PHARAMACEUTICAL COSMETICS LABORATORY AND LECTURE PDF

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HANDOUT - PRELIM

OVERVIEW OF COSMETIC SCIENCE

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TOPIC 1: WEEK 2 COSMETIC PRODUCT DEVELOPMENT (LECTURE)

WHAT IS COSMETICS? •

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.

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WHAT IS COSMETIC SCIENCE? •

Cosmetic science is the study of the effects that raw materials and mixtures can have on parts of the human body like hair, skin, lips, and nails. The subject of cosmetic science actually overlaps with a number of sciences including Chemistry, Physics and Biology but also includes softer topics like Marketing and Market Research.

HISTORY OF COSMETIC SCIENCE •

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The word ‘‘cosmetic’’ is derived from the Greek word Kosm tikos, meaning ‘‘having the power to arrange, skilled in decorating giving kosmein, ‘‘to adorn,’’ and kosmos, ‘‘order, harmony’’. 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 mating and hunting. cosmetics have been used with essentially the same three goals in mind, namely: 1. to enhance personal appeal through decoration of the body 2. to camouflage flaws in the integument 3. to alter or improve upon nature Several historical vignettes showing the role of cosmetics down through the ages: ✓ Vases of alabaster and obsidian for cosmetics discovered by Flinders Petrie in 1914 illustrate that the ancient Egyptians were well versed in

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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, The Roman physician, Galen of Pergamon (130–200 AD), is said to have innovated that time-honored toiletry: cold cream (Cera Alba). The Babylonians were said by Herodotus (490–420 b.c.) 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.

RAW MATERIALS USED IN COSMETICS •

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The raw materials that are used in most cosmetics around the world are listed in the International Nomenclature of Cosmetic Ingredients Dictionary. The latest edition of the INCI Dictionary has over 22,000 entries. In reality, those thousands of options can all be simplified, and it has come up that there are really only three types of cosmetic ingredients. These include functional, aesthetic and claims.

TYPES OF COSMETIC INGREDIENTS A. 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 have ever used or made has at least one functional ingredient. SAM

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B. 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, antioxidants, ant-irritants, and delivery systems.

relevant to their assigned function. They should be in good health and capable of handling the duties assigned to them.

3. PREMISES → The premises for manufacturing should be suitably located, designed, constructed, and maintained.

4. EQUIPMENT

C. 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.

→ Equipment should be designed and located to suit the production of the product. ✓ Design and Construction ✓ Installation and Location ✓ Maintenance

5. SANITATION AND HYGIENE → Sanitation and hygiene should be practiced avoiding contamination of the manufacturing of products. It should cover personnel, premises, equipment/apparatus and production materials and containers.

ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE •

The objective of the Cosmetic Good Manufacturing Practice ( GMP ) Guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control.

1. QUALITY MANAGEMENT SYSTEM → A quality system should be developed, established, and implemented as a means by which stated policies and objectives will be achieved. It should define the organizational structure, functions, responsibilities, procedures, instructions, processes, and resources for implementing the quality management. ✓ enhanced productivity ✓ customer satisfaction ✓ increased reputation ✓ project success ✓ the best practices ✓ reduced rework ✓ evidence based decisions ✓ increased productivity

2. PERSONNEL → There should be an adequate number of personnel having knowledge, experience, skill, and capabilities

5S' STANDS FOR FIVE JAPANESE WORDS WITH: • • • • •

Seiri (Sort) Seiton (Set) Seiso (Shine) Seiketsu (Standardization) Shisuke (Sustain)

6. PRODUCTION ✓ ✓ ✓ ✓ ✓ ✓ ✓

Starting Materials Batch Numbering System Weighing and Measurement Procedure and Processing Dry Products Wet Products Labelling and Packaging

PRODUCTION a. 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 SAM

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sanitized according to well established 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.

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7. QUALITY CONTROL → 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

8. INTERNAL AUDIT → An internal audit 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.

b. BATCH NUMBERING SYSTEM •

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Every finished product should bear a production identification number which enables the history of the product to be traced. A batch numbering system should be specific for the product and a particular batch number shall not be repeated for the same product in order to avoid confusion.

c. DRY PRODUCTS •

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

9. STORAGE → Storage areas should be of sufficient capacity → Storage areas should be designed or adapted to ensure good storage conditions.

