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 Spironolactone in an Extemporaneously Prepared Suspension at Two Temperatures

1993 ◽  
Vol 27 (10) ◽  
pp. 1198-1199 ◽  
Author(s):  
Milap C. Nahata ◽  
Richard S. Morosco ◽  
Thomas F. Hippie
Keyword(s):  
Storage Period ◽  
Hplc Method ◽  
Initial Concentration ◽  
Ph Changes ◽  
Stability Indicating ◽  
Two Temperatures ◽  
The Mean ◽  
Glass Bottles ◽  
The Stability ◽  
Mean Concentration

OBJECTIVE: To determine the stability of spironolactone in an extemporaneously prepared suspension at 22 and 4°C over a three-month storage period. DESIGN: Spironolactone suspension (1 mg/mL) was prepared in syrup NF, carboxymethylcellulose, and purified water USP. The suspension was stored in ten amber glass prescription bottles; five were stored at 22°C and five at 4°C. Samples were drawn from each bottle and analyzed in duplicate (n=10) on days 0, 7, 14, 28, 42, 56, 70, and 91. Spironolactone concentrations were measured by a reproducible and stability-indicating HPLC method. Inspection of visual and pH changes also was performed on each study day. RESULTS: The mean concentration of spironolactone was always higher than 98 percent of its initial concentration. The pH and appearance of the suspension did not change substantially. CONCLUSIONS: Spironolactone was stable in a suspension containing syrup, carboxymethylcellulose, and purified water for three months during storage in amber glass bottles at both 22 and 4°C.

Effect of Preparation Method and Storage on Rifampin Concentration in Suspensions

1994 ◽  
Vol 28 (2) ◽  
pp. 182-185 ◽  
Author(s):  
Milap C. Nahata ◽  
Richard S. Morosco ◽  
Thomas F. Hipple
Keyword(s):  
Storage Time ◽  
Solution Method ◽  
Preparation Method ◽  
Hplc Method ◽  
Measured Concentration ◽  
Preparation Methods ◽  
Initial Concentration ◽  
Stability Indicating ◽  
The Mean ◽  
And Storage

OBJECTIVE: To determine the effect of four preparation methods and extended storage on rifampin concentration in extemporaneously prepared suspensions. DESIGN: Four preparation methods were used: mixing intravenous (iv) rifampin in syrup (A); manufacturer's recommended technique of mixing capsule (Rifadin) contents in syrup (B); triturating capsule contents in syrup into a paste and adding remaining syrup while mixing (C); and triturating capsule contents in syrup into a paste, adding syrup, retriturating the slurry, and adding remaining syrup while mixing (D). Samples were drawn from each of five bottles of each of the four preparations stored at 4 °C, immediately after mixing (day 0), and on days 7, 14, 28, 42, 56, 70, and 91 days during storage. Rifampin wes measured by a stability-indicating HPLC method. RESULTS: The measured mean concentrations of rifampin were nearly 100 percent of the initial concentration in the suspension prepared from iv rifampin solution (method A) during the first 56 days of storage. In contrast, the measured concentrations were substantially lower than expected in the suspensions prepared by methods B, C, and D. The mean rifampin concentrations in suspensions prepared by methods B, C, and D were only 14.5, 38.6, and 68 percent, respectively, of the initial concentration achieved by method A. The rifampin concentrations increased with storage time in suspensions prepared by methods B, C, and D. The mean rifampin concentration was lower than 90 percent during the first 14 days with methods B and C, and the first 7 days with method D. The highest mean concentrations were observed on day 42 with method B, and on day 28 with methods C and D. All methods yielded 90% of the labeled potency (10 mg/mL) on day 56. CONCLUSIONS: Our results showed that preparation method can influence the dispersion, and thus the measured concentration, of rifampin in aliquots of suspensions prepared from capsules and stored in plastic bottles. Suspensions prepared from capsules led to lower-than-expected rifampin concentrations; those prepared from iv rifampin did not. Rifampin was stable in each type of suspension for 56 days at 4 °C.

