Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
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17 December 2018 | By European Pharmaceutical Review
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
22 October 2018 | By European Pharmaceutical Review
In this issue: LC-MS multi-attribute methods for the characterising and QC testing therapeutics, integrating data from Quality Control and Production to enable fast and informed decisions, and Solid-state NMR spectroscopy: using freeze drying to predict the stability of biological products.
Linkam highlights the work of Dr Henning Gieseler from the Division of Pharmaceutics at the Friedrich-Alexander University Erlangen-Nuremberg in the field of pharmaceutical freeze drying
25 January 2018 | By Linkam Scientific Instruments Limited
Market leaders in temperature controlled microscopy and established manufacturers of advanced freeze drying microscopes, Linkam Scientific Instruments, report on the work of Dr Henning Gieseler from the Friedrich-Alexander University (FAU) Erlangen-Nuremberg on his research and development activities in the field of freeze drying for the pharmaceutical industry.
Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that freeze-drying is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique.1,2
12 September 2017 | By
Senior Lecturer in Pharmaceutics at King's College London
12 September 2017 | By Steve Bremer (European Pharmaceutical Review)
Dr Paul Royall, Senior Lecturer in Pharmaceutics at King’s College London, and Programme Director of the MSc in Pharmaceutical Analysis and Quality Control, has joined European Pharmaceutical Review's Editorial Advisory Board.
Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…
30 June 2017 | By Abdulmalik Alqurshi (Taibah University), Ben Forbes (Kings College London), John Strang (National Addiction Centre), Patrick Courtney (tec-connection), Paul G. Royall (Kings College London)
Opioid overdose in the US and in Europe is on the rise, and the role of prescription-sourced drugs such as oxycodone cannot be underestimated...
29 June 2017 | By European Pharmaceutical Review
In this Formulation Development & Delivery In-Depth Focus: A report on the use of freeze-drying to develop orally disintegrating tablets; a review of mucosal drug delivery; an interview on drug delivery through the skin; and a profile of three analytical technologies used to develop drug delivery systems...
27 June 2017 | By Niamh Marriott (European Pharmaceutical Review)
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...