Stability of Insulin Detemir Injection in Different Primary Packaging Systems at Room Temperature

2019 ◽  
pp. 089719001986785
Author(s):  
Harsh S. Shah ◽  
Rochelle F. Rubin ◽  
Gargi R. Lakhwani ◽  
Robert DiGregorio ◽  
Rutesh H. Dave
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Insulin Detemir ◽  
Hospital Setting ◽  
Assay Method ◽  
Patient Specific ◽  
Glass Vial ◽  
Glass Syringe ◽  
Plastic Syringe ◽  
The Stability

Purpose: To assess the stability of insulin detemir at controlled room temperature (RT) at 25°C in different packaging systems over 7 days. Methods: The degradation characteristics of insulin detemir were determined based on the assay results in different packaging systems (pinhole glass vial, closed glass vial, glass syringe, and plastic syringe) at RT using a reverse-phase high-performance liquid chromatography (HPLC) assay method for insulin injection. Each packaging system was compared to insulin detemir stored in the original packaged closed glass vial at 2°C to 8°C. Results: Insulin detemir stored in a closed glass vial and a glass syringe showed minor degradation at the end of day 7 (98.96% ± 1.49% and 99.78% ± 0.10%, respectively). Insulin detemir stored in plastic syringe decreased to 94.90% ± 2.50% by day 3 and to 93.52% ± 0.29% by day 7. Storage in pin-hole glass vial showed an increase in the assay (152.13% ± 0.12%) by day 7. Conclusion: Stability studies in different packaging systems demonstrated that insulin detemir remained stable for at least 7 days in a closed glass vial or glass syringe, but for only 3 days in a plastic syringe at RT. This study will allow pharmacists in the hospital setting to deliver patient-specific insulin doses into an insulin syringe with confidence in the stability.

Stability of dronabinol capsules when stored frozen, refrigerated, or at room temperature

2016 ◽  
Vol 73 (14) ◽  
pp. 1088-1092 ◽  
Author(s):  
Michael F. Wempe ◽  
Alan Oldland ◽  
Nancy Stolpman ◽  
Tyree H. Kiser
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Oxidative Degradation ◽  
Storage Condition ◽  
Sesame Oil ◽  
Forced Degradation ◽  
Product Packaging ◽  
Time Points ◽  
The Stability ◽  
Minimal Reduction

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.

Stability of extemporaneously prepared rosuvastatin oral suspension

2017 ◽  
Vol 74 (19) ◽  
pp. 1579-1583 ◽  
Author(s):  
Abdel Naser Zaid ◽  
Rania Shtayah ◽  
Ayman Qadumi ◽  
Mashour Ghanem ◽  
Rawan Qedan ◽  
...  
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Stability Studies ◽  
Organoleptic Properties ◽  
The Stability

Abstract Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

scholarly journals The Effect of Ultrasound, Oxygen and Sunlight on the Stability of (−)-Epigallocatechin Gallate

Molecules ◽  
2018 ◽  
Vol 23 (9) ◽  
pp. 2394 ◽  
Author(s):  
Jiajun Zeng ◽  
Huanhua Xu ◽  
Yu Cai ◽  
Yan Xuan ◽  
Jia Liu ◽  
...  
Keyword(s):  
Aqueous Solution ◽  
High Performance ◽  
Room Temperature ◽  
Degradation Rate ◽  
Epigallocatechin Gallate ◽  
Important Conclusion ◽  
Beneficial Effects ◽  
Periodontal Infection ◽  
The Stability ◽  
Ultrasonic Conditions

