Introduction The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published several quality or ‘Q’ guidelines for stability testing of active substances and drug…
Introduction The evaluation of the different climatic conditions and the mean kinetic temperature (MKT) by each of the 194 WHO member states resulted in the recommended storage conditions for long-term…
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of…
Introduction The appearance, physical attributes and functionality of the pharmaceutical product are as important as chemical stability. There is a wide variety of finished drug products, and it is fair…
Introduction The stability of a pharmaceutical product is a relative concept, in that it is dependent on the protectiveness of the container closure system, the recommended storage conditions and the…
Introduction to pharmaceutics One of the earliest impressions that many new pharmacy and pharmaceutical science students have of their chosen subject is the large number of long and sometimes unusual-sounding names that…
The gastrointestinal tract is complex. Fig. 19.1 outlines some of the main structures involved in, and key physiological parameters that affect oral drug absorption. In order to gain an insight…
Biopharmaceutics can be defined as the study of how the physicochemical properties of drugs, dosage forms and routes of administration affect the rate and extent of drug absorption. The relationship between the…
The growth and multiplication of bacteria can be examined in terms of individual cells or populations of cells. During the cell division cycle a bacterium assimilates nutrients from the surrounding medium…
Bacterial cells contain approximately 80% water by weight and this accounts for their very low refractility, i.e. they are transparent when viewed under ordinary transmitted light. Consequently, in order to…