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Journal articles on the topic 'Lyophilized Vials'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Rajesh, Akki* M.Gayatri Ramya M.Hymavathi P.Dinesh Kumar. "DEVELOPMENT, EVALUATION AND STABILITY OF ZOLEDRONIC ACID I.V INJECTION BY LYOPHILIZATION TECHNIQUE." Indo American Journal of Pharmaceutical Sciences 04, no. 07 (2017): 2042–46. https://doi.org/10.5281/zenodo.834723.

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The objective of the study is to develop a stable lyophilized formulation of Zoledronic acid for injection for better stability and for long term storage. The lyophilized product of all the formulations (F1- F6) prepared were an appearance of white to white Lyophilized cake. mannitol was used with water for injection . The filled vials were loaded into lyophilizer and lyophilized them as per cycle. Different composition of additives was used and the different pH concentrations of 5.7 to 6.7 were adjusted with sodium citrate were tried to formulate the formulation. The pH of all the formulation

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Muzzio, Cristian Rodrigo, Nicolás Gabriel Dini, and Laura Daniela Simionato. "Determination of moisture content in lyophilized mannitol through intact glass vials using NIR micro-spectrometers." Brazilian Journal of Pharmaceutical Sciences 47, no. 2 (2011): 289–97. http://dx.doi.org/10.1590/s1984-82502011000200010.

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Determination of moisture content in lyophilized solids is fundamental to predict quality and stability of freeze-dried products, but conventional methods are time-consuming, invasive and destructive. The aim of this study was to develop and optimize a fast, inexpensive, noninvasive and nondestructive method for determination of moisture content in lyophilized mannitol, based on an NIR micro-spectrometer instead of a conventional NIR spectrometer. Measurements of lyophilized mannitol were performed through the bottom of rotating glass vials by means of a reflectance probe. The root mean standa

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VIÑA-ROMERO, MICAELA M., RUTH RAMOS-DIAZ, IVETTE MOURANI-PADRON, et al. "Extended Stability of Reconstituted Lyophilized Erwinia L-asparaginase in Vials." In Vivo 34, no. 5 (2020): 2419–21. http://dx.doi.org/10.21873/invivo.12055.

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Panda, Sunil Kumar, and Subas Chandra Dinda. "Development of lyophilization cycle for direct thrombin Inhibitor and influence of excipients and process parameter during the cycle." International Current Pharmaceutical Journal 3, no. 5 (2014): 259–64. http://dx.doi.org/10.3329/icpj.v3i5.18533.

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The objective of this study was to develop stable lyophilized product of Bivalirudin, a direct thrombin inhibitor with good reconstitution time, % yield of good vials and cake quality. The % loss of crystallinity was determined by DSC for any crystallographic changes of the bulking agent after freeze drying. The glass transition temperature of 5% w/v of Bivalirudin, 3% w/v of mannitol and 0.03% of sodium acetate was approximately ?31°C and the collapse temperature was approximately -28°C. Tubular vials were found to withstand the thermal transition during freeze drying. Water content was inver

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André, Pascal, Salvatore Cisternino, Fouad Chiadmi, et al. "Stability of Bortezomib 1-mg/mL Solution in Plastic Syringe and Glass Vial." Annals of Pharmacotherapy 39, no. 9 (2005): 1462–66. http://dx.doi.org/10.1345/aph.1e620.

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BACKGROUND: The proteasome inhibitor bortezomib (BTZ), used in antineoplastic chemotherapy, must be diluted in NaCl 0.9% for injection and stored for no more than 3 hours in a syringe or 8 hours in a vial. Better information on its stability could improve storage. OBJECTIVE: To assess the stability of BTZ solution (1 mg/mL) in syringes and vials. METHODS: BTZ 1-mg/mL solutions were prepared by adding sterile NaCl 0.9% to Velcade vials containing 3.5 mg of lyophilized BTZ. Syringes were filled with 1 mL of solution and stored in the dark at 5 °C or 60 °C; others were not protected from light an

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Blinkova, Larisa, Danik M. Martirosyan, Yury Pakhomov, Olga Dmitrieva, Rachel Vaughan, and Michael Altshuler. "Nonculturable forms of bacteria in lyophilized probiotic preparations." Functional Foods in Health and Disease 4, no. 2 (2014): 66. http://dx.doi.org/10.31989/ffhd.v4i2.29.

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Background: Nonculturable cells are formed under stress. These viable but nonculturable (VBNC) cells retain the ability to revert to active growth and division when conditions become favorable, or after treatment with resuscitating factors. Information about the possible presence of VBNC in bacterial lyophilized probiotic preparations, foodstuffs, live vaccines, etc., indicates that human as well as animal intestines are a significant area for research.Methods: Samples were stored for different periods of time (up to 30 years) according to the manufacturers’ manuals. Total counts were conducte

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Cooper, G. R., S. J. Smith, D. A. Wiebe, M. Kuchmak, and W. H. Hannon. "International survey of apolipoproteins A1 and B measurements (1983-1984)." Clinical Chemistry 31, no. 2 (1985): 223–28. http://dx.doi.org/10.1093/clinchem/31.2.223.

