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Biologicals : Journal of the... Nov 2023Here we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was...
Here we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to assess the use of alternative methods for measuring Lf. Participants were asked to use an in-house Enzyme Linked Immunosorbent Assay (ELISA) developed at NIBSC, or other suitable in-house methods, to determine ELISA-specific Lf values (Lf-eq units are specific only for pre-calibration of antitoxin in the flocculation test) of 16/302 to compare to those of the flocculation test. Nine laboratories participated by performing the NIBSC ELISA, one laboratory performed flocculation by laser light-scattering following an in-house protocol, and three laboratories performed ELISA following in-house protocols. The results intimate that these alternative methods could be useful for monitoring consistency of production at different stages of vaccine manufacturing.
Topics: Humans; Tetanus Toxoid; Flocculation Tests; Calibration; Enzyme-Linked Immunosorbent Assay; Biological Assay; Reference Standards
PubMed: 37657313
DOI: 10.1016/j.biologicals.2023.101701 -
Applied Radiation and Isotopes :... Oct 2023Lu decays through low-energy β- and γ-emissions in addition to conversion and Auger electrons. To support the use of this radiopharmaceutical in Switzerland, a Lu...
Lu decays through low-energy β- and γ-emissions in addition to conversion and Auger electrons. To support the use of this radiopharmaceutical in Switzerland, a Lu solution was standardised using the β-γ coincidence technique, as well as the TDCR method. The solution had no Lu impurity. Primary coincidence measurements, with plastic scintillators for beta detection, were carried out using both analogue and digital electronics. TDCR measurements using only defocusing were also made. Monte Carlo calculations were used to compute the detection efficiency. The coincidence measurements with both analogue and digital electronics are compatible within one standard uncertainty, but they are lower than (and discrepant with) the TDCR measurements. An ampoule of this solution was submitted to the BIPM as a contribution to the Système International de Référence.
PubMed: 37597267
DOI: 10.1016/j.apradiso.2023.110986 -
Pathogens (Basel, Switzerland) Jun 2023Infection with and may lead to diffuse cutaneous leishmaniasis. The cure is exceptional, especially for the strange case of this lady. Case report: The patient...
Infection with and may lead to diffuse cutaneous leishmaniasis. The cure is exceptional, especially for the strange case of this lady. Case report: The patient acquired the disease in childhood and remained with lesions for over 30 years, albeit several treatments. She worsened after a pregnancy, developing disseminated lesions. Miltefosine with amphotericin B and pentamidine resulted in remission. Lesions reappeared after one year, accompanied by intra-nasal infiltration of the disease. The nasal spraying of a single ampoule of pentavalent antimoniate resulted in the sustained disappearance of the nasal symptoms and all the cutaneous lesions. After over eight years, she remains disease-free, albeit under renal replacement therapy. The high nasal mucosal antimonial concentration may explain the long-lasting cure via new MHC class I epitope-specific CD8+ cell clones against present in the nasal mucosa.
PubMed: 37513737
DOI: 10.3390/pathogens12070890 -
Heliyon Jul 2023Applications in both science and industry have received increased attention as a result of bulk single crystals with particular orientations. However, due to the...
Applications in both science and industry have received increased attention as a result of bulk single crystals with particular orientations. However, due to the instability of organic crystals at high temperatures and stress, there is an interest in growing good-quality bulk single crystals with stable thermal and mechanical properties. Here, the 2-amino 4-methylpyridinium 4-nitrophenolate 4-nitrophenol (2A4MPPP) crystal was prepared employing a single-wall ampoule and the vertical Bridgman technique. Structure and functional groups were determined by XRD, NMR, and FTIR studies. More importantly, detailed thermal and kinetic properties such as activation energy, frequency factor, rate constant, and Avrami exponent are discussed. The mechanical stability and dielectric studies are also demonstrated for the title compound. According to the single crystal XRD investigation, 2A4MPPP is a member of the orthorhombic crystal system with the Pna21 space group. Through the TGA and DTA analyses, it was confirmed that the compound starts to melt at 98 °C and complete melting occurs at 103.3 °C. The dielectric experiments reveal the crystal's poor dielectric constant and high-frequency dielectric loss. Vickers microhardness investigations show that grown 2A4MPPP belongs to the soft materials group. As a result of these findings, the 2A4MPPP crystal should be well suited for usage in thermomechanical, microelectronic, optical communications, and nonlinear optical applications.
