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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…
This article reviews the trends in freeze drying highlighted at recent Parenteral Drug Association (PDA) conferences...
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…
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
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...
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...
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
Linkam Scientific Instruments, announce the launch of the FDVS platform, a lyophilisation system to replicate large scale freeze drying processes...
Lab M Ltd, a Neogen company, introduces its Pinnacle™ MMGA (ISO), Mineral Modified Glutamate Agar, pre-poured media plate. The new plate is formulation compliant to ISO 16649-1 and performance compliant to ISO 11133 for the recovery of stressed and injured E. coli in food, water and feed samples.
Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...
Blood transfusions have been used successfully since the early 1900s, and blood banks have been in use since 1914. After donation, whole blood is separated into several components for processing and storage under different conditions, and one of these components is the red blood cell fraction.
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to make the recipient believe they are receiving something they are not in order to establish whether the true active agent has a noticeable remedy to the ailment it is intended to…
Controlled nucleation is the most significant new development in freeze drying in quite some time.
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
