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Pharmaceutical Manufacturing and Packing Sourcer
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While it seems that a new drug launch draws all the attention to the specific drug substance, it is clear that the authorities only approve a drug product which contains more than just the specific drug substance alone. In reality, the drug product is a combination of the drug, a formulation of functional excipients and their processing. The formulation and processing is critical for the pharmacokinetic profile of the drug substance in vivo, which is part of its efficacy and safety. The optimal efficacy and safety is dependent on the drug concentration at the receptor site, the input rate and the duration of receptor interaction. In a recent draft guideline the FDA addresses the need to evaluate the pharmacokinetic-pharmacodynamic correlation to develop the optimal drug delivery system in terms of maximised efficacy and safety profile for the drug substance (1).
According to the Biopharmaceutics Drug Classification (BCS), drugs are classified according to their aqueous solubility and membrane permeability (2). Drugs with poor solubility but high permeability are classified as 'Class 2' compounds. Their oral bioavailability can be expected to be dependent on the solubilisation kinetic in the gastric juice of the GI tract.
A formulation for a 'Class 2' drug will focus on solubility enhancement or solubilisation to improve the bioavailability and pharmacokinetic profile. Many different technologies have been proposed, especially particle size reduction to the nanometer range and solid dispersions. About a decade ago, self-emulsifying drug delivery systems (DDS) entered into the pharmaceutical development scene as a potential technology to enhance oral bioavailability.
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Industry Events |
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6th European Forum for Qualified Person for Pharmacovigilance (QPPV)
24-26 April 2012, London, UK
This event is for European qualified persons for pharmacovigilance; deputy qualified persons; senior pharmacovigilance regulators and inspectors; CROs and consultants providing QPPV services; and national responsible persons for pharmacovigilance.
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DASGIP Product Catalog 2012 now available for download
The new DASGIP Product Catalogue is now available online. The catalogue offers a user-friendly update on our technology. You will find a comprehensive overview on our portfolio including information on recently launched products such as our Bioprocess Software Suite DASware and the Minibioreactor System DASbox.
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