scholarly journals Carbidopa Capsules for Insulinoma Diagnostic: Compounding and Stability Study

2020 ◽  
Vol 4 (3-4) ◽  
pp. 99-104
Author(s):  
Christophe Curti ◽  
Fanny Mathias ◽  
Morane Savelli ◽  
Philippe Garrigue ◽  
Edouard Lamy ◽  
...  
Keyword(s):  
Single Dose ◽  
Hospital Pharmacy ◽  
Room Temperature ◽  
Active Pharmaceutical Ingredient ◽  
Oral Formulation ◽  
Stability Study ◽  
Dose Administration ◽  
Disease Associations ◽  
One Year ◽  
The Stability

AbstractBackgroundCarbidopa is a drug mainly used to treat Parkinson’s disease. Associations with levodopa or with levodopa/entacapone are commercialized, but there is no oral formulation of carbidopa alone available in Europe. As carbidopa can also be used as premedication of adult patients for insulinoma diagnosis, it must be compounded as single dose mg capsules. The single dose administration of a magistral preparation implies the compounding of only one capsule, or the loss of consequent quantities of active pharmaceutical ingredient. As an alternative solution, carbidopa capsules could be compounded as batches of hospital preparation.MethodWith this objective, a stability-indicating dosing method for 200 mg carbidopa capsules was developed. Then, the compounding process was assessed according to the European Pharmacopeia requirements. Finally, the stability of carbidopa capsules stored protected from light at room temperature was studied for one year.Results200 mg carbidopa capsules compounding process was validated on three independent batches. The beyond use date was fixed at one year.ConclusionOur work confirms that carbidopa 200 mg capsules can be realized in hospital pharmacy and its stability allows the compounding of large batches.

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 Co-Amorphous Simvastatin-Nifedipine with Enhanced Solubility for Possible Use in Combination Therapy of Hypertension and Hypercholesterolemia

Molecules ◽  
2018 ◽  
Vol 23 (9) ◽  
pp. 2161 ◽  
Author(s):  
Cecilia Martínez-Jiménez ◽  
Jorge Cruz-Angeles ◽  
Marcelo Videa ◽  
Luz Martínez
Keyword(s):  
Combination Therapy ◽  
Amorphous State ◽  
Active Pharmaceutical Ingredient ◽  
Molar Ratio ◽  
Amorphous System ◽  
Enhanced Solubility ◽  
Significant Area ◽  
One Year ◽  
The Stability ◽  
Therapy Of Hypertension

The high index of simultaneous incidence of hypertension and hypercholesterolemia in the population of many countries demands the preparation of more efficient drugs. Therefore, there is a significant area of opportunity to provide as many alternatives as possible to treat these illnesses. Taking advantage of the solubility enhancement that can be achieved when an active pharmaceutical ingredient (API) is obtained and stabilized in its amorphous state, in the present work, new drug-drug co-amorphous formulations (Simvastatin SIM- Nifedipine NIF) with enhanced solubility and stability were prepared and characterized. Results show that the co-amorphous system (molar ratio 1:1) is more soluble than the pure commercial APIs studied separately. Aqueous dissolution profiles showed increments of solubility of 3.7 and 1.7 times for SIM and NIF, correspondingly, in the co-amorphous system. The new co-amorphous formulations, monitored in time, (molar fractions 0.3, 0.5 and 0.7 of SIM) remained stable in the amorphous state for more than one year when stored at room temperature and did not show any signs of crystallization when re-heating. Inspection on the remainder of a sample after six hours of dissolution showed no recrystallization, confirming the stability of co-amorphous system. The enhanced solubility of the co-amorphous formulations makes them promising for simultaneously targeting of hypertension and hypercholesterolemia through combination therapy.

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).

