Blog articles

Review of the book „Arzneiformenlehre“ (lessons of drug dosage forms)

Written by Dr. Janet Thode Posted in Think out of the box

In today's blog article I’d like to think outside the box and describe my impressions of the book "Arzneiformenlehre" by Uwe Weidenauer (2nd edition, 2019, published in “wissenschaftliche Verlagsgesellschaft Stuttgart”, ISBN: 978-3-8047-3187-5).

This book has accompanied me on the last holiday and some relaxed days at the pool I dipped into it. Since I mainly worked in the fields of parenteralia so far, I thought it might make sense to get also a little bit familiar with the production of other dosage forms such as tablets, drops or ointments. This book offers a possibility, although the viewpoint has surprised me a bit. It is often written from the perspective of manufacturing in the pharmacy, which is quite interesting, but what I didn’t expect.

Verification of compendial methods – LAL as an example

Written by Dr. Janet Thode Posted in Method validation

For drug release, not only the presence of the active pharmaceutical ingredient in claimed concentration and potency is important but also a low amount of impurities. Such impurities can be, for example, production related. An example is biotechnological manufacturing of drugs (e.g. therapeutic proteins) using bacteria. In sterile, e.g. parenterally administered drugs, no germs are allowed to be present and additionally no bacterial "residues". These can be fever-inducing components of the cell membrane of certain bacteria, so-called endotoxins. They can be detected by various methods, one of which is the Limulus Amoebocyte Lysate (LAL) test.

Why should a maximum pressure of 30 psi be applied to the bacterial retention test?

Written by Dr. Janet Thode Posted in Filter validation

Recently, I've been asked if I know why the ASTM F838 bacterial challenge test sets a maximum pressure of 30 psi (= 2.07 bar). Should this limit not be exceeded as no retention capability of the filter upwards can be provided? The answer to this question is a clear no. Filter membranes are still bacteria-retaining even at much higher pressures.