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Abstract We report here results of a worldwide survey of apolipoprotein (apo) A1 and B measurements. A lyophilized pool of human serum was developed for the survey to test its suitability as a candidate Reference Material. Seventy-five laboratories from 18 countries responded to invitations to participate. Using several methods, they evaluated the mass concentration of apo A1 and B in the proposed Reference Material. The bias between laboratories and between analytical methods was then characterized. Fifty-five laboratories reported results before the deadline on measurement of at least one ap

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Abdul-Fattah, Ahmad M., Richard Oeschger, Holger Roehl, et al. "Investigating factors leading to fogging of glass vials in lyophilized drug products." European Journal of Pharmaceutics and Biopharmaceutics 85, no. 2 (2013): 314–26. http://dx.doi.org/10.1016/j.ejpb.2013.06.007.

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Yaswanth, Allamneni*1 T.E.G.K Murthy2 Mandava Venkata Basaveswara Rao3 Y. Udaya Bhaskara Rao4 M. Sivanath5. "VALIDATION OF RP-HPLC ANALYTICAL METHOD FOR ESTIMATION OF CARMUSTINE IN BULK AND LYOPHILIZED VIALS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 09 (2017): 416–23. https://doi.org/10.5281/zenodo.1036370.

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Carmustine is an anti-neoplastic agent. A reverse phase high-performance liquid chromatographic (RP-HPLC) assay method was developed by slightly modifying the USP method and validated for quantitative determination of carmustine in bulk drug and in lyophilized vials. The column utilized for the estimation of assay was 4.6 mm X 15-cm, 5-μm Packing L1 (C18) and the mobile phase employed was a mixture of acetonitrile and water in the ratio of 3:7. The detection was carried out at a wavelength of 200 nm with PDA detector. The flow rate is 1.5 mL per minute at a set temperature of 4-6°C with a tota

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Mazur, T. V., and О. V. Yablonska. "INFLUENCE OF TEMPERATURE AND ATMOSPHERIC FACTOR ON THE VIABILITY OF LYOPHILICALLY DRIED CULTURE HEMOLYTIC PASTEURELLA." Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology 22, no. 2 (2021): 242–46. http://dx.doi.org/10.36359/scivp.2021-22-2.28.

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The question of the stability of lyophilized culture, namely - the maximum preservation of its viability – is an extremely important indicator of microbiological work. Of particular interest is the study of the impact on the preservation of the viability of the lyophilized culture of the gas composition of the ampoule filler after the actual lyophilization. In this regard, an analysis was performed and the viability of hemolytic pasteurella cells was evaluated, the ampoules of which were filled with nitrogen, argon, respectively, or simply sealed in a vacuum atmosphere. The experiment used mat

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SA, Mohammed. "Vaccine Wastage and its Contributing Factors in Public Health Facilities of Oromia Special Zone, Ethiopia: Explanatory Sequential Mixed Method Design." Vaccines & Vaccination Open Access 7, no. 2 (2022): 1–14. http://dx.doi.org/10.23880/vvoa-16000153.

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Background: Although the availability of vaccines is crucial to achieve comprehensive and equitable immunization coverage. This study assessed vaccine wastage and its contributing factors in public health facilities in Ethiopia. Methods: A facility-based explanatory sequential mixed method was used. An institutional-based cross-sectional study design used to assess the vaccine wastage and vaccine cold chain management in all (27) health facilities offering consistence vaccination service and assessed the knowledge and attitude of 127 vaccinators and handlers. Finally, a phenomenological study

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Härdter, Nicole, Tim Menzen, and Gerhard Winter. "Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach." Pharmaceutics 13, no. 10 (2021): 1695. http://dx.doi.org/10.3390/pharmaceutics13101695.

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Primary containers made of cyclic olefin polymer (COP) have recently gained attention since they may overcome several risks and shortcomings of glass containers as they exhibit a high break resistance, biocompatibility, and homogeneous heat transfer during lyophilization. On the downside, COP is more permeable for gases, which can lead to an ingress of oxygen into the container over time. Since oxidation is an important degradation pathway for monoclonal antibodies (mAbs), the continuous migration of oxygen into drug product containers should be avoided overall. To date, no long-term stability

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Thalen, Marcel, Anne-Sophie Debrie, Loic Coutte, et al. "Manufacture of a Stable Lyophilized Formulation of the Live Attenuated Pertussis Vaccine BPZE1." Vaccines 8, no. 3 (2020): 523. http://dx.doi.org/10.3390/vaccines8030523.

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Current pertussis vaccines protect against disease, but not against colonization by and transmission of Bordetella pertussis, whereas natural infection protects against both. The live attenuated vaccine BPZE1 was developed to mimic immunogenicity of natural infection without causing disease, and in preclinical models protected against pertussis disease and B. pertussis colonization after a single nasal administration. Phase 1 clinical studies showed that BPZE1 is safe and immunogenic in humans when administered as a liquid formulation, stored at ≤−70 °C. Although BPZE1 is stable for two years

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Mahapatra, Chayna Singha, Aruna Kuniyal, Shyma K. Latheef, and Pronab Dhar. "Stability Characteristics of Freeze-Dried IVRI-CSF-BS Classical Swine Fever Vaccine." International Journal of Current Microbiology and Applied Sciences 11, no. 9 (2022): 113–19. http://dx.doi.org/10.20546/ijcmas.2022.1109.013.

