PSMB (PCOS pt.1)

Cosmetics

means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, includes any article intended for use as a component of cosmetic.

Kosm tikos

The word ‘‘cosmetic’’ is derived from the Greek word __

having the power to arrange

Kosm tikos means?

‘‘to adorn’’

kosmein means?

“order, harmony”

kosmos means?

mating and hunting

But the true origin of cosmetics probably lies further still in antiquity, because early cave paintings of 30,000 years ago depict the use of body adornment (rudimentary cosmetics) in the rituals of __.

Flinders Petrie in 1914

Vases of alabaster and obsidian for cosmetics discovered by __ illustrate that the ancient Egyptians were well versed in the use of eye and face paints, body oils, and ointments.

Theophrastus (363–278 BC)

a student of Aristotle, demonstrated considerable knowledge of the compounding of perfumes

Galen of Pergamon (130–200 AD)

The Roman physician, is said to have innovated that timehonored toiletry: cold cream (Cera Alba).

Herodotus (490–420 b.c.)

The Babylonians were said by __ to be well practiced in the use of depilatories and the eye adornment

Alexander the Great (356–323 b.c.)

reported the use of unguents, incense, and other cosmetics by the countries of the Indo-Sumerian civilization

Functional ingredients

are the ones that provide the benefit of cosmetics. They include cleansers (surfactants), conditioning agents, colorants, fragrances, reactive ingredients, film formers, and drug actives. Every cosmetic you’ve ever used or made has at least one functional ingredient.

Aesthetic ingredients

are those that help make delivery of the functional ingredients more acceptable. These are ingredients like solvents, thickeners, preservatives, fragrances, pH adjusters, plasticizers, fillers, appearance modifiers, anti-oxidants, antiirritants, and delivery systems.

Claims ingredients

are ingredients added to a formula at a low level for the primary purpose of getting to put the ingredient name on the label. This includes ingredients like natural extracts, vitamins, proteins, biotechnology, and fanciful made-up ingredient names

Quality Management System

A __ system should be developed, established and implemented as a means by which stated policies and objectives will be achieved. It should define the organisational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management.

Personnel

There should be an adequate number of __ having knowledge, experience, skill and capabilities relevant to their assigned function. They should be in good health and capable of handling the duties assigned to them

Premises

The __ for manufacturing should be suitably located, designed, constructed and maintained

Equipment

should be designed and located to suit the production of the product.

• Design and Construction

• Installation and Location

• Maintenance

three key pillars of Equipment Management mentioned in the guidelines

Sanitation and Hygiene

should be practiced to avoid contamination of the manufacturing of products. It should cover personnel, premises, equipment/apparatus and production materials and containers

• Water

• Verification of materials

• Rejected materials

3 Starting materials

Water

Special Attention should be paid to water, since it is an important raw material. Water production equipment and water systems should supply quality water. Water systems should be sanitized according to wellestablished procedures

Verification of materials

All deliveries of raw materials and packaging materials should be checked and verified for their conformity to specifications and be traceable to the product

Rejected materials

Deliveries of raw materials that do not comply with specification should be segregated and disposed according to standard operating procedures

Batch Numbering System

• Every finished product should bear a production identification number which enables the history of the product to be traced.

• should be specific for the product and a particular batch number shall not be repeated for the same product in order to avoid confusion.

Dry Products

Handling of dry materials and products should be given special attention. Where possible, dust-containing production system, central vacuum system or other suitable methods should be employed.

Wet Products

The used of closed systems of production and transfer is recommended

Labelling and Packaging

• Packaging line should be inspected for clearance prior to operation. Equipment should be clean and functional. All materials and products from previous packaging operation should have been removed.

• Samples should be taken and checked at random during labelling and packaging operations.

• Each labelling and packaging line should be clearly identified to avoid mixup

Quality Control

is an essential part of GMP. It provides assurance that cosmetic products will be of consistent quality appropriate to their intended use.

• Reprocessing

• Returned products

two specific categories of "non-standard" product flow fall under Quality Control management

Internal Audits

may be conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors, if necessary

Storage

• should be of sufficient capacity

• should be designed or adapted to ensuregood storage conditions

Regulatory issuance governing cosmetic product notification

• The company or person responsible for placing the cosmetic products in the market must notify the regulatory authority responsible for cosmetics of each Member State where the product will be marketed, of the place of manufacture or of initial importation before the product is placed in the market, using the Product Notification Form prescribed by the regulatory authority

• The product can only be marketed after notification has been sent to the regulatory authority and acknowledgement has been received

• Aiming to streamline the process by updating the submission of application requirements from the previously manual form to online submissions, the Food and Drug Administration (FDA) allowed online application process.

• This modernization was kickstarted in March 2013 through FDA Memorandum Circular No. 2013- 011

1. Brand Name/Product Name/Product Variants

2. Product Type

3. Particulars of the Product

4. Intended Use

5. Product Presentations

6. Local Company Responsible for Placing the Cosmetic Product in the Market

7. Establishment Information

8. Person Representing the Local Company

9. Product Ingredient List

9 Information should be Declared in the Product Notification

• Submission

• Payment

• Download Result

• Revalidation

Procedures in the Application for Cosmetic Product Notification in the Philippines

The application process has four (4) main parts:

Submission

• This is now done through the FDA’s portal at fda

• Once you have filled up the necessary details of the cosmetic product to be notified, you can submit the application with the FDA through their portal.

