BLT Stages

In order to produce Lyclear Dermal Cream it is important that the quality of the components in the cream can be guaranteed. There are two important components that are examined in the QC-laboratory: permethrin, which is the active component in the cream, and formaldehyde, which is a preservative. The aim of this study is to perform a revalidation of the current analytical method of Lyclear Dermal Cream for the determination of permethrin and formaldehyde. In addition, a new method for the determination of 3-phenoxybenzylalcohol and total related substances will be validated. The validation of the three methods is performed according to the validation parameters: specificity, linearity, accuracy, precision (intra-assay and intermediate precision), range, detection and quantification limit. The system suitability is evaluated each time prior to the analysis. The method is specific for the determination of permethrin and has a linear response in the concentration range of 60 – 140 %. The method is accurate in the concentration range 80 - 120 %. The recovery of the method is valued at 100 ± 1 %. The method is considered to be precise and repeatable. The intra-assay and intermediate precision are both valued at 0,5 %. The method is specific for the determination of formaldehyde. There is a linear response in the concentration range 60 - 140 %. The method is accurate in the concentration range 80 - 120 %. The recovery of the method is estimated at 100 ± 3 %. The method is considered to be precise and repeatable. The intra-assay precision and intermediate precision are valued at 0,8 % and 1,4 %. The method for the determination of 3-phenoxybenzylalcohol and the total related substances is specific and has a linear response in the range 0,10 - 5,00 % of nominal permethrin concentration. The method is accurate in the concentration range 0,10 - 4,00 % and has a recovery of 100 ± 4 %. The method is considered to be precise and repeatable. The intra-assay and intermediate precision are estimated are 1,9 % and 19,5 %, respectively. The LOD was valued at 0,001 % and the LOQ at 0,003 % of the nominal concentration of permethrin. The validation shows that the current method for the identification and determination of permethrin and formaldehyde in Lyclear Dermal Cream as well as the method for the determination of 3-phenoxybenzylalcohol and total related compounds meets the standards and is suitable for the analysis of Lyclear Dermal Cream.

 

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.