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Freeze-drying (lyophilization) of biologically active materials including attenuated live virus vaccine is an well accepted method for ensuring stability and preserving the vaccine potency. As freeze- drying does not ensure complete stability, studies for stability of freeze-dried vaccines after exposure at different temperatures are required. Heat stability of classical swine fever (CSF) virus vaccine is also urgently needed in tropical countries including India where the disease is still endemic. In this study, the thermostability of freeze- dried vials of live attenuated CSF vaccines were i

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Guzhvynska, S. О., А. P. Paliy та О. M. Kornieikov. "Study of the stability of the main indicators of probiotic cultures Lactobacillus рlantarum No. 7 and Bifidobacterium adolescentis no. 17 in the bacterial mixture during storage". Veterinary Medicine: inter-departmental subject scientific collection, № 107 (8 листопада 2021): 70–74. http://dx.doi.org/10.36016/vm-2021-107-12.

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The article presents the results of studying the stability of the main indicators of probiotic cultures Lactobacillus plantarum No. 7 and Bifidobacterium adolescentis No. 17 as part of a bacterial mixture during storage. The prebiotic component lactulose was added to the bacterial mixture at a concentration of 1.5%. The stability of the synbiotic bacterial mixture in vials and capsules when stored under appropriate conditions (in a place protected from light, at a temperature of 4–8°C) has been studied. Experiments have shown that the preservation of the liquid form of the bacterial mixture wi

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Ullrich, Sabine, Stefan Seyferth, and Geoffrey Lee. "Measurement of Shrinkage and Cracking in Lyophilized Amorphous Cakes Part 3: Hydrophobic Vials and the Question of Adhesion." Journal of Pharmaceutical Sciences 104, no. 6 (2015): 2040–46. http://dx.doi.org/10.1002/jps.24441.

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Ajdarić, Jovana, Svetlana Ibrić, Aleksandar Pavlović, Ljubiša Ignjatović, and Branka Ivković. "Prediction of Drug Stability Using Deep Learning Approach: Case Study of Esomeprazole 40 mg Freeze-Dried Powder for Solution." Pharmaceutics 13, no. 6 (2021): 829. http://dx.doi.org/10.3390/pharmaceutics13060829.

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A critical step in the production of Esomeprazole powder for solution is a period between the filling process and lyophilization, where all vials, partially closed, are completely exposed to environmental influences. Excessive instability reflects in pH value variations caused by oxygen’s impact. In order to provide pH control, which consequently affects drug stability, Esomeprazole batches, produced in the same way, were kept in partially closed vials for 3 h at temperatures of 20 °C and −30 °C, after which they were lyophilized and stored for long-term stability for 36 months. The aim of the

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Blynskaya, E. V., S. V. Tishkov, K. V. Alekseyev, and S. V. Minaev. "Mathematical modeling of the stage of freezing in technology of lyophilized drugs." Russian Journal of Biotherapy 17, no. 2 (2018): 15–21. http://dx.doi.org/10.17650/1726-9784-2018-17-2-15-21.

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The purposeof this work is to demonstrate the existing possibilities and methodology of mathematical modeling of the freezing phase in the technology of lyophilization of vials filled with a solution containing a pharmaceutical substance and auxiliary substances. The freezing process is crucial for the subsequent stages of primary sublimation and the drying stage. So it is at the stage of freezing that ice crystals are formed and a certain microstructure forming the pores for subsequent stages and influencing the speed of all stages in the future. The developed methods allow estimating the kin

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Barr, J. R., V. L. Maggio, D. G. Patterson, et al. "Isotope dilution--mass spectrometric quantification of specific proteins: model application with apolipoprotein A-I." Clinical Chemistry 42, no. 10 (1996): 1676–82. http://dx.doi.org/10.1093/clinchem/42.10.1676.

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Abstract An enzymatic hydrolysis isotope dilution-mass spectrometric method was developed for reference quantification of specific proteins. The analytical procedure involved measuring a reproducibly hydrolyzed peptide (serving as the primary standard) unique to a specific protein. This new mass spectrometric method was evaluated by assessing the concentration of apolipoprotein (apo) A-I in the European Community Bureau of Reference (BCR) lyophilized Certified Reference Material (CRM 393). We used the method to make 96 measurements (4 replicate analyses of 4 enzymatic digests of 6 vials of BCR

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McQueen, M. J., R. L. Patten, A. R. Henderson, S. Krishnan, D. E. Wood, and S. Webb. "Proficiency testing for creatine kinase isoenzyme CK-2 (CK-MB) in Ontario." Clinical Chemistry 36, no. 12 (1990): 2102–5. http://dx.doi.org/10.1093/clinchem/36.12.2102.