One-Year Stability of the Devereux Early Childhood Assessment for Preschoolers, Second Edition

2017 ◽  
Vol 36 (8) ◽  
pp. 829-834
Author(s):  
John S. Carlson ◽  
Dylan S. T. Voris
Keyword(s):  
Early Childhood ◽  
Rating Scales ◽  
Progress Monitoring ◽  
Stability Study ◽  
Early Childhood Assessment ◽  
Parent Rating ◽  
Devereux Early Childhood Assessment ◽  
One Year ◽  
The Stability

The Devereux Early Childhood Assessment (DECA) and recently updated Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2) are strength-based measures that can inform early intervention. Whereas the short-term psychometric properties of these parent rating scales are strong, little is known about their long-term stability. Study findings from a diverse Head Start sample ( N = 282, DECA; N = 346, DECA-P2) revealed 12-month, test–retest reliability of protective factors ( r = .65) to be equivalent on the DECA-P2 and the DECA. The stability of parent ratings of behavior concerns appears improved in the newer edition ( r = .53 vs. r = .46). Additional consideration should be given to the stability of the DECA-P2 and its use as short- and long-term social, emotional, and behavioral intervention progress monitoring tool.

A Dose-Ranging Study of Azathioprine Pharmacokinetics After Single-Dose Administration of a Delayed-Release Oral Formulation

1997 ◽  
Vol 37 (1) ◽  
pp. 38-46 ◽  
Author(s):  
Bradley J. Zins ◽  
William J. Sandborn ◽  
Jeffrey A. McKinney ◽  
Dennis C. Mays ◽  
Erik C. VAN Os ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Formulation ◽  
Dose Administration ◽  
Single Dose Administration ◽  
Delayed Release ◽  
Dose Ranging

scholarly journals STABILITY STUDY OF MODIFIED MUSTA-TRIPHALADIAVALEHA WITH RESPECT TO BASELINE MICROBIAL PROFILE USED IN THALASSEMIA MAJOR

2020 ◽  
Vol 8 (10) ◽  
pp. 4578-4586
Author(s):  
Bhumi Mori ◽  
Cholera Mira ◽  
Patel K. S. ◽  
Kori V. K.
Keyword(s):  
Classical Method ◽  
Herbal Product ◽  
Thalassemia Major ◽  
Stability Study ◽  
Microbial Profile ◽  
Humid Condition ◽  
One Year ◽  
The Stability ◽  
Plastic Containers ◽  
Made In

Introduction: stability study of Modified Musta- Triphaladi Avaleha was done for 12 months (1 year) to know the stability of formulation in reference of its phyto-constituents and microbial growth therein. Modi-fied Musta-Triphaladi Avaleha have been used in Thalassemia children as an adjuvant therapy prepared with various herbal product. Methods: Modified Musta-Triphaladi Avaleha was made in Pharmacy with standard classical method (Avaleha Kalpana) as per AFI part-1 (The Ayurvedic formulary of India, part-1 part- A) In present study, stability with respect to its Microbial profile of Modified Musta-Triphaladi Ava-leha carried out. Avaleha was stored in 2 plastic containers during different climatic condition. Avaleha were studied at regular intervals for a period of 1 month to analysis Mycological findings and presence of Microorganisms by wet mount preparation and Gram stain test respectively. Results: At the end of study both Avaleha container has not present of microbes after 1 year of preparation, even in different climate and temperature. Conclusion: Since it is traditional Avaleha kalpana, the shelf life period was about one year (Sharangdhar Samhita) The presented study reflects that Microbiological findings of Modified Musta-Triphaladi Avaleha was negative at room temperature, warm and cold, dry and humid condition.

scholarly journals Evaluation of an ELISA for metanephrines in feline urine

2018 ◽  
Vol 30 (6) ◽  
pp. 887-893
Author(s):  
Thanikul Srithunyarat ◽  
Anna Svensson ◽  
Sofia Hanås ◽  
Odd V. Höglund ◽  
Ragnvi Hagman ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Home Environment ◽  
Human Urine ◽  
Room Temperature ◽  
Storage Time ◽  
Stability Study ◽  
Urine Samples ◽  
Urine Sampling ◽  
The Stability ◽  
And Storage

