9,789 results match your criteria BioPharm International[Journal]


Sustained release of recombinant thrombomodulin from cross-linked gelatin/hyaluronic acid hydrogels potentiate wound healing in diabetic mice.

Eur J Pharm Biopharm 2018 Dec 12. Epub 2018 Dec 12.

nstitute of Clinical Pharmacy and Pharmaceutical Sciences, Southern Taiwan University of Science and Technology, Tainan, Taiwan. Electronic address:

Thrombomodulin (TM) is a type-I transmembrane glycoprotein expressed on the surfaces of endothelial cells and epidermal keratinocytes. It is known to regulate blood coagulation, inflammation, and cell-cell adhesion. A recombinant TM, which contains an epidermal growth factor - like domain and serine/threonine-riches domain, has been demonstrated to stimulate cell proliferation and migration of keratinocytes and wound healing. Read More

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December 2018

Redox-Responsive Prodrug-like PEGylated Macrophotosensitizer Nanoparticles for Enhanced Near-Infrared Imaging-guided Photodynamic Therapy.

Eur J Pharm Biopharm 2018 Dec 11. Epub 2018 Dec 11.

CAS Key Laboratory of Soft Matter Chemistry, Hefei National Laboratory for Physical Sciences at the Microscale, and Department of Chemical Physics, iCHEM, University of Science and Technology of China, Jinzai road 96, Hefei,230026, Anhui, China. Electronic address:

Efficient delivery of hydrophobic photosensitizer (PS) into tumor cells is a key step for photodynamic therapy (PDT). Redox-responsive polymeric nanoparticles of amphiphilic macro-photosensitizer has designed and prepared as a prodrug-like pro-photosensitizer (pro-PS) for PDT. PEG works as the hydrophilic block and the near infrared (NIR) brominated BODIPY derivative (BDP) works as the hydrophobic PS, and they were linked via the disulfide bond as PEG-SS-BDP, which could be broken for drug release owing to the high GSH concentration inside tumor cells. Read More

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December 2018

Elastic recovery of filler-binders to safeguard viability of Lactobacillus rhamnosus GG during direct compression.

Eur J Pharm Biopharm 2018 Dec 10. Epub 2018 Dec 10.

University of Antwerp, Department of Pharmaceutical, Biomedical and Veterinary Sciences, Laboratory of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, B-2610 Wilrijk, Belgium. Electronic address:

Tablets are increasingly explored as dosage form for oral probiotics, especially for applications such as pharyngitis and dental health. In such tablets, the dry form increases the stability and the shelf life of the product. In addition, the probiotic cells are entrapped in the tablet matrix, which protects them against the environmental factors in the human body. Read More

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December 2018

An adaptive dose-finding design based on both safety and immunologic responses in cancer clinical trials.

Stat Biopharm Res 2018 30;10(3):185-195. Epub 2018 Apr 30.

Department of Surgery, Cardinal Bernardin Cancer Center, Loyola University, Chicago, Maywood, IL, USA.

Dose-finding in cancer clinical trials has been dominated by algorithmic designs on the principle that the highest tolerable dose is also the most effective dose. This assumption no longer applies to the biologic treatments that are characterized by different toxicity and/or efficacy profiles to the extent that the best therapeutic dose might be well below any dose that produces serious toxicity. As such, we propose a two-stage design with focus on immunotherapy trials, incorporating both safety and efficacy information. Read More

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Comparison of Four Commercial IgG-Enzyme-Linked Immunosorbent Assays for the Detection of Tick-Borne Encephalitis Virus Antibodies.

Vector Borne Zoonotic Dis 2018 Dec 4. Epub 2018 Dec 4.

3 Interregional Blood Transfusion SRC, Bern, Switzerland.

Tick-borne encephalitis (TBE) is the most important arboviral disease in many parts of Europe and Asia. Both the diagnosis of TBE as well as the conduction of surveillance studies are based on the demonstration of specific antibodies. For reasons of simplicity, automatization, and quick availability of test results, enzyme-linked immunosorbent assays (ELISAs) are the method of choice for anti-TBE virus antibody detection. Read More

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December 2018

Freeze/thaw of IGG solutions.

Eur J Pharm Biopharm 2019 Jan 4;134:185-189. Epub 2018 Dec 4.

Department of Pharmacy-Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-Universität München, 81377 Munich, Germany. Electronic address:

In this communication, the effect of mannitol and trehalose crystallization on the unfolding of IgG, a monoclonal antibody, in the frozen state with repeat freeze/thaw under different pH conditions was explored. Formulations were annealed at -20 °C for 20 h five times (interrupted by freeze/thaw). This was done to induce excipient crystallization. Read More

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January 2019

Individualized in vitro and in silico methods for predicting in vivo performance of enteric-coated tablets containing a narrow therapeutic index drug.