(−)-Epigallocatechin gallate (EGCG), is the main catechin found in green tea, and has several beneficial effects. This study investigated the stability of EGCG aqueous solution under different stored and ultrasonic conditions to determine whether it can be used with an ultrasonic dental scaler to treat periodontal infection. Four concentrations (0.05, 0.1, 0.15, 2 mg/mL) of EGCG aqueous solution were prepared and stored under four different conditions (A: Exposed to neither sunlight nor air, B: Exposed to sunlight, but not air, C: Not exposed to sunlight, but air, D: Exposed to sunlight and air) for two days. The degradation rate of EGCG was measured by high performance liquid chromatography (HPLC). On the other hand, an ultrasonic dental scaler was used to atomize the EGCG solution under four different conditions (a: Exposed to neither air nor sunlight, b: Not exposed to air, but sunlight, c: Not exposed to sunlight, but air, d: Exposed to air and sunlight), the degradation of EGCG was measured by HPLC. We found that the stability of EGCG was concentration-dependent in water at room temperature. Both sunlight and oxygen influenced the stability of EGCG, and oxygen had a more pronounced effect on stability of EGCG than sunlight. The most important conclusion was that the ultrasound may accelerate the degradation of EGCG due to the presence of oxygen and sunlight, but not because of the ultrasonic vibration. Thus, EGCG aqueous solution has the potential to be used through an ultrasonic dental scaler to treat periodontal infection in the future.

scholarly journals Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend® SF PH4

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Anne-Claire Bonnaure ◽  
Romain Bellay ◽  
Pauline Rault ◽  
Marie-Antoinette Lester ◽  
Pierre-Nicolas Boivin
Keyword(s):  
Degradation Product ◽  
Sodium Benzoate ◽  
High Performance ◽  
Room Temperature ◽  
Inflammatory Diseases ◽  
Oral Suspension ◽  
Stability Indicating Method ◽  
Physicochemical Stability ◽  
The Stability ◽  
Physical And Chemical

Abstract Background Prednisone is a corticosteroid used in several inflammatory diseases and cancers. In France, no available prednisone drinkable formulation exists. Instead, an oral syrup of prednisone with ethanol, sodium benzoate and simple syrup is produced. However, sodium benzoate can induce neonatal icterus and alcohol is not authorized for children below 3 years of age. The aim of this study was to determine the stability of 5 mg/mL prednisone oral suspension in a commercial compounding excipient: Syrspend® SF PH4. Methods Three batches of oral suspensions were prepared, using micronized prednisone and Syrspend® SF PH4. They were packaged in amber glass vials and stored at room temperature. On day 0, 1, 4, 10, 30, 60 and 90, we observed physical and chemical stability (pH measurement, osmolality measurement, residual concentrations of prednisone and degradation product identification). A stability indicating method was developed using high performance liquid chromatography with Ultraviolet detection at 254 nm. Results Prednisone concentrations remained stable within ± 5 % of nominal values for 60 days. No degradation product and change of physicochemical properties were detected. Conclusion This study showed that 5 mg/mL prednisone oral suspension in Syrspend® SF PH4 is stable for 60 days, at room temperature and protected from light.

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.

Multitemperature Stability and Degradation Characteristics of Pergolide Mesylate Oral Liquid

2010 ◽  
Vol 23 (6) ◽  
pp. 570-574 ◽  
Author(s):  
Brandon R. Shank ◽  
Clyde M. Ofner
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Degradation Process ◽  
First Order ◽  
Drug Concentrations ◽  
Relative Standard ◽  
Oral Liquid ◽  
The Stability ◽  
Initial Drug

The stability of pergolide mesylate in an oral aqueous liquid was studied. Stability and solubility data were used to determine the degradation characteristics of the drug in this formulation. Samples were stored in the dark at 35°C, 45°C, and 60°C. At 1, 2, 4, 8, 12, and 16 weeks, samples were removed and stored in a −80°C freezer for high performance liquid chromatography (HPLC) assay at a later date. The initial drug concentration of 0.30 mg/mL was determined by assay after storage at −80°C. A solubility of 6.9 mg/mL was found for pergolide mesylate in the oral liquid at room temperature with a relative standard deviation (RSD) of 4.0%. The degradation process is considered first-order at 25°C and 35°C. At higher temperatures (45°C and 60°C), a color change and curvature at the latter time points in degradation profiles are ascribed to the presence of methylcellulose. The activation energy calculated for degradation of pergolide mesylate in the oral liquid was 21.3 kcal/mol. The time to reach 90% potency (t90) values were calculated to be 43 days and 3 days, respectively, for storage at 25°C and 35°C. Drug concentrations up to ~6 mg/mL can be maintained as a solution at room temperature with this formulation.

