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Excipients - Articles and news items
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…
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 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…
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.
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.
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.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics