Cosmetics introduction Prepared by Begad Mohamed, BSc. Of pharmacy , diploma of pharmaceutical compounding , Diploma of clinical pharmacy, clinical pharmacist at CCHE 57357, Cairo, Egypt. AGENDA: • Cosmetic definition • Regulation concept • Important terms • Cosmetics products classification • Dosage forms What is science? science is the organized body of knowledge that is derived from a systematic observation of natural events and conditions and that can be verified or tested by further investigations. EX.: chemistry, biology, and physics. Is cosmetic science considered a real science? • Commercial science that tries to find reasons for selling a product. • Comparative science many manufacturers compare their own products to other manufacturers’ products and try to convince consumers • Traditional science, such as chemistry or physics , performing a number of tests and reactions. • Borderline science as it is a transition among a number of different scientific fields, including pharmacy, chemistry, dermatology, and marketing, among others Basic knowledge required for cosmetics • Anatomy and physiology • Chemical • Pharmacological • Guidelines, rules, and regulations (labeling and packaging) • Analytical sciences as well as microbiology • Marketing and business Is It a Drug or a Cosmetic? According to Food, Drug and Cosmetic (FD&C) Act • Cosmetics : Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part there for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting structure or function Is It a Drug or a Cosmetic? Drugs: “Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” FDA REGULTIONS: There are two categories of drugs: • OTC drugs • prescription-only drugs the legal difference between a cosmetic and a drug in the US is determined by a product’s intended use In the US, certain products can be cosmetics and drugs at the same time if they meet the definitions of both cosmetics and drugs (OTC drug–cosmetic products) DRUG_ COSMETICS PRODUCTS EXAMPLES: • Toothpaste that contains fluoride to prevent tooth decay ( Prevent disease ). cosmetic function is to clean , and refresh the teeth • Antiperspirants that not only mask bad body odor but also alter the normal process of perspiration • Mouthwash that contains ingredients to prevent and/or treat gingivitis • Facial foundations that also contain sunscreens to protect the skin from the harmful radiation of the sun. • Facial cleansers that contain antiacne active ingredients to prevent and/or treat acne vulgaris. • Hand soaps that contain antibacterial agents to kill germs. Important terms: • Toiletries (personal care products): term used for products that are used to clean the body, hair, and teeth, for example, a bodywash, shampoo, and toothpaste. • Color cosmetics, makeup, and decorative care products : products primarily applied by women to make themselves more attractive, for example, a lipstick, mascara, and nail polish. How is the intended use of a product determined? • Claims: reflect the expected effects of a particular product. cosmetic claims include moisturizes skin, while drug claims include reduces wrinkles. Cosmetics cannot be marketed with drug claims • the FDA issues a warning letter to the companies making drug claims to their cosmetic products and recommends them to change the wording of their claims in order to avoid regulatory difficulties. How is the intended use of a product determined? • Consumer Perception : it reflects whether a claim that was intended to be a cosmetic claim is understood as a cosmetic claim and is not misinterpreted. • The History of an Ingredient’s Use : the present of active pharmaceutical ingredient in therapeutic concentration , so it will be consider drug even the claim of this product is cosmetic. Popular Cosmetic Claims Used to make products sound catchy and raise consumer’s interest. • Cosmeceuticals : o In the past used only for prescribed only product , but to day? o In fact bioactive ingredients that product contain are not drugs o Examples for bioactive ingredients o include vitamins, antioxidants, proteins, anti-inflammatory agents o No comment from FDA o In japan called quasi-drugs Popular Cosmetic Claims Popular Cosmetic Claims • Nutraceuticals : o dietary supplements or nutraceuticals ( not considered as cosmetics) o These products often claim to make the hair, skin, and nails look healthier, shinier, and stronger. o natural ingredients and pharmaceuticals. Dietary supplements are also regulated