scholarly journals Stability study of metronidazole cream, extemporaneously made in pharmacy

2021 ◽  
Vol 31 (Supplement_2) ◽  
Author(s):  
Andrius Dambrauskas
Keyword(s):  
Relative Humidity ◽  
Shelf Life ◽  
High Performance ◽  
Stability Study ◽  
Stress Factors ◽  
Alkaline Media ◽  
Acid Media ◽  
Microbiological Examination ◽  
The Face ◽  
The Stability

Abstract Background Rosacea is a chronic recurrent disease, characterized by facial redness, dilated blood vessels, inflammatory rash elements on the face. The pharmacy produces 2% metronidazole cream extemporaneously for the treatment of the disease, as there is no such cream concentration on the market. The treatment of the disease is usually long, so the shelf life of the cream is very important for the patient, especially for those who do not have the opportunity to reach the manufacturing pharmacy. The aim of this investigation was to determine the stability and shelf life of metronidazole cream. Methods Long-term stability study of metronidazole cream was applied at 25 ± 2° C, 60 ± 5% relative humidity; accelerated stability test at 40 ± 2 °C, 75 ± 5% relative humidity. The influence of stress conditions were evaluated on the stability of metronidazole cream. It was determined metronidazole cream texture and microbiological examination was applied. Results It was found that color (white), odor (odorless), integrity (homogeneous), pH (6.8) did not change during storage of metronidazole (6 months). Mechanical properties of the metronidazole cream: firmness, shear, consistency and cohesion throughout the study remained stable. High performance liquid chromatography in the full stability study showed that metronidazole concentrations did not fluctuate within ± 5%. Stress factors such as acid media, alkaline media, hydrogen peroxide, daylight and heat did not affect the stability of the cream. A microbiological examination of the metronidazole cream suited European Pharmacopoeia requirements. Conclusions The extemporaneously made metronidazole cream were stable for 6 months.

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 Limitations and Challenges in the Stability of Cysteamine Eye Drop Compounded Formulations

2021 ◽  
Vol 15 (1) ◽  
pp. 2
Author(s):  
Cristina Martín-Sabroso ◽  
Mario Alonso-González ◽  
Ana Fernández-Carballido ◽  
Juan Aparicio-Blanco ◽  
Damián Córdoba-Díaz ◽  
...  
Keyword(s):  
Shelf Life ◽  
Stability Study ◽  
Eye Drops ◽  
Microbiological Analysis ◽  
Nitrogen Gas ◽  
Long Term Stability ◽  
Main Degradation Product ◽  
The Stability ◽  
Unstable Molecule

Accumulation of cystine crystals in the cornea of patients suffering from cystinosis is considered pathognomonic and can lead to severe ocular complications. Cysteamine eye drop compounded formulations, commonly prepared by hospital pharmacy services, are meant to diminish the build-up of corneal cystine crystals. The objective of this work was to analyze whether the shelf life proposed for six formulations prepared following different protocols used in hospital pharmacies is adequate to guarantee the quality and efficacy of cysteamine eye drops. The long-term and in-use stabilities of these preparations were studied using different parameters: content of cysteamine and its main degradation product cystamine; appearance, color and odor; pH and viscosity; and microbiological analysis. The results obtained show that degradation of cysteamine was between 20% and 50% after one month of storage in the long-term stability study and between 35% and 60% in the in-use study. These data confirm that cysteamine is a very unstable molecule in aqueous solution, the presence of oxygen being the main degradation factor. Saturation with nitrogen gas of the solutions offers a means of reducing cysteamine degradation. Overall, all the formulae studied presented high instability at the end of their shelf life, suggesting that their clinical efficacy might be dramatically compromised.

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.

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).

scholarly journals Stability and Compatibility of Diphenhydramine Hydrochloride in Intravenous Admixtures: A New Look at an Old Drug

2018 ◽  
Vol 54 (5) ◽  
pp. 330-334
Author(s):  
Daniel Sabins ◽  
Tuong Diep ◽  
Pamela McCartan ◽  
Shashi Patel ◽  
Fang Zhao
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Hplc Method ◽  
Stability Study ◽  
Limited Data ◽  
Diphenhydramine Hydrochloride ◽  
Drug Concentrations ◽  
The Stability ◽  
Initial Drug ◽  
Predetermined Time

