Medgenix, Perrigo Wevelgem
Droplets of oil in water allow us to transport oil soluble materials and to release them on a chosen target. Cosmetics, paints, foods are often based on these ‘emulsions’. Understanding the lifetime and destruction of emulsions is obviously a crucial aspect.
Particle characterization by means of microscopic analysis is a powerful tool in the research and development (R&D) and Quality Control (QC) for the control of the emulsion stability and homogenity. The aim of this assay is the standardization of microscopic evaluation of emulsions. For that purpose, guidelines for good and bad emulsions are recorded. As well, a standard operating procedure (SOP) will help any authorized person to be able to perform the analysis independently.
First of all, each emulsion is evaluated and mapped microscopically. Hereafter three products are examined in detail in terms of galenica. For each step of the preparation process a microscopic analysis is performed. The purpose of this examination is to explain certain phenomena wich are noted in the standardization.
A microscopical image of a stable and a broken emulsion is brought together. This allows to obtain a better estimation in a microscopical examination. Furthermore standardisation of evaluation of emulsions is created by measuring the samples.
The active component hydrocortisone doesn’t dissolve in the cream. This causes the formation of agglomerates. As long as the agglomerates are devided homogeneously, they are acceptable according to the standard.
Because while producing Fenuril cream, the standard cleaning procedures are not followed between separate preparations of different batches, lesser refined dispersion of each batch is caused, except for the first one
Agglomerates (≥100 µm) are acceptable in Tantum only if the separate individual droplets are smaller than 100 µm.
The galenic preparation of an emulsion experiences some limitations at labscale. Not all preparation steps are to be kept under control and aren’t accurately traceable. Therefore the obtained results aren’t completely reliable.
Creating a standardisation for the evaluation of emulsions is not evident. The use of a SOP provides an efficient process with high quality. The guidelines regarding a minimum weight for the preparation of a microscopic sample is recommended to be included in the SOP.
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