Glycerol derivatives Propylene glycol , triethylene glycol, propylene glycol . COLORS: the color of lipstick is most important commercial and appealing view. the color is imparted by 2 ways: By staining the skin with a solution of dyestuff which can penetrate the outer layer of lip skin. By covering lips with colored layer. Commonly used dyes are: Staining dyes( s oluble dyes ) - flourescein, eosin. Insoluble dyestuff and lake colors-calcium, barium, aluminium and strontium.

10. 13 PRESERVATIVES, PERFUMES,SURFACTANTS AND OTHER ADDITIVES: Preservatives are used for prevention of growth of microbes. E.g. methyl / propyl paraben . Perfume is used to mask the odor. Surfactants are used to promote wetting properties. Antioxidants are used to prevent rancidification. – e.g. BHT, BHA. FATS: Petroleum jelly , lanolin , paraffin oil and cocoa butter are used in this category. Provides emollient and lubricating effects.

11. First the raw materials like solvents, oils and waxy material are melted in separate stainless steel container. The solvents and oils are mixed with color pigments. Then the mixture is passed through roller mill grinding the pigments to avoid grainy feel in lipsticks. after the pigment mass is grounded and mixed it and added to hot wax until uniform color and consistency is obtained. MOLDING •Once the lipstick mass is mixed and free of air, it is ready to be poured in tubes. 14

12. 20 CHARACTERISTICS APPEARANCE: It has smooth surface with uniform color . It is free from defects which includes pinholes and grittiness . It should have stable shelf life . And should not eliminate color . It should be dermatological safe , non toxic and non irritant . It must consist of stable color easy to apply and stay on for prolong period of time. Should not be excessive greasy or tacky . It should not melt at high temperature (45 degree) and should not harden at cold temperature (7-10 degree). Selection of color and flavor should be acceptable and pleasant .

13. 21 FORMULATION RELATED PROBLEMS SWEATING: caused due to high oil content or inferior oil binding. BLEEDING: separation of colored liquids from waxy bases. BLOOMING: due to higher percentage of cetyl alcohol . STREAKING: expected to be caused due to titanium dioxide.

14. 22 EVALUATION PARAMETER Melting point evaluation should be done to know the problems during handling and storage. The melting point should generally be above 50 degree Celsius . breaking point of lipsticks should be evaluated for conforming strength of lipsticks. Force of application to evaluate the value of force to apply to surface . Stability is an important evaluation parameter . stability for long time and short time are evaluated.

15. SHAMPOOS 23

16. 25 Shampoo is a preparation meant for cleaning hair of dust, dirt , and also to impart luster and gloss to hair. pH = 5-9 CLASSIFICATION: BASED ON APPEARANCE: clear liquid, liquid creams, clear gels, paste, powder, dry. BASED ON FUNCTIONALITY: conditioning, therapeutic, anti-dandruff, mild(baby), acid-balance shampoos.

17. 26 INGREDIEN T S DETERGENTS: sodium lauryl sulphate, sodium lauryl sarcosinate. FOAM BOOSTERS and STABILIZERS: amide oxides, ethanol amides. CONDITIONING AGENTS/EMOLIENS: glycol esters, lanolin, fatty alcohols . VISCOSITY MODIFIERS/THICKENING AGENTS: methyl cellulose, ethyl cellulose

18. Cold cream and vanishing cream 40

19. 41 Definition A cream is a topical preparation usually for application to the skin. Pharmaceutical creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base. Creams may also contain suitable antimicrobial or preservatives unless the medicaments or basis have sufficient bactericidal and fungicidal activity

20. 42 Types of cream Creams are of two types: Aqueous creams Oily creams. In case of aqueous creams the emulsions are oil-in- water type (Vanishing cream) , and In case of oily creams emulsions are of water-in-oil type (Cold cream).