Purpose: Intravenous (IV) admixtures of diphenhydramine are widely used in hospitalized patients to prevent or treat hypersensitivity reactions. However, there is limited data to support the admixture preparation in this manner. This study was designed to investigate the stability and compatibility of diphenhydramine in IV admixtures with a goal to establish a 14-day beyond-use dating with storage under refrigeration. Methods: The commercially available 50 mg/mL diphenhydramine hydrochloride injection vials were used to prepare the 0.2 and 1.0 mg/mL IV admixtures in 0.9% sodium chloride injection and 5% dextrose injection in 50 mL polyvinyl chloride (PVC) bags. The IV bags were sealed and stored under refrigeration (2°C-8°C) for the stability study. At each predetermined time point, samples were taken for visual inspection, pH measurement, and analysis by a stability-indicating high-performance liquid chromatography (HPLC) method. Results: The freshly prepared IV admixtures appeared clear, colorless, and particulate-free with pH readings of 4.44 to 4.60. The initial drug concentrations of all samples were confirmed by HPLC to be within 101.8% to 103.6% of the label claims. Over the 14 days of the study period, there was no significant change in the appearance or pH values for all stability samples. The HPLC results also confirmed that there was no more than ±2% change of the initial drug concentration in any stability samples. Conclusion: Diphenhydramine hydrochloride IV admixtures of 0.2 and 1.0 mg/mL are compatible with 0.9% sodium chloride injection and 5% dextrose injection in PVC bags. These IV admixtures are stable chemically and physically for up to 14 days when stored under refrigeration (2°C-8°C).

scholarly journals The Link between Polyphenol Structure, Antioxidant Capacity and Shelf-Life Stability in the Presence of Fructose and Ascorbic Acid

Molecules ◽  
2020 ◽  
Vol 25 (1) ◽  
pp. 225 ◽  
Author(s):  
Inbal Hanuka Katz ◽  
Eden Eran Nagar ◽  
Zoya Okun ◽  
Avi Shpigelman
Keyword(s):  
Ascorbic Acid ◽  
Antioxidant Capacity ◽  
Shelf Life ◽  
High Performance ◽  
Degradation Kinetics ◽  
Model System ◽  
Absorption Capacity ◽  
Component Model ◽  
Freeze Dried ◽  
The Stability

Polyphenols play an important role in the sensorial and health-promoting properties of fruits and vegetables and display varying structure-dependent stability during processing and shelf-life. The current work aimed to increase the fundamental understanding of the link between the stability of polyphenols as a function of their structure, presence of ascorbic acid and fructose and total antioxidant capacity (TAC), using a multi-component model system. Polyphenol extract, used as the multi-component model system, was obtained from freeze-dried, high polyphenol content strawberry (Fragaria × ananassa ‘Nerina’) and twenty-one compounds were identified using high-performance liquid chromatography-mass spectrometry (HPLC-MS). The TAC and the first-order degradation kinetics were obtained, linking the polyphenol stability to its chemical structure, with and without the presence of fructose and ascorbic acid. The TAC (measured by oxygen radical absorption capacity (ORAC) and ferric reducing antioxidant potential (FRAP) assays) was not dramatically affected by storage temperatures and formulation, while polyphenol stability was significantly and structure dependently affected by temperature and the presence of ascorbic acid and fructose. Anthocyanins and phenolic acids were more unstable in the presence of ascorbic acid, while flavonol stability was enhanced by its presence. Shelf life study performed at 37 °C revealed significantly higher stability of purified polyphenols vs. the stability of the same polyphenols in the strawberry extract (multi-component system).

scholarly journals HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 323
Author(s):  
Emanuela Scudellaro ◽  
Luciana Tartaglione ◽  
Fabio Varriale ◽  
Carmela Dell’Aversano ◽  
Orazio Taglialatela-Scafati
Keyword(s):  
Mass Spectrometry ◽  
Relative Humidity ◽  
Shelf Life ◽  
Orphan Drug ◽  
Chromatographic Method ◽  
Stability Study ◽  
Accelerated Stability ◽  
Definition Of

This work was aimed at the definition of a chromatographic method able to separate and quantify impurities present in sapropterin-containing drugs during an accelerated stability study. The chromatographic method was applied to the orphan drug Kuvan® and to its corresponding generic sapropterin Dipharma (Diterin®), both of which are approved for the treatment of hyperphenylalaninemia-induced symptoms. The two products tested had a similar manufacture date and both had an approved stability shelf-life of three years. Samples were analyzed by HPLC at T = 0 and after six months of storage at 40 °C and 75% relative humidity. Identification of the impurities was supported by a detailed mass spectrometry and MS/MS profile. The analysis demonstrated an overall higher stability for the Diterin® formulation, which was related to a lower increase of some impurities compared to Kuvan®.

scholarly journals Stability test for mastitis reagent ad us. vet.

2013 ◽  
Vol 29 (2) ◽  
pp. 399-404
Author(s):  
V. Vukovic ◽  
M. Vicentijevic ◽  
N. Plavsa
Keyword(s):  
Relative Humidity ◽  
Shelf Life ◽  
Ph Value ◽  
Storage Conditions ◽  
Stability Test ◽  
Initial State ◽  
The Stability

In the stability test of the mastitis reagent ad us.vet., as the finished product, three production series were tested in quantities of 500 ml of the sample, under appropriate storage conditions. For the testing, the appropriate uniformity of temperature and relative humidity was provided. Also, the procedure of the stability test was determined, which included the initial state, then every three months until the end of the first trial and a final testing at the end of shelf life (0, 3, 6, 9, 12 and 18 months). Of the tested parameters the following were included: appearance, pH value of the solution, dry residue (in %) and microbiological purity.

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