Functionality-type and chemical-composition separation of poly(lactide-co-glycolide) using gradient elution normal-phase liquid chromatography with basic and acidic additives.

End groups of poly(Lactide-co-glycolide) (PLGA) play an important role in determining the properties of polymers for use in drug delivery systems. For instance, it has been reported that the encapsulation efficiency in PLGA microspheres varies significantly between ester-terminated and acid-terminated PLGA. More importantly, the in-vivo degradation time of such polymer excipients is influenced by the functional end-group of the copolymer used.

A Cocktail Interaction Study Evaluating the Drug-Drug Interaction Potential of the Perpetrator Drug ASP8477 at Multiple Ascending Dose Levels.

ASP8477 (molecular weight 325.36 g/mol) is a fatty acid amide hydrolase inhibitor intended for the treatment of neuropathic pain. Results from in vitro studies indicated that ASP8477 is a direct inhibitor of cytochrome P450 (CYP) 2C8, 2C9, 2C19, 2D6, and 3A4 enzymes at expected efficacious concentrations, with the strongest effect on CYP2C19; a phase 1 study confirmed ASP8477 to be a CYP2C19 inhibitor.

The application of control charts in regulated bioanalysis for monitoring long-term reproducibility.

In regulated bioanalysis, the acceptance of results is batch-wise. When during clinical development derived pharmacokinetic or pharmacodynamic results from different studies will be combined or compared, it is recommendable to monitor the long-term reproducibility of bioanalytical assays. Long-term reproducibility can be evaluated by control charts generated from control samples included in each batch.

Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus.

Background: Ipragliflozin (ASP1941) is a selective sodium glucose cotransporter 2 inhibitor in clinical development for the treatment of patients with type 2 diabetes mellitus (T2DM).

Objectives: The primary objective was to evaluate the safety profile and tolerability of ipragliflozin as a glucose-lowering agent in combination with stable metformin therapy in patients with T2DM. A secondary objective was to evaluate the effect of ipragliflozin on the pharmacokinetic (PK) properties of metformin.

Determination of streptomycin and dihydrostreptomycin in milk and honey by liquid chromatography with tandem mass spectrometry.

Two liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods were developed for the determination of streptomycin (STR) and its derivative dihydrostreptomycin (DHSTR) in milk and honey. These aminoglycoside antibiotics are used as veterinary drugs. In the EU, the presence of dihydro- and streptomycin residues in honey is forbidden, the maximum residue level (MRL) in milk is 200 microg/kg.

Determination of residues of quaternary ammonium disinfectants in food products by liquid chromatography-tandem mass spectrometry.

A liquid chromatography-tandem mass spectrometry method has been developed for the determination of residues of alkylbenzyldimethylammonium, didecyldimethylammonium, didodecyldimethylammonium, and benzyldodecylhydroxyethylammonium compounds in various food matrixes. These quaternary ammonium compounds (QAs) are used in the food industry as disinfectants. According to the Dutch Food Law, the total mass (expressed as cetyltrimethylammonium chloride) of QAs in food products shall not exceed the legislative limit of 0.

Characterisation of core-shell latexes by flow field-flow fractionation with multi-angle light scattering detection.

Flat channel asymmetrical flow field-flow fractionation with multi-angle light scattering (MALS) detection was used to study the swelling behaviour of core-shell particles with either carboxylated or hydroxylated shells as a function of pH and ionic strength. The equilibration time of the most heavily carboxylated core-shells appeared to be of the order of several hours. At low ionic strength (5 mM), the carboxylated core-shells showed a definite swelling response to a change in pH in the range from 5 to 10, ranging from a hydrodynamic radius increase of 24 to 118%, depending on the degree of carboxylation.