Jenapharm GmbH & Co. KG

The Contraceptive Counselling (COCO) study tested whether a structured approach to assessing patient needs and expectations improved method choice and satisfaction with the contraceptive decision-making process.

Physicians and women were invited to complete needs-based contraceptive counselling sessions using a structured questionnaire. Physicians recorded the individual responses online; women evaluated the process using an immediate post-consultation questionnaire and then via a structured online interview 6 months later.

A total of 92 gynaecologists and 1176 women participated: 951 women completed the immediate post-consultation survey and 145 took part in the 6 month online evaluation. There was a substantial increase in satisfaction with the current contraceptive method: the number of women reporting they were 'very satisfied' with their contraceptive method increased by 30%. This applied to starters and switchers as well as to women continuing with their previous method. Women were highly satisfied with the structured approach; 95% rated the counselling as 'good' or 'very good' and 'comprehensive and detailed'.

Using a structured approach to share information tailored to women's needs can help them choose from a broader range of methods and, in some cases, change to a method more suitable to their individual needs, and ultimately increase satisfaction with their choice.

Ethinylestradiol (EE) as a highly active and low dosed compound is prone to oxidative degradation. The stability of the drug substance is therefore a critical parameter that has to be considered during drug formulation. Beside the stability of the drug substance, granule particle size and moisture are critical quality attributes (CQA) of the fluid bed granulation process which influence the tableting ability of the resulting granules. Both CQA should therefore be monitored during the production process by process analytic technology (PAT) according to ICH Q8. This work focusses on the effects of drying conditions on the stability of EE in a fluid-bed granulation process. We quantified EE degradation products 6-alpha-hydroxy-EE, 6-beta-hydroxy-EE, 9(11)-dehydro-EE and 6-oxo-EE during long time storage and accelerated conditions. PAT-tools that monitor granule particle size (Spatial filtering technology) and granule moisture (Microwave resonance technology) were applied and compared with off-line methods. We found a relevant influence of residual granule moisture and thermic stress applied during granulation on the storage stability of EE, whereas no degradation was found immediately after processing. Hence we conclude that drying parameters have a relevant influence on long term EE stability.

According to the ICH Q8 guideline, analytic technologies (PAT) are important tools for characterization and optimization of pharmaceutical manufacturing processes. Particle size as a critical quality attribute for granules is therefore an important parameter that should be monitored during the fluid bed granulation process. This work focusses on optimizing position and configuration of an SFT-sensor for the in-line measurement of particle size distribution in a Glatt GPCG 3 fluid bed granulator. As model-substances, different grades of microcrystalline cellulose were used. The in-line measured particle size and particle rate in the sensor were evaluated. A sensor position in the deceleration zone of the granulator was found to be promising for in-line particle size measurement. Most reliable data were generated in this position when the probe was placed in a distance of 11cm from the chamber wall to avoid bias by the inlet air stream. No major influence of rotation angle of the probe was found in this position. Furthermore, an entire fluid bed granulation process was successfully monitored with the sensor installed in the optimized setting.