REGULATORY ISSUANCE GOVERNING COSMETIC PRODUCT NOTIFICATION •

d. WET PRODUCTS •

The use of closed systems of production and transfer is recommended

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e. LABELLING AND PACKAGING •

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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 mix-up.

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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.

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WHAT INFORMATION SHOULD BE DECLARED IN THE PRODUCT NOTIFICATION? ✓ ✓ ✓ ✓ ✓ ✓

Brand Name/Product Name/Product Variants Product Type Particulars of the Product Intended Use Product Presentations Local Company Responsible for Placing the Cosmetic Product in the Market ✓ Establishment Information ✓ Person Representing the Local Company ✓ Product Ingredient List

→ 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. 4. 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.

PROCEDURES IN THE APPLICATION FOR COSMETIC PRODUCT NOTIFICATION IN THE PHILIPPINES •

The application process has four (4) main parts: ✓ Submission ✓ Payment ✓ Download Result, and ✓ Revalidation

APPLICATION PROCESS 1. Submission → This is now done through the FDA’s portal at https://www.fda.gov.ph → 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. 2. Payment → Filing fee depends on the number of years of the validity of the registration. 3. 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.

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HANDOUT - PRELIM

HAIR PRODUCTS (PART 1)

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TOPIC 2: WEEK 3 COSMETIC PRODUCT DEVELOPMENT (LECTURE)

HAIR AND HAIR FOLLICLES • • •

Hair is composed primarily of proteins (88%). These proteins are of a hard fibrous type known as keratin. Keratin protein is comprised of what we call "polypeptide chains”.

TYPES OF HAIR • •

Ellus (lanugo) hair: short, fine, downy, unpigmented hair on body. Terminal hair: long, thick, pigmented hair found on scalp, legs, arms, and body.

SHAPES OF HAIR CHEMICAL COMPOSITION OF HAIR •

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Hair made up of 20 amino acids. → Body produces 11 of the 20, the remainder must come from diet. Proteins are sources of amino acids. A healthy diet is necessary for healthy hair.

The shape of the hair shaft determines whether hair is straight or curly. • If the shaft is round, the hair is straight. • If the shaft is oval, the hair is wavy. • If the shaft is flat, the hair is curly or kinky

HAIR COLOR • •

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All-natural hair colors are the result of two types of hair pigments. Both of these pigments are Melanin type, produced inside the hair follicle and packed into granules found in the fibers. Eumelanin is the dominant pigment in brown hair and black hair, while Pheomelanin is dominant in red hair

ANATOMY OF HAIR

NORMAL SCALP HAIR GROWTH PATTERNS • • • • • • •

Average total number of scalp hairs is 100,000 hairs. Average rate of growth is 0.35 mm/day. Hair grows faster in summer than in winter. Average daily loss is 25-100 hairs /day. Fastest growth is between 15-30 years. Female hair grows faster than male hair Due to estrogen (a female hormone), it causes higher ratio of hair follicle of female than males.

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THE SHAFT A. The medulla – not affected when hair is treated B. The cortex – located in the middle. Most affected when hair is treated C. The cuticle – outer part

HAIR LIFE CYCLE • There are 3 phases in the hair life cycle. “Hair shedding usually occurs in the transition phase but can also occur in the resting phase.

THE ROOT A. The hair bulb B. The erector pili muscles

HAIR SHAFT •

There are 3 main layers of the hair shaft.

Active-Growth Phase (ANAGEN): Active growth period is 2-5 years before replacement

Transition Phase (CATAGEN): lasts one or two weeks & hair follicle shrinks about 80%. 1. CUTICLE: • The outermost layer of the hair. It consists of a single layer of transparent, scale like cells that overlap like shingles on a roof. A healthy, compact cuticle layer is the hair’s primary defense against damage. 2. CORTEX: • The middle layer of hair; a fibrous protein core formed by elongated cells containing melanin pigment. About 90 percent of hair weight comes from the cortex. Protein structures located in the cortex provide hair elasticity. Changes resulting from chemical services occur in the cortex. 3. MEDULLA: • Innermost layer; also referred to as the pith(Core) of the hair. It is composed of round cells. Very fine and naturally blonde hair may not even have a medulla. Thick, coarse hair and beard hair always contain a medulla.