21. 43 Preparation of creams Preparation of the oil phase : Flake/powder ingredients, sometimes dry blended in advance, are dispersed into mineral oil or silicone oil . Heating may be required to melt some ingredients. Hydration of aqueous phase ingredients : Emulsifiers, thickeners and stabilizers are dispersed into water in a separate vessel. Heating may be required to accelerate hydration. Forming the Emulsion : The two phases are blended under vigorous agitation to form the emulsion. Dispersion of the active ingredient : The active ingredient often makes up only a small proportion of the formulation; this must be efficiently dispersed to maximize yield and product effectiveness.

22. 44 US E S For Vanishing cream Used as adhesive for makeup powders. Reduces loss of moisture from dry skin. Smoothens the skin and keeps it soft. Prevents skin from roughening and chapping. For Cold cream Typically used to cleanse the face off makeup Heavily moisturises dry skin. Can also be used as a balm for dry cracked lips. It can also be used as a shaving cream alternative for men .

23. V A N ISHI N G C R EAM Spread easily & disappear rapidly These creams are composed of emollient ester vanishing creams were advertised as beauty creams , they were also used as a base for face powders . Early loose powders did not adhere well, particularly if the skin had been cleansed with soap and water. Adhesion of the powder was improved if the skin was coated with a surface cream. 45

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25. Cold Cream Dehydrated skin – moisturizing cream Moisturizing cream must provide a non – volatile residual film Humectant in the aqueous phase of the cream 48

26. Properties of a cream 49

27. 50 Materials Active ingredient : Drug or raw materials are used as active ingredient Base : Base is used as carrier of the drug. Preservative : Preservatives are used to protect the drug from microbial content. Antioxidant : It is used to prevent oxidation of the drug that causes degradation. Surfactant : Used to prevent surface tension of two immiscible phases. Complexing agent : It enhances the stability and prolongs action. Viscosity enhancer : Decrease the flow property of creams. Humectants : Protect the drug from moisture.

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29. 53 Evaluation of creams A developed cream formulation is evaluated pharmaceutically for various parameters such as: Rheological properties like apparent viscosity Stability pH External character Spread ability Drug diffusion Stability and primary skin irritation test on animals and healthy human volunteers

30. Toothpastes (Dentifrices) A dentifrice is a substance used with a toothbrush for the purpose of cleaning the accessible surfaces of the teeth (American Dental Association) or Paste or gel cleaner used to clean and improve the aesthetic or pleasing appearance and health of teeth . 58

31. 59 How does toothpaste work on our teeth? Abrasives —Most toothpaste contain abrasive ingredients that help scrub away stains and plaque on your teeth . The abrasives have to be harsh on plaque but gentle on your teeth so it does not damage your enamel. This ingredient also helps to polish your teeth so they look fresh and clean after you brush your teeth

32. 60 Common Ingredients in Toothpastes AND THEIR USES Con s titue n t Abrasive Water Humectants Detergent Thickening agent Flavoring agent Sweetening agent Therapeutic agent(s) Color or preservative 10.Binder Purpose Cleaning/stain removal Solvent for ingredients Provide creamy texture Surfactant/foam builder Controls viscosity Improves taste Enhances flavor Active ingredient(s) Color or preservative Holds ingred. together

33. 61 Good tooth paste parameters Easy to extrude from package Does not run off the toothbrush Holds its shape to a large extend after extrusion 4.Uniform Not too hard Disperses readily while the teeth are being brushed 7.Has shiny surface 8.pH of formulation between 4.0-9.0

34. 77 Hair dyes ⁄ hair colorants Purpose to hide gray colour of hair to change the colour of hair In olden days, naturally occurring hair colouring agent lead sulphides used to colour hair. Also henna, indigo used to colour the hairs.