Eur J Pharm Biopharm 2018 Dec 5. Epub 2018 Dec 5.

University of Greifswald, Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), Felix-Hausdorff-Straße 3, 17489 Greifswald, Germany. Electronic address:

The efficacy of narrow therapeutic index (NTI) drugs is closely related to their plasma concentration-time profile. Particularly for these compounds interindividual variability of gastrointestinal (GI) parameters relevant to in vivo drug release may result in fluctuations of the plasma concentration. The present study focused on assessing the influence of individual GI pH- and transit profiles on drug release of enteric valproate tablet formulations by means of individualized in vitro dissolution experiments. Read More

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December 2018

Chemically identical but physically different: a comparison of spray drying, hot melt extrusion and cryo-milling for the formulation of high drug loaded amorphous solid dispersions of naproxen.

Eur J Pharm Biopharm 2018 Dec 5. Epub 2018 Dec 5.

KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, Leuven B-3000, Belgium. Electronic address:

In spite of the large research efforts in the past two decades, it is still difficult, if possible at all, to predict what manufacturing technology will lead to the best amorphous solid dispersions (ASDs) in terms of drug to polymer ratio ("drug loading") and physical stability. In general, ASDs can be prepared by solvent based methods, heat based methods and mechanochemical activation. In the current study, one manufacturing technique per category was selected: spray drying, hot melt extrusion and cryo-milling, respectively. Read More

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December 2018

Hydroxycamptothecin nanoparticles based on poly/oligo (ethylene glycol): Architecture effects of nanocarriers on antitumor efficacy.

Eur J Pharm Biopharm 2019 Jan 5;134:178-184. Epub 2018 Dec 5.

School of Pharmacy, Heilongjiang University of Chinese Medicine, No. 24, Heping Road, Xiangfang District, Harbin 150040, China.

Nanoparticles decorated with hydrophilic PEG chains had been emerged as effective drug delivery system due to their biocompatibility and biodegradability, while, the influence of their architecture on antitumor efficacy remained challenging. In this study, the linear poly(ethylene glycol) (PEG), brush oligo(triethylene glycol) (TEG), and oligo(ethylene glycol) dendron (G2), which showed the similar molar mass but different architecture, were utilized as nanocarriers to prepare 10-hydroxycamptothecin (HCPT) nanoparticles. It was found that all of three HCPT NPs (PEG NPs, TEG NPs, and G2 NPs) presented similar DLCs (∼60%), zeta potentials (-13 to -16 mv), and stabilities, meanwhile, the particle sizes, morphologies, release profiles, and anticancer efficacies were affected by the architecture of nanocarriers. Read More

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January 2019

Use of Generally Recognized as Safe or Dietary Compounds to Inhibit Buprenorphine Metabolism: Potential to Improve Buprenorphine Oral Bioavailability.

Biopharm Drug Dispos 2018 Dec 5. Epub 2018 Dec 5.

Dept. of Pharmaceutics, VCU School of Pharmacy, 410 N. 12th Street, Richmond, VA, 23298.

The present study evaluated the potential of five generally recognized as safe (GRAS) or dietary compounds (α-mangostin, chrysin, ginger extract, pterostilbene and silybin) to inhibit oxidative (CYP) and conjugative (UGT) metabolism using pooled human intestinal and liver microsomes. Buprenorphine was chosen as the model substrate as it is extensively metabolized by CYPs to norbuprenorphine and by UGTs to buprenorphine glucuronide. Chrysin, ginger extract, α-mangostin, pterostilbene and silybin were tested for their inhibition of formation of norbuprenorphine or buprenorphine glucuronide in both intestinal and liver microsomes. Read More

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December 2018
4 Reads

Pharmacokinetics and metabolism of pemafibrate, a novel selective peroxisome proliferator-activated receptor-alpha modulator, in rats and monkeys.

Biopharm Drug Dispos 2018 Dec 5. Epub 2018 Dec 5.

Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Machida, Tokyo, 194-8543, Japan.

The metabolic profiles and pharmacokinetics of pemafibrate, a novel selective peroxisome proliferator activated receptor-alpha modulator currently launched as an antidyslipidemic drug, were investigated in vitro using hepatocytes from rats, monkeys, and humans and in vivo in rats and monkeys. Hepatocytes from rats, monkeys, and humans all biotransformed pemafibrate to its demethylated form (M1). The bioavailabilities of pemafibrate in Sprague-Dawley rats and cynomolgus monkeys were 15% and 87%, respectively, after a single oral administration of pemafibrate (1 mg/kg). Read More

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December 2018
1 Read

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects.

BioDrugs 2018 Dec 3. Epub 2018 Dec 3.

Department of Pharmacy, Peking University People's Hospital, Beijing, China.

Objective: The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects.

Methods: We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg. Read More

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December 2018
1 Read
2.989 Impact Factor

Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial.

