Topics Covered

1. Introduction 2. Baby Care Products 3. Quality Control of Cosmetics 1. General Evaluation 2. Qualitative Analysis 3. Microbiological Evaluation 4. Dermatotoxicological Studies 1. Safety Evaluation 2. Efficacy Evaluation 5. Conclusion

1. Introduction
Cosmetic Greek word Kosmein = to adron Def. Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance Cosmeceutical popularized by Albert Kligman to bridge the gap between Cosmetics and Pharmaceuticals Make Up used to connote Cosmetics poet Richard Cranshaw

1.1 Biology and Structure of Skin

Epidermis showing four layers and corresponding four important cells

1.2 Pediatric Skin Care

Anatomical Differences between Baby & Adult Skin Cells normal number Melanocytes less pigmented Dermis fibroblasts less in number Hypodermis adipoblasts small size, triglyceride Hair very thin, faintly pigmented

1.2 Pediatric Skin Care

Physiological Differences Between Baby & Adult Skin Dermal Absorption Pharmacokinetic parameters Diaper Area & Non-Diapered Area TEWL pH

2. Baby Care Products

Intended for use on new born babies to children upto 5 years Functional rather than decorative Criteria for consideration during development High quality raw material Non irritant substances Allergen free pH- skin friendly Addition of anti-oxidants, chelating agents, skin barrier protective ingredients

2.1 Baby Cosmetics Types

Cleansing cosmetics Bath products Soaps & Syndets Shampoos Cleansing Milk Baby Wipes Protective Cosmetics Face/Body Creams Baby Oil Baby Powder

2.2 Baby Shampoo

pH : 6-7 Mild surfactants (e.g. non ionics & amphoteric) Avoidance of eye contact - Polysorbate 20 & PEG 600 distearate controls viscocity

2.2 Baby Shampoo - Formulation

Magnesium Laureth Sulfate Cocamidopropryl Betaine Polysorbate 20 mild foaming agent Amphoteric Surfactant non ionic detergent

PEG 600 Distearite

Tetrasodium EDTA Citirc Acid
Ingredients Magnesium Laureth Sulfate (27.5%A) Cocamidopropyl Betaine (30%A) Polysorbate 20 PEG 600 Distearate Preservative Perfume Citric Acid to pH 6.0 Colour Water (deionized)

Emulsifier
Chelating Agent Buffering Agent
%w/w 11.00 5.00 1.00 3.50 q.s. q.s. q.s. q.s. 100.00

2.3 Body Cream

Face/Body Moisturizing effect Napkin Zone protect from aggressions O/W cream W/O cream or water free ointment talc, kaolin, ZnO Barrier Creams winter

2.3 Body Cream Formulation

Water Glycerine, propylene Glycol Mineral Oil, petrolatum Cetyl Alcohol, Stearyl Alcohol, Stearic Acid EDTA Dimethicone (silicone)
Ingredient Mineral Oil Pertrolatum Stearic acid Stearyl alcohol Cetyl alcohol Triethanolamine Propylene glycol Water Perfume, preservatives, etc.

Vehicle Humectant Prevents water loss Emulsifiers Prevents rancidity Gives silky feel
Wt % 30.00 2.00 1.20 1.00 0.70 0.65 1.00 63.45 q.s.

2.4 Baby Oil

Cleansing and Moisturizing effect

Mineral Oil Type

Natural Veg Oil Type

High Moisturizing effect Clogs the pores prevents natural release of toxins If accidentally ingested vitamin deficiencies

Low Moisturizing effect More therapeutic effect

2.4 Baby Oil - Formulation

Mineral Oil Ingredient Mineral Oil Octyl palmitate Wt% 70.00 5.00 Vegetable Oil Caprylic/Capric Triglyceride

Coconut nucifera (Coconut) Oil

Gardenia tahitensis Flowers (Monoi) Persea gratissima (Avocado) Oil Prunus ameniaca (Apricot) Kernel Oil Camellia sanqua Oil Lavandula angustifolia (Lavender) Oil

Isopropyl myristate
Cyclomethicone Perfumes, solubilisers, antioxidants, etc.

10.00
15.00 q.s.

Anthemis nobilis (Chamomile)Oil

Simmondsia chinensis (Jojoba) Oil Tocopherol (Natural Vitamin E)

2.5 Baby Powder

Absorb Moisture Prevent irritation of fragile skin Talc need sterilization Contamination with Clostridium tetanie NZ 4 child deaths Britain 2 child deaths

2.5 Baby Powder - Formulation

Ingredient Talc Starch Zinc Oxide Perfume Wt% 77.90 20.00 2.00 0.10

3. QUALITY CONTROL OF COSMETICS

Quality Control - Quality Control is the process involved within the system to ensure job management, competence and performance during the manufacturing of the product or service to ensure it meets the quality plan as designed. Quality control Includes 1. General Pharmaceutical Evaluations of Baby Cosmetics 2. Qualitative Analysis of Various Classes of Cosmetic Compounds 3. Stability Studies

3.1 General Pharmaceutical Evaluations of Baby Cosmetics

Evaluation of Baby Shampoos Clarity Viscosity pH Surface Tension Detergency & Cleansing Action Foam Quality Wetting Action