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 Long-Term Stability of Lorazepam in Sodium Chloride 0.9% Stored at Different Temperatures in Different Containers

2019 ◽  
Vol 55 (3) ◽  
pp. 188-192
Author(s):  
M. L. Colsoul ◽  
A. Breuer ◽  
N. Goderniaux ◽  
J. D. Hecq ◽  
L. Soumoy ◽  
...  
Keyword(s):  
Time Management ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Period ◽  
Term Stability ◽  
Long Term Stability ◽  
Glass Bottles ◽  
The Stability

Background and Objective: Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Method: Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Results: Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Conclusion: Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.

Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography

2021 ◽  
pp. 2434-2439
Author(s):  
Saravanan. R ◽  
Somanathan. T ◽  
Gavaskar D ◽  
Tamilvanan M
Keyword(s):  
Development Strategy ◽  
Tenofovir Disoproxil Fumarate ◽  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Assay Method ◽  
Equilibration Time ◽  
Elution Time ◽  
Detailed Method ◽  
The Stability

A novel, economic, simple, precise and time-efficient reverse-phase high performance liquid chromatographic (RPHPLC) method has been established for the simultaneous assay determination of Dolutegravir, Lamivudine and Tenofovir Disoproxil fumarate in tablet formulation. This research paper presents the detailed method development strategy and the outcome of validation challenges. The RPHPLC method was developed using a 150 x 4.6mm, 5µm C18 column, with a gradient mode using 0.1% (v/v) trifluoroacetic acid buffer and methanol, the detection was performed at 260nm. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of Dolutegravir/Lamivudine/Tenofovir Disoproxil fumarate tablets. Total elution time was about 5 min and equilibration time of about 2 min which allows analysis of more than 100 samples per day. The method reported in this study is compatible to mass spectrometry and is thus extremely useful for stability studies.

Development of Oral Microemulsions of Morus alba Extract for Osteoarthritis

2014 ◽  
Vol 1060 ◽  
pp. 41-44
Author(s):  
Thapani Noi-Ang ◽  
Anusorn Charoensin ◽  
Aksiporn Warangkanagool ◽  
Athid Kulkong ◽  
Nattaporn Soonthornsit ◽  
...  
Keyword(s):  
Phase Diagrams ◽  
High Performance ◽  
Room Temperature ◽  
Ternary Phase ◽  
Physical Stability ◽  
Visual Observation ◽  
Stability Study ◽  
Ternary Phase Diagrams ◽  
The Stability ◽  
Precipitation Phase

This study aimed to develop oral microemulsions (MEs) containing M. alba extract. The stability study of the extract incorporated in the ME was also included. First, pseudo-ternary phase diagrams were constructed using caprylic/capric triglyceride (oil), PEG-8 caprylic/capric glycerides (S), polyglyceryl-3 diisostearate (CoS). Propylene glycol (PG) was used as a cosolvent. Then, the formulations were chosen to incorporate MSE and subjected to stability testing at 4o C, room temperature (RT) and 45o C at 75% RH for 8 weeks. Physical stability of the formulations was assessed by visual observation on the precipitation, phase separation and cloud point. Chemical stability was determined by quantitative analysis of oxyresveratrol using high performance liquid chromatography (HPLC). The results showed that with increasing the ratio of S/CoS, the area of ME existing region in phase diagrams increased. The addition of PG into aqueous phase at ratio 1:1 slightly affected the formation of MEs. Physical stability was not affected by temperature but was influenced by the components of the formulations. However, degradation of the extract was affected by both temperature and components of the formulations. The extract was stable at 4o C and RT. However, at 45o C, it degraded about 16-57%, depending on the components of the formulations. The best ME formulation consisted of 10% caprylic/capric triglyceride, 80% PEG-8 caprylic/capric glycerides and polyglyceryl-3 diisostearate (4:1), and 10% water and PG (1:1).

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