scholarly journals Formulation of Buprenorphine for Sublingual Use in Neonates

2011 ◽  
Vol 16 (4) ◽  
pp. 281-284 ◽  
Author(s):  
Ellena A. Anagnostis ◽  
Rania E. Sadaka ◽  
Linda A. Sailor ◽  
David E. Moody ◽  
Kevin C. Dysart ◽  
...  
Keyword(s):  
Room Temperature ◽  
Storage Time ◽  
Storage Temperature ◽  
Sublingual Administration ◽  
Tandem Mass ◽  
Abstinence Syndrome ◽  
Length Of Treatment ◽  
The Mean ◽  
The Stability ◽  
Length Of Hospitalization

OBJECTIVES The only medication used sublingually in the neonate is buprenorphine for the treatment of neonatal abstinence syndrome (NAS). Compared with morphine, buprenorphine reduces the length of treatment and length of hospitalization in neonates treated for NAS. The objective of this study was to characterize the stability of ethanolic buprenorphine for sublingual administration. METHODS Buprenorphine solution was prepared and stored in amber glass source bottles at either 68°F to 77°F (20°C-25°C) or 36°F to 46°F (2.2°C-7.8°C). Samples were collected from each of these batches on days 0, 3, 7, 14, and 30. Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days. Buprenorphine concentration was assessed by liquid chromatography–electrospray ionization–tandem mass spectrometry. RESULTS Neither storage temperature (p=0.65) nor storage time (p=0.24) significantly affected buprenorphine concentrations. All of the mean concentrations, regardless of storage temperature, were above 95% of the labeled concentration, and the potency was maintained for samples stored either in the original amber glass source bottles or in oral syringes. CONCLUSIONS An ethanolic buprenorphine solution is stable at room temperature for 30 days.

Effects of storage temperature and time before centrifugation on ionized calcium in blood collected in plain vacutainer tubes and silicone-separator (SST) tubes.

1984 ◽  
Vol 30 (4) ◽  
pp. 553-556 ◽  
Author(s):  
J Toffaletti ◽  
N Blosser ◽  
K Kirvan
Keyword(s):  
Room Temperature ◽  
Storage Temperature ◽  
Ionized Calcium ◽  
Blood Collection ◽  
Healthy Individuals ◽  
Blood Samples ◽  
The Mean ◽  
Whole Blood Samples ◽  
The Stability ◽  
Blood Collection Tubes

Abstract We studied the stability of ionized calcium and pH in samples stored at either room temperature or 4 degrees C, in centrifuged and uncentrifuged blood-collection tubes and in centrifuged tubes containing a silicone-separator gel (SST tubes). At room temperature, in uncentrifuged blood from healthy individuals, mean ionized calcium usually increased no more than 10 mumol/L per hour; at 4 degrees C it did not change detectably for 70 h. This stability was fortuitous, however: the concentrations of both hydrogen and lactate ions in these samples increased, apparently with offsetting effects on the concentration of ionized calcium. Blood stored for 70 h at 4 degrees C in centrifuged SST tubes, although showing a slightly greater change in ionized calcium, had less change of pH and no change in the ionized calcium corrected to pH 7.4. In 11 heparinized whole-blood samples from eight patients in intensive care, the mean change per hour in ionized calcium and pH after storage at room temperature was +10 mumol/L and -0.04 units, respectively.

scholarly journals Effects of storage temperature, storage time, and Cary-Blair transport medium on the stability of the gut microbiota

2019 ◽  
Vol 13 (5) ◽  
pp. 256-260
Author(s):  
Naoyoshi Nagata ◽  
Mari Tohya ◽  
Fumihiko Takeuchi ◽  
Wataru Suda ◽  
Suguru Nishijima ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Storage Time ◽  
Storage Temperature ◽  
Transport Medium ◽  
The Stability ◽  
Temperature Storage

Stability of Bortezomib 1-mg/mL Solution in Plastic Syringe and Glass Vial

2005 ◽  
Vol 39 (9) ◽  
pp. 1462-1466 ◽  
Author(s):  
Pascal André ◽  
Salvatore Cisternino ◽  
Fouad Chiadmi ◽  
Audrey Toledano ◽  
Joël Schlatter ◽  
...  
Keyword(s):  
Storage Temperature ◽  
Color Change ◽  
Hplc Method ◽  
Initial Concentration ◽  
Plastic Syringe ◽  
The Mean ◽  
The Stability ◽  
And Storage ◽  
Mean Concentration ◽  
Antineoplastic Chemotherapy

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 and stored at 22 °C. Velcade vials containing 1 mL of solution were stored at 5 °C in the dark. Samples were taken at various times over 23 days and assayed in duplicate. An HPLC method for assaying the stability of BTZ was validated. Appearance and pH were recorded. RESULTS: There was no color change or precipitation in the samples, and the pH was stable. Oxidation, light, and storage temperature all affected the chemical stability of BTZ. The mean concentrations of BTZ in syringes stored for 2, 3, and 5 days at 60, 22, and 5 °C were >95% of the initial concentration. The mean concentration of BTZ in vials stored for 5 days at 5 °C was >95% of the initial concentration. CONCLUSIONS: BTZ stored refrigerated in vials or syringes and protected from light is chemically stable for 5 days after reconstitution.

Stability of Donepezil in an Extemporaneously Prepared Oral Liquid

2006 ◽  
Vol 19 (5) ◽  
pp. 282-285 ◽  
Author(s):  
Weeranuj Yamreudeewong ◽  
Eric Kurt Dolence ◽  
Deborah Pahl
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Time ◽  
Microbial Growth ◽  
Storage Period ◽  
Significant Loss ◽  
Ambient Room Temperature ◽  
Oral Liquid ◽  
Liquid Preparation ◽  
The Stability

The stability of donepezil in an extemporaneously prepared oral liquid was studied. An aqueous liquid formulation of donepezil was prepared by reconstituting the powder from triturated 5-mg tablets with equal amounts of deionized water and 70% sorbitol solution with an expected donepezil concentration of 1 mg/mL. Polyethylene terephthalate plastic bottles containing donepezil liquid preparation were stored at ambient room temperature (22° C-26° C) and in the refrigerator (4° C-8° C). After a storage time of 1, 2, 3, and 4 weeks, donepezil liquid samples were analyzed in triplicate for donepezil concentrations by high-performance liquid chromatography. The concentrations of donepezil were found to be within the acceptable limit (± 10% of the initial concentration) in all test samples, which indicated that donepezil liquid preparation was stable at room temperature and in the refrigerator for up to 4 weeks. In addition, our study findings indicated that there was no microbial growth in the extemporaneously prepared donepezil liquid preparation after a storage period of 4 weeks in the refrigerator. In summary, the results of our study revealed that donepezil is stable (no significant loss of donepezil concentration and no microbial growth) in an extemporaneously prepared oral liquid when stored in the refrigerator for up to 4 weeks.

scholarly journals Influence of storage time and temperature on the activity of urease

2019 ◽  
Vol 51 (2) ◽  
pp. 159-163
Author(s):  
B. Alev ◽  
S. Tunali ◽  
R. Yanardag ◽  
A. Yarat
Keyword(s):  
Room Temperature ◽  
Storage Time ◽  
Urease Activity ◽  
Storage Temperature ◽  
Practical Importance ◽  
Storage Conditions ◽  
Relative Activity ◽  
Significant Loss ◽  
Long Term Storage ◽  
Activity Measurements

Enzymes are made of protein, that is why they are sensitive molecules and are affected by storage conditions. A small change in enzyme activity during storage may cause a big error in analysis results. The aim of the study was to evaluate the effects of storage time and temperature on urease activity. Urease solutions were prepared at different activities (from 100 to 2000 U/mL) and stored at room temperature, in the refrigerator (4°C), and in the deep freezer (-18°C and -80°C). Activity measurements were made at regular intervals until 28 days by the modified Weatherburn method. The relative activities of 100-1000 U/mL urease solutions stored at room temperature, 4, -18 or -80°C were 75% and below after 4 days. Twenty-eight days later, for 2000 U/mL urease solutions, only at room temperature, the relative activity was reduced to 37%, while at 4, -18 or -80°C, the relative activities were above 80%. Since urease can be maintained at 4°C for 28 days without significant loss of activity, it has practical importance. Low-activity urease solutions (such as 100-1000 U/mL) should not be stored at -18 or -80°C for short or long term storage, they should be stored at 4°C only for one day. Keywords: Urease activity, storage time, storage temperature

scholarly journals Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome

2021 ◽  
Vol 26 (4) ◽  
pp. 395-404
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Walter Kraft ◽  
Gagan Kaushal
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Condition ◽  
Stability Study ◽  
Neonatal Abstinence Syndrome ◽  
Limited Information ◽  
Abstinence Syndrome ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C–8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days. RESULTS Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days. CONCLUSIONS Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.

scholarly journals Influence of Storage Conditions and Preservatives on Metabolite Fingerprints in Urine

Metabolites ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. 203 ◽  
Author(s):  
Xinchen Wang ◽  
Haiwei Gu ◽  
Susana A. Palma-Duran ◽  
Andres Fierro ◽  
Paniz Jasbi ◽  
...  
Keyword(s):  
Large Scale ◽  
Storage Time ◽  
Storage Temperature ◽  
Urinary Metabolites ◽  
Storage Conditions ◽  
Inhibitory Effect ◽  
Urine Samples ◽  
C Storage ◽  
Liquid Chromatography Tandem Mass ◽  
The Stability

Human urine, which is rich in metabolites, provides valuable approaches for biomarker measurement. Maintaining the stability of metabolites in urine is critical for accurate and reliable research results and subsequent interpretation. In this study, the effect of storage temperature (4, 22, and 40 °C), storage time (24 and 48 h), and use of preservatives (boric acid (BA), thymol) and para-aminobenzoic acid (PABA) on urinary metabolites in the pooled urine samples from 20 participants was systematically investigated using large-scale targeted liquid chromatography tandem mass spectrometry (LC-MS/MS)-based metabolomics. Statistical analysis of 158 reliably detected metabolites showed that metabolites in urine with no preservative remained stable at 4 °C for 24 and 48 h as well as at 22 °C for 24 h, but significant metabolite differences were observed in urine stored at 22 °C for 48 h and at 40 °C. The mere addition of BA caused metabolite changes. Thymol was observed to be effective in maintaining metabolite stability in urine in all the conditions designed, most likely due to the inhibitory effect of thymol on urine microbiota. Our results provide valuable urine preservation guidance during sample storage, which is essential for obtaining reliable, accurate, and reproducible analytical results from urine samples.

Stability of Amiodarone in an Oral Suspension Stored under Refrigeration and at Room Temperature

1997 ◽  
Vol 31 (7-8) ◽  
pp. 851-852 ◽  
Author(s):  
Milap C. Nahata
Keyword(s):  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Oral Suspension ◽  
Storage Container ◽  
Three Samples ◽  
Two Temperatures ◽  
The Mean ◽  
The Stability ◽  
Tablet Dosage

OBJECTIVE: Amiodarone is currently available in a tablet dosage form, which cannot be used in young pediatric patients. The objective of our study was to determine the stability of amiodarone in an oral suspension stored at two temperatures. METHODS: Commercially available amiodarone tablets (200 mg each) were dissolved in purified water and a suspension prepared in methylcellulose 1 % and syrup to yield a concentration of 5 mg/mL. The dosage form was stored in 10 glass and 10 plastic prescription bottles. One-half of the bottles were stored at 4 °C and the others at 25 °C. Three samples were taken from each bottle at 0, 7, 14, 28, 42, 56. 70, and 91 days (n = 15). Amiodarone concentrations were measured by a validated and stability-indicating HPLC method; the pH was also determined in each sample. The drug was considered stable if its concentration exceeded 90% of the original concentration. RESULTS: The mean concentration of amiodarone was 90% or more at 4 °C for 91 days and at 25 °C for 42 days. The concentration was not affected by the type of storage container. Over 91 days, the pH did not change at 4 °C; it decreased slightly from 4.4 to 4.3 at 25 °C. CONCLUSIONS: Amiodarone was stable in an oral suspension for 3 months under refrigeration and for 6 weeks at room temperature.

scholarly journals Diagnosis of soil-transmitted helminths using the Kato-Katz technique: What is the influence of stirring, storage time and storage temperature on stool sample egg counts?

2021 ◽  
Vol 15 (1) ◽  
pp. e0009032
Author(s):  
Felix Bosch ◽  
Marta S. Palmeirim ◽  
Said M. Ali ◽  
Shaali M. Ame ◽  
Jan Hattendorf ◽  
...  
Keyword(s):  
Stool Sample ◽  
Room Temperature ◽  
Storage Time ◽  
Storage Temperature ◽  
Negative Impact ◽  
The Other ◽  
Time Points ◽  
Soil Transmitted Helminths ◽  
Slide Preparation ◽  
Stool Samples

Background Soil-transmitted helminths infect about one fifth of the world’s population and have a negative impact on health. The Kato-Katz technique is the recommended method to detect soil-transmitted helminth eggs in stool samples, particularly in programmatic settings. However, some questions in its procedure remain. Our study aimed to investigate the effect of storage time, storage temperature and stirring of stool samples on fecal egg counts (FECs). Methodology/Principal findings In the framework of a clinical trial on Pemba Island, United Republic of Tanzania, 488 stool samples were collected from schoolchildren. These samples were evaluated in three experiments. In the first experiment (n = 92), two Kato-Katz slides were prepared from the same stool sample, one was stored at room temperature, the other in a refrigerator for 50 hours, and each slide was analyzed at nine time points (20, 50, 80, 110, 140 minutes, 18, 26, 42 and 50 hours). In the second experiment (n = 340), whole stool samples were split into two, one part was stored at room temperature, and the other part was put in a refrigerator for 48 hours. From each part one Kato-Katz slide was prepared and analyzed at three time points over two days (0, 24 and 48 hours). In the third experiment (n = 56), whole stool samples where stirred for 15 seconds six times and at each time point a Kato-Katz slide was prepared and analyzed. Mean hookworm FECs of Kato-Katz slides stored at room temperature steadily decreased following slide preparation. After two hours, mean hookworm FECs decreased from 22 to 16, whereas no reduction was observed if Kato-Katz slides were stored in the refrigerator (19 vs 21). The time x storage interaction effect was statistically significant (coefficient 0.26, 95% CI: 0.17 to 0.35, p < 0.0001). After 24 hours mean hookworm FECs dropped close to zero, irrespective of the storage condition. Whole stool samples stored at room temperature for one day resulted in a mean hookworm FEC decrease of 23% (p < 0.0001), compared to a 13% reduction (p < 0.0001) if samples were stored in the refrigerator. Fecal egg counts of A. lumbricoides and T. trichiura remained stable over time regardless of storage temperature of whole stool samples. Finally, we found a significant reduction of the variation of hookworm and T. trichiura eggs with increasing rounds of stirring the sample, but not for A. lumbricoides. For hookworm we observed a simultaneous decrease in mean FECs, making it difficult to draw recommendations on stirring samples. Conclusions/Significance Our findings suggest that stool samples (i) should be analyzed on the day of collection and (ii) should be analyzed between 20–30 minutes after slide preparation; if that is not possible, Kato-Katz slides can be stored in a refrigerator for a maximum of 110 minutes.

scholarly journals Stability of hepatitis B virus pregenomic RNA in plasma specimens under various temperatures and storage conditions

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e11207
Author(s):  
Pakkapon Rattanachaisit ◽  
Sirinporn Suksawatamnuay ◽  
Supachaya Sriphoosanaphan ◽  
Kessarin Thanapirom ◽  
Panarat Thaimai ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Room Temperature ◽  
Plasma Samples ◽  
Freeze Thaw ◽  
B Virus ◽  
The Mean ◽  
Clinically Significant ◽  
The Stability ◽  
And Storage

Background Hepatitis B virus (HBV) pregenomic RNA (pgRNA) has gained increasing attention owing to its role in replication of covalently closed circular DNA (cccDNA) in HBV. This marker has the potential to be used in clinical programs aimed to manage HBV infections. However, several reports on HBV pgRNA levels in clinical cases have conflicting results. RNA is easily degraded when exposed to heat and other environmental stressors. However, the stability of HBV pgRNA, during blood sample collection before the standard automated quantification, has never been estimated. This study aimed to demonstrate the effect of two different temperature conditions and storage durations on the stability of HBV pgRNA. Method Blood from forty patients with chronic hepatitis B infection, who also showed evidence of active HBV DNA replication, was collected and processed within 2 h of collection. Plasma from each patient was divided and stored at 4 °C and 25 °C (room temperature) for six different storage durations (0, 2, 6, 12, 24, and 48 h) and subsequently transferred to −80 °C for storage. The effect of multiple cycles of freezing and thawing of plasma at −20 °C or −80 °C was evaluated using samples from ten patients. Quantification of pgRNA from the samples was performed simultaneously, using the digital polymerase chain reaction (dPCR) method. The differences in pgRNA levels at baseline and each time point were compared using generalized estimating equation (GEE). A change greater than 0.5 log10 copies/mL of pgRNA is considered clinically significant. Statistical analyses were conducted using Stata 16.0. Results The mean HBV pgRNA level in the initially collected plasma samples was 5.58 log10copies/mL (ranging from 3.08 to 8.04 log10 copies/mL). The mean pgRNA levels in samples stored for different time periods compared with the initial reference sample (time 0) significantly decreased. The levels of pgRNA for 6, 12, 24, and 48 h of storage reduced by −0.05 log10 copies/mL (95% confidence interval (CI) −0.095 to −0.005, p = 0.03), −0.075 log10 copies/mL (95% CI [−0.12 to −0.03], p = 0.001), −0.084 log10 copies/mL (95% CI [−0.13 to −0.039], p =  < 0.001), and −0.120 log10 copies/mL (95% CI [−0.17 to −0.076], p =  < 0.001), respectively. However, these changes were below 0.5 log10 copies/mL and thus were not clinically significant. Compared with the samples stored at 4 °C, there were no significant differences in pgRNA levels in samples stored at 25 °C for any of the storage durations (−0.01 log10 copies/mL; 95% CI [−0.708 to 0.689], p = 0.98). No significant difference in the levels of pgRNA was observed in the plasma samples, following four freeze-thaw cycles at −20 °C and −80 °C. Conclusion The plasma HBV pgRNA level was stable at 4 °C and at room temperature for at least 48 h and under multiple freeze-thaw cycles. Our results suggest that pgRNA is stable during the process of blood collection, and therefore results of pgRNA quantification are reliable.

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