3.1.1 Evaluation of Baby Shampoos

Clarity Cloud point & Clear point - difference 100C Viscosity Rotational Viscometer 1- 100 rpm @ 23.20.40C 500-1500 cps pH pH meter, undiluted shampoo 6.5-8.5 Surface Tension Traube Stalagmometer, 10% shampoo (200C) =
. . . . . 2

3.1.1 Evaluation of Baby Shampoos

Detergency & Cleansing Action Gravimetric method - % sebum removed after washing is calculated Foam Quality Foam Volume DLS stirrer, 500 rpm, 10 sec Foam Density rubber stopper method Wetting Action Canvas Disc sinking test time reqd. to sink disc

3.1.2 Evaluation of Baby Creams

pH pH meter 4.5 6 (skin pH) Viscosity Brook-Field Viscometer, spindle no. S-06 Spreadability Parallel plate method
=

Centrifugation Test 5000 rpm, 10 min (200C) = effect of gravity for 1 yr. 24 hr, 7, 14, 21, 28 days no phase separation

3.1.2 Evaluation of Baby Creams

Rheological Studies Beaker inclined checked for consistency Electrophoretic properties Zeta potential assess flocculation sign of oil droplet aggregation and instability Determination of Total Fatty Substance Oil phase extracted with ether extracts filtered and weighed.

3.1.3 Evaluation of Baby Powders

Determination of matter insoluble in boiling water
1g (wetted with spirit) + 200ml H2O boiled filtered - dried and weighed

Test for solubility of colors

1g + 50ml H2O boiled filtrate 10ml soln. + 15 ml spirit (reflex & filtered) colorless/faintly colored

Determination of fineness
10g in 150 sieve running tap water residue dried & weighed

Determination of moisture and volatile matter

5g in porcelain dish dried & weighed

Determination of pH of aq. Suspension

10g + 90ml H2O suspension(within 5min) pH meter

3.1.3 Evaluation of Baby Powders

Pay off
Measure of adherence to the puff or skin Incorrect compaction, adversely effects this pressure

Pressure Testing
Penetrometer Penetration of a sharp metal point into pressed powder

Breakage Testing
Godet dropped onto a wooden board from 8-10 in. height chip or break

3.1.4 Evaluation of Baby Oils

Refractive Index (R.I.) measure of purity Melting point Capillary tube method Slip melting point method Wiley melting point method Iodine Value measure of degree of unsaturation
= ( ) 12.69 . ()

Peroxide Value degree of lipid oxidation

= 1000 . ()

3.2 Qualitative Instrumental Analysis

1. 2. 3. 4. Analysis of Actives Analysis of Surfactants Analysis of Preservatives Analysis of Residual Toxic Compounds

3.2.1 Analysis of Actives

Analyte 2- Chloro Ethanol Glycerine Sample Shampoos Hair Care Products Technique GC Volumetry

Aloins
Alkanol Amines Carbocysteine Quaternary Ammonium Compounds

Skin Care
Shampoos Shampoos Hair Care

GC-MS
LC UV/Visible LC

N-Nitrosodiethanol amine

Shampoos Cream Emulsions

Shampoos Creams Gels Shampoos Lotions Elements

LC & GC

Glycolic Acid

LC

EDTA Vitamins A,C,E

LC LC

Antimony
Selenium Lead

Shampoos
Shampoos Talcum Powder Shampoos

VU/Visible Electro Chemical

UV/Visible LC UV/Visible FAAS ETAAS LC Volumetry

Zinc Pyrithione

Shampoos

3.2.2 Analysis of Surfactants

Amphoteric Surfactants
Surfactant Cocoamidopropyl Betaine Matrix Baby Bath Baby Shampoos Other Facial Cleansers Baby Bath Technique LC FTR - ATR NIR

Coco Betaine

3.2.3 Analysis of Preservatives

3.2.3 Analysis of Preservatives

Preservatives Parabens Ethyl Matrix Sample Preparation Analytical Technique (Methyl Benzyl) Butyl Shampoo Body Lotion Sample extraction with H2O:MeCN by Vortex mixer and heating One gram of sample is diluted in 10 ml of THF:H2O mixture derivitized with 2,4 dinitrophenyl hydrazine in acidic medium and then is buffered to pH 6-8

LC-UV/V, C18 Column

Formaldehyde Imidazolidmyl urea

Different Cosmetics

LC-UV/V, C18 Column & H2O:MeCN(30:70) as mobile phase

Quaternery Ammonium Compounds

Creams

Homogenization with MeOH or 0.1M HCl acidified MeOH, centrifuged and submitted to a cation exchange catridge. Eluate is evaporated and redissolved in MeOH for running TLC

