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Journal of Pharmaceutical Sciences

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  1. Ester Hydrolysis of Polysorbate 80 in mAb Drug Product: Evidence in Support of the Hypothesized Risk After the Observation of Visible Partic...

    Journal of Pharmaceutical Sciences 103(8):2268 (2014) PMID 24942482

    An observation of visible particulate matter was made during formulation development of a mAb and investigations initiated to understand the colloidal instability of the formulation. It was observed that there was a loss of polysorbate in the IgG formulation and concurrent hydrolysis of polysorbate...
  2. Numerical modelling of transdermal delivery from matrix systems: parametric study and experimental validation with silicone matrices.

    Journal of Pharmaceutical Sciences 103(8):2366 (2014) PMID 24984880

    We have introduced a numerical transient model describing matrix systems where the drug dissolution can be non-instantaneous. Furthermore, our model can describe complex interactions within a multi-layered matrix and the matrix to skin boundary. The power of the modelling approach presented here is...
  3. Chemical modification of hyaluronic Acid for intraoral application.

    Journal of Pharmaceutical Sciences 103(8):2414 (2014) PMID 24985030

    This study was aimed to investigate chemical preactivated thiomers for their potential use in mucosal drug delivery. Thiomers-thiolated polymers-are mucoadhesive polymers with sulfhydryl group-bearing side chains. Thiomers are synthesized by covalent attachment of low molecular mass compounds bearin...
  4. Determination of the optimal cell-penetrating peptide sequence for intestinal insulin delivery based on molecular orbital analysis with self...

    Journal of Pharmaceutical Sciences 102(2):469 (2013) PMID 23160942

    We sought to determine the CPP that most effectively enhanced intestinal insulin absorption. An in situ loop absorption study using 26 penetratin analogues suggested that the chain length, hydrophobicity, and amphipathicity of the CPPs, as well as their basicity, contribute to their absorption-enhan...
  5. Effects of submicron particles on formation of micron-sized particles during long-term storage of an interferon-beta-1a solution.

    Journal of Pharmaceutical Sciences 102(2):347 (2013) PMID 23233283

    We present evidence that homogeneous submicron particles can influence the growth rate of larger particles upon long-term storage in a temperature-dependent manner. Interferon-beta-1a was thermally stressed at 50°C for 6 h and characterized using nanoparticle tracking analysis (NTA), microflow digi...
  6. Solubility prediction of drugs in mixed solvents using partial solubility parameters

    Journal of Pharmaceutical Sciences 100(10):4368 (2011) PMID 21630276

    Solubility of drugs in binary and ternary solvent mixtures composed of water and pharmaceutical cosolvents at different temperatures were predicted using the Jouyban-Acree model and a combination of partial solubility parameters as interaction descriptors in the solution. The general...
  7. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: Goals, properties of the PhRMA dataset, and comparison with l...

    Journal of Pharmaceutical Sciences 100(10):4050 (2011) PMID 21523782

    This study is part of the Pharmaceutical Research and Manufacturers of America (PhRMA) initiative on predictive models of efficacy, safety, and compound properties. The overall goal of this part was to assess the predictability of human pharmacokinetics (PK) from preclinical data and...
  8. PLGA microdevices for retinoids sustained release produced by supercritical emulsion extraction: Continuous versus batch operation layouts

    Journal of Pharmaceutical Sciences 100(10):4357 (2011) PMID 21638283

    Retinyl acetate (RA) was selected as a model compound to be entrapped in poly(lactic-co-glycolic)acid (PLGA) microspheres using supercritical emulsion extraction (SEE). Several oil-in-water emulsions prepared using acetone and aqueous glycerol (80% glycerol, 20% water) were processed...
  9. Prolonged circulation half-life of interferon γ activity by gene delivery of interferon γ-serum albumin fusion protein in mice.

    Journal of Pharmaceutical Sciences 100(6):2350 (2011) PMID 21246562

    We tried to increase the circulation half-life of IFNγ after its gene delivery by designing a novel fusion protein of IFNγ with mouse serum albumin (MSA). Western blot analysis confirmed that IFNγ-MSA was expressed as a fusion protein, but hardly formed dimer as IFNγ did. The biological activity...
  10. Usefulness of a nanoparticle formulation to investigate some hemodynamic parameters of a poorly soluble compound.

    Journal of Pharmaceutical Sciences 100(6):2194 (2011) PMID 21491443

    Drug solubility is an important issue when progressing investigational compounds into clinical candidates. The present paper describes the development and characterization of a nanosuspension that was formulated to overcome problems with poor water solubility and possible adverse events caused by cos...