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ICH Q3D Guideline for Elemental Impurities – How BASF supports its pharmaceutical customers towards compliance - BASF SE

19-Mar-2015 - On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The required comprehensive view on a products’ elemental...
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The in-PharmaTechnologist Anti-counterfeiting Forum - William Reed Business Media

18-Mar-2015 - Drug counterfeiting: a pharmaceutical industry problemCounterfeiters rely on two things: poorly secured pharmaceutical supply chains; and the fact people want to pay less for less for drugs.Most fake erectile dysfunction drugs seized in Europe contain at least some trace of...
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Overview of the specialty excipients market for OSDF pharmaceuticals - William Reed Business Media

09-Mar-2015 - Consumption patterns in the 4 key global markets (Europe, US, India, China) Key market drivers and restraints and their impact on consumption Competitive landscape in the Specialty excipients market globally and local specificitiesMarket outlook: where will be the opportunities in the next...
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Quality Risk Management for excipients - Capsugel

09-Mar-2015 - Capsugel is the first hard capsule manufacturer to receive the EXCiPACT™ certification. The certification provides independent validation that Capsugel’s European manufacturing sites maintain excipient Good Manufacturing Practices (GMPs) and comply with current European Union regulations in the manufacturing of empty,...
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Dow AFFINISOL™ polymers for Solubility Enhancement - Dow Pharma & Food Solutions

09-Mar-2015 - Dow has developed the AFFINISOL™ line of excipients to enable solubility enhancement.Hypromellose acetate succinate (HPMCAS) has proven effective at producing stable amorphous solid dispersions for poorly soluble APIs. We will highlight: Utility of commercial grades of AFFINISOL™ HPMCAS AFFINISOL™ HPMCAS Quality by...
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The Solid Dose, Latest News from Colorcon - Colorcon Inc.

16-Feb-2015 - With a commitment to serve customers through product and service excellence, Colorcon’s Solid Dose newsletter brings you information to help make a positive contribution towards the quality of your products. Published 3 or 4 times a year, the Solid Dose...
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A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement - Butterworth

03-Feb-2015 - The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the...
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Customized Biosimilarity Analytical Testing from Catalent - Catalent

26-Jan-2015 - Assessment of biosimilar molecules requires an orthogonal analytical approach.  Any one particular analytical technique is not able to fully define the physical and biological characteristics of the original biotherapeutic or its potential biosimilar.  Instead, a panel of analytical techniques must...
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OptiPact™ Technology Introduced by Catalent - Catalent

19-Jan-2015 - Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced the launch of OptiPact™, an integrated service and technology offer based on the company’s expertise in roller...
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A brief history of bioavailability - William Reed Business Media

30-Sep-2014 - Tablets have been around for almost 200 years. In this presentation we trace the history of their development, from the accidental invention of the sustained release pill through to the latest breakthroughs in bioavailability enhancement, this talk will take us...
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Maximize Excipient Purity to Optimize Efficacy - Croda

29-Sep-2014 - The purity of your excipient can have a profound impact on your formulation’s performance, affecting both the stability of the drug and the final formulation.  Croda’s Super Refined™ range offers the most highly-purified excipients available, providing the power of purity...
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BASF Pharma solutions for Orally Disintegrating Tablets - BASF SE

25-Sep-2014 - ODTs are becoming increasingly popular for various reasons. For the consumer or patient, they offer a much more convenient administration, while healthcare companies can use them to differentiate their offer by creating line extensions.In this webinar you will learn about...
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Bioavailability market dynamics - William Reed Business Media

23-Sep-2014 - How healthy is demand for bioavailability enhancement services? Is the growth of the generics sector driving the market or do innovative pharma firms determine the type of solubility solutions that are available.When biopharmaceutical are injected they are 100% bioavailable, but...
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Nondestructive, single tablet analysis - Metrohm – customized analysis for the pharmaceutical industry

16-Jun-2014 - NIRS Spectroscopy allows rapid (<30 s) and nondestructive screening of solid dosage forms. It requires neither sample preparation nor solvent use. Interferences that derive from scattering are minimized by converting to second-derivative spectra.
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Developing textures with DC Polyols - Roquette

16-Jun-2014 - Different methodologies for assessing the texture and organoleptic properties of chewable polyols-based tablets.
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Determination of moisture in a protein sample using a portable NIR instrument - Thermo Fisher Scientific

03-Jun-2014 - Near infrared spectroscopy has been used effectively to measure moisture in a wide variety of samples. Due to the large overtone band for water in NIR, levels of accuracy tend to be high and limits of detection are lower than...
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BASF Pharma Solutions for Dermal Drug Delivery - BASF SE

03-Jun-2014 - Transdermal drug delivery is an exciting and challenging area. How can skin permeation be improved? What is the key to drug solubilization in transdermal delivery systems? BASF's Skin Delivery platform seeks to provide understanding, solutions and materials for the delivery...
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Smart strategies for sustained release matrix tablets: Compritol® 888 ATO - Gattefossé Pharma

19-May-2014 - This white paper gives an overview of how Compritol® 888 ATO provides clinically relevant sustained drug release profiles along with biopharmaceutical, formulation and manufacturing advantages.We provide an insight on formulation critical attributes, how Compritol® can be used in a range...
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Benzocaine Degradation in Orodispersible Tablet (ODT) Platforms - Roquette

12-May-2014 - The goal of this study was to determine the effect of different marketed ODT platforms on the chemical stability of an amino-containing drug.The results showed that the stability of Benzocaine in the ODTs was clearly modified by the composition of...
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Elemental Impurity Analysis in Pharmaceuticals - Butterworth

06-May-2014 - A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test....

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