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Abstract Three surveys of the measurement and interpretation of creatine kinase (CK; EC 2.7.3.2) isoenzyme 2 (CK-MB) were conducted in Ontario, Canada, in 1989. Of the clinical laboratories participating, 66% used immunological methods and 24% used electrophoretic methods. Although reference ranges and interpretative routines varied widely, 95% of the laboratories reported correct interpretations for 10 of the 15 vials tested. The only major problems occurred with samples with very low total CK activity. Within-survey duplicate results compared well, and 89% of the laboratories had consistent

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Dmitrieva, M. V., Bu Lugen, A. Р. Polozkova, О. L. Orlova, I. I. Krasnyuk, and I. I. Krasnyuk(jr.). "SELECTION OF A CRYOPROTECTOR FOR PRODUCTION A LYOPHILIZED LIPOSOMAL DOSAGE FORM OF THE INDOLOCARBAZOLE DERIVATIVE LHS‑1269." Russian Journal of Biotherapy 20, no. 1 (2021): 74–79. http://dx.doi.org/10.17650/1726-9784-2021-20-1-74-79.

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Introduction. One of the key tasks in freeze‑drying of drug is to choose the optimal cryoprotector that provides a high‑quality lyophilized product.The aim of research. Selection of cryoprotectant and its concentration for the preparation of lyophilizate of the liposomal dosage form of the indolocarbazole derivative LHS‑1269.Materials and methods. Substance LHS‑1269 ≥99 % (N. N. Blokhin National Medical Research Center of Onco logy), egg phosphatidylcholine Е РС S (Lipoid, Germany), cholesterol ≥99 % (Sigma‑Aldrich, Japan), polyethylene glycol‑2000‑distearoyl phosphatidylethanolamine (Lipoid,

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Suthiram, Janine, Thomas Ebenhan, Biljana Marjanovic-Painter, Mike M. Sathekge, and Jan Rijn Zeevaart. "Towards Facile Radiolabeling and Preparation of Gallium-68-/Bismuth-213-DOTA-[Thi8, Met(O2)11]-Substance P for Future Clinical Application: First Experiences." Pharmaceutics 13, no. 9 (2021): 1326. http://dx.doi.org/10.3390/pharmaceutics13091326.

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Substance P (SP) is a small peptide commonly known as a preferential endogenous ligand for the transmembrane neurokinin-1 receptor. Nuclear Medicine procedures currently involve radiolabeled SP derivatives in peptide radioligand endotherapy of inoperable glioblastoma. Promising clinical results sparked the demand for facile production strategies for a functionalized 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-[Thi8, Met(O2)11]-SP to allow for rapid Gallium-68 or Bismuth-213 complexation. Therefore, we provide a simple kit-like radiotracer preparation method that caters for the gal

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Goldblatt, D., B. D. Plikaytis, M. Akkoyunlu, et al. "Establishment of a New Human Pneumococcal Standard Reference Serum, 007sp." Clinical and Vaccine Immunology 18, no. 10 (2011): 1728–36. http://dx.doi.org/10.1128/cvi.05252-11.

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ABSTRACTLot 89SF has been the reference standard serum pool used in pneumococcal enzyme-linked immunosorbent assays (ELISAs) since 1990. In 2005, it was estimated that there remained between 2 and 5 years' supply of lot 89SF. Since lot 89SF was the reference standard used in the evaluation of the seven-valent pneumococcal conjugate vaccine Prevnar (PCV7), the link to clinical efficacy would be severed if stocks became completely depleted. Furthermore, demonstration of immune responses comparable to those elicited by PCV7 is a licensure approach used for new pneumococcal conjugate vaccines, so

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Copur, Mehmet S., Curtis Gnewuch, Megan Schriner, et al. "Potential cost savings by dose down-rounding of monoclonal antibodies in a community cancer center." Journal of Oncology Pharmacy Practice 24, no. 2 (2017): 116–20. http://dx.doi.org/10.1177/1078155217692400.

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Purpose Increasing new cancer cases and approval of effective but expensive new drugs extending survival have led to unsustainable cancer care costs. Potential cost savings by a hypothetical dose down-rounding project of monoclonal antibodies at a community-based cancer center is presented. Methods From October 2014 through October 2015, metastatic cancer patients receiving monoclonal antibodies at CHI-Health St Francis Cancer Treatment Center in Grand Island, Nebraska, were identified through electronic health records. A total of 11 different types of monoclonal antibodies that were administe

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Guirguis, Hany R., Flay Charbonneau, Ivan Tyono, Matthew C. Cheung, and Rena Buckstein. "Shelf-Life Extension Of Azacitidine: A Cancer Centre Experience On Waste and Cost Reduction In The Treatment Of Myelodysplastic Syndromes." Blood 122, no. 21 (2013): 1749. http://dx.doi.org/10.1182/blood.v122.21.1749.1749.

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Abstract Background Azacitidine (AZA) is a nucleoside metabolic inhibitor indicated for the treatment of patients with myelodysplastic syndromes (MDS). In Canada, it is supplied as a lyophilized powder in 100-mg vials priced at 628 Canadian dollars (C$). The product monograph indicates that the reconstituted drug may be held under refrigerated conditions (2-8°C) for up to a maximum of 8 hours. At a recommended dosing of 75 mg/m2 x 7 days and average body surface areas (BSA) ranging between 1.7-1.9 m2, most patients require more than a single vial reconstituted each day resulting in a drug wast

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Fooladi, Shahrzad, Mehdi Ansari, Fariba Sharififar, Shirin Pournourmohammadi, Behzad Lame Rad, and Neda Mohamadi. "Effect of Salvia rhytidea Benth. extract on serum glucose, gut alphaglucosidase in healthy and streptozotocin-induced diabetic rats." Journal of Ayurvedic and Herbal Medicine 2, no. 2 (2016): 40–42. http://dx.doi.org/10.31254/jahm.2016.2203.

