A rapid in-process control (IPC) test to monitor the functionality of taste masking polymer coatings using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS).

Monitoring of the coating end-point of functional coatings during the coating application process is desirable. Since currently available PAT methods require expensive test equipment, there is a need for a rapid test that can easily be applied without major investment. BARDS is a novel technique that has the potential to economise the production process of these kinds of pellet and tablet formulations. The thickness of a controlled release coating is a key factor that determines the release rate of the drug in the gastro-intestinal tract or other targeted functionalities such as taste masking or moisture protection. Correspondingly, the amount of drug per unit mass of pellets decreases with increasing thickness of the functional coating. In this study, the functional polymer loading of the coating process is investigated by testing pellets via BARDS technology (Broadband Acoustic Resonance Dissolution Spectroscopy). The technique offers a rapid approach (<200 s) to characterising functional coatings at-line during their manufacture. Measurements are based on reproducible changes in the compressibility of a solvent during dissolution which is monitored acoustically via associated changes in the frequency of induced acoustic resonances. In case of enteric coatings a steady state acoustic lag time is associated with the erosion of the enteric coatings in acidic dissolution test media. This lag time is indicative of the coating layer thickness, assuming that the quality of the film coating is high. BARDS represents a possible future surrogate test for IPC testing, as a PAT method and possibly also for conventional USP dissolution testing. BARDS data correlate directly with the thickness of the functional coating, its integrity and also with the drug loading as validated by UV-Vis spectroscopy.

[Breastfeeding protection according to the law on the reform of maternity protection]. / Stillschutz nach dem Gesetz zur Neuregelung des Mutterschutzrechts.

On 1 January 2018, a new Maternity Protection Act came into force in Germany. The Maternity Protection Act has been made more appropriate and coherent by the reform. In addition, the regulations on maternity protection have been structured better and made clearer. The aim of the law remains to ensure a responsible balance between health protection for a pregnant or breastfeeding woman and her (unborn) child on the one hand and the self-determined decision of the woman about her employment on the other. To improve the effectiveness of the law in this sense, the hazards of a modern working world for pregnant and breastfeeding mothers and the duties of maternity protection had to be better contoured. It will improve women's opportunities and strengthen their rights to pursue their careers during pregnancy and breastfeeding without compromising their health and that of their child. The reform should ensure a uniform level of health protection during pregnancy, after delivery and during breastfeeding for all women, regardless of occupational group. In particular, the protection of breastfeeding women secured by the Maternity Protection Act is described in more detail in this article.

Dissolution media simulating the proximal canine gastrointestinal tract in the fasted state.

Human biorelevant media have been shown to be a useful tool in pharmaceutical development and to provide input for in silico prediction of pharmacokinetic profiles after oral dosing. Dogs, in particular Beagles, are often used as animal models for preclinical studies. Key differences in the composition of human and canine gastric and intestinal fluids are described in the literature and underscore the need to develop a discrete set of biorelevant media, adapted to the conditions of the proximal canine gastrointestinal (GI) tract, to improve forecast and interpretation of preclinical results using in vitro dissolution studies. Canine biorelevant media can also be used in the development of oral dosage forms for companion animals, which is a rapidly growing market. The compositions of Fasted State Simulated Gastric Fluid canine (FaSSGFc) and Fasted State Simulated Intestinal Fluid canine (FaSSIFc) are adapted to the physiological composition of the corresponding gastrointestinal fluids in terms of pH, buffer capacity, osmolality, surface tension, as well as the bile salt, phospholipid, and free fatty acid content (in terms of concentration and reported subtypes). It was demonstrated that canine Fasted State Simulated Intestinal Fluid (FaSSIFc) is superior in predicting the solubility of model compounds in Canine Intestinal Fluid (CIF) compared to the human biorelevant media (FaSSIF and FaSSIF-V2). Two different versions of FaSSGFc, composed at pH 1.5 and pH 6.5, offer the possibility to design in vitro studies which correspond to the in vivo study design, depending on whether pentagastrin is used to decrease the gastric pH in the dogs or not. Canine biorelevant media can therefore be recommended to achieve more accurate forecasting and interpretation of pharmacokinetic studies of oral drug products in dogs.