Resting Phase (TELOGEN): After five or six weeks, dermal papilla reconnects to base of hair follicle and bloodstream. The hair reenters the active-growth phase, and a new hair begins to form

EXOGEN (NEW HAIR PHASE) • •

This is part of the resting phase where the sheds and a new hair continues to grow Approximately 50 to 150 hairs can fall out considered to be normal hair shedding

MINIATURISATION • •

The hair starts growing slower and not that long Each cycle, become weaker, slower and gets weaker

PRP- PLATELET RICH PLASMA •

It encourages collagen production that is responsible for thickening of hair

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HANDOUT - PRELIM

HAIR PRODUCTS (PART 2)

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TOPIC 2: WEEK 4 COSMETIC PRODUCT DEVELOPMENT (LECTURE) TYPES AND PREPARATIONS OF HAIR CARE PRODUCTS

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SHAMPOO • •

The word shampoo is derived from Hindustani chāmpo. Shampoo 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.

IDEAL PROPERTIES: 1. 2. 3. 4. 5. 6.

Smooth and shiny Produce Foam No irritation Removes dirt completely Impart fragrance Readily removed

FUNCTIONS: ✓ ✓ ✓ ✓ ✓ ✓

Completely removes dirt Protects the Hair Cleaning of hair Soothe the scalp skin Nourishment of hair Treating dandruff, lice, or other scalp problems

COMPOSITION OF SHAMPOO ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

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Based on Appearance Powder Shampoos Liquid Shampoos or Lotion Gel Shampoos or Solid Cream Cream Shampoos Oil Shampoos Miscellaneous-anti dandruff, medicated shampoo

Medicated shampoo example: → Selsun blue (Selenium sulfide)

Water – has the higher amount Surfactants – SLS (Sodium Lauryl Sulfate) Foam boosters and stabilizers Opacifiers Clarifying agents Antidandruff agents Conditioning Agents Thickening agents Sequestering Agents – to prevent for scum formation

HAIR TONICS AND CONDITIONERS •

The term “hair tonic” has been used for some hair preparations because the term is used in therapeutics. Hair tonic is one kind of hair repairing tonic and it is used for retexturing the hair. There are two distinct types of products: 1. Products those deals with specific problems of the hair. E.g., greasy hair, dandruff. 2. Those products which are intended for improving, restoring, & maintaining the condition of the hair.

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The purpose of this products is to cure, to reduce, and to restrain some abnormalities in the function of scalp. In the past, it was often made of irritant, keratolytic and rubefacient compounds. The recent trend is that the treatment should rather bring about a return to a normal state & promote balance.

CLASSIFICATION OF SHAMPOO • • • • • •

II. Based on Use Conditioning Shampoos Antidandruff and Therapeutic Baby Balancing Clarifying

MEDICATED PRODUCTS

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✓ Also known as no rinse conditioner ✓ 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.

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

Example: Selsun blue (Selenium sulfide)

CONDITIONERS •

Hair 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. ✓ Hair conditioner restores the texture & appearance of the rough & harsh hair. ✓ Hair conditioner are used to render the hair shiny, easy to comb & free from dryness. 16

PURPOSE OF HAIR CONDITIONER 1. Restoring moisture is one of the main important purpose. 2. Hair should be manageable after wash. 3. Its vital role is to be smoothing the hair follicles. 4. Should maintain the pH of the hair .

FUNCTIONS OF HAIR CODITIONER 1. 2. 3. 4. 5.

Non- irritant Smooth & soften the hair Texture 4.Protective sheath Tighten the cuticle scales Provide bounce

TYPES OF CONDITIONERS 1. Pack Conditioners ✓ It is heavy and thick. ✓ In the form of cream ✓ Contains a high content of surfactant to be 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.

2. Leave in Conditioners

3. 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 a) Moisturizers • These are organic solvent concentrated with humectant. • Humectant is used to retain the moisture into the hair. • These conditioners may not contain protein. b) Re-constructers • It contains proteins for hydrolyzation. • Human hair keratin protein has a low molecular weight. • This protein penetrates the hair shaft & gives a shiny hair. c) 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.

COMPOSITIONS OF CONDITIONERS ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Surfactants Partially or totally hydrolyzed proteins Oily materials Glossers Humectant Thickeners Bodying agent Perfumes

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HAIR COLORANTS •