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Salvia rhytidea Benth. is one of the endemic species in Iran which has been used as anti-diabetic in traditional medicine. The aim of this study was to evaluate the hypoglycemic effect of Salvia rhytidea Benth. methanol extract on healthy and induced diabetic rats. Determination of alphaglucosidase activity also was the other objective. Aerial parts of the plant were extracted after authentication with methanol 80% by macerating method. The methanol extract was evaporated under reduced pressure to evaporate its methanol content then lyophilized and stored in screw cap vials. Plant LD50 was det

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Nica-Badea, Delia, Manole Cojocaru, and Aurelian Udristioiu. "Role of the Isoform p-53 Protein in Failed Cases of Chronic Lymphocytic Leukemia." Blood 136, Supplement 1 (2020): 18. http://dx.doi.org/10.1182/blood-2020-137364.

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Introduction It was discovered in the last few years that the production of some percentage of mutant p-53 proteins, with the increased stability in type B lymphocytes, leads to the carcinogenesis process. This discovery led to the identification and quantification of the p-53 protein by different methods such as immuno-histochemistry (IHC), polymerase chain reaction (PCR), single-stranded peptide microarray, (SSPMa), next-generation sequencing (NGS), and the sandwich enzyme-linked immunosorbent assay (sandwich ELISA). Method Using the ELISA technique, the frequency of p-53 protein expression

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Díez-Domingo, Javier, Corinne Vandermeulen, Tauseefullah Akhund, et al. "632. Clinical Experience with a New Fully Liquid Presentation of the MenACWY-CRM Vaccine. Results from Two Multicenter, Randomized, Controlled, Observer-Blind, Phase 2b Studies." Open Forum Infectious Diseases 8, Supplement_1 (2021): S419—S420. http://dx.doi.org/10.1093/ofid/ofab466.830.

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Abstract Background Currently, licensed MenACWY-CRM conjugate vaccine presentation (Lyo/Liq) consists of two vials (lyophilized MenA, liquid MenCWY) to be reconstituted before injection. A new, fully liquid, single vial formulation has been developed and evaluated in two clinical studies in adolescents and adults aimed at demonstrating immunological non-inferiority of the liquid presentation for MenA. Methods Overall, 1337 subjects, 10 to 40 years of age (y), were exposed to a single 0.5 mL intramuscular dose of MenACWY Liquid and 1332 to MenACWY-CRM(Lyo/Liq). MenACWY-CRM Liquid was aged befor

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Youkhana, Kimberley, Megan Sell, and Charles Greenberg. "A Single Center Approach to Managing Hospitalized Patients with Quantitative Fibrinogen Deficiency That Cost-Saving and Maintains High-Quality, Evidence-Based Care." Blood 144, Supplement 1 (2024): 7576. https://doi.org/10.1182/blood-2024-208046.

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Introduction Hospitalized patients with inherited or acquired disorders of afibrinogenemia or hypofibrinogenemia need fibrinogen replacement to prevent bleeding or stop hemorrhage. Guidelines recommend using cryoprecipitate (CP) or fibrinogen concentrates (FC) for replacement. While both options are plasma derived, they vary in hospital acquisition cost, purity and fibrinogen concentration (FCo). CP is made by thawing leuko-depleted fresh frozen donor plasma (not pathogen reduced), then centrifuged and resuspended in plasma and kept below freezing (shelf-life ~1 yr) and has a FCo of 3-30 g/L p

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Ashraf, Amir Reza, Tim Ken Mackey, Róbert György Vida, et al. "Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study." Journal of Medical Internet Research 26 (November 7, 2024): e65440. http://dx.doi.org/10.2196/65440.

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Background Over the past 4 decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved with the recent development of glucagon-like peptide 1 agonists, such as semaglutide. However, off-label use of drugs such as Ozempic for cosmetic weight loss has surged in popularity, raising concerns about potential misuse and the emergence of substandard and falsified products in the unregulated supply chain. Objective This study aims to conduct a multifactor investigation of product quality and patient safety risks associat

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Chao, Chien-Chung, Zhiwen Zhang, Tatyana Belinskaya, et al. "Investigation of the Sterility of Diluent in Prefilled Syringes Used for Vaccine Reconstitution at Department of Defense Recruit Training Sites." Military Medicine 185, no. 9-10 (2020): e1440-e1446. http://dx.doi.org/10.1093/milmed/usaa181.