Payment

Filing fee depends on the number of years of the validity of the registration

Download Results

• There are instances when the FDA will send an email requiring additional documents or information concerning the application.

• Compliance with the email by submitting the required documents or supplying the needed information is a requisite to the FDAs approval of the notification.

• On the other hand, the failure to comply with the additional documents or information required will lead to the rejection of the application for notification

Revalidation

Acknowledged cosmetic notifications may be revalidated for a new validity date, where the new validity date will be based on the date of submission of the revalidation application

Hair

• is composed primarily of proteins (88%) These proteins are of a hard fibrous type known as keratin

• made up of 20 amino acids

Keratin

is comprised of what we call "polypeptide chains.”

11

Body produces __ of the 20, the remainder must come from diet.

Proteins

are sources of amino acids

Hair Color

All natural hair colors are the result of two types of hair pigments.

Eumelanin

it is the dominant pigment in brown hair, and black hair

Pheomelanin

it is dominant in red hair

• Vellus (lanugo) hair

• Terminal hair

2 types of hair

Vellus (lanugo) hair

short, fine, downy, unpigmented hair on body

Terminal hair

long, thick, pigmented hair found on scalp, legs, arms, and body

straight

If the shaft is round, the hair is __

wavy

If the shaft is oval, the hair is __

curly or kinky

If the shaft is flat, the hair is __

• Shaft

  • Medulla

  • Cortex

  • Cuticle

• Root

  • hair bulb

  • erector pili muscles

Anatomy of hair

• Cuticle

• Cortex

• Medulla

3 main layers of the hair shaft

Cuticle

The outermost layer of the hair

Cortex

The middle layer of hair; a fibrous protein core formed by elongated cells containing melanin pigment

Medulla

Innermost layer; also referred to as the pith (Core) of the hair

• Active-growth phase (ANAGEN)

• Transition phase (CATAGEN)

• Resting phase (TELOGEN)

3 Hair life cycle

Active-Growth Phase (ANAGEN):

this period is 2-5 years before replacement

Transition Phase (CATAGEN)

lasts one or two weeks & hair follicle shrinks about 80%

Resting Phase (TELOGEN)

After five or six weeks, dermal papilla reconnects to base of hair follicle and bloodstream. The hair re-enters the active-growth phase and a new hair begins to from

Shampoo

• is derived from Hindustani chāmpo

• is a hair care product that is used for the removal of oils, dirt, skin particles, dandruff, environmental pollutants and other contaminant particles that gradually build up in hair

• Based on Appearance

  • Powder Shampoos

  • Liquid Shampoos or Lotion

  • Gel Shampoos or Solid Cream

  • Cream Shampoos

  • Oil Shampoos

  • Miscellaneous-anti dandruff, medicated shampoo

• II. Based on Use

  • Conditioning Shampoos

  • Antidandruff and Therapeutic

  • Baby

  • Balancing

  • Clarifying

Classifications of Shampoo

• Water

• Surfactants

• Foam boosters and stabilizers

• Opacifiers

• Clarifying agents

• Antidandruff agents

• Conditioning Agents

• Thickening agents

• Sequestering Agents

Compositions of Shampoos

Hair tonic

• This term has been used for some hair preparations because the term is used in therapeutics. This is one kind of hair repairing tonic and re-texturing the hair. There are two distinct types of products

  • Products those deals with specific problems of the hair. E.g., greasy hair, dandruff.

  • Those products which are intended for improving, restoring, & maintaining the condition of the hair

Medicated products

• The purpose of this products is to cure, to reduce, to restrain & some abnormality in the function of scalp.

• In the past, use was often made of irritant, keratolytic, rubifacient compounds.

• The recent trend is that the treatment should rather bring about a return to a normal state & promote balance.

• Medicated products are mainly deal with dandruff, seborrhea & hair loss.

Conditioners

• are viscous liquid that is applied to the hair & are usually used after washing the hair with shampoo.

• It is designed to restore hair to its natural state.

• It has the ability to repair damage hair by providing shiny look to the hair fibers.

• restores the texture & appearance of the rough & harsh hair.

• are used to render the hair shiny, easy to comb & free from dryness.

1. Pack conditioners

2. Leave in conditioners

3. Ordinary conditioners

3 Types of conditioners

Pack conditioners

• It is heavy and thick.

• A high content of surfactant it is able to bind the hair structure & glue the hair surface scale together & tend to form thicker layer on the hair surface.

• These are usually applied to the hair for a longer time.

Leave in conditioners

• They are thinner & have different surfactants.

• It is lighter, less viscous mixture & provides a significantly thinner layer on the hair.

• This is designed to be used in a similar way to hair oil preventing tangling of hair & keeping it smooth.