Stability of Sotalol in Two Liquid Formulations at Two Temperatures

2003 ◽  
Vol 37 (4) ◽  
pp. 506-509 ◽  
Author(s):  
Milap C Nahata ◽  
Richard S Morosco
Keyword(s):  
Dosage Form ◽  
Physical Stability ◽  
Initial Concentration ◽  
Three Samples ◽  
Life Threatening ◽  
Two Temperatures ◽  
The Mean ◽  
The Stability ◽  
Liquid Dosage Form ◽  
Mean Concentration

BACKGROUND: Sotalol is used in certain pediatric patients to treat, suppress, or prevent the recurrence of life-threatening ventricular arrhythmias. However, it is commercially unavailable in a liquid dosage form. The use of an extemporaneously prepared liquid dosage form must be supported by the documentation of the chemical and physical stability of sotalol. OBJECTIVE: To determine the stability of sotalol hydrochloride extemporaneously prepared from tablets in 2 oral suspensions stored at 2 temperatures. METHODS: Five bottles contained Ora Plus: Ora Sweet (1:1) and the other 5 bottles had 1% methylcellulose:simple syrup NF (1:9), with a sotalol concentration of 5 mg/mL. Three samples were collected from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days and analyzed by a stability-indicating HPLC analytical method (n = 15). RESULTS: At 4°C, the mean concentration of sotalol was at least 98.9% of the original concentration in Ora Plus: Ora Sweet suspension and 95.5% of the initial concentration in 1% methylcellulose:simple syrup during storage for 3 months. At 25°C, the mean concentration of sotalol was ≥95.5% of the original concentration in Ora Plus: Ora Sweet suspension and 94.4% of the initial concentration in 1% methylcellulose:simple syrup during storage for 3 months. The pH did not change substantially during the study period. Further, no changes in physical appearance were seen during the study. CONCLUSIONS: Sotalol hydrochloride can be prepared in either of 2 liquid dosage forms and stored in plastic bottles for 13 weeks at 4 or 25°C without substantial loss of potency.

Instant 99mTc-Labelled Glucoheptonate Kit for Kidney Imaging

1983 ◽  
Vol 22 (05) ◽  
pp. 246-250 ◽  
Author(s):  
M. Al-Hilli ◽  
H. M. A. Karim ◽  
M. H. S. Al-Hissoni ◽  
M. N. Jassim ◽  
N. H. Agha
Keyword(s):  
Sodium Hydroxide Solution ◽  
Normal Subjects ◽  
Organ Distribution ◽  
Stable Complex ◽  
Scintillation Camera ◽  
Ph Adjustment ◽  
The Mean ◽  
The Stability ◽  
Kidney Imaging ◽  
Mean Concentration

Gelchromatography column scanning has been used to study the fractions of reduced hydrolyzed 99mTc, 99mTc-pertechnetate and 99mTc-chelate in a 99mTc-glucoheptonate (GH) preparation. A stable high labelling yield of 99mTc-GH complex in the radiopharmaceutical has been obtained with a concentration of 40-50 mg of glucoheptonic acid-calcium salt and not less than 0.45 mg of SnCl2 2 H2O at an optimal pH between 6.5 and 7.0. The stability of the complex has been found significantly affected when sodium hydroxide solution was used for the pH adjustment. However, an alternative procedure for final pH adjustment of the preparation has been investigated providing a stable complex for the usual period of time prior to the injection. The organ distribution and the blood clearance data of 99mTc-GH in rabbits were relatively similar to those reported earlier. The mean concentration of the radiopharmaceutical in both kidneys has been studied in normal subjects for one hour with a scintillation camera and the results were satisfactory.

scholarly journals Effects of heat treatment and storage temperature on the use of açaí drink by nutraceutical and beverage industries

2012 ◽  
Vol 32 (1) ◽  
pp. 9-14 ◽  
Author(s):  
Tatiane Regina Albarici ◽  
José Dalton Cruz Pessoa
Keyword(s):  
Temperature Effect ◽  
Storage Temperature ◽  
Life Time ◽  
Reaction Rate Constant ◽  
Anthocyanin Content ◽  
Order Kinetic ◽  
First Order ◽  
The Stability ◽  
And Storage ◽  
Anthocyanin Degradation

This study assesses the storage temperature effect on the anthocyanins of pasteurized and unpasteurized açaí pulp. The data was obtained using a pasteurized and lyophilized pulp (PLP) to evaluate the temperature effect (0, 25, and 40 °C). Part of non-pasteurized frozen pulp (NPP) was pasteurized (NPP-P) at 90 °C for 30 seconds; both pulps were stored at 40 °C. The anthocyanin content reduction in the drink was evaluated from the half-life time (t1/2), activation energy (Ea), temperature quotient (Q10), and the reaction rate constant (k). The t1/2 of the PLP anthocyanins stored at 40 °C was 1.8 times less than that stored at 25 °C and 15 times less than that stored at 0 °C; therefore, the higher temperatures decreased the stability of anthocyanins. The pasteurization increased the t1/2 by 6.6 times (10.14 hours for NPP and 67.28 hours for NPP-P). The anthocyanin degradation on NPP-P followed a first order kinetic, while NPP followed a second order kinetic; thus it can be said that the pasteurization process can improve the preservation of anthocyanins in the pulp.