Pain Med 2018 Nov 29. Epub 2018 Nov 29.

Section of Thoracic Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.

Introduction: Rib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.

Objectives: Based on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.

Methods: Prospective, double-blinded, randomized, controlled trial of 51 patients. Read More

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November 2018

Effect of high uric acid on the disposition of metformin: in vivo and in vitro studies.

Biopharm Drug Dispos 2018 Nov 28. Epub 2018 Nov 28.

Department of Pharmacy, the First Hospital of Lanzhou University, Lanzhou, 730000, China.

Metformin is always used the baseline antidiabetic therapy of patients with type 2 diabetes mellitus (T2DM) and hyperuricemia. Metformin excreted into urine through active secretion mediated by rOCTs and rMATE1.The aim of this study was to identify the effects of high uric acid on the disposition and its mechanism. Read More

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November 2018
8 Reads

Development of a flow-through USP 4 apparatus drug release assay for the evaluation of amphotericin B liposome.

Eur J Pharm Biopharm 2019 Jan 24;134:107-116. Epub 2018 Nov 24.

Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI 48109, United States; Biointerfaces Institute, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI 48109, United States. Electronic address:

AmBisome® is a liposomal formulation of amphotericin B (Amp B), a complex parenteral antifungal product with no US FDA approved generic version available to date. For generic Amp B liposomal product development, examination of the drug release profile is important for product quality control and analytical comparability evaluation with the reference listed drug. Yet, there is no standardized in vitro drug release (IVR) assay currently available for Amp B liposomes. Read More

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January 2019
3.380 Impact Factor

Printfills: 3D printed systems combining fused deposition modeling and injection volume filling. Application to colon-specific drug delivery.

Eur J Pharm Biopharm 2019 Jan 24;134:138-143. Epub 2018 Nov 24.

Department of Pharmacy and Pharmaceutical Technology, Universidad de Sevilla, C/Profesor García González 2, 41012 Seville, Spain.

Three-dimensional printing has become a feasible manufacturing technique for pharmaceutical products providing cheap and accurate freeform systems with a great potential for personalized-dose drugs. Fused Deposition Modeling (FDM) highlights among other 3D technologies due to its low cost and easy to operate but, until now, it has the drawbacks of the low drug loaded and the impossibility to print thermosensitive drugs. So, intermediate processes such as hot melt extrusion are frequently associated with FDM. Read More

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January 2019
1 Read

Lipid nanocapsules decorated and loaded with cannabidiol as targeted prolonged release carriers for glioma therapy: In vitro screening of critical parameters.

Eur J Pharm Biopharm 2019 Jan 22;134:126-137. Epub 2018 Nov 22.

Department of Pharmaceutics and Food Technology, Complutense University, Madrid, Spain; University Institute of Industrial Pharmacy, Complutense University, Madrid, Spain. Electronic address:

The therapeutic potential of cannabinoids has been truly constrained heretofore due to their strong psychoactive effects and their high lipophilicity. In this context, precisely due to the lack of psychoactive properties, cannabidiol (CBD), the second major component of Cannabis sativa, arises as the phytocannabinoid with the most auspicious therapeutic potential. Hence, the incorporation of CBD in lipid nanocapsules (LNCs) will contribute to overcome the dosing problems associated with cannabinoids. Read More

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January 2019
3 Reads

Physiologically based absorption modeling to predict bioequivalence of controlled release and immediate release oral products.

Eur J Pharm Biopharm 2019 Jan 22;134:117-125. Epub 2018 Nov 22.

Dissolution Sciences, Slovenia.

Physiologically based absorption modeling was conducted to predict bioequivalence (BE) for immediate release (IR) and controlled release (CR) formulations. In case of the CR formulation of a BCS class 1 drug, sensitivity analyses were conducted to investigate the impact of gastrointestinal (GI) transit time and absorption scaling factors in caecum and colon on formulation PK. The regional absorption profiles of the test and reference formulations were compared to provide additional confidence on the BE predictions. Read More

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January 2019
2 Reads

Prevention of hepatic stellate cell activation using JQ1- and atorvastatin-loaded chitosan nanoparticles as a promising approach in therapy of liver fibrosis.

Eur J Pharm Biopharm 2019 Jan 22;134:96-106. Epub 2018 Nov 22.

Department of Pharmaceutical Technology, Faculty of Pharmacy & Biotechnology, The German University in Cairo (GUC), Cairo, Egypt.

Preventing hepatic stellate cell (HSC) activation represents a promising approach to resolve liver fibrosis. Several drugs have been reported to delay/prevent HSCs activation, however with limited clinical benefits. The latter may be in part attributed to the limited ability of such drugs in targeting more than one pathway of HSC activation. Read More

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January 2019
1 Read

Solid lipid nanoparticles for the delivery of anti-microbial oligonucleotides.

