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Formulation

 

Recombinant protein
Recombinant protein
article

A history of recombinant protein technology in small molecule drug discovery

28 October 2014 | By Rick Davies, Associate Director, AstraZeneca / Ian Hardern, Senior Research Scientist, AstraZeneca / Ross Overman, Associate Principal Scientist, AstraZeneca

Recombinant protein production is a prerequisite and essential component of most modern small molecule drug discovery programs. Target proteins are required to underpin screening, structural and mechanistic studies providing data that drives chemical design. From the initial establishment of recombinant protein production in the pharmaceutical industry in the 1980s, systems…

Pharmaceutical Salts
Pharmaceutical Salts
article

Pharmaceutical salts of small molecule drugs: opportunities and challenges

28 October 2014 | By Axel Becker, Scientist, Merck KGaA

Over the past decades, pharmaceutical drug development has undergone some significant changes, a prominent example for this being the emergence of biomolecular drugs (New Biological Entities, NBEs) such as antibodies and peptides. However, classical small molecule drugs (New Chemical Entities, NCEs) are far from being a dying species, and in…

article

Novel methodologies for determining the mineral content of complex multivitamin tablets

5 September 2014 | By Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada

Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…

article

Techniques to preserve product quality in pharmaceutical freeze drying

3 July 2014 | By , ,

In a pharmaceutical freeze drying process, it is mandatory to preserve product quality. This means that for a given formulation that has to be freeze dried, the temperature has to remain below a limit value corresponding to the eutectic temperature for a product that crystallises after freezing, with the goal…

article

NMR – Recent developments for isotope profiling

3 July 2014 | By

Fraudulent misrepresentation, substitution or imitation of premium products has always been a problem for both the regulatory authorities and the pharmaceutical industry. The task of finding and preventing counterfeit products is particularly challenging1,2. Several analytical techniques are available to help characterise pharmaceutical compounds: physical profile; X-ray diffraction; infrared spectroscopy; mass…

Thus the combination of complex physical properties of powders and numerous environmental variations, such as humidity, illustrate why powder processing is so challenging.
Thus the combination of complex physical properties of powders and numerous environmental variations, such as humidity, illustrate why powder processing is so challenging.
article

Pharmaceutical powders characterisation – the need for a multivariate approach

3 July 2014 | By Brian Armstrong and Katrina Brockbank, Freeman Technology

Powders and bulk materials are widely used in industry as raw materials, intermediates and finished products. Indeed, over 60% of the value of pharmaceutical sales worldwide is accounted for by powder formulations, typically as tablet/capsule/sachet or in the form of an inhalable powder. Whilst they are used extensively, they are…

Dennis Douroumis
Dennis Douroumis
article

Hot melt extrusion processing for the development of sustained release products

15 April 2014 | By Dennis Douroumis, Reader in Pharmaceutical Sciences at the University of Greenwich and the Director of Centre for Innovation in Process Engineering and Research

Hot Melt Extrusion (HME) has attracted increased interest for the development of pharmaceutical dosage forms over the last decade. It is a versatile processing technology which produces extrudates in the form of solid dispersions and solid solutions. Among the various applications, HME has been adopted for the development of sustained…

Pills Powder
Pills Powder
article

Excipients in medicines for children: scientific and regulatory paradigms

15 April 2014 | By Ali Al-khattawi, Postdoctoral Research Associate, Aston University / Afzal R. Mohammed, Senior Lecturer in Pharmaceutics, Aston University

There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the ‘active pharmaceutical ingredient’…

Pills
Pills
article

Excipient selection in biologics and vaccines formulation development

19 February 2014 | By M. Babu Medi and Ramesh Chintala, Vaccine Drug Product Development, Merck & Co, Inc and Akhilesh Bhambhani, Novel Adjuvants, Formulation and Delivery Technologies, Merck & Co, Inc.

Excipients are an integral part of pharmaceutical products and play an important role in the formulation development of both small and large molecule pharmaceuticals. The type and extent of excipient use depends on several factors, including the type of active ingredient, route of administration, dosage form, target population and indication…