Seven test methods for stable formulations.
From rheology to storage stability under ICH: we characterise cosmetic formulations using every essential formulation method – for our own product line and under contract.
Rheological investigations
Rheological investigations – that is, measurements of flow and deformation behaviour – comprise the determination of the elastic and viscous components of formulations. Measurements on the rotational viscometer can be carried out in rotational or oscillatory mode.
In particular, the influence of the following factors on the rheological properties of the overall system can be evaluated:
- various gelling agents
- emulsifiers
- cosmetic active ingredients
- pH value
- tonicity
Zeta potential measurements
The zeta potential is a measure of the repulsion or attraction between particles. Measuring it offers detailed insight into the dispersion mechanism and is the key to controlling dispersion behaviour via electrostatic forces. The zeta potential is therefore an essential parameter in the development of stable emulsion systems.
When formulating a new suspension or emulsion, most of the time is spent on stability testing of different recipes under varying external conditions. The zeta potential can be used to test those recipes so that inadequate samples are identified and rejected at an early stage.
By measuring the fundamental parameters that influence stability – zeta potential, particle size, pH value and viscosity – it becomes possible to identify the mechanisms affecting the stability of a dispersion. This considerably reduces the cost and time required for stability testing.
Analyses of the distribution of the inner phase in emulsions and creams
Determining the size distribution of the inner phase in disperse systems such as creams and milks is an essential element in the development of new cosmetics. Green River Polymers carries out the corresponding measurements as a matter of routine.
Freeze-fracture analyses
To characterise the phase structure of emulsion systems more closely, Green River Polymers performs freeze-fracture electron microscopy (SEM) analyses.
We also interpret the test results and propose appropriate improvements to the system.
Active release studies
The release of actives from topical preparations within a defined period is an important parameter for assessing the quality of a cosmetic product. Since every formulation has its own release characteristics, in vitro release studies allow conclusions to be drawn about the condition and properties of the cosmetic.
Green River Polymers carries out active release studies on both liquid and semi-solid cosmetic formulations. The Franz diffusion cell system serves as the in vitro release apparatus. Depending on the type of formulation and on the active to be evaluated, various synthetic or semi-synthetic membranes are used.
After an initial lag time has elapsed, release is determined under “quasi-stationary” conditions – the quantity of active released is then proportional to the square root of time. The values obtained during this matrix-controlled phase feed into all further calculations as product-specific parameters.
Preservative challenge tests to Ph. Eur.
Green River Polymers performs preservative challenge tests in accordance with the European Pharmacopoeia (Ph. Eur.) for liquid, semi-solid and solid cosmetic products. The standardised test organisms used are primarily:
- Staphylococcus aureus
- Candida albicans
- Pseudomonas aeruginosa
Storage stability studies to ICH
Our storage stability studies comprise the preparation of study designs and testing for the physical, physico-chemical and microbial stability of cosmetics in the intended primary packaging. In line with the ICH guidelines, we routinely run studies under the following conditions:
Long-term test conditions
25 °C, 60 % RH – test duration 12 months to 5 years.
Accelerated test conditions
30 °C, 65 % RH and 40 °C, 75 % RH – test duration 6 months to 5 years.
In the climate chambers we use, temperature and relative humidity are monitored and recorded electronically 24 hours a day, 365 days a year. In the event of a power failure, an in-house emergency generator is available.
Product analyses during the storage studies
- chemical stability testing of the actives by HPLC, LC-MS, FTIR and NMR
- pH measurements
- rheological analyses
- determination of microbial status
The advice that goes with it
- the choice of suitable, validatable analytical methods
- chemical, physical and microbial aspects of stability studies
- the interpretation of test results
- the influence of formulation and packaging on product stability
- references to regulatory requirements
- and much more
On request, Green River Polymers also carries out photostability studies.
Related topics from our research.
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ArticleLiquid-crystalline emulsions
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OverviewResearch at Green River Polymers
In-house development in Innsbruck and contract research for cosmetics companies worldwide. →
Your formulation – put to the test.
Whether a single analysis or a complete stability programme: we tailor scope, methodology and schedule to your project.
Enquire about contract research →Have a question? Use our contact form – or write to us at info@green-river.eu