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Excipients - Articles and news items


Quantification of Tablets Containing Multiple APIs: Using Transmission Raman

Whitepapers / 25 October 2016 / Cobalt Light Systems

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…

Ingredients In-Depth Focus 2016

Ingredients In-Depth Focus 2016

Issue 5 2016, Supplements, Z Homepage promo / 20 October 2016 / European Pharmaceutical Review

In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle…

New third-party audit scheme for excipient suppliers

New third-party audit scheme for excipient suppliers

Ingredients, Issue 5 2015, Manufacturing & Packaging / 22 October 2015 / 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 within a realistic frequency? Equally, suppliers of excipients to their many pharmaceutical customers face an avalanche of audits. With both sides having limited resources is there a third-party audit solution which meets regulatory expectations and is efficient in resources?

The SSPC: leading the way for next-generation medicines manufacture

The SSPC: leading the way for next-generation medicines manufacture

Ingredients, Issue 4 2015 / 3 September 2015 / 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 state-industry investment, which supports a globallyleading research team of 38 investigators, 34 post-doctoral researchers and 60 PhD candidates. As the largest research collaboration in Ireland and one of the largest globally within the pharmaceutical area, the SSPC transcends company and academic boundaries. Its role is to link experienced scientists and engineers in academia and the pharmaceutical industry, to address critical research challenges and to deliver industry-relevant solutions, which result in job growth and retention within the pharmaceutical industry…

Pills Powder

Excipients in medicines for children: scientific and regulatory paradigms

Ingredients, Issue 2 2014 / 15 April 2014 / 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’ which are added to the formulation to achieve a specific function. This may include aiding in the processing or manufacture of the drug delivery system such as lubricants or flow aids, controlling the release of the active ingredient to achieve modified release, enhance patient acceptability by improving taste of medicines or to develop easily swallowed dosage forms.

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The central role of excipients in drug formulation

Ingredients, Issue 2 2013 / 18 April 2013 / 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 tablets containing only this drug. Hence, the formulation of levothyroxine tablets requires the combination of the hormone with one or more nonmedical agents known as pharmaceutical inactive ingredients or excipients that serve varied and specific pharmaceutical functions1.

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Breaking old habits: Moving away from commonly used buffers in pharmaceuticals

Ingredients, Issue 3 2012 / 10 July 2012 / 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 to use in commercial dosage forms. A number of alternative buffers have also gone through the approval process to be proven safe, and the use of histidine and tromethamine is becoming increasingly common in parenteral formulations. This article highlights the advantages of some lesser known buffers with the hope that bringing these excipients into the clinic and market more often will help to augment the tools formulators have available in achieving stable protein formulations.

The US Food, Drug and Cosmetic Act of 1938 required manufacturers and pharmaceuticals companies to be responsible for the safety of drug additives / excipients in their products in response to a tragedy where 100 children were killed from the presence of diethylene glycol in an antibacterial product. To help clarify what is needed to establish a new excipient, the FDA released a guidance document in 2005 entitled ‘Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients’, outlining the safety studies needed in order to have an excipient approved1,2. Recent articles have called for the need for more alternative excipients for the use in formulations1,3,4.


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