化妆品在生产过程中的稳定性控制

TURBISCAN Cosmetics DEVELOPMENT AND CONTROL OF COSMETICAND PHARMACEUTICAL PRODUCTS The stability of cosmetic and pharmaceutical products is one of the key parameter for the good quality of theproduct and the satisfaction of the customers. Moreover， the large range of product forms in these fields (milk，cream， foam， etc.)， their various end-use properties and storage conditions make the stability tests long andtedious. Finally， the important number of components in these products leads to a complex interpretation of thedata obtained via classical analytical techniques. Application 1： Long term stability analysis X Common method： The stability analyses of cosmetic and pharmaceutical products are done by visual observationof samples stored at low (+4℃)， ambient and high (+35 to +50℃) temperatures during up tosix months， depending on the temperature. The subjectivity of these tests， which highly dependon the operator， and their lack of traceability lead to tedious and sometimes poor qualityresults. Moreover， as it is necessary to wait all this time before releasing a new formulation tothe production， the development times are far too long considering the importance of fashionfor this market. The stability tests are therefore subjective and constitute a long time process that ismore and more incompatible with the requirements of the marketing. X Turbiscan method： The Turbiscan ags is a fully automated ageing station， which enables to store samples at threedifferent temperatures (from ambient to +60℃) and to perform analyses on its own (from themeasurement to the data processing). The analysis is done via a Turbiscan LAb that identifiesand quantifies instability phenomena. Once a correlation has been established between theTurbiscan and the classical techniques， a warning level can be set in the software， detectingautomatically the products that are not fulfilling the requirements. Detection of instability can bedone in less than two weeks. Using the Turbiscan ags， the stability tests of cosmetic and pharmaceutical productsare accelerated up to 15 times， enabling to increase the development capacity for newproducts and to improve their reliability. It is therefore possible to be closer to themarket. Application 2： End-use properties of foam Common method： Many cosmetic products are now formulated as foam (hair， shower or shaving foam)， and theirstability will depend on the end-use property. Therefore， it is important to test the time ofbreaking of the air bubbles to match the customer expectations. These tests are mainly donevisually in a volumetric cylinder using a timer. They are not sufficiently reproducible and remaintedious and subjective. The control of the breaking of cosmetic foams is done through visual methods that aretedious and subjective. Turbiscanmethod： The Turbiscan LAb is suitable for testing both long and short time foam breaking thanks to thepossibility of working in scan or fixed head mode. It is also possible to compute kinetics ofripening of the air bubbles and compare samples very easily. The method is flexible， objectiveand traceable. The Turbiscan LAb allows a quick and accurate measurement of the foam breaking. Cosmetics Application 3： New product development Common method： When developing a new formulation it is important to have as much information as possible onthe product in order to be able to anticipate possible stability issues and problems raising whilegoing to large scale. However， bottle tests do not give much information on the instability takingplace and it is therefore necessary to use other analytical techniques that are not alwayssuitable to highly complex mixtures like cosmetic products. The understanding of the stability of cosmetic products is necessary but often verycomplex. X Turbiscan method： The Turbiscan LAb enables to identify and monitor destabilisation phenomena (migration orparticle size variation) in complex systems as it measures macroscopic parameters directlyrelated to the concentration and the particle size of the system. Therefore， it helps explainingthe destabilisation mechanism by determining which instability is taking place in the system andto evaluate its intensity in an objective and traceable way. Using the Turbiscan LAb， product developments are not only shortened but alsodocumented and contain many information helping the formulator to understand hisproducts. Application 4： Scale-up XxcCommon method： The scale-up of a new formulation from the R&D lab to the production is a key step in thedevelopment of a product. It is costly and sensitive to many various parameters， which makes ita difficult task. The success of this step is usually highly dependent on the expertise of thepeople in charge and it is difficult to obtain consistent results. The scale-up process is a difficult step in the development of a product that is rarelyoptimised through scientific approaches. x Turbiscan method： One of the parameters computed with the Turbiscan LAbExpert is giving a direct measurement ofthe dispersion state of the product through a simple measurement that does not require anyexternal parameter. This quick analysis enables to monitor if the product is the same as the onedesigned by the lab. This parameter being set as one of the specification of the product， it canbe checked in the different steps of the production process， enabling a constant control of thequality of the product. The Turbiscan LAb enables to compute parameters that will help the scale-up and theproduction processes through a global measurement of the dispersion state of theproduced batches. The Turbiscan LAb finds applications in the whole life of a cosmetic or pharmaceutical product development，from the formulation of a new system and its understanding to the end-use property testing and the stabilityanalyses for R&D and quality control purposes. It makes it a flexible and useful technique， which enables to shortenthe analyses and to perform objective and traceable measurements. Formulaction