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Abstract Introduction Measles, mumps, and rubella (MMR) and varicella (VAR) vaccines are the two vaccines administered in large recruit training sites (RTS) that require a single-use syringe to be prefilled with the diluent (ie water) before vaccine reconstitution. Since there are no preservatives in either MMR or VAR vaccines, it is critical to maintain the diluent sterile to ensure the sterility of the reconstituted vaccine. The Department of Defense/Defense Health Agency has instructions on reconstitution of lyophilized vaccines and guidelines for their storage. Vaccine manufacturers provid

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Voropaev, A. A., O. T. Cidipova, O. V. Fadeikina, and D. S. Davydov. "Viability assessment of <i>Salmonella enterica</i> subsp. <i>enterica</i> serovar Abony NCTC 6017 in ampoules and vials by the accelerated shelf-life testing method." Biological Products. Prevention, Diagnosis, Treatment 24, no. 4 (2024): 467–75. https://doi.org/10.30895/2221-996x-2024-24-4-467-475.

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INTRODUCTION. A key priority in maintaining a collection of microorganisms is to ensure the stability of characteristics and the viability of microbial cultures during their storage and transport. In addition, some applications of collection strains as control samples require accurate data on the number of viable microbial cells in each sample. Therefore, it is necessary to develop and implement an analytical procedure for predicting the guaranteed shelf life of test strains.AIM. This study aimed to predict the guaranteed shelf life for test strains in a variety of primary packaging by assessi

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Hardesty, Brandon M., Stacy Plum, Karen Thibaudeau, Martin Lee, and Amy D. Shapiro. "Pharmacokinetics of Intravenous Infusion of Glu-Plasminogen Concentrate in Patients with Hypoplasminogenemia." Blood 126, no. 23 (2015): 3498. http://dx.doi.org/10.1182/blood.v126.23.3498.3498.

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Abstract Background: Hypoplasminogenemia is a rare multisystem disease associated with fibrous deposition on mucous membranes throughout the body, primarily affecting the eyes, ears, sinuses, tracheobronchial tree, genitourinary tract, and gingiva. The best defined clinical manifestation of hypoplasminogenemia is ligneous conjunctivitis, which is characterized by thick, woody (ligneous) growths on the conjunctiva of the eye. Several genetic defects leading to plasminogen deficiency have been identified. Replacement therapy with exogenous plasminogen can achieve resolution of the lesions, but n

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Langer, Carolin, Hanns-Christian Mahler, Atanas Koulov, et al. "Method to Predict Glass Vial Fogging in Lyophilized Drug Products." Journal of Pharmaceutical Sciences 109, no. 1 (2020): 323–30. http://dx.doi.org/10.1016/j.xphs.2019.08.024.

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Pelletier, O., and C. Arratoon. "Precision of glucose measurements in control sera by isotope dilution/mass spectrometry: proposed definitive method compared with a reference method." Clinical Chemistry 33, no. 8 (1987): 1397–402. http://dx.doi.org/10.1093/clinchem/33.8.1397.

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Abstract This improved isotope-dilution gas chromatographic/mass spectrometric (GC/MS) method, in which [13C]glucose is the internal standard, meets the requirements of a Definitive Method. In a first study with five reconstituted lyophilized sera, a nested analysis of variance of GC/MS values indicated considerable among-vial variation. The CV for 32 measurements per serum ranged from 0.5 to 0.9%. However, concentration and uncertainty values (mmol/L per gram of serum) assigned to one serum by the NBS Definitive Method (7.56 +/- 0.28) were practically identical to those obtained with the prop

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Zhai, Suling, Haiyun Su, Richard Taylor, and Nigel K. H. Slater. "Pure ice sublimation within vials in a laboratory lyophiliser; comparison of theory with experiment." Chemical Engineering Science 60, no. 4 (2005): 1167–76. http://dx.doi.org/10.1016/j.ces.2004.09.078.

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Schiele, F., J. Muller, E. Colinet, and G. Siest. "Production and certification of an enzyme reference material for gamma-glutamyltransferase (CRM 319). Part 1: Preparation and characterization." Clinical Chemistry 33, no. 11 (1987): 1971–77. http://dx.doi.org/10.1093/clinchem/33.11.1971.

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Abstract We have produced a batch of lyophilized gamma-glutamyltransferase as enzyme reference material. The "light" enzyme form was purified from pig kidney to a relatively high specific activity (120 kU/g) and was essentially free of contaminating enzymes. The partly purified gamma-glutamyltransferase, lyophilized in a matrix containing bovine serum albumin (Fraction V, 60 g/L), yielded a batch of 4000 ampules and was stored at -20 degrees C. The vial-to-vial variability with respect to the catalytic concentration of the final product (CV 0.6%) and its stability (predicted loss of activity a

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Goggs, Robert, Signe Cremer, and Marjory B. Brooks. "Evaluation of cytokine concentrations in a trehalose-stabilised lyophilised canine platelet product: a preliminary study." Veterinary Record Open 7, no. 1 (2020): e000366. http://dx.doi.org/10.1136/vetreco-2019-000366.

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BackgroundPlatelet transfusion is indicated for haemorrhage due to severe thrombocytopenia and for trauma associated coagulopathy. Febrile non-haemolytic transfusion reactions are a common complication of platelet transfusions in people and may be due to accumulated inflammatory cytokines. The present study aimed to determine the cytokine profile of a novel canine lyophilised platelet product following reconstitution, to assess the lyophilised platelets’ activation response to physiological platelet agonists and to compare the cytokine profiles of basal and stimulated canine lyophilised platel

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Oo, Aung Naing, Pruthu Thekkur, Aye Mya Cha Thar, Kyaw Ko Ko Htet, and Htar Htar Lin. "Small Session Size and Big Vial Size: Operational Research Assessing Open Vial Vaccine Wastage at the Service Delivery Points in the Mandalay Region of Myanmar During 2018." Tropical Medicine and Infectious Disease 5, no. 2 (2020): 60. http://dx.doi.org/10.3390/tropicalmed5020060.