Eur J Pharm Biopharm 2019 Jan 20;134:166-177. Epub 2018 Nov 20.

Nanovector Srl., Via Livorno 60, 10144 Turin, Italy.

Novel alternatives to antibiotics are urgently needed for the successful treatment of antimicrobial resistant (AMR) infections. Experimental antibacterial oligonucleotide therapeutics, such as transcription factor decoys (TFD), are a promising approach to circumvent AMR. However, the therapeutic potential of TFD is contingent upon the development of carriers that afford efficient DNA protection against nucleases and delivery of DNA to the target infection site. Read More

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January 2019
5 Reads

Sortagging of liposomes with a murine CD11b-specific VHH increases in vitro and in vivo targeting specificity of myeloid cells.

Eur J Pharm Biopharm 2019 Jan 20;134:190-198. Epub 2018 Nov 20.

BioMed X GmbH, Im Neuenheimer Feld 583, 69120 Heidelberg, Germany.

The therapeutic index of drugs can be increased via drug encapsulation in actively targeted, meaning ligand modified drug delivery systems. The manufacturing of such targeted drug delivery systems, in particular the conjugation between drug carrier and ligand, can be done by enzymatic conjugation methods, exploiting the site-specific, bioorthogonal nature of these reactions. The use of such enzymes like Sortase-A transpeptidase requires efficient purification methods, as residuals of the enzyme may be responsible for immunogenic potential and drug product instabilities. Read More

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January 2019
2 Reads

Dipeptides as co-formers in co-amorphous systems.

Eur J Pharm Biopharm 2019 Jan 20;134:68-76. Epub 2018 Nov 20.

Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.

Drug-amino acid co-amorphous systems have become increasingly well-investigated systems to improve dissolution rate of poorly water-soluble drugs. In this study, dipeptides were investigated as co-formers for co-amorphous systems based on the hypothesis that dipeptides might combine the inherent properties of the two included amino acids. Co-amorphization of the model drug mebendazole was investigated with five dipeptides, tryptophan-phenylalanine, phenylalanine-tryptophan, aspartic acid-tyrosine, histidine-glycine and proline-tryptophan. Read More

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January 2019
7 Reads

Pharmacokinetics of topically applied tacrolimus dissolved in Marinosolv, a novel aqueous eye drop formulation.

Eur J Pharm Biopharm 2019 Jan 19;134:88-95. Epub 2018 Nov 19.

Clinical Department for Farm Animals and Herd Management, University of Veterinary Medicine Vienna, Veterinärplatz 1, Vienna, Austria.

Corticosteroids and macrolide immunomodulators such as tacrolimus are effective drugs for the topical treatment of inflammatory eye diseases like allergic conjunctivitis or dry eye. However, tacrolimus is practically insoluble in aqueous solutions and is therefore currently formulated as dispersion. This leads to low bioavailability. Read More

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January 2019
4 Reads

Biotherapeutic Antibody Subunit LC-MS and Peptide Mapping LC-MS Measurements to Study Possible Biotransformation and Critical Quality Attributes In Vivo.

J Pharm Sci 2018 Nov 19. Epub 2018 Nov 19.

Bioanalysis, Immunogenicity and Biomarkers, In Vitro/In Vivo Translation Platform.

Biotransformation monitoring involves tracking drug modification occurring during in-life studies. Critical Quality Attribute (CQA) monitoring from forced degraded drug material or in-life sample sets can provide an in-depth assessment of product quality for support in early or late stage drug development. For CQA analysis, biotherapeutic mAb subunit analysis and peptide mapping liquid chromatography-mass spectrometry (LC-MS) approaches are utilized, although typically from an in vitro setting (e. Read More

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November 2018
1 Read

Solid lipid nanoparticles and nanostructured lipid carriers: A review emphasizing on particle structure and drug release.

Eur J Pharm Biopharm 2018 Dec 27;133:285-308. Epub 2018 Oct 27.

Universidad Nacional de Colombia, Sede Bogotá, Facultad de Ciencias, Departamento de Farmacia, Grupo de investigación en Desarrollo y Calidad de Productos Farmacéuticos y Cosméticos, Ciudad Universitaria, Carrera 30 45-03, edificio 450, código postal 111321, Bogotá, Colombia. Electronic address:

Colloidal systems based on lipids have attracted attention during the last two decades as a delivery method of drugs that are poorly soluble in water. The investigations carried out have focused on the development of different formulations using a wide variety of excipients and active molecules. However, there is no consensus on the structure of the particles in these colloidal systems. Read More

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December 2018
1 Read

Predicting local drug availability of locally acting lozenges: From method design to a linear level A IVIVC.

Eur J Pharm Biopharm 2018 Dec 26;133:269-276. Epub 2018 Oct 26.

