scholarly journals Bio-analytical Approach for Stability Studies of Bendroflumethiazide Materials

2021 ◽  
pp. 195-203
Author(s):  
B. Veeraswami ◽  
V. M. K. Naveen
Keyword(s):  
Stability Study ◽  
Stability Studies ◽  
Dry Extract ◽  
Long Term Stability ◽  
Analytical Stability ◽  
Ich Guidelines ◽  
The Stability ◽  
Efficacy Prediction

In this paper a comprehensive study of stability related, and evidence based best practices of Bio-analytical stability on Bendroflumethiazide drug samples are studied. The proposed approach is very significant and essential for the drugs development process address the specify the acceptancy, purity, efficacy, prediction of strength and quality of the drugs. The stability study constituents several methods like Bench-Top, Auto-sampler, Freeze-Thaw, Dry-extract, Wet-extract, Short-term, long-Term stability studies at relative intervals results the complete stability information about the drug under the proposed and validated method. There ported out comes of this methos shows this drug have good stability according to ICH guidelines.

scholarly journals Bio-Analytical Stability Studies of Nadolol Material

2021 ◽  
pp. 130-140
Author(s):  
B. Veeraswami ◽  
V. M. K. Naveen
Keyword(s):  
Quantitative Measure ◽  
Drug Analysis ◽  
Stability Study ◽  
Stability Studies ◽  
Experimental Conditions ◽  
Long Term Stability ◽  
Analytical Stability ◽  
Ich Guidelines

The best practices of Bio-analytical stability studies on drug samples are very crucial and essential for the drugs development process as it specify the acceptancy, purity, efficacy, prediction of strength and quality of the drugs. The main objective of this stability studies on Nadolol the proposed approach of chromatographic separation was administered in isocratic way by using asymmetric C18 column of 40:60 percent of acetonitrile and 0.1% OPA at a flow rate of 1 ml/min is a quantitative measure for drug analysis in biological matrix for more reliable, selective, reproducible and sensitive.  This stability study constituents several methods like Bench-Top, Auto-sampler, Freeze-Thaw, Dry-extract, Wet-extract, Short-term, long-Term stability studies at various intervals gave the complete stability information about these drugs. The results of these stability studies are accepted based on ICH guidelines represents this drug has a good stability under the present experimental conditions. 

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 New β-Carotene-Chitooligosaccharides Complexes for Food Fortification: Stability Study

Foods ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. 765 ◽  
Author(s):  
Alma Bockuviene ◽  
Jolanta Sereikaite
Keyword(s):  
Freeze Drying ◽  
Stability Study ◽  
Food Fortification ◽  
Kinetics Parameters ◽  
Long Term Stability ◽  
First Order Kinetics ◽  
The Stability ◽  
Β Carotene ◽  
Carotene Degradation

The application of β-carotene in food industry is limited due to its chemical instability. The drawback may be overcome by designing new delivery systems. The stability of β-carotene complexed with chitooligosaccharides by kneading, freeze-drying and sonication methods was investigated under various conditions. The first-order kinetics parameters of the reaction of β-carotene degradation were calculated. The complexation improved the stability of β-carotene at high temperatures and ensured its long-term stability in the dark at 4 °C and 24 °C, and in the light at 24 °C. In water solutions, the best characteristics were exhibited by the complexes prepared by freeze-drying and sonication methods. In the powder form, the complexes retained their colour for the period of the investigation of four months. The calculated total colour differences of the complexes were qualified as appreciable, detectable by ordinary people, but not large. Therefore, β-carotene-chitooligosaccharides complexes could be used as a new delivery system suitable for food fortification.

Quality of Reamed Surface Using Serrated Blades as Compared to a Conventional Acetabular Reamer

2013 ◽  
Author(s):  
Annie Levasseur ◽  
Jérémie Ménard ◽  
Victor Songmené ◽  
Julio Fernandes ◽  
Yvan Petit
Keyword(s):  
Experimental Testing ◽  
Three Dimensional ◽  
Laser Scanner ◽  
Numerical Control ◽  
Long Term Stability ◽  
Surface Irregularities ◽  
The Stability ◽  
Acetabular Implant