by the FDA; however, they are defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994 o vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes and metabolites. Dietary supplements can also be extracts or concentrates and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. Popular Cosmetic Claims • Organic Products o An ingredient’s source does not determine its safety (cyanogenic glycoside , present in apple seeds and apricot seeds ) o aloe extract, chamomile extract, and lemon seed extract. o General concern with natural ingredients that they contain mixture of component o not defined in any of the FDA’s laws or regulations o the term is regulated by the Agricultural Marketing Service of the US Department of Agriculture (USDA) o The categories are the following: 100% organic, organic, made with more than 70% organic ingredients, and made with less than 70% organic ingredients. Popular Cosmetic Claims • Hypoallergenic Products o Produce fewer allergic reactions o refers to products that do not contain ingredients known to cause allergic reactions, such as fragrances. • Cruelty-Free Products o Not tested on animal Popular Cosmetic Claims • Preservative-Free Products o Paraben free( paraben may cause allergy) • Dermatologist Recommended o Mainly depended on survey • Clinically Proven o the claim “clinically proven” without being aware of the study details is still not very informative. • Patented Formula o Patent may be relate to technique of preparation , that mean its not related to efficacy. Cosmetics dosage forms: Dosage Forms for Cosmetic Applications • Solution: oSolutions can be classified based on the types of solvent used: Water-based solutions contain water as the vehicle. Examples eye makeup remover, hand soap, and many shampoos. Hydroalcoholic solutions contain a mixture of water and alcohol as the vehicle. Examples hair spray, mouthwash, aftershave cologne, and facial toner. Anhydrous solutions the vehicle. The solvents can be organic solvent, such as for base coat or nail polish remover. Solvents can also be oily components, ex. Massage oil Dosage Forms for Cosmetic Applications • Emulsion : Dosage Forms for Cosmetic Applications Emulsion: • Emulsions are widely used dosage forms in the cosmetics industry due to their advantages over other dosage forms. They have a unique texture and provide a nice skin feel, and they are used as vehicles to deliver both hydrophilic and hydrophobic ingredients. • O/W emulsions :low concentration from fatty material , it is suitable for hair conditioners, shaving creams, or facial moisturizing creams. • W/O emulsions are preferred when a larger amount of oil is desired in the formulation ( grease and water resistant ), ex. Dipper rash , sunscreen • water-in-silicon (W/Si) emulsions: unique, no greasy skin feel and quick smooth. Ex. facial foundations, cream eyeshadows, and certain sunscreens. Dosage Forms for Cosmetic Applications Emulsion according to viscosity classified to : • Lotion: Ex.: facial cleansing milks, liquid foundations, aftershave balms, and nonaerosol sunscreen sprays • Cream: EX. : facial moisturizing creams, leave-in hair conditioners, sunscreens, cream eyeshadows Dosage Forms for Cosmetic Applications Ointment : EX. :hair styling products, diaper rash Paste : tooth paste Suspension : • Water-based : suspensions • Hydroalcoholic : facial toners • Anhydrous :organic solvent-based nail polishes, and any liquid colored cosmetics containing pigments as color additives, such as mascara, liquid Dosage Forms for Cosmetic Applications Suspension : Dosage Forms for Cosmetic Applications Powder (Including Loose and Pressed Powder) : powder is an intimate mixture of dry, finely divided chemicals • Loose powder : mineral facial powders, blushes, and some eye shadows, as well as for baby powder and bath salts • Pressed powders : eye shadows ,facial powders and bath bomb Dosage Forms for Cosmetic Applications Gel : o hair styling gels, facial cleansing gels, shaving gels, aftershave gels, after-sun gels, extrudable deodorant and/or antiperspirant gels, and hand sanitizer gels o Classified to two types : Water-based formulations, such as facial cleansers; and Hydroalcoholic formulations, such as hair styling gels and hand sanitizers. Dosage Forms for Cosmetic Applications • Stick : • lipsticks, lip liners, eyeshadow sticks, eyeliners and concealers, as well as personal care products, such as deodorant/antiperspirant sticks and sunscreen sticks .