Catecholamines can be used to evaluate neuroendocrine tumors, stress, and potentially pain, but catecholamines degrade rapidly. Their metabolites normetanephrine (NME) and metanephrine (ME) have better stability in urine. In cats, urine sampling in a home environment would be beneficial to reduce effects of clinical stress and simplify sampling. We evaluated a human urine ELISA for analysis of NME and ME in feline urine, and investigated the effects of acidification, cat tray pellets, and storage time at room temperature up to 8.5 h. In 26 feline urine samples, mean NME concentration was 192 ± 80 ng/mL, mean intra- and inter-assay CV was 6.5% and 4.2%, respectively, and spike recovery was 98–101%, but dilutional recovery was unsatisfactory. For ME, mean intra- and inter-assay CV was 10.2% and 4.1%, respectively. Mean urine ME concentration was 32.1 ± 18.3 ng/mL, close to the kit’s lowest standard, and spike recovery was 65–90%; the ELISA could not be validated for ME. The stability study, performed for NME on 12 urine samples, did not identify differences between acidified and non-acidified samples, cat tray pellets, or storage time, and no interaction effects. The ME ELISA was not suitable for feline urine; performance of the NME ELISA was acceptable, except for dilution recovery. For analysis of NME, feline urine can be sampled at home using cat tray pellets and stored at room temperature up to 8.5 h without acidification.

scholarly journals STABILITY STUDY OF ETHYLCELLULOSE COATED-TOCOTRIENOL MICROCAPSULES PREPARED BY SOLVENT EVAPORATION AND SPRAY DRYING TECHNIQUES

2020 ◽  
pp. 197-201
Author(s):  
SILVIA SURINI ◽  
NADIA HUSNUL KHOTIMA
Keyword(s):  
Spray Drying ◽  
Room Temperature ◽  
Elevated Temperatures ◽  
Entrapment Efficiency ◽  
Stability Study ◽  
Solvent Evaporation ◽  
Natural Form ◽  
Drying Techniques ◽  
Percentage Yield ◽  
The Stability

Objective: Tocotrienol is a natural Vitamin E compound with greater antioxidant activity than tocopherol. However, tocotrienol is considered unstable,which limits its handling and use in various product formulations. In this study, to enhance the stability of tocotrienol, tocotrienol oil was convertedinto a powder through a microencapsulation method using ethylcellulose (EC) as the coating material.Methods: Tocotrienol microcapsules were formulated with EC in ratios of 1:2 and 1:3 by solvent evaporation (SE) and spray drying techniques.The obtained microcapsules were then characterized in terms of shape and morphology, particle size, entrapment efficiency, percentage yield,flow properties, water content, swelling, and drug release. In addition, stability studies at both room temperature and elevated temperatures wereperformed.Results: Our results demonstrated that the tocotrienol microcapsules were of a white-yellowish powder of irregular shape, with particle sizes between1 μm and 60 μm and entrapment efficiency of 21.60% and 99.75%. After 12 weeks of storage at room temperature, the remaining level of tocotrienolin the microcapsules was 96.46–97.74%. In the accelerated stability study at elevated temperatures, the resulting k25 values ranged from 1.02×10-5 to1.32×10-5/h. Thus, the predicted shelf-life (t90) of the microencapsulated tocotrienol was determined to be between 11.01 and 14.27 months.Conclusion: The microencapsulation of tocotrienol with EC using SE and spray drying techniques produced a solid form of tocotrienol that wasconsiderably more stable than the natural form of tocotrienol.

Stability of phencyclidine and Amphetamines in Urine Specimens

1991 ◽  
Vol 37 (12) ◽  
pp. 2141-2142 ◽  
Author(s):  
R Hughes ◽  
A Hughes ◽  
B Levine ◽  
M L Smith
Keyword(s):  
Room Temperature ◽  
Drugs Of Abuse ◽  
Stability Study ◽  
The Other ◽  
Gas Chromatography Mass Spectrometry ◽  
Stability Data ◽  
The Stability ◽  
Proper Interpretation ◽  
Drug Free ◽  
Urine Specimens

Abstract Knowledge about the stability of drugs in biological specimens can be critical to the proper interpretation of results. Stability of drugs of abuse in biological specimens has been recently reviewed (1). Two drugs for which limited stability data have been published are phencyclidine (PCP) and amphetamine (AMP)/methamphetamine (MA). Therefore, we undertook a stability study of these drugs in urine specimens. Urine samples from five drug-free individuals were fortified with PCP, AMP, and MA at three concentrations. These specimens were divided into aliquots; one was stored at room temperature (25 °C), the other in the refrigerator (4 °C). Over a six-month period, aliquots of each specimen were quantified by gas chromatography-mass spectrometry (2). A known control was analyzed with each batch; results were within 10% of the expected value.

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