University of Greifswald, Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, 3 Felix Hausdorff Street, Greifswald 17489, Germany. Electronic address:

Lozenges are commonly applied in the treatment of sore throat. They often contain drugs intended to exert their effect locally in the oral cavity and throat. In the recent past, an increasing interest in development of generic products for locally acting lozenges could be noted. Read More

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December 2018
2 Reads

Corrigendum to "Polyglutamic acid-based nanocomposites as efficient non-viral gene carriers in vitro and in vivo" [Euro. J. Pharm. Biopharm. 79 (2011) 473-484].

Eur J Pharm Biopharm 2018 Dec 23;133:161. Epub 2018 Oct 23.

CSIR - Institute of Genomics and Integrative Biology, Delhi University Campus, Delhi, India; CSIR - Indian Institute of Toxicology Research, Mahatma Gandhi Marg, Lucknow, India. Electronic address:

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December 2018
1 Read

Hyaluronan-based dissolving microneedles with high antigen content for intradermal vaccination: Formulation, physicochemical characterization and immunogenicity assessment.

Eur J Pharm Biopharm 2019 Jan 16;134:49-59. Epub 2018 Nov 16.

Division of BioTherapeutics, Leiden Academic Centre for Drug Research (LACDR), Leiden University, P.O. Box 2300, Einsteinweg 55, 2333 CC Leiden, the Netherlands. Electronic address:

The purpose of this study was to optimize the manufacturing of dissolving microneedles (dMNs) and to increase the antigen loading in dMNs to investigate the effect on their physicochemical properties. To achieve this, a novel single-array wells polydimethylsiloxane mold was designed, minimizing antigen wastage during fabrication and achieving homogeneous antigen distribution among the dMN arrays. Using this mold, hyaluronan (HA)-based dMNs were fabricated and tested for maximal ovalbumin (OVA) content. Read More

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January 2019
4 Reads

Predictive PBPK modeling as a tool in the formulation of the drug candidate TMP-001.

Eur J Pharm Biopharm 2019 Jan 16;134:144-152. Epub 2018 Nov 16.

Fraunhofer Institute for Molecular Biology and Applied Ecology, Max-von-Laue-Str. 9, 60438 Frankfurt/Main, Germany; Institute of Pharmaceutical Technology, Goethe University, Max-von-Laue-Str. 9, 60438 Frankfurt/Main, Germany. Electronic address: http://www.ime.fraunhofer.de.

Since many drugs in the therapy scheme of multiple sclerosis (MS) are applied parenterally with significant side effects, oral treatment is the most accepted therapy option for chronic diseases like MS. The drug candidate TMP-001, which has disease-modifying properties, can be applied orally. Beside other symptoms, swallowing disorders have a major impact not only on the health status and quality of life of MS patients, but also impede reliable drug therapy. Read More

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January 2019
9 Reads

Improved adaptive randomization strategies for a seamless Phase I/II dose-finding design.

J Biopharm Stat 2018 Nov 17:1-15. Epub 2018 Nov 17.

c Division of Biostatistics,Wake Forest School of Medicine , Winston-Salem , NC.

In this article, we propose and evaluate three alternative randomization strategies to the adaptive randomization (AR) stage used in a seamless Phase I/II dose-finding design. The original design was proposed by Wages and Tait in 2015 for trials of molecularly targeted agents in cancer treatments, where dose-efficacy assumptions are not always monotonically increasing. Our goal is to improve the design's overall performance regarding the estimation of optimal dose as well as patient allocation to effective treatments. Read More

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November 2018
3 Reads

Detection and kinetics of persistent neutralizing anti-interferon-beta antibodies in patients with multiple sclerosis. Results from the ABIRISK prospective cohort study.

J Neuroimmunol 2019 Jan 7;326:19-27. Epub 2018 Nov 7.

Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address:

Two validated assays, a bridging ELISA and a luciferase-based bioassay, were compared for detection of anti-drug antibodies (ADA) against interferon-beta (IFN-β) in patients with multiple sclerosis. Serum samples were tested from patients enrolled in a prospective study of 18 months. In contrast to the ELISA, when IFN-β-specific rabbit polyclonal and human monoclonal antibodies were tested, the bioassay was the more sensitive to detect IFN-β ADA in patients' sera. Read More

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January 2019
13 Reads

Conversion of PLGA nanoparticle suspensions into solid dosage forms via fluid bed granulation and tableting.

Eur J Pharm Biopharm 2019 Jan 14;134:77-87. Epub 2018 Nov 14.

