scholarly journals Evaluation of Transport Media and Specimen Transport Conditions for the Detection of SARS-CoV-2 by Use of Real-Time Reverse Transcription-PCR

2020 ◽  
Vol 58 (8) ◽  
Author(s):  
Amy A. Rogers ◽  
Russell E. Baumann ◽  
Gwynngelle A. Borillo ◽  
Ron M. Kagan ◽  
Hollis J. Batterman ◽  
...  

ABSTRACT The global coronavirus (CoV) disease 2019 (COVID-19) pandemic has resulted in a worldwide shortage of viral transport media and raised questions about specimen stability. The objective of this study was to determine the stability of severe acute respiratory syndrome CoV 2 (SARS-CoV-2) RNA in specimen transport media under various storage conditions. Transport media tested included UTM, UTM-RT, ESwab, M4, and saline (0.9% NaCl). Specimen types tested included nasopharyngeal/oropharyngeal swabs in the above-named transport media, bronchoalveolar lavage (BAL) fluid, and sputum. A high-titer SARS-CoV-2 remnant patient specimen was spiked into pooled SARS-CoV-2 RNA-negative specimen remnants for the various medium types. Aliquots of samples were stored at 18°C to 26°C, 2°C to 8°C, and −10°C to −30°C and then tested at time points up to 14 days. Specimens consistently yielded amplifiable RNA with mean cycle threshold differences of <3 over the various conditions assayed, thus supporting the use and transport of alternative collection media and specimen types under a variety of temperature storage conditions.

1939 ◽  
Vol 39 (2) ◽  
pp. 131-142 ◽  
Author(s):  
S. G. Rainsford

1. Silver nitrate or sodium merthiolate can be used for the sterilization of suspensions of B. typhosus and neither have any immediate destructive effect on the Vi, O or H antigens.2. Two methods of employing silver nitrate as a sterilizing agent are described.3. Physiological saline solution with silver nitrate added is bactericidal for B. typhosus and the staphylococcus but has no inhibitory action on the growth of moulds.4. Vaccines sterilized and preserved with silver nitrate after storage for 6 months at 7° C. were found to have retained their Vi antibody stimulating properties.5. A vaccine sterilized and preserved with “katadyn” after storage for 18 months at 7° C. still contained some Vi antigen and was superior as an immunogenic agent to a freshly prepared heat-killed-phenolized vaccine.6. It would appear that the stability of Vi antigen is increased by the addition of silver within certain limits, but this effect is only obtained if low temperature storage conditions are maintained.7. A vaccine sterilized and preserved with sodium merthiolate after 6 months' storage at 7°C. failed to stimulate any Vi antibody in the rabbit.


2008 ◽  
Vol 8 (1) ◽  
pp. 93-96 ◽  
Author(s):  
Alija Uzunović ◽  
Edina Vranić

Stability testing of an active substance or finished product provides information of the variation of drug substance or final product with time influenced by a variety of environmental factors such as temperature, humidity and light. Knowledge gained from stability studies enables understanding of the effects of the environment on the drugs.The aim of our study was to determine the stability of cefuroxime axetil oral suspension at different temperature storage conditions (stored at room /20°C/ and refrigerated /5°C/ conditions). Determination of cefuroxime (as cefuroxime axetil) was performed by dissolution testing.Fractions of the released cefuroxime axetil were compared usingJ2 value. After interpolating data for dissolution profiles at room and refrigerated conditions the following f2values were obtained: 62,56; 56,32 and 36,18 on 3rd, 6th and 10th day, respectively. These values indicate similarities in drug release from analyzed cefuroxime axetil oral suspension on 3rd, 6th day, and differences on 10th day.Based on our results, we may assume that cefuroxime axetil oral suspension preserves its stability for 10 days after reconstitution under room and refrigerated conditions. It is obvious, according to the f2 value obtained on the 10th day, that there is a difference between the released ceforoxime axetil from oral suspension at room (87,68%) and refrigerated (92,35%) conditions. Concentration changes can be caused by the mechanisms associated with drug release and hydrolytical decomposition of the sample and higher temperatures during longer period of storage.


2016 ◽  
Vol 36 (4) ◽  
pp. 410-414 ◽  
Author(s):  
Robiyanto Robiyanto ◽  
Syed Tabish R. Zaidi ◽  
Madhur D. Shastri ◽  
Ronald L. Castelino ◽  
S. Troy Wanandy ◽  
...  