Effect of Irradiation, Packaging, and Postirradiation Cooking on the Thiamin Content of Chicken Meat

1999 ◽  
Vol 62 (11) ◽  
pp. 1303-1307 ◽  
Author(s):  
SABINE VAN CALENBERG ◽  
BEN PHILIPS ◽  
WIM MONDELAERS ◽  
OSWALD VAN CLEEMPUT ◽  
ANDRE HUYGHEBAERT
Keyword(s):  
Storage Temperature ◽  
Electron Beams ◽  
Vacuum Packaging ◽  
Chicken Meat ◽  
Chicken Breast ◽  
X Rays ◽  
Breast Meat ◽  
The Mean ◽  
And Storage ◽  
Chicken Breast Meat

The effect of irradiation with X rays or electrons, irradiation and storage temperature, and postirradiation cooking on the thiamin content of vacuum- or air-packaged minced chicken meat was examined. Samples irradiated with 3-kGy X rays (50 Gy/min) or electrons (5 kGy/min) contained less thiamin than the control specimens, but no differences between both irradiation methods were detected. The thiamin content in samples stored and/or irradiated at 5°C was between 13 and 24 μg per 100-g product lower than in samples stored and/or ionized at −18°C. The same difference in thiamin content was found for specimens packaged in a vacuum or air package, respectively. Vacuum packaging lead to a greater loss of drip than air-packaged samples. The biggest loss of thiamin, 31.1 and 28.0% for X rays and electron beams, respectively, was measured for vacuum-packaged specimens stored and irradiated at 5°C. Compared with the cooked minced chicken breast meat, a higher thiamin content (6 to 17 μgof thiamin per 100-g product) was obtained for the raw samples. When irradiation and vacuum packaging were compared as two separate preservation techniques, the two methods had approximately the same effect on the thiamin content of the minced chicken meat. The mean temperature of the samples after cooking was 87.2 ± 4.9°C. However, significant differences in internal temperature after cooking of the samples were measured between air- and vacuum-packaged samples.

Effect of sample storage temperature and buffer formulation on faecal immunochemical test haemoglobin measurements

2017 ◽  
Vol 24 (4) ◽  
pp. 176-181 ◽  
Author(s):  
Erin L Symonds ◽  
Stephen R Cole ◽  
Dawn Bastin ◽  
Robert JL Fraser ◽  
Graeme P Young
Keyword(s):  
Room Temperature ◽  
Storage Temperature ◽  
Test Accuracy ◽  
Sample Collection ◽  
Storage Duration ◽  
Initial Concentration ◽  
Faecal Immunochemical Test ◽  
Immunochemical Test ◽  
New Formulation ◽  
And Storage

Objectives Faecal immunochemical test accuracy may be adversely affected when samples are exposed to high temperatures. This study evaluated the effect of two sample collection buffer formulations (OC-Sensor, Eiken) and storage temperatures on faecal haemoglobin readings. Methods Faecal immunochemical test samples returned in a screening programme and with ≥10 µg Hb/g faeces in either the original or new formulation haemoglobin stabilizing buffer were stored in the freezer, refrigerator, or at room temperature (22℃–24℃), and reanalysed after 1–14 days. Samples in the new buffer were also reanalysed after storage at 35℃ and 50℃. Results were expressed as percentage of the initial concentration, and the number of days that levels were maintained to at least 80% was calculated. Results Haemoglobin concentrations were maintained above 80% of their initial concentration with both freezer and refrigerator storage, regardless of buffer formulation or storage duration. Stability at room temperature was significantly better in the new buffer, with haemoglobin remaining above 80% for 20 days compared with six days in the original buffer. Storage at 35℃ or 50℃ in the new buffer maintained haemoglobin above 80% for eight and two days, respectively. Conclusion The new formulation buffer has enhanced haemoglobin stabilizing properties when samples are exposed to temperatures greater than 22℃.

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.

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