Institute of Pharmaceutical Technology and Biopharmacy, University of Muenster, Corrensstraße 48, 48149 Münster, Germany. Electronic address:

Incorporating poorly soluble drugs into polymeric nanoparticles is a widely investigated approach to improve their biopharmaceutical performance. Poly(DL-lactide-co-glycolide) (PLGA) nanoparticle formulations have previously been tested and recommended as drug carriers for peroral administration of poorly soluble porphyrin derivatives intended for photodynamical therapy. Based on those PLGA formulations the present study investigates conventional techniques like fluid bed granulation and tableting for conversion of such polymeric nanoparticle suspensions into solid dosage forms. Read More

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January 2019
4 Reads

Cubosomes for topical delivery of the antimicrobial peptide LL-37.

Eur J Pharm Biopharm 2019 Jan 13;134:60-67. Epub 2018 Nov 13.

Department of Chemistry and Chemical Engineering, Applied Chemistry, Chalmers University of Technology, Göteborg, Sweden.

In this study, the use of cubosomes for topical delivery of the antimicrobial peptide (AMP) LL-37 was investigated. Topical delivery of AMPs is of great interest for treatment of skin infections caused by bacteria, such as Staphylococcus aureus. AMP containing cubosomes were produced by three different preparation protocols and compared: (i) pre-loading, where LL-37 was incorporated into a liquid crystalline gel, which thereafter was dispersed into nanoparticles, (ii) post-loading, where LL-37 was let to adsorb onto pre-formed cubosomes, and (iii) hydrotrope-loading, where LL-37 was incorporated during the spontaneously formed cubosomes in an ethanol/glycerol monooleate mixture. Read More

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January 2019
10 Reads

On-demand manufacturing of immediate release levetiracetam tablets using pressure-assisted microsyringe printing.

Eur J Pharm Biopharm 2019 Jan 13;134:29-36. Epub 2018 Nov 13.

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Electronic address:

Fast and accurate manufacturing of individually tailored solid dosage forms is one of the main challenges for personalized medicine. The use of 3D printers has recently been studied to determine their suitability for personalized drug manufacturing. In the current work, formulations free of organic solvents were developed for a pressure-assisted microsyringe printing method (PAM). Read More

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January 2019
10 Reads

Simultaneous Detection of Glutamate Dehydrogenase and Toxin A/B: Comparison of the C. DIFF QUIK CHEK COMPLETE and RIDASCREEN Assays.

Ann Lab Med 2019 Mar;39(2):214-217

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Various commercial assays have recently been developed for detecting glutamate dehydrogenase (GDH) and/or toxin A/B to diagnose infection (CDI). We compared the performance of two assays for the simultaneous detection of GDH and toxin A/B, using 150 stool samples: C. DIFF QUIK CHEK COMPLETE (QCC; TechLab, Blacksburg, VA, USA) and RIDASCREEN GDH (RC-GDH) and Toxin A/B (RC-Toxin A/B; R-Biopharm, Darmstadt, Germany). Read More

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Development of doxorubicin hydrochloride loaded pH-sensitive liposomes: Investigation on the impact of chemical nature of lipids and liposome composition on pH-sensitivity.

Eur J Pharm Biopharm 2018 Dec 8;133:331-338. Epub 2018 Nov 8.

Université de Strasbourg, CNRS, CAMB UMR 7199, F-67000 Strasbourg, France. Electronic address:

This study investigates the impact of the chemical nature of lipids and additive on the formulation and properties of pH sensitive liposomes. The objective is to understand the respective role of the formulation parameters on the liposome properties in order to optimize the conditions for efficient encapsulation of doxorubicin (DOX). These liposomes should be stable at physiological pH, and disrupt in slightly acidic media such as the tumor microenvironment to release their DOX load. Read More

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December 2018
3 Reads

Evaluation of chemometric approaches for polymorphs quantification in tablets using near-infrared hyperspectral images.

Eur J Pharm Biopharm 2019 Jan 7;134:20-28. Epub 2018 Nov 7.

Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Copenhagen, Denmark. Electronic address:

Near-Infrared hyperspectral imaging (HSI-NIR) is a useful technique for pharmaceutical research and industry alike. It can provide important surface information such as the polymorphs quantification and its distribution over the tablet. Several chemometric tools are applied for this purpose, with MCR-ALS and PLS regression being the most common approaches. Read More

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January 2019
2 Reads

siRNA-mediated protein knockdown in precision-cut lung slices.

Eur J Pharm Biopharm 2018 Dec 7;133:339-348. Epub 2018 Nov 7.

University of Groningen, Groningen Research Institute of Pharmacy, Department of Pharmaceutical Technology and Biopharmacy, Antonius Deusinglaan 1, 9713 AV Groningen, the Netherlands.

Small interfering RNA (siRNA) can induce RNA interference, which leads to the knockdown of messenger RNA (mRNA) and protein. As a result, siRNA is often used in vitro and in vivo to unravel the function of genes and as a therapeutic agent to disrupt excessive expression of disease-related genes. However, there is a large gap between in vitro and in vivo models in terms of simplicity, flexibility, throughput, and translatability. Read More

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December 2018
4 Reads

Betulin silver nanoparticles qualify as efficient antimelanoma agents in in vitro and in vivo studies.

