During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for hu...

Background: Phthalates are widely used as plasticizers in polyethylene terephthalate (PET) products. Several pharmaceutical products have been stored in PET containers, and due to serious health effects of phthalates, migration levels of them into pharmaceutical products must be determined. In the present study, leaching levels of four common phthalate esters including di-n-butyl phthalate (DBP...

Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized ...

Microalgae contain a variety of bioactive lipids with potential applications in aquaculture feed, biofuel, food and pharmaceutical industries. While microalgae-derived polyunsaturated fatty acid (PUFA) and their roles in promoting human health have been extensively studied, other lipid types from this resource, such as phytosterols, have been poorly explored. Phytosterols have been used as addi...

Traditional pharmaceutical analysis is focused almost exclusively on the end products of manufacturing processes. Samples are taken from drug substance or drug product batches and analyzed in a remote laboratory. The samples typically go through stages of documentation, sample preparation, analysis, data analysis and documentation once more, prior to the reporting of the analytical results. Thi...

An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration...