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Dissolution of capsule with cross-linking
In this article, Jigar Shah, Senior Group Leader in Analytical Development at Baroque Pharmaceuticals, explores the intricacies of capsule dissolution testing.
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Dissolution Testing
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Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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Pharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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ebook: Nanoparticle formulations: overcoming dissolution challenges
This ebook explores the potential of nanoparticle formulations for drug delivery, as well techniques to predict in vivo bioavailability of these dosage forms.
news
BARDS: a potential in-process stability testing method
Study finds Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS) to be a potentially more time-efficient and cost-effective method for solid dose stability testing.
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Raman spectroscopy for nasal suspension characterisation
Researchers show that combining morphologically-directed Raman spectroscopy (MDRS) with dissolution analysis allows for particle size analysis in fully formulated nasal suspension sprays.
podcasts
EPR Podcast Episode 2 – Bioavailability enhancement with Dr Deanna Mudie, Lonza
In this podcast, Lonza’s Dr Deanna Mudie explains the importance of bioavailability, how to achieve desired bioavailability and top tips for how to select the correct dissolution media for your testing needs.
news
UK MHRA announces two Class 2 medicine recalls
A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.
news
Avet recalls tetracycline HCl capsules to consumer level
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
news
MHRA announces two medicine recalls
The Medicines and Healthcare products Regulatory Agency has issed two alerts for medicine recalls in the UK due to out of specification dissolution results and an error in decommissioning.
news
In silico techniques – a JPAG event
European Pharmaceutical Review attended a JPAG event, exploring the plethora of uses for in silico techniques in the pharmaceutical industry.
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ICH M9: biopharmaceutics classification system-based biowaivers
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
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Clinically relevant dissolution specifications: selection and assessment
Setting specifications for new oral products can be challenging. Too lenient, and there is a risk of passing batches of inadequate quality; too stringent, and there is a risk of rejecting acceptable batches.
news
AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...
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Dissolution testing in the modern world
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
