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LAT1 and LAT2 are heterodimeric large amino acid transporters that are expressed in various tissues, including the intestinal wall, blood-brain barrier, and kidney. These transporters consist of membrane spanning light chain and heavy chain, and they act as 1:1 exchangers in concert with other amino acid transporters. Only a few drugs (less than 10) are(More)
The use of paper-based test platforms in cell culture experiments is demonstrated. The arrays used for two-dimensional cell cultures were prepared by printing patterned structures on a paper substrate using a hydrophobic polydimethylsiloxane (PDMS) ink. The non-printed, PDMS-free areas formed the array for the cell growth experiments. Cell imaging was(More)
Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the approval of immediate release (IR) solid oral dosage forms containing ranitidine hydrochloride are reviewed. According to the current Biopharmaceutics Classification System (BCS), ranitidine hydrochloride should be assigned to Class III.(More)
In vitro dissolution tests can be used to waive in vivo bioequivalency studies (biowaiver), if drug has high solubility and high permeability according to biopharmaceutics classification system (BCS I). Then absorption of BCS I drugs is not dependent on drug dissolution or gastrointestinal transit time and the solid dosage form behaves like oral solution.(More)
The paracellular space defines the passive permeation of hydrophilic compounds in epithelia. The goal of this study was to characterise the paracellular permeation pathway in the human intestinal wall and differentiated epithelial cell models (MDCKII, Caco-2 and 2/4/A1). The permeabilities of hydrophilic polyethylene glycols (PEG) were investigated in(More)
The goals of this study were to evaluate human retinal pigment epithelial cell line (ARPE-19) for cell encapsulation and to optimize the alginate-based microencapsulation. We used immortalized ARPE-19 cells and the transfected sub-line that expresses secreted alkaline phosphatase (SEAP) reporter enzyme. Alginate was cross-linked with different divalent(More)
Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be(More)
Models for predicting oral drug absorption kinetics were developed by correlating absorption rate constants in humans (K(a)) with computational molecular descriptors. The K(a) values of a set of 22 passively absorbed drugs were derived from human plasma time-concentration profiles using a deconvolution approach. The K(a) values correlated well with(More)
The efficacy of central nervous system (CNS) drugs may be limited by their poor ability to cross the blood-brain barrier (BBB). Transporters, such as p-glycoprotein, may affect the distribution of many drugs into the CNS in conjunction with the restricted paracellular pathway of the BBB. It is therefore important to gain information on unbound drug(More)
Current hepatocyte models do not mimic the human liver morphology and functions properly and, therefore, drug metabolism, excretion, and toxicity in the liver are inadequately predicted. In this study, we established three-dimensional (3D) hepatic cell cultures in hydrogels of peptide nanofibers. The aim was to establish an improved 3D phenotype of HepG2(More)