Eur J Pharm Biopharm 2019 Jan 7;134:1-19. Epub 2018 Nov 7.

Institute of Pharmacology and Toxicology Clinic of the Goethe University Frankfurt Main, D-60590 Frankfurt Main, Germany. Electronic address:

The current study was purported to assess the: (i) in vitro toxicity of betulin silver nanoparticles (AgNPs-B), bare and capped with polyethylene glycol (PEG), on two murine melanoma cell lines (B164A5 and B16Ova) and on healthy cell lines (keratinocytes and melanocytes), and (ii) in vivo antitumor efficacy of PEGylated AgNPs-B in an experimental melanoma model. Bare and PEG-capped AgNPs-B were synthesized by a chemical reduction method resulting in stable and non-aggregated spherical AgNPs-B and PEG-AgNPs-B, of narrow size distributions and mean hydrodynamic diameters of 25 nm and 75 nm, respectively. In vitro assessments were achieved by MTT and Annexin V-FITC assays and in vivo evaluation involved non-invasive techniques for the surveillance of the physiological skin parameters changes and histopathological examination of the harvested organs. Read More

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January 2019
6 Reads

Robust mucosal and systemic responses against HTLV-1 by delivery of multi-epitope vaccine in PLGA nanoparticles.

Eur J Pharm Biopharm 2018 Dec 5;133:321-330. Epub 2018 Nov 5.

Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address:

In this investigation, the immunogenicity of HTLV-1 fusion epitope-loaded PLGA nanoparticles (NPs) was assessed in the absence or presence of co-encapsulated CpG ODN adjuvant, in a mice model. For this purpose, the multi-epitope chimera including Tax, env, and gag immunodominant HTLV-1 epitopes was encapsulated in biodegradable PLGA NPs with or without CpG adjuvant. PLGA nanospheres produced by a double emulsion method had a size of <200 nm, and encapsulation efficiency of chimera antigen was 85%. Read More

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December 2018
2 Reads

Comparative evaluation of dimeric and monomeric forms of ADAPT scaffold protein for targeting of HER2-expressing tumours.

Eur J Pharm Biopharm 2019 Jan 5;134:37-48. Epub 2018 Nov 5.

Department of Protein Technology, KTH - Royal Institute of Technology, SE-10691 Stockholm, Sweden.

ADAPTs are small engineered non-immunoglobulin scaffold proteins, which have demonstrated very promising features as vectors for radionuclide tumour targeting. Radionuclide imaging of human epidermal growth factor 2 (HER2) expression in vivo might be used for stratification of patients for HER2-targeting therapies. ADAPT6, which specifically binds to HER2, has earlier been shown to have very promising features for in vivo targeting of HER2 expressing tumours. Read More

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January 2019
8 Reads
3.383 Impact Factor

An adaptive multi-stage phase I dose-finding design incorporating continuous efficacy and toxicity data from multiple treatment cycles.

J Biopharm Stat 2018 Nov 7:1-16. Epub 2018 Nov 7.

b Cancer Center Statistics , Mayo Clinic , Rochester , MN , USA.

Phase I designs traditionally use the dose-limiting toxicity (DLT), a binary endpoint from the first treatment cycle, to identify the maximum-tolerated dose (MTD) assuming a monotonically increasing relationship between dose and efficacy. In this article, we establish a general framework for a multi-stage adaptive design where we jointly model a continuous efficacy outcome and continuous/quasi-continuous toxicity endpoints from multiple treatment cycles. The normalized Total Toxicity Profile (nTTP) is used as an illustration for quasi-continuous toxicity endpoints, and we replace DLT with nTTP to take into account multiple grades and types of toxicities. Read More

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November 2018
4 Reads

Genetic Resistance to Avian Leukosis Viruses Induced by CRISPR/Cas9 Editing of Specific Receptor Genes in Chicken Cells.

Viruses 2018 Nov 2;10(11). Epub 2018 Nov 2.

Institute of Molecular Genetics, Czech Academy of Sciences, Videnska 1083, CZ 14220 Prague 4, Czech Republic.

Avian leukosis viruses (ALVs), which are pathogens of concern in domestic poultry, utilize specific receptor proteins for cell entry that are both necessary and sufficient for host susceptibility to a given ALV subgroup. This unequivocal relationship offers receptors as suitable targets of selection and biotechnological manipulation with the aim of obtaining virus-resistant poultry. This approach is further supported by the existence of natural knock-outs of receptor genes that segregate in inbred lines of chickens. Read More

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November 2018
8 Reads

Oxcarbazepine free or loaded PLGA nanoparticles as effective intranasal approach to control epileptic seizures in rodents.

