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In this application note, HORIBA discuss using raman spectroscopy to study the distribution of compounds in pharmaceutical drug products...
In this infographic, the Royal Pharmaceutical Society offers a more complete picture from excipient experts...
The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…
The ability to predict multiple constituents of a final dosage form in one fast, non-destructive measurement can reduce analysis time. This is especially important when quantification of multiple APIs is required for tests such as content uniformity, assay and ID...
In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle...
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
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…
In Issue #4 2015: NGS, Informatics, Spray Drying, Excipients, Rapid Methods, NIR, PAT, Regulatory Insight and much more...
3 September 2015 | By Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC
The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million…
Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step, a liquid feed into a powder and is an ideal process when precise attributes such as particle size, morphology and stability are required. This…
In Issue #2 2014: Mass Spectrometry and Stem Cells in-depth focuses, Hot Melt Extrusion, PAT, Excipients, Microbiology plus much more...
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’…
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…
18 April 2013 | By Pascal Furrer, Pharmacist
Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture…
10 July 2012 | By David Sek, Research Scientist, Pfizer
One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available…