IntroductionIntraperitoneal tigecycline is a potential option for the treatment of peritoneal dialysis (PD)-associated peritonitis caused by microorganisms resistant to commonly used antibiotics. However, the stability of tigecycline must be assessed in the PD solution before evaluating its safety and therapeutic efficacy in PD-associated peritonitis. The objective of this study was to investigate the stability of tigecycline in 3 types of PD solutions at different temperatures for various time points.MethodsA total of 27 PD bags (9 PD bags for each type of PD solution; 1.5% glucose, 7.5% icodextrin, and 1.5% glucose pH neutral) containing 2 μg/mL of tigecycline were prepared and stored at either 4, 25, or 37°C. An aliquot was withdrawn immediately before (0 hour) and after pre-defined time points. Each sample was analyzed in duplicate for the concentration of tigecycline using a stability-indicating high-performance liquid chromatography (HPLC) technique. Samples were also assessed for pH, color changes, and evidence of precipitation immediately after preparation and on each day of analysis.ResultsTigecycline in all 3 types of PD solutions retained more than 90% of its initial concentration for at least 216, 72, and 8 hours at 4, 25, and 37°C, respectively. There was no evidence of precipitation at any time under the tested storage conditions. The pH and color of tigecycline admixed PD solutions stored at 4, 25, and 37°C remained essentially unchanged for 336, 96, and 48 hours respectively.ConclusionThe results obtained from the study provide a platform for future clinical studies aiming to determine the safety and therapeutic efficacy of intraperitoneally administered tigecycline for the treatment of PD-associated peritonitis.


Author(s):  
Avilash Carpenter ◽  
M.K. Gupta ◽  
Neetesh Kumar Jain ◽  
Urvashi Sharma ◽  
Rahul Sisodiya

Aim: The main of the study is to formulate and develop orally disintegrating fast dissolving tablet of Metoclopramide hydrochloride. Material & Methods: Before formulation and development of selected drug, the standard curve in buffer was prepared and absorbance at selected maxima was taken. Then two different disintegrating agents were selected and drug was mixed with disintegrating agents in different ratio. Various Preformulation parameters and evaluation of tablet i.e. disintegration time, dissolution time, friability, hardness, thickness were measured by standard procedure. Result & Discussion: The angle of repose for all the batches prepared. The values were found to be in the range of 30.46 to 36.45, which indicates good flow property for the powder blend according to the USP. The bulk density and tapped density for all the batches varied from 0.49 to 0.54 g/mL and 0.66 to 0.73, respectively. Carr’s index values were found to be in the range of 23.33 to 25.88, which is satisfactory for the powders as well as implies that the blends have good compressibility. Hausner ratio values obtained were in the range of 1.22 to 1.36, which shows a passable flow property for the powder blend based on the USP. The results for tablet thickness and height for all batches was found to range from 4.45 to 4.72 mm and 3.67 to 3.69 mm, respectively. Hardness or breaking force of tablets for all batches was found to range from 32.8 to 36.2 N. Tablet formulations must show good mechanical strength with sufficient hardness in order to handle shipping and transportation. Friability values for all the formulations were found to be in the range of 0.22 % to 0.30 %. Conclusion: Orally disintegrating tablets were compressed in order to have sufficient mechanical strength and integrity to withstand handling, shipping and transportation. The formulation was shown to have a rapid disintegration time that complied with the USP (less than one minute). The data obtained from the stability studies indicated that the orally disintegrating mini-tablets of MTH were stable under different environmental storage conditions. Keywords: Formulation & Development, Fast Dissolving Tablet, Metoclopramide, Anti-Emetic Drug, Oral Disintegrating Tablet


2013 ◽  
Vol 5 (6) ◽  
pp. 397 ◽  
Author(s):  
Kyoung Yong Jeong ◽  
Soo-Young Choi ◽  
In-Soo Han ◽  
Jae-Hyun Lee ◽  
Joo-Shil Lee ◽  
...  

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 225
Author(s):  
Ines Mack ◽  
Mike Sharland ◽  
Janneke M. Brussee ◽  
Sophia Rehm ◽  
Katharina Rentsch ◽  
...  

Amoxicillin-clavulanic acid (AMC) belongs to the WHO Essential Medicines List for children, but for optimal antimicrobial effectiveness, reconstituted dry powder suspensions need to be stored in a refrigerated environment. Many patients in low- and middle-income countries who are sold AMC suspensions would be expected not to keep to the specified storage conditions. We aimed to assess the stability of both ingredients in liquid formulations and dispersible tablets, combined with nationally representative data on access to appropriate storage. Degradation of amoxicillin (AMX) and clavulanic-acid (CLA) was measured in suspensions and dispersible tablets commercially available in Switzerland at different ambient temperatures (8 °C vs. 28 °C over 7 days, and 23 °C vs. 28 °C over 24 h, respectively). Data on access to refrigeration and electricity were assessed from the USAID-funded Demographic and Health Survey program. In suspensions, CLA degraded to a maximum of 12.9% (95% CI −55.7%, +29.9%) at 8°C and 72.3% (95% CI −82.8%, −61.8%) at a 28 °C ambient temperature during an observation period of 7 days. Dispersible tablets were observed during 24 h and CLA degraded to 15.4% (95% CI −51.9%, +21.2%) at 23 °C and 21.7% (−28.2%, −15.1%) at a 28 °C ambient temperature. There is relevant degradation of CLA in suspensions during a 7-day course. To overcome the stability challenges for all active components, durable child-appropriate formulations are needed. Until then, prescribers of AMC suspensions or pharmacists who sell the drug need to create awareness for the importance of proper storage conditions regarding effectiveness of both antibiotics and this recommendation should be reflected in the WHO Essential Medicines List for children.