Eur J Pharm Biopharm 2018 Dec 3;133:309-320. Epub 2018 Nov 3.

Department of Drug Sciences, Laboratory of Drug Delivery Technologies, University of Catania, Via Santa Sofia, 64, 95123, Italy.

The brain as a target for drug delivery is a challenge in pharmaceutical research. Among the several proposed strategies, the intranasal route represents a good strategy to deliver drugs to the brain. The goal of this study was to investigate the potential use of oxcarbazepine (OXC) to enhance brain targeting efficiency after intranasal (IN) administration. Read More

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December 2018
2 Reads

Effect of renal ischemia on urinary excretion of lithium in rats.

Biopharm Drug Dispos 2018 Nov;39(9):448-451

Department of Pharmaceutics, School of Pharmacy, Aichi Gakuin University, Nagoya, Japan.

Lithium, administered to patients with bipolar disorders, is mainly excreted in the urine, and tubular reabsorption is involved. This study characterized the renal excretion of lithium in rats subjected to renal ischemia for 60 min or 90 min. After intravenous injection of lithium chloride at 25 mg/kg, the pharmacokinetic parameters of lithium were determined. Read More

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November 2018

Medical biostatistics, the fourth edition.

Authors:
Hua Guo

J Biopharm Stat 2018 ;28(6):1231-1232

a Biostatistics , Allergan PLC , Madison NJ , USA.

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January 2018

Biorelevant in vitro assessment of dissolution and compatibility properties of a novel paediatric hydrocortisone drug product following exposure of the drug product to child-appropriate administration fluids.

Eur J Pharm Biopharm 2018 Dec 29;133:277-284. Epub 2018 Oct 29.

University of Greifswald, Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), Felix-Hausdorff-Strasse 3, 17489 Greifswald, Germany. Electronic address:

Alkindi® is a novel oral multi-particulate taste-masked formulation of hydrocortisone for use in children with the rare disease adrenal insufficiency. The objective of the present work was to study the biorelevant dissolution and compatibility properties of Alkindi® granules following exposure to administration fluids including breast milk, artificial milk, whole milk and water. To provide in vitro data for a representative patient collective, dosing conditions in neonates, infants and pre-school children were assessed. Read More

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December 2018
3 Reads

Incorporation and effects of mesoporous SiO-CaO nanospheres loaded with ipriflavone on osteoblast/osteoclast cocultures.

Eur J Pharm Biopharm 2018 Dec 29;133:258-268. Epub 2018 Oct 29.

Departamento de Bioquímica y Biología Molecular, Facultad de Ciencias Químicas, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain. Electronic address:

Mesoporous nanospheres in the system SiO-CaO (NanoMBGs) with a hollow core surrounded by a radial arrangement of mesopores were characterized, labeled with FITC (FITC-NanoMBGs) and loaded with ipriflavone (NanoMBG-IPs) in order to evaluate their incorporation and their effects on both osteoblasts and osteoclasts simultaneously and maintaining the communication with each other in coculture. The influence of these nanospheres on macrophage polarization towards pro-inflammatory M1 or reparative M2 phenotypes was also evaluated in basal and stimulated conditions through the expression of CD80 (as M1 marker) and CD206 (as M2 marker) by flow cytometry and confocal microscopy. NanoMBGs did not induce the macrophage polarization towards the M1 pro-inflammatory phenotype, favoring the M2 reparative phenotype and increasing the macrophage response capability against stimuli as LPS and IL-4. Read More

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December 2018
1 Read

Inhalable poly(lactic-co-glycolic acid) (PLGA) microparticles encapsulating all-trans-Retinoic acid (ATRA) as a host-directed, adjunctive treatment for Mycobacterium tuberculosis infection.

Eur J Pharm Biopharm 2019 Jan 29;134:153-165. Epub 2018 Oct 29.

Drug Delivery and Advanced Materials Team, School of Pharmacy, Royal College of Surgeons in Ireland, and Tissue Engineering Research Group, Royal College of Surgeons in Ireland, Ardilaun House, 121 St Stephens Green, Dublin 2, Ireland; Trinity Centre for Bioengineering, Trinity College Dublin, Dublin 2, Ireland; Ireland and Centre for Research in Medical Devices (CURAM), NUI Galway, Ireland. Electronic address:

Ending the tuberculosis (TB) epidemic by 2030 was recently listed in the United Nations (UN) Sustainable Development Goals alongside HIV/AIDS and malaria as it continues to be a major cause of death worldwide. With a significant proportion of TB cases caused by resistant strains of Mycobacterium tuberculosis (Mtb), there is an urgent need to develop new and innovative approaches to treatment. Since 1989, researchers have been assessing the anti-bacterial effects of the active metabolite of vitamin A, all trans-Retinoic acid (ATRA) solution, in Mtb models. Read More

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January 2019
3 Reads