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Necessity of Cosmetic Product Stability, Shelf-life and Safety in Personal Care Market

NECESSITY OF COSMETIC PRODUCT STABILITY FOR SHELF LIFE AND SAFETY IN THE PERSONAL CARE MARKET

Vijaykumar R Zala, Assistant Manager Formulation Development,
Mikasa Cosmetics (Division of MESO Private Limited), Ahmedabad, Gujarat, INDIA,
vijayzala@meso-in.com

I’m inspired to write this article to increase the awareness of cosmetic product stability as well as safety because gradually climate weather is changing and I had seen many products into the market which are not stable and seen many brands are failing into the market because young entrepreneurs maybe don’t know about the stability, safety and shelf life of the cosmetic product or maybe not giving the importance because of time, manpower as well as money. Any cosmetic industry to sustain in the market for the long term, stability, safety, and shelf life playing a major role, once consumer picks up unstable or unsafe product from the market, the brand will vanish. My idea to write this article is to increase the importance of the stability, safety, and shelf life of cosmetic products.

Why does stability need to conduct?
Cosmetic product formulation which contains more polyunsaturated fatty acid vegetable oils like creams, lotions, oils will become rancid and give a pungent smell over a period or many time perfume of the cosmetic product will be changed completely due to rancidity.

Cosmetic product formulation which filled in containers whose cap is not tightened properly with the container and due to this water loss will happen over a period and the product becomes thicker than expected thickening. The consumer can reject the product if it is launched in the market without improvising the cap or container.

A cosmetic product like transparent shampoo, face wash and hand wash formulation which filled in a transparent bottle and selling into the cold region, many times transparent product becomes cloudy and in shelf some of the samples are clear and some of the samples are cloudy so the consumer will reject the product and product and brand both will vanish from the market.

A cosmetic product like creams and lotions are filled in packaging and that packaging is not UV protected so due to this issue variations in product color can happen.

There are many more, but these are a few examples/issues which can be identified before launching the product in the market based on conducted stability study.

Stability and safety of the cosmetic product
Stability means the product that consumers will use must be stable and safe to a certain time, and that time is called shelf-life. The shelf-life of any cosmetic product can be derived or predicted based on the stability of that product. Stability is playing a major role in cosmetic products formulation development as well as in manufacturing.

Ideally, stability study needs to conduct as per the country standard like in India needs to follow the FDA guideline. There are mainly two international guidelines also available like COLIPA guidelines on stability testing of cosmetic products and ISFCC (international federation societies of cosmetic chemists) The fundamentals of stability testing. I will touch upon the stability guideline which is generally used in Indian cosmetic companies. A stability study needs to conduct in the final packaging before launching the product.

Room temperature stability study which needs to be checked, up to the shelf life like 24months or 36months based on the company requirement needs to set the stability protocol. Here a sample of the product needs to test periodically like initially, 1, 2, 3, 6, 12, 24, & 36Months.

In-room temperature stability study is the long-term stability study which needs to check up to the expected shelf life and in that first needs to prepare the stability protocol where needs to include the testing parameters based on the product formulation with the help of standards like BIS standards are generally used in INDIA. Based on the testing parameter needs to check the formulation as per the time interval and needs to maintain the record of the results.

Accelerated temperature stability study (40°C temperature and 75% relative humidity) which needs to check up to the 6months or 12Months based on the company requirement needs to set the stability protocol. Here a sample of the product needs to test periodically like initially, 1, 2, 3, 6 & 12Months.

Accelerated stability study needs to do the same as per the above-mentioned protocol and guideline. Accelerated stability study is mainly to predict the shelf life of the cosmetic product. +/- 10% variation in the testing parameters is generally acceptable in accelerated stability study to predict the shelf life. Accelerated stability study will not give the guarantee for the shelf life but it can give more confidence about the shelf life.

The freezing temperature stability study (4 to 8°C temperature in freeze) needs to check up to the shelf life like 24months or 36months based on the company requirement needs to set the stability protocol. Here a sample of the product needs to test periodically like initially, 1, 2, 3, 6, 12, 24, & 36Months.