35. 78 Ideal characteristics of hair dyes: Ideal characteristics of hair dyes Non toxic & non-irritant to skin /hairs. Impart same color which indicate on its label. Easy to apply . Have reasonable stability or shelf life. Not dermatitics sensitizer. The colour that imparts to the hair must be stable to air, light, water & shampoo

36. About our Hair Human hair is made of keratin, water and dead cells Each strand of hair is made up of three layers; Cuticle, Cortex & Medulla 79

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38. 81 CLASSIFICATION OF HAIR DYES: Temporary colorants Semi- permanent colorants Permanent colorants Lightner or bleaches

39. 82 TEMPORARY COLORANTS Imparts colour to the hair for a short time. Washed off during 1st shampoo . It consists of a mixture of a suitable dyestuff with an acid either in powder or liquid form. Examble 1. Powder product simple mixture of dyestuff with citric / tartaric acid in a sachet or capsule. Use : content of package dissolved in 1/2 pint of warm water & solution poured over the wet hair. Mech : Penetration of color to the hair cuticle not to cortex or medulla.

40. 83 SEMI- PERMANENT COLORANTS Gives stronger colour to hairs. Withstand 6-8 subsequent shampoo. It is basic dyestuff of nitro-amino dyes -picric acid (2,4-dinitro-6-aminophenol) 4-nitro-1-2-phenylene diamine :Imparts red or yellow colour. Anthraquinones: gives blue color. ex:-1,4-diamino anthraquinones .

41. 84 Offical FORMULA: Dissolve the dyestuff in a mixture of the alkyolamides& anionic surfactant. Separately dissolve acid & quaternary ammoia. Comp. in the water & add colour to solution while stirring. 1. Quaternary amm.comp 12.0 g 2. Anionic surfactant 9.6 g 3. Lactic acid 4.8 g 4. Alkyloamides 12.0 g 5. Dyes stuff 1.2 g 6. Water 60.4 g

42. 85 PERMANENT COLORANTS used to intensify the natural colour, completely change the colour of hairs give a shade near to natural colour of hair. It includes, Vegetable dyes Ex : Henna: it contains powdered leaves of lawsonia alba, L . spinosa, L. inemis. Henna powder Henna leaves Alcohol Water Perfumes 10 g 44 g 4 5 . 8 g 0.25 g

43. 2.Metallic hair dyes: Metal oxies used to dye hairs. a). Lead dyes: solution of lead acetate & it reduces action of keratin, forms insoluble lead salts. Shades depend on concentration of lead used. Formula Precipited sulphur Lead acetate Glycerine Water 1.3 g 1.6 g 9.6 g 87.5 g b).Bismuth dyes: produce range of color from blond to dark chestnut. Formula A Bismuth citrate 50 gm Formula B Water 50 gm Sodium thiosulphate 6 gm Water 94 gm 86

44. 87 c) Silver dyes The hair 1st treated with aq. ammonia solution of silver nitrate. After that solution of pyrogallol is applied. A greenish black color is produced Formula SO L UTION 1 Silver nitrate 5 gm Ammonium nitrate 3 gm Water To 100 gm Ammonium hydroxide q.S SO L UT I O N 2 Pyrogallol 4 gm Alcohol 46 gm Water 50 gm

45. 88 Ligtner or bleaches It termed as decolorising preparation because they lighten the natural colour. The destruction of melanin caused by use of oxidising agent. Formula This powder mixture is to be mixed with hydrogen peroxide before use. Amm.bicarbonate 20 gm Amm bosulphate 10 gm Light mag carbonate 50 gm Light ca carbonate 20 gm

46. 89 Formulation of hair dyes: The main ingredient of formulation will be; Base: solution, emulsion, gel, powder Dyes: oxidation base Alkali; Ammonia Antioxidant: Ammonium thioglycolate

47. 90 Mechanism of hair dyeing Uses a medium size molecule. causes a slight alkaline reaction to swell the hair shaft , causing the cuticle to rise. This allows some color molecules to enter the cortex , and some to coat the cuticle . A neutral or slightly acid after-rinse is used to stop the alkaline swelling reaction, allow the cuticle to close, and trap the color molecules inside. Less damaging than permanent dyes. Causes a mild chemical and physical change in the hair shaft.

48. 91 E v alu a tio n : Sensitization test Long term toxic effect

49. SUNSCREENS 92