Ordinary conditioners

• It combines some aspects of both packs & leave in ones.

• These are generally applied after the use of shampoo.

• Further, it can be characterized into 3 main type

• Moisturizer

• Re-constructers

• Detangles

3 types of Ordinary conditioners

Moisturizers

• These are organic solvent concentrated with humectant.

• Humectant is to retain the moisture into the hair.

• This conditioners may not contain protein.

Re-constructers

• It contains proteins for hydrolization.

• Human hair keratin protein has a low molecular weight.

• This protein penetrates the hair shaft & gives a shiny hair

Detanglers

• These are acidifiers & have low pH.

• The function is to close the cuticle of the hair, which cause tangles.

• The protection or shield mechanism is done by surfactant & polymers.

• Surfactants

• Partially or totally hydrolyzed proteins

• Oily materials

• Glossers

• Humectant

• Thickeners

• Bodying agent

• Perfumes

8 Compositions of Conditioners

The colouring of hair

is one of the most important acts of adornment among those made by men and women since the origin of man

• To change the natural colour

• To colour the white hair which begin to appear with age

• To change the colour of the hair temporarily on a particular occasion

The reasons for getting the hair coloured have been

1. non-injurious to hair shaft

2. no primary irritant action

3. no toxic effect

4. stable to air, sunlight, friction and sweat

5. should not change colour

6. stable over time in the aqueous solutions

7. should not produce different colouration on different parts of the same hair

8. should have affinity for Hair Keratin

8 CHARACTERISTICS OF AN IDEAL HAIR COLOURANT

• Modifiers

• Antioxidants

• Alkali

• Soaps

• Ammonia

• Wetting agents

• Fragrance

7 Raw Materials in Hair dyes

Amino compounds

Dye chemicals are usually __

Modifiers (Resorcinol)

may bring out color tones, such as green or purple, which complement the dye pigment.

Antioxidants (Sodium sulfite)

protect the dye from oxidizing with air.

Alkali (Ammonium hydroxide)

are added to change the pH of the dye formula, because the dyes work best in a highly alkaline composition

• Temporary hair color

• Semi-permanent hair color

• Permanent hair color

3 Types of hair colorant

Temporary hair color

• is available in various product forms including rinses, shampoos, gels, sprays, foams.

• This type of hair color is typically used to give brighter, more vibrant shades or colors such as orange or red.

• they have value in that they can be easily and quickly removed without bleaching or application of a different coloring product.

• These colorants do not penetrate into cortex or medulla.

• As such the dye is easily removed with shampoo so known as temporary hair color

Semi-permanent hair color

• Give stronger & more permanent coloration to hair than temporary hair colorant

• Some colors are removed in 4-8 shampooing

• Mixture is prepared before preparing color shades

• Should be studied on white wool or hair

• has no ammonia

• Nitrophenyledenediamine

• Nitroaminopheols

• Aminoanthraquinones

Dyes used in semi-permanent hair color

• raise the cuticle of the hair fiber so the tint can penetrate

• facilitate the formation of tints within the hair fiber

• bring about the lightening action of peroxide

3 Purpose of Permanent hair color

Permanent Hair color

• these haircolor products and lighteners contain both a developer, or oxidizing agent, and an alkalizing ingredient as part of their ammonia or an ammonia substitute

hydrogen peroxide

Permanent hair color

• When the tint (color) containing the alkalizing ingredient is combined with the developer (usually __), the peroxide becomes alkaline and diffuses through the hair fiber, entering the cortex, where the melanin is located.

• The lightening occurs when the alkaline __ breaks up the melanin and replaces it with new color.

Hair care product performance and safety

ultimately determine product success and longevity. For best market results, precisely planned performance and safety evaluations are required

international regulatory agencies

of product safety to ensure that new-to market products will not pose health risks or harm to consumers

• Phase I: Pre-clinical testing

• Phase II: Clinical study data collection and evaluation

2 Phases of comprehensive hair care product performance testing:

Phase I: Pre-clinical testing

Because hair care products will contact the skin and hair and will likely contact the eyes, __ dermal and ocular toxicity and irritation testing is required early in the safety evaluation process.

Phase II: Clinical Study Data Collection and Evaluation

• Panelists are recruited and scheduled according to the initial study design and timeline.

• Clinical data can vary in type, complexity, and collection intervals

• Trichological (Hair Count) Analysis

• Traction Test

• “Hair Pluck” Test

• Regimented Combing Technique

• Tensile Test

5 Phase II: Hair product performance tests

Trichological (Hair Count) Analysis

determines changes in hair growth patterns. During this test, a trained professional uses a dermascope or videoscope to survey the scalp and record changes in observed hair growth patterns

Traction Test

• is used to measure hair shedding patterns.

• Prior to shampooing, 20-60 strands of subjects’ hair are grasped at the base of the strands and tugged firmly away from the scalp. Active hair shedding is indicated by pulling more than 10% of strands from the scalp.

• Gravimetric pull analysis

• Sabouraud’s' sign

• the pull-out sign

3 Other names of traction test