2009 ◽  
Vol 14 (2) ◽  
pp. 153-159 ◽  
Author(s):  
William J. Burk ◽  
Jaap Denissen ◽  
Muriel D. Van Doorn ◽  
Susan J.T. Branje ◽  
Brett Laursen

This report examined the stability and reliability of self-reported conflict frequency in relationships with mothers, fathers, and best friends. Participants were drawn from three independent samples in the Netherlands (n = 72, M = 15.6 years), Germany (n = 242, M = 19.7 years), and the United States (n = 250, M = 19.8 years). Participants completed both topic-based surveys and interaction-based diary assessments of conflict frequency. Within samples, comparable levels of internal consistency and temporal stability emerged in each relationship for both assessment techniques. Topic-based and interaction-based assessments of conflict frequency were moderately correlated in each relationship within samples. Daily topic-based assessments with short intervals between time points may provide the most advantageous assessment strategy for obtaining reliable measures of conflict frequency in adolescents’ close relationships.


1989 ◽  
Vol 35 (10) ◽  
pp. 972-974 ◽  
Author(s):  
Alain Lamarre ◽  
Pierre J. Talbot

The stability of human coronavirus 229E infectivity was maximum at pH 6.0 when incubated at either 4 or 33 °C. However, the influence of pH was more pronounced at 33 °C. Viral infectivity was completely lost after a 14-day incubation period at 22, 33, or 37 °C but remained relatively constant at 4 °C for the same length of time. Finally, the infectious titer did not show any significant reduction when subjected to 25 cycles of thawing and freezing. These studies will contribute to optimize virus growth and storage conditions, which will facilitate the molecular characterization of this important pathogen.Key words: coronavirus, pH, temperature, infectivity, human coronavirus.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1029
Author(s):  
Francesca Selmin ◽  
Umberto M. Musazzi ◽  
Silvia Franzè ◽  
Edoardo Scarpa ◽  
Loris Rizzello ◽  
...  

Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (<0.2). Samples were stable independently of syringe materials and storage conditions. Only strong mechanical stress (e.g., shaking) caused massive aggregation of lipid nanoparticles and mRNA degradation. These proof-of-concept experiments support the hypothesis that vaccine doses can be safely prepared in a dedicated area using an aseptic technique and transferred without affecting their stability.


2016 ◽  
Vol 73 (14) ◽  
pp. 1088-1092 ◽  
Author(s):  
Michael F. Wempe ◽  
Alan Oldland ◽  
Nancy Stolpman ◽  
Tyree H. Kiser

Abstract Purpose Results of a study to determine the 90-day stability of dronabinol capsules stored under various temperature conditions are reported. Methods High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was used to assess the stability of dronabinol capsules (synthetic delta-9-tetrahydrocannabinol [Δ9-THC] mixed with high-grade sesame oil and other inactive ingredients and encapsulated as soft gelatin capsules) that were frozen, refrigerated, or kept at room temperature for three months. The dronabinol capsules remained in the original foil-sealed blister packs until preparation for HPLC–UV assessment. The primary endpoint was the percentage of the initial Δ9-THC concentration remaining at multiple designated time points. The secondary aim was to perform forced-degradation studies under acidic conditions to demonstrate that the HPLC–UV method used was stability indicating. Results The appearance of the dronabinol capsules remained unaltered during frozen, cold, or room-temperature storage. Regardless of storage condition, the percentage of the initial Δ9-THC content remaining was greater than 97% for all evaluated samples at all time points over the three-month study. These experimental data indicate that the product packaging and the sesame oil used to formulate dronabinol capsules efficiently protect Δ9-THC from oxidative degradation to cannabinol; this suggests that pharmacies can store dronabinol capsules in nonrefrigerated automated dispensing systems, with a capsule expiration date of 90 days after removal from the refrigerator. Conclusion Dronabinol capsules may be stored at room temperature in their original packaging for up to three months without compromising capsule appearance and with minimal reduction in Δ9-THC concentration.


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