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The World Health Organization (WHO) recommends immunization programmes to monitor vaccine wastage at storage and service delivery points. As there were no vaccine wastage assessments in Myanmar, we aimed to assess the vaccine wastage rates in the Mandalay region. We conducted a cross-sectional descriptive study with the inclusion of all immunization sessions conducted through the twenty randomly selected subcentres in the year 2018. The wastage rates were calculated by aggregating vaccine utilization data from selected subcentres. The vaccine wastage rates for Bacillus Calmette–Guérin (BCG) (5

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ElKassas, Khaled, Krishnakumar Chullipalliyalil, Michael McAuliffe, Sonja Vucen, and Abina Crean. "Fluorescence spectroscopy for the determination of reconstitution time of an in-vial lyophilised product." International Journal of Pharmaceutics 597 (March 2021): 120368. http://dx.doi.org/10.1016/j.ijpharm.2021.120368.

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Thienpont, Linda, Lothar Siekmann, Alexander Lawson, Elisabeth Colinet, and Andrȳ De Leenheer. "Development, validation, and certification by isotope dilution gas chromatography-mass spectrometry of lyophilized human serum reference materials for cortisol (CRM 192 and 193) and progesterone (CRM 347 and 348)." Clinical Chemistry 37, no. 4 (1991): 540–46. http://dx.doi.org/10.1093/clinchem/37.4.540.

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Abstract The Community Bureau of Reference of the European Communities has produced four batches of lyophilized serum Certified Reference Materials, two for cortisol (CRM 192 and 193) and two for progesterone (CRM 347 and 348). For cortisol, one of the pools consisted of serum from healthy blood donors, whereas the second batch was supplemented with pure cortisol. The progesterone Reference Materials contained only endogenous hormone concentrations. Assessment of vial-to-vial variability in the cortisol and progesterone concentrations showed no between-sample inhomogeneity, and the materials w

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Trivedi, Mahendra Kumar, Alice Branton, Dahryn Trivedi, Gopal Nayak, Sambhu Charan Mondal, and Snehasis Jana. "Phenotyping and Genotyping Characterization of Proteus vulgaris After Biofield Treatment." International Journal of Genetics and Genomics 3, no. 6 (2015): 66–73. https://doi.org/10.11648/j.ijgg.20150306.12.

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Proteus vulgaris (P. vulgaris) is widespread in nature, mainly found in flora of human gastrointestinal tract. The current study was attempted to investigate the effects of Mr. Trivedi’s biofield treatment on lyophilized as well as revived state of P. vulgaris for antimicrobial susceptibility pattern, biochemical characteristics, and biotype. P. vulgaris cells were procured from Micro BioLogics Inc., USA, in sealed pack bearing the American Type Culture Collection (ATCC 33420) number and stored according to the recommended storage protocol until needed for experiments. Lyophilized vial o

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Trivedi, Mahendra Kumar, Alice Branton, Dahryn Trivedi, Gopal Nayak, Sambhu Charan Mondal, and Snehasis Jana. "Phenotyping and Genotyping Characterization of Proteus vulgaris After Biofield Treatment." International Journal of Genetics and Genomics 3, no. 6 (2015): 66–73. https://doi.org/10.5281/zenodo.191284.

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Proteus vulgaris (P. vulgaris) is widespread in nature, mainly found in flora of human gastrointestinal tract. The current study was attempted to investigate the effects of Mr. Trivedi’s biofield treatment on lyophilized as well as revived state of P. vulgaris for antimicrobial susceptibility pattern, biochemical characteristics, and biotype. P. vulgaris cells were procured from Micro BioLogics Inc., USA, in sealed pack bearing the American Type Culture Collection (ATCC 33420) number and stored according to the recommended storage protocol until needed for experiments. Lyophilized vial o

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Chakraborty, Nabanita, and Gautam Kumar Joardar. "Assessment of vaccine wastage in an immunization clinic of a tertiary care hospital, Kolkata, West Bengal." International Journal Of Community Medicine And Public Health 6, no. 11 (2019): 4959. http://dx.doi.org/10.18203/2394-6040.ijcmph20195088.

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Background: Universal Immunization Programme was launched by Government of India in 1985 with the aim of immunizing all children and pregnant women across the country free of cost. However high vaccine wastage and lack of proper vaccine management could not meet the demand and increased the cost.Methods: A descriptive record based study was conducted in the immunization clinic of KPC Medical College and Hospital. Vaccination records of all children and pregnant women attending clinic from 1st July 2018 to 30th June 2019 was retrieved from the immunization registers.Results: Wastage rate was fo

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Miyamoto, Kahori, Misato Yanagisawa, Hiroaki Taga, Hiromichi Yamaji, Tomomi Akita, and Chikamasa Yamashita. "Optimization of Very Low-Dose Formulation of Vitamin D3 with Lyophilizate for Dry Powder Inhalation System by Simple Method Based on Time-of-Flight Theory." Pharmaceutics 13, no. 5 (2021): 632. http://dx.doi.org/10.3390/pharmaceutics13050632.