The freezing temperature stability study is mainly to predict the emulsion stability as well as perfume solubility in the final cosmetic products. It will also give more ideas for the surfactant-based products like over a period the transparent product will remain transparent or it will turn cloudy.

Again, it depends upon the company's requirements. This I am provided to get the idea of time interval, some companies are doing the testing every 15days.

There are a few more stress studies some companies are doing to get more confidence which is as mentioned here.

Sunlight or UV light study, this study generally conducts to check whether the product is stable under Sunlight or UV light, this test ideally can conduct for 1month to keep the sample in Sunlight or UV light. Cosmetic product color stability can be checked based on this test and if color change and color fade in the cosmetic product observed, needs to add color stabilization molecule like UV absorber (benzophenone-3, Ethylhexyl methoxy Cinnamate, Sodium metabisulphite, etc.) each molecule have their positives and negatives so based on the literature and your own experience it needs to be selected for color protection molecule, for example, if sodium metabisulphite used in emulsion-based products, sometime it will reduce the viscosity of products and sometimes it will break the emulsion so it is to be used after doing thorough literature study as well as stress study. All the issues can observe under the stability study as well as stress study so that before launching the product can be resolved.

Centrifuge test is mainly to check the emulsion separation, creaming as well as sedimentation in the products, ideally, a sample is to be tested in a centrifuge at 3000rpm and for 1 to 2 hours, further, if any emulsion separation, creaming, sedimentation is not observed in the product, it means that formulation is ok and if any separation and sedimentation are observed, needs to modify the formulation.

A freeze and thaw study test can conduct for the checking of emulsion stability like some emulsions are stable at 40°C but not stable at 4-8°C temperature and emulsion turn into crystallization. So this test can give clarity about the emulsion. This test can be conducted like 1day at freeze and alternate one 1day at room temperature, repeat the same for at least 4 to 6 times so that can get a better idea about the emulsion stability.

Sometimes a product will fail into the accelerated (40°C) stability but it will pass at the room temperature up to the shelf life so needs to keep in mind the accelerated stability study will give confidence for a longer period, but it can not be replicated the same in room temperature so based on the experience needs to make a decision.

A preservative efficacy test or microbial challenge test can conduct to check the preservative system is effective or not. If the formulation is not passing the preservative efficacy test or challenge test, needs to improve the preservative system or needs to change the preservative system. Mainly Ecocert and Organic products are a little bit difficult to preserve so this kind of product needs to keep the backup one more preservative system that passes the preservative efficacy test or challenge test. In the market, many products fail due to improper preservative systems.

50 to 55°C Stress study is mainly to check the emulsion stability in a shorter time like in any emulsion-based product it is required to keep at 50 to 55°C for 15 days to 30 days and in this period if the emulsion is not breaking it means that the product emulsion will stay stable for 2 to 3 years at ambient temperature. Another example is that any products which contain suspended beads or scrubbing particles also need to be checked in the same way. This test is to be conducted because the many areas have hot temperatures and even in warehouse temperatures will go above 45°C and even container export by sea can have the higher temperature so strong emulsion system can be built based on this test.

First needs to check the stress study of prototype formulation which marketing team had approved, needs to take a small pilot batch and check, after that needs to take a scale-up batch and check so finally when first commercial production batch will start, above all samples give more confidence for the final batch and can save and build a brand.

The dermatological test needs to conduct and based on that came to know the product is nonirritant and safe for use. Nowadays all big brands are claiming our products are dermatologically tested.

There is very little published research to support specific to stability because every day new products are entering the market so standard stability can not be defined so ideally cosmetic product manufacturer who knows their products and packaging has to design the stability protocol on scientific bases and accordingly needs to evaluate the product and its product shelf life.

Based on my experience I can say that there is no single product that cannot change over some time so better to check the stability study as well as stress study and based on that issues can be optimized or resolved.

It is a very deep subject and can not be mastered by writing or reading some articles, but I just touch upon it to increase the awareness and importance so that Indian cosmetic companies can get deeper into it.

I firmly believe that the company or brand owner is responsible for the stability, safety, and shelf life so each company or brand owner has to allocate the budget for this activity and based on this only can get the best stable and safe cosmetic product.

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