PubMed: 37501972
DOI: 10.1016/j.heliyon.2023.e18260 -
BMJ Case Reports Jul 2023Several factors have been identified as contributing to medication administration errors, including look-alike, sound-alike (LASA) errors. LASA errors are important...
Several factors have been identified as contributing to medication administration errors, including look-alike, sound-alike (LASA) errors. LASA errors are important causes of serious adverse events arising from spinal injection of tranexamic acid, which can be confused with ampoules of local anaesthesia.We present a case of accidental injection of 250 mg of tranexamic acid rather than prilocaine during spinal anaesthesia. The patient developed lower extremities myoclonus, followed by generalised convulsions and ventricular fibrillation, that was reverted within 6 min. Severe cardiogenic shock requiring both inotropic and vasopressor therapy followed, along with a classic apical ballooning pattern on echocardiography and elevated myocardial injury markers, indicating Takotsubo cardiomyopathy. The patient's condition progressively improved to full recovery, and she was discharged from hospital after 1 month with no neurological deficit or cardiac dysfunction.To our knowledge, this is the 28th reported case of accidental spinal injection of tranexamic acid. We present a brief review of previously published cases.
Topics: Female; Humans; Tranexamic Acid; Myoclonus; Ventricular Fibrillation; Takotsubo Cardiomyopathy; Injections, Spinal
PubMed: 37463777
DOI: 10.1136/bcr-2022-251814 -
Chemistry (Weinheim An Der Bergstrasse,... Oct 2023The crystalline lithium oxonitridophosphate Li P O N , was obtained in an ampoule synthesis from P N and Li O. The compound crystallizes in the triclinic space group P...
The crystalline lithium oxonitridophosphate Li P O N , was obtained in an ampoule synthesis from P N and Li O. The compound crystallizes in the triclinic space group P with a=5.125(2), b=9.888(5), c=10.217(5) Å, α=70.30(2), β=76.65(2), γ=77.89(2)°. Li P O N is a double salt, the structure of which contains distinctive complex anion species, namely non-condensed P(O,N) tetrahedra, and P(O,N) double tetrahedra connected by one N atom. Additionally, there is mixed occupation of O/N positions, which enables further anionic species by variation of O/N occupancies. To characterize these motifs in detail, complementary analytical methods were applied. The double tetrahedron exhibits significant disorder in single-crystal X-ray diffraction. Furthermore, the title compound is a Li ion conductor with a total ionic conductivity of 1.2×10 S cm at 25 °C, and a corresponding total activation energy of 0.47(2) eV.
PubMed: 37436099
DOI: 10.1002/chem.202301986 -
Molecules (Basel, Switzerland) Jun 2023In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should...
Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities.
In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess the quality of medicinal products. In the present study, these recommendations were implemented in Capillary Electrophoresis method development for the quality control of a drug product containing trimecaine, by applying Analytical Quality by Design. According to the Analytical Target Profile, the procedure should be able to simultaneously quantify trimecaine and its four impurities, with specified analytical performances. The selected operative mode was Micellar ElectroKinetic Chromatography employing sodium dodecyl sulfate micelles supplemented with dimethyl-β-cyclodextrin, in a phosphate-borate buffer. The Knowledge Space was investigated through a screening matrix encompassing the composition of the background electrolyte and the instrumental settings. The Critical Method Attributes were identified as analysis time, efficiency, and critical resolution values. Response Surface Methodology and Monte Carlo Simulations allowed the definition of the Method Operable Design Region: 21-26 mM phosphate-borate buffer pH 9.50-9.77; 65.0 mM sodium dodecyl sulfate; 0.25-1.29% /-butanol; 21-26 mM dimethyl-β-cyclodextrin; temperature, 22 °C; voltage, 23-29 kV. The method was validated and applied to ampoules drug products.
Topics: Cyclodextrins; Micelles; Chromatography, Micellar Electrokinetic Capillary; Trimecaine; Sodium Dodecyl Sulfate; Borates; Reproducibility of Results
PubMed: 37375300
DOI: 10.3390/molecules28124747 -
European Journal of Hospital Pharmacy :... Jun 2023Prefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of...