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It has been previously reported that active vitamin D3 (VD3) is a candidate drug that can repair alveolar damage in chronic obstructive pulmonary disease at a very low dose. We herein report the optimization of a very low-dose formulation of VD3 for dry powder inhalation by a simple method based on time-of-flight (TOF) theory. As the preparation content of VD3 is very low, aerodynamic particle size distribution cannot be measured by pharmacopeial methods that require quantification of the main drug. Thus, a simple method based on TOF theory, which can measure aerodynamic particle size distribu

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Lambo, Kikelomo, Martha Prescott, Owens Wiwa, Jude Adebowale, and Kubura Daradara. "Minimizing Vaccine Wastage in Nigeria: A National Assessment of Vaccine Wastage Rates and Potential Determinants." Vaccines 12, no. 8 (2024): 900. http://dx.doi.org/10.3390/vaccines12080900.

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High vaccine wastage can serve as a critical barrier to achieving the gains of vaccination, especially in a country like Nigeria, where data on vaccine wastage are sparsely available. We determined the country-wide vaccine wastage rates and their determinants through a mixed-methods study conducted across 576 health facilities (primary and secondary) in 24 states in Nigeria. We collected facility-based immunization records from June 2018 to May 2019, in addition to healthcare workers’ interviews and observations of fixed and outreach sessions. The results show that open-vial wastage ranged fro

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Dubick, Michael A., Ryan Dorfman, Harold G. Klemcke, Bijan S. Kheirabadi, and John B. Holcomb. "Stability of Activated Recombinant Human Factor VII (rFVIIa) after 28 Days Storage at 24° C and 43° C." Blood 112, no. 11 (2008): 4074. http://dx.doi.org/10.1182/blood.v112.11.4074.4074.

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Abstract The stability of rFVIIa (Novo Seven) was evaluated over a 28 day period. Lyophilized recombinant factor VIIa (1.2 mg/vial configuration) powder was tested at recommended storage conditions of 4°C or accelerated stability testing conditions of 24°C and 65% ± 5% relative humidity (RH) and 43°C plus 65% ± 5% RH. No significant change was noted in the appearance of any of the rFVIIa samples based on turbidity and visual appearance of the lyophilized cake and reconstituted liquid product. rFVIIa activity was determined by bioassay using a modified prothrombin time (PT). Chemical integrity

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Japhet, Yeigba B. "Sequential effects of experimental Newcastle disease virus on performance and severity of clinical manifestation of the disease in three indigenous Nigerian genotypes of chickens." Journal of Animal Science and Veterinary Medicine 7, no. 6 (2022): 189–97. http://dx.doi.org/10.31248/jasvm2022.351.

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Newcastle disease has been identified as a killer viral infection associated with high case fatality in poultry. This study was conducted to evaluate the sequential effects of experimental Newcastle disease on the performance and severity of clinical manifestation of the disease in three indigenous Nigerian genotypes of chickens. A total of 180 day-old Nigerian indigenous chicks consisting of 60 Naked necks (NN), 60 Frizzle feathers (FF) and 60 Normal feathers (NF) (45 experimental and 15 control per genotype) were used for the study. These chicks had no symptoms of Newcastle disease at the co

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Rathod, Dhaval, Zhengming Chen, Christine M. Slover, Frank Kung, Junichi Morita, and Sean T. Nguyen. "Cefiderocol For Injection: Compatibility Testing Using the MINI-BAG Plus Container System and the VIAL-MATE Adaptor." Journal of Pharmacy Technology, June 19, 2023. http://dx.doi.org/10.1177/87551225231179585.

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Background: Cost-effective and convenient modalities are required to facilitate the administration of antibiotics in hospital and outpatient settings. Objective: This study investigated the physical compatibility of the MINI-BAG Plus Container System and VIAL-MATE Adaptor with the 1 g drug product vials used for cefiderocol. Methods: Qualitative testing of the MINI-BAG Plus Container System (50 and 100 mL of 5% dextrose injection or 0.9% sodium chloride injection), using empty vials and vials containing lyophilized cefiderocol powder, was conducted in triplicate on MINI-BAGs that were hung and

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Strongrich, Drew, Fredric Lim, Lokesh Kumar, and Alina Alexeenko. "Fluid dynamics of rapid-depressurization controlled ice nucleation in pharmaceutical lyophilization." Physics of Fluids 37, no. 3 (2025). https://doi.org/10.1063/5.0251237.

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Controlled ice nucleation is used in manufacturing of lyophilized pharmaceutical drugs, biologics and vaccines to improve consistency in freezing, drying and resulting quality and stability across product batches. The rapid-depressurization-controlled ice nucleation (RD-CIN) based on fast expansion of pressurant gas has been applied in industry since the early 2000s, however, the exact mechanism of action remained obscure affecting its reliability, especially for small vials, large fill volumes and large-scale lyophilizers. We develop experimental measurements and computational methodology inc

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