RESUMEN
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.
RESUMEN
In this study a novel High Performance Liquid Chromatography for the assay of nystatin in oral and vaginal tablets were optimized and validated using Box-Behnken experimental design. The method was performed in the isocratic mode on a RP-18 column (30 °C) using a mobile phase consisting of ammonium acetate 0.05 M buffer/ Methanol mixture (30:70) and a flow-rate of 1.0 mL/min. The specificity, linearity, precision, accuracy, LOD and LOQ of the method were validated. The method was linear over the range of 5-500 µg/mL with an acceptable correlation coefficient (r(2) = 0.9996). The method's limit of detection (LOD) and quantification (LOQ) were 0.01 and 0.025 µg/mL respectively. The results indicate that this validated method can be used as an alternative method for assay of nystatin.
RESUMEN
Ongoing concerns exist regarding the dangers inherent when handling cytotoxics, particularly drugs which are in parenteral formulations. On occasions, nurses and medical doctors have been preparing and administrating these drugs in the open spaces of wards in the absence of suitable personal protective equipment (PPE) and safety cabinets. To explore further into the severity of occupational hazards, we conducted our research in order to evaluate the healthcare's understanding of occupational exposure to cytotoxics and occurrence of any side effects. A cross-sectional study using a self-administered questionnaire was distributed amongst oncology nurses in nine specialized cancer centers in Tehran. The questionnaire was based on most reputable international guidelines, aiming to evaluate the attitude, knowledge and safe practices of nurses' handling cytotoxic drugs. The gathered data and reported side effects were compared between "oncology/hematology" and "non-oncology" participants. The majority of nurses from oncology wards were aware of the potential hazards associated with handling of chemotherapy and reported high levels of compliance with the use of PPE during reconstitution of antineoplastic agents. Almost all nurses reported the use of a safety cabinet during preparation, however only 55 % reported that they have annual medical checkups and 45 % reported having received specialized training. This work was also to evaluate the experimental procedures as well as cleaning solutions used to reduce the level exposure. While the level of knowledge about antineoplastic agents is high among nurses, along with the level of PPE use, medical surveillance and employee training seems to be lagging behind.