Quality control of cosmetics (1).pdf

Quality control of cosmetics Dr Javed Skin Care Products skin care products are categorized into three functional groups: • Drugs: To prevent diseases by altering the structure and function of the body. • Cosmetics: To beautify and improve the skin. • Cosmeceuticals: An intermediate classificatio...

Quality control of cosmetics Dr Javed Skin Care Products skin care products are categorized into three functional groups: • Drugs: To prevent diseases by altering the structure and function of the body. • Cosmetics: To beautify and improve the skin. • Cosmeceuticals: An intermediate classification for cosmetic products that may enhance the function of the skin. The skin-care product groups can also be classified by their physical properties. • Emulsions (creams) • Lotions • Paste • Suspension, • Powder, gels, sticks and aerosols. Most common forms of skin care products are emulsions (creams). • FDA does not have regulations specifying GMPs for cosmetics, but under the law, cosmetics must not be manufactured under conditions that would allow them to become contaminated or harmful (Federal Food, Drug, and Cosmetic Act, section 602(c)). Quality control of Cosmetics Quality control could be basically divided into: 1. Raw material and packaging material quality control 2. Finished product quality control. 3. Microbiological quality control 4. Production line quality control. Raw Material • Physical Parameters: Colour, odour, density, refractive index, viscosity, etc. • Chemical Parameters: Like assay of active ingredients, impurities present, etc. • Drugs & Cosmetic act specifies the limits of impurities in cosmetic raw materials like lead, arsenic and heavy metals. FDA regulations and guidance address some heavy metals as cosmetic ingredients or impurities: • Mercury in cosmetics: Mercury compounds are allowed in cosmetics only as preservatives in eye area products. They may be used only in a very small amount—the mercury must not be more than 65 parts per million (ppm) in the finished product • Mercury is not allowed in any other cosmetic products except in a trace amount of less than 1 ppm and only if its presence is unavoidable under good manufacturing practice (GMP) Lead in cosmetics: FDA recommends maximum level of 10 parts per million (ppm) for lead as an impurity in cosmetic lip products and externally applied cosmetic. Arsenic, lead, and mercury in color additives: These are the limits for color additives used in cosmetics as per the FDA: Arsenic: Not more than 3 ppm Lead: Not more than 20 ppm Mercury: Not more than 1 ppm • Chromium: Chromium hydroxide green and chromium oxide green are both permitted for use as color additives in externally applied cosmetics, including use in the eye area, in amounts consistent with GMP Packaging material quality control: Main purpose of packaging material quality control is to weed out defective packaging. The defects could be classified into: Critical defects : A defect that likely to prevent performance /function of the item. Which lead to total spoilage like cracked neck of bottle. It may be unsafe for users. Major defects: These defects are very obvious which is likely to result in failure and/or reduce the usability of the product for its intended purpose Minor defects: These defects are minor in nature that is not likely to reduce materially the usability of product for its intended Based on sampling plan, samples are drawn and inspected. Finished product evaluation • The quality control of cosmetics is important to ensure the efficacy and safety of products and its raw-materials. Some current techniques used by the cosmetic industry can be applied to the evaluation of cosmetics are: • Sensory analysis • Rheology • Small angle X-ray scattering (SAXS) Sensory analysis Sensory analysis is the process of examining the properties (texture, flavor, taste, appearance, smell, etc.) of a product through the senses (sight, smell, taste, touch and hearing) of the panelists or the consumer themselves. • There are four different methods to perform the sensorial analysis that are most used, they are: • affective, • discriminative, • descriptive and • methods to evaluate the effectiveness of the product. • The affective methods represent the consumer opinion and evaluate how much consumers like or dislike a product. • The discriminative test is better represented by the Triangular test. It allows differentiating one between three different samples and is very useful in the quality control of cosmetics. The ideal is to perform this evaluation with twelve to forty volunteers, who will receive the three samples and should indicate the different one between them. • The descriptive tests provide a broad sensory description about the product that is being evaluated, helping to predict the consumer acceptance and what consumers think about such product Sensory analysis: Auto evaluation Use tests by consumers • A use test evaluates the consumers’ perception of product efficacy and cosmetic properties based on parameters that they can observe or feel. They must be conducted on a sufficient number (see Statistical Guidance) of people. There are two main types of use tests: • Blind use tests are product tests without providing any information such as brand, decor, communication which could influence the consumers’ judgement and alter their perception of the effect of the product alone. • Concept use tests are product tests combined with elements of communication that help to check whether the concept, the communication and the effect of the product as perceived by the consumers match up information from concept use tests are used to complement that contained in the product efficacy dossier. Sensorial-evaluation tests by trained expert panels • The sensorial evaluation enables a profile of the product to be drawn up according to predefined criteria. They must be conducted with the help of a panel of trained experts, following a well-defined protocol, with precise sensorial criteria. Sensory analysis: Evaluation by professional experts Tests under medical supervision: These tests in relation to the cosmetic benefits of a product are performed under the control of a physician. The parameters are evaluated by clinical observation and/or scoring. They can be quantified by comparison with initial results or with an untreated control or a placebo or a reference product. Tests under the control of other professionals • The tests can be conducted by a suitably qualified professional. Examples includes paramedical practitioners, hairdressers, aestheticians or other professional experts. The above would evaluate the performance of a product in terms of tactile and visual appreciation against a previously established scale Test to evaluate effectiveness of the product • Performed in true conditions of use and the volunteer may use only the product that is being assessed. • These tests could be conduct by the evaluation of dermatologists, by the evaluation of volunteers, and even, by the measurement of one parameter by equipment, such as the equipment that measures hydration, sebum and trans epidermal water loss, to define if a product is really effective. • Based on these clinical evaluations, a company could create an efficacy claim to the product Rheology • Rheological properties ( viscosity, flow properties) helps in determining the stability and shelf life of products. • Cosmetic product is exposed to stress conditions (high and low temperatures, solar irradiation) and Viscosity is measured periodically at determined period and the flow behavior of product is monitored. Small Angle X-ray Scattering • The SAXS technique have being used for the analysis of cosmetics, in order to evaluate the presence of liquid crystalline structures, called liquid-crystals, which are known to increase the stability of formulations becoming, therefore, desirable in cosmetics. • An initial analysis of the presence of liquid crystals in a cosmetic emulsion could be done using a polarized light microscope, but it should be confirmed and better analyzed by means of Small Angle X-Ray Scattering. • When a microscope slide containing a sample of the system is studied and it presents structures that reflect the incident light, it is an evidence of the presence of liquid crystals. So, they should be submitted to SAXS analysis to confirm this expectation. • The SAXS method requires a synchrotron light source that is formed by means of a particle accelerator, and using a monochromatic beam, that is used to irradiate the sample. • After that, the scattering of the rays in small angle should be analyzed. • Liquid crystals can be analyzed by SAXS since they are able to disperse the Xrays focused on it. • In the SAXS line is used an X-rays detector and an multichannel analyzer to capture the intense of the SAXS measures. Production Line Quality Control: • This type of quality control is practiced in large scale assembly type production units wherein so many different types of products are assembled into final product. Main aim is to ensure good quality of outgoing goods. • Procedure involves drawing of random samples from production line at different intervals and these samples are inspected and if the product quality is found below the standard. Entire production is taken up for 100% rechecking Evaluation for creams Test for irritancy: • The bases used in the formulation of creams may cause irritation or allergic reactions. Irritancy of the preparation is evaluated by patch test. • Mark an area (1sq.cm) on the left-hand dorsal surface. The cream was applied to the specified area and time was noted. • Observed for Irritancy, erythema, edema at regular intervals up to 24 hrs. • If any sign of irritancy, then its reported Spreadability test • Cream base should spread easily without too much drag and should not produce greater friction in the rubbing process. Spreadability was calculated using the spreadability apparatus made of wooden board with scale and two glass slides having two pans on both sides mounted on a pulley. • Sample is placed between the two glass slides and 100 g weight was placed on the glass slide for 5 min to compress the sample to a uniform thickness. Weight (250 g) was added to the pan. • The time in seconds required to separate the two slides was taken as a measure of spreadability. Test for Microbial Growth • Test for Microbial Growth Agar media was prepared then the formulated cream was inoculated on the plate’s agar media by streak plate method and a controlled is prepared by omitting the cream. The plates were placed in the incubator and are incubated in 37˚C for 24 hours. After the incubation period, the plates were taken out and the microbial growth were checked and compared with the control. b. Test for Preservative Efficacy Requirements • Microorganisms: Cultures of Aspergillus niger, Candida albicans, Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus, each containing 100000 to 1000000 cells/mL • Medium: Tryptone Azolectin Tween (TAT) broth. Procedure • Using pour plate technique, the number of microorganisms initially present in the preparation are determined. • Solutions of different samples of the preparation are made and mixed with TAT broth separately. • All the cultures of the microorganisms are added into each mixture, under aseptic conditions and incubated. • The number of microorganisms in each sample are counted on 7th, 14th, 21st and 28th days of inoculation. • Microbial Limits • On the 14th day, the number of vegetative cells should not be more than 0.1% of initial concentration. The viable yeasts and moulds should be below or equal to initial concentration. • On 28th day, the number of organisms should be below or equal to initial concentration. Stability studies • The stability studies are carried out as per ICH guidelines. • The cream is filled in the bottle and kept in humidity chamber maintained at 30 ± 2°C/65 ± 5% RH and 40 ± 2°C/75 ± 5% RH for 2 months. • At the end of studies, samples are analyzed for all the evaluation parameters. •