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

Ingredients %w/w

Magnesium Laureth Sulfate (27.5%A) 11.00

Cocamidopropyl Betaine (30%A) 5.00

Polysorbate 20 1.00

PEG 600 Distearate 3.50

Preservative q.s.

Perfume q.s.

Citric Acid to pH 6.0 q.s.

Colour q.s.

Water (deionized) 100.00

Magnesium Laureth Sulfate mild foaming agent

Cocamidopropryl Betaine Amphoteric Surfactant

Polysorbate 20 non ionic detergent

PEG 600 Distearite Emulsifier

Tetrasodium EDTA Chelating Agent

Citirc Acid Buffering Agent

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

Ingredient Wt %

Mineral Oil 30.00

Pertrolatum 2.00

Stearic acid 1.20

Stearyl alcohol 1.00

Cetyl alcohol 0.70

Triethanolamine 0.65

Propylene glycol 1.00

Water 63.45

Perfume, preservatives, etc. q.s.

Water Vehicle

Glycerine, propylene Glycol Humectant

Mineral Oil, petrolatum Prevents water loss

Cetyl Alcohol, Stearyl Alcohol, Stearic Acid Emulsifiers

EDTA Prevents rancidity

Dimethicone (silicone) Gives silky feel

2.4 Baby Oil

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

Cleansing and Moisturizing effect

2.4 Baby Oil - Formulation

Mineral Oil

Ingredient Wt%

Mineral Oil 70.00

Octyl palmitate 5.00

Isopropyl myristate 10.00

Cyclomethicone 15.00

Perfumes, solubilisers,

antioxidants, etc.

q.s.

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

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 Wt%

Talc 77.90

Starch 20.00

Zinc Oxide 2.00

Perfume 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 @ 23.2±0.40C

500-1500 cps

pH

pH meter, undiluted shampoo

6.5-8.5

Surface Tension

Traube Stalagmometer, 10% shampoo (200C)

𝜎 = 𝜌. 𝑔.𝑉

2. 𝜋. 𝑟. 𝑛

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

𝑆 = 𝑚 × 𝐿

𝑇

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 150µ 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

𝐼𝑜𝑑𝑖𝑛𝑒 𝑉𝑎𝑙𝑢𝑒 =(𝐵 − 𝑆) × 𝑁 × 12.69

𝑆𝑎𝑚𝑝𝑙𝑒 𝑤𝑡. (𝑔)

Peroxide Value – degree of lipid oxidation

𝑃𝑒𝑟𝑜𝑥𝑖𝑑𝑒 𝑉𝑎𝑙𝑢𝑒 = 𝑆 − 𝐵 × 𝑁 × 1000

𝑆𝑎𝑚𝑝𝑙𝑒 𝑤𝑡. (𝑔)

3.2 Qualitative Instrumental Analysis

1. Analysis of Actives

2. Analysis of Surfactants

3. Analysis of Preservatives

4. Analysis of Residual Toxic Compounds

3.2.1 Analysis of Actives Analyte Sample Technique

2- Chloro Ethanol Shampoos GC

Glycerine Hair Care Products Volumetry

Aloins Skin Care GC-MS

Alkanol Amines Shampoos LC

Carbocysteine Shampoos UV/Visible

Quaternary Ammonium Compounds Hair Care LC

N-Nitrosodiethanol amine Shampoos

Cream

Emulsions

LC & GC

Glycolic Acid Shampoos

Creams

Gels

LC

EDTA Shampoos LC

Vitamins A,C,E Lotions LC

Elements

Antimony Shampoos VU/Visible

Electro Chemical

Selenium Shampoos UV/Visible

LC

Lead Talcum Powder

Shampoos

UV/Visible

FAAS

ETAAS

Zinc Pyrithione Shampoos LC

Volumetry

3.2.2 Analysis of Surfactants

Amphoteric Surfactants

Surfactant Matrix Technique

Cocoamidopropyl Betaine Baby Bath

Baby Shampoos

Other Facial Cleansers

LC

FTR - ATR

Coco Betaine Baby Bath NIR

3.2.3 Analysis of Preservatives

3.2.3 Analysis of Preservatives

Preservatives Matrix Sample Preparation Analytical Technique

Parabens

(Methyl Ethyl Butyl

Benzyl)

Shampoo

Body Lotion

Sample extraction

with H2O:MeCN by Vortex mixer and heating LC-UV/V, C18 Column

Formaldehyde

Imidazolidmyl urea

Different

Cosmetics

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 &

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 Compounds

Residual Compound Residual Compound

formed during the

synthesis of

Technique

1,4 – dioxane Ethoxylated Alcohols and

Ethoxylated Alkyl Amines

GC

GC-MS

LC

N-Nitrosamines Reaction between

amines with nitrating

agents

Chemiluminiscence

detector TEA coupled

with GC/LC

Formaldehyde Ethoxylation process LC-UV

Sodium monochlorate Betane

Cocoamidoporpyl

betaine

LC-UV

Dicholoroacetic acid Betane

Cocoamidoporpyl

betaine

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 Test system Endpoints

EPISKINTM human skin model

(commercial system)

Reconstructed human

epidermal

Cell viability

(MTT-test)

EpiDermTM human skin model

(commercial system)

Reconstruced human

epidermal

Cell viability

(MTT-test)

SkinEthicTM human skin model

(commercial system)

Reconstructed human

epidermal

Cell viability

(MTT-test)

Mouse skin integrity function

test (SIFT)

Excised mouse skin Transepidermal water loss (TEWL)

and electrical resistance

Non-perfused pig ear test Pig ear TEWL

4.1 Safety Evaluation

Eye irritation test

Alternative tests Test system Endpoint

Bovine corneal opacity and

permeability (BCOP) test

Excised cornea from the bovine

eye

Opacity and permeability of the

cornea

Isolated rabbit eye (IRE) test IRE corneal swelling Corneal opacity and fluorescein

retention

Chicken enucleated eye test

(CEET)

IRE corneal swelling Corneal opacity and fluorescein

retention

Hen’s egg test – chorioallantoic

membrane (HET-CAM)

Hen’s egg CAM 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 Measured Properties Technique

Skin surface moisture Stratum corneum hydration,

Cutaneous pH,

epicutaneous emulsion quality

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