TLC-UV/V

Benzethonium Chloride BenzoicAcid Chlorphenesin DMDMH Methylisothiazoline

Different Cosmetics

TLC, in Si & Al plates, with Ethylacetate:isopropylether:ETOH:25 %NH3 as eluent

3.2.4 Analysis of Toxic Residual

Residual Compound Residual Compound formed during the synthesis of

Compounds
Technique

1,4 dioxane

Ethoxylated Alcohols and GC Ethoxylated Alkyl Amines GC-MS LC Reaction between amines with nitrating agents Ethoxylation process Betane Cocoamidoporpyl betaine Betane Cocoamidoporpyl betaine Chemiluminiscence detector TEA coupled with GC/LC LC-UV LC-UV

N-Nitrosamines

Formaldehyde Sodium monochlorate

Dicholoroacetic acid

GC

3.3 Microbiological Evaluation

I. Test for microbial count II. Investigation for the presence of specific microorganisms III. PET (Preservative Efficacy Test)

Establishment of microbial limits i. Products of baby, eye, mucus membrane 100 cfu/g in 0.5g of product ii. Other products 1000 cfu/g in 0.1 g of product iii. Pathogenic microorganisms Pseudomonas aeruginosa, Staphylococcus aureus and C. albaicans must not be detected in above two products

3.3.1 Test for microbial count

Sample Preparation
10% homogenous soln./suspension prepared with sterile buffered peptone saline soln. at pH 7 Non soluble products - 0.1% Tween 80

Bacterial and Fungal Counts

1ml soln. + 15ml melted agar Bacteria TSA 30-350C for 5 days Yeast and moulds SCA - 20-250C for 5-7 days Anaerobic plate count used for talcs and powders
Clostridium tetani MLA, preredused 5% defibrinated sheep blood Anaerobic jar (5-10% CO2) Subcultured - cooked meat broth incubated at 350C for 2 days Detection - differential spore stain

3.3.2 Investigation for the presence of specific microorganisms

Enterobacteria and other gram-negative organisms
1ml soln. + 100ml EEB (Entirobacteria Enrichment Broth) incubated 35-370C for 24-48 hrs. Subcultured - VRBG agar - 35-370C for 18-24 hrs. Detection

Escherichia coli
1ml + 100ml Mac Conkey broth 43-450C for 18-24 hrs. Subcultured - Mac Conkey agar 43-450C for 18-24 hrs. Lactose fermenting gm ve detected

Pseudonomas aeruginosa
1ml + 100ml TSB - 35-370C for 24-48 hrs. Subcultured - Cetrimide agar - 35-370C for 24-48 hrs. Detection

3.3.2 Investigation for the presence of specific microorganisms

Staphylococcous aureus
1ml + 100ml TSB - 35-370C for 24-48 hrs. Subcultured - Baird Parker agar - 35-370C for 24-48 hrs. Detection

Molecular Diagnosis
Very rapid (27 hrs.) ATP bioluminiscence PCR Assay

3.3.3 Preservative Efficacy Test

4. DERMATOTOXICOLOGICAL STUDIES
Safety Evaluation Acute systemic toxicity Skin corrosion/irritation Eye irritation Skin absorption Miscellaneous Efficacy Evaluation Stratum Corenum Moisture TEWL

4.1 Safety Evaluation

Ban on animal testing Aim for non-animal testing 3 Rs
Reduction (animal number) Refinement (reducing the pain and distress) Replacement (animals by non-sentient material)

4.1 Safety Evaluation

Acute Toxicity NRU cytotoxicity assay Skin Irritation
Alternative test EPISKINTM human skin model (commercial system) EpiDermTM human skin model (commercial system) Test system Reconstructed human epidermal Reconstruced human epidermal Endpoints Cell viability (MTT-test) Cell viability (MTT-test)

SkinEthicTM human skin model (commercial system)

Mouse skin integrity function test (SIFT) Non-perfused pig ear test

Reconstructed human epidermal

Excised mouse skin Pig ear

Cell viability (MTT-test)

Transepidermal water loss (TEWL) and electrical resistance TEWL

4.1 Safety Evaluation

Eye irritation test
Alternative tests Bovine corneal opacity and permeability (BCOP) test Isolated rabbit eye (IRE) test Chicken enucleated eye test (CEET) Hens egg test chorioallantoic membrane (HET-CAM) Test system Excised cornea from the bovine eye IRE corneal swelling IRE corneal swelling Hens egg CAM Endpoint Opacity and permeability of the cornea Corneal opacity and fluorescein retention Corneal opacity and fluorescein retention Damage to chicken CAM

4.1 Safety Evaluation

Skin absorption studies

4.1 Safety Evaluation

Comedogenicity Subacute and subchronic toxicity Genotoxicity/mutagenicity UV-induced toxic effects (phototoxicity, hotogenotoxicity, photoallergy) Carcinogenicity Reproductive and developmental toxicity

4.2 Efficacy Evaluation

Features to be evaluated Skin surface moisture Measured Properties Stratum corneum hydration, Cutaneous pH, epicutaneous emulsion quality Technique Corneometry, pHmetry, evaporimetry

Transepidermal water loss Erythema

Perspiration Cutaneous microcirculation

Evaporimetry Laser Doppler velocimetry

5. Conclusion
Baby Cosmetic ingredients mild Non irritant Non allergent Less concentration of preservatives, perfumes Quality is an essential aspect in baby cosmetic products as it effects safety and efficacy