OBJECTIVES
Prefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of converting from vials and ampoules to PFS have been explained in previous drug-specific economic models; however, these models have limited generalisability to different drugs, healthcare settings and other countries. Our study aims to (1) present a comprehensive economic model to assess the impact of switching from vials to PFS delivery; and (2) illustrate through two case studies the model's utility by highlighting important features of shifting from vials to PFS.
METHODS
The economic model estimates the potential benefit of switching to PFS associated with four key outcomes: preventable adverse drug events (pADE), preparation time, unused drugs, and cost of supplies. Model reference values were derived from existing peer-reviewed literature sources. The user inputs specific information related to the department, drug, and dose of interest and can change reference values. Two hypothetical case studies are presented to showcase model utility. The first concerns a cardiac intensive care unit in the United Kingdom administering 30 doses of 1 mg/10 mL atropine/day. The second concerns a coronavirus (COVID-19) intensive care unit in France that administers 30 doses of 10 mg/25 mL ephedrine/day.
RESULTS
Total cost savings per hospital per year, associated with reductions in pADEs, unused drugs, drug cost and cost of supplies were £34 829 for the atropine example and €104 570 for the ephedrine example. Annual preparation time decreased by 371 and 234 hours in the atropine and ephedrine examples, respectively.
CONCLUSIONS
The model provides a generalisable framework with customisable inputs, giving hospitals a comprehensive view of the clinical and economic value of adopting PFS. Despite increased costs per dose with PFS, the hypothetical case studies showed notable reductions in medication preparation time and a net budget savings owing to fewer pADEs and reduced drug wastage.
PubMed: 37369597
DOI: 10.1136/ejhpharm-2022-003620 -
Dalton Transactions (Cambridge, England... Jul 2023Anhydrous copper tellurite sulfate, CuTeO(SO), has been synthesized vapor transport reactions in sealed silica glass ampoules. In measurements of magnetization ,...
Anhydrous copper tellurite sulfate, CuTeO(SO), has been synthesized vapor transport reactions in sealed silica glass ampoules. In measurements of magnetization , magnetic susceptibility , specific heat and X-band electron spin resonance, a long-range antiferromagnetic order at = 13 K and an - magnetic phase diagram have been established. One-third of Cu ions were found to form magnetically silent dimers. A peak in dielectric permittivity , which accompanies the Néel order, allows considering CuTeO(SO) as a magnetoelectric multiferroic material of the second type. Density functional theory calculations provided estimations of leading exchange interaction parameters.
PubMed: 37357965
DOI: 10.1039/d3dt01290e -
The Journal of Reproduction and... Aug 2023Although freeze-drying sperm can save space, reduce maintenance costs, and facilitate the transportation of genetic samples, the current method requires breakable,...
Although freeze-drying sperm can save space, reduce maintenance costs, and facilitate the transportation of genetic samples, the current method requires breakable, custom-made, and expensive glass ampoules. In the present study, we developed a simple and economical method for collecting freeze-dried (FD) sperm using commercially available plastic microtubes. Mouse epididymal sperm suspensions were placed in 1.5 ml polypropylene tubes, frozen in liquid nitrogen, and dried in an acrylic freeze-drying chamber, after which they were closed under a vacuum. The drying duration did not differ between the microtube and glass ampoule methods (control); however, the sperm recovery rate was higher using the microtube method, and the physical damage to the sperm after rehydration was also reduced. Intracytoplasmic sperm injection (ICSI) using FD sperm stored in microtubes at -30°C yielded healthy offspring without reducing the success rate, even after 9 months of storage. Air infiltration into all microtubes stored at room temperature (RT) within 2 weeks of storage caused a drastic decrease in the fertilization rate of FD sperm; underwater storage did not prevent air infiltration. RT storage of FD sperm in microtubes for 1 week resulted in healthy offspring after ICSI (5-18%), but the addition of silica gel or CaCl did not improve the success rate. Our novel microtube method is currently the simplest and most effective method for treating FD sperm, contributing to the development of alternative low-cost approaches for preserving and transporting genetic resources.
Topics: Animals; Mice; Male; Plastics; Semen; Freeze Drying; Spermatozoa; Sperm Injections, Intracytoplasmic; Semen Preservation
PubMed: 37357399
DOI: 10.1262/jrd.2023-034