Background: Hip arthroplasty requires the preparation of the acetabular cavity to allow a proper contact between the bone and the implant. It is essential to allow osseointegration and long-term stability of the implant. The aim of this study was to conduct experimental testing to evaluate the quality of reamed surfaces using a serrated blade acetabular reamer as compared to a conventional rasp reamer. Method of Approach: Reaming tests were performed on a computerized numerical control tools machine at a rotational speed of 250 rpm and 3 different penetration speeds: 0.20 mm/s, 0.55 mm/s and 0.90 mm/s. For each reamer, a complete semi-hemispherical hole was perforated in 7 polyurethane samples. The reamed surfaces were digitized with a three-dimensional high resolution (40 μm) self-positioning laser scanner to carry out a quantitative analysis of the surface quality. Results: Results demonstrated that the cutting edge and the penetration speed influence the quality of the reamed surface. The serrated blade was found to reduce surface irregularities (ranging between 0.19 mm to 0.21 mm for the conventional rasp and between 0.07 mm and 0.12 mm for the serrated blades), and to reduce inaccuracies on the reamed cavity diameter (0.13 mm ± 0.05mm for the rasps and 0.06 mm ± 0.03mm for the serrated blade). Conclusions: The use of such tool by the surgeon may influence the stability of the acetabular implant and reduce the risks of revision surgery.

scholarly journals Evolution of the Stabilis® Database: Creation of a Level of Evidence for Stability Studies

2018 ◽  
Vol 3 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Elise D’Huart ◽  
Pauline Lider ◽  
Jean Vigneron ◽  
Béatrice Demoré
Keyword(s):  
Analytical Method ◽  
Antiviral Drugs ◽  
Stability Study ◽  
Antifungal Drugs ◽  
Quality Level ◽  
Stability Studies ◽  
Level Of Evidence ◽  
Stability Data ◽  
The Stability

AbstractBackgroundStabilis®is an international database on stability and compatibility of drugs. The stability data comes mainly from publications of pharmaceutical journals. As the quality of the published stability studies is not equivalent, the objective of this work was to propose a level of evidence for the physico-chemical stability studies selected for the database.MethodsAt first, we evaluated the main pharmacological class consulted by the users. This work was then divided into 5 steps: (1) updating of the criteria to validate a stability study, (2) creating a grid rating articles, (3) rating of the articles of stability studies for anticancer, antifungal and antiviral drugs by 2 evaluators, (4) creation of new screens in the database to enter rating, to visualize the pictograms and commentaries by the users, (5) creation of a guideline to explain the different levels of evidence.ResultsThe main pharmacological class consulted by Stabilis®users is the anticancer drugs and then antiinfectives. We have selected anticancer, antifungal and antiviral drugs for our study. Two hundred and forty publications were evaluated. The highest level attributed was A for anticancer and antifungal drugs and C for antiviral drugs. This difference can be explained by the fact that the majority of publications about antiviral drugs were older.The most frequent anomalies in the rating of articles were an incomplete or imperfect validation of the analytical method (high value of the coefficient of variation) and a defect in the evaluation of the stability indicating capacity.It must be noted that the level of evidence is not the quality level of the analytical method but the mixture of the quality of the method validation and of the results. This aspect was a choice of the Stabilis®team and seems important because the security of the patient is impacted by both aspects.ConclusionsThis new function contributes to help the Stabilis®users to evaluate the stability data published and to take a decision for their use in daily practice. This function will be progressively extended to other pharmacological classes of injectable drugs and then for non-injectable preparations.

Analysis of Corn Straw Pyrolysis Bio-Oil Composition

2015 ◽  
Vol 737 ◽  
pp. 14-19
Author(s):  
Huan Huan Wei ◽  
Yun Long Liu ◽  
Dong Yu Chen
Keyword(s):  
Fast Pyrolysis ◽  
Fluidized Bed Reactor ◽  
Stability Studies ◽  
Oil Composition ◽  
Corn Straw ◽  
Long Term Stability ◽  
Bio Oil ◽  
Oil Water

The fast pyrolysis of corn straw in the fluidized bed reactor to produce bio-oil, the preliminary qualitative research on the composition of the bio-oil was analyzed by GC-MS to provide the basis for their purification, refining and long-term stability studies. The result shows that: the bio-oil producted by corn straw pyrolysis contains 66 components, mainly containing phenol, furan, acetic acid, propanoic acid, ethanone, vanillin, aldehyde, bio-oil water content is 33% and pH is 3.1, which has a great significance to improve the quality of bio-oil.

scholarly journals Stability study of nasal powder formulation containing nanosized lamotrigine

2020 ◽  
Vol 90 (1) ◽  
pp. 27-31
Author(s):  
Péter Gieszinger ◽  
Gábor Katona ◽  
Piroska Szabó-Révész ◽  
Rita Ambrus
Keyword(s):  
Local Effect ◽  
Stability Study ◽  
System Effect ◽  
In Vitro Drug Release ◽  
Long Term Stability ◽  
The Past ◽  
The Stability ◽  
Degradation Effect

Drug administration through the nose offers great possibilities which have been discovered in the past few decades. Besides the most known local effect, systemic and central nervous system effect is also available, the administration is non-painful and the degradation effect of the gastrointestinal tract can be avoided. Amongst the nasal formulations, powders have become more popular as their stability is favorable compared to the liquid formulations and a higher dose can be administered in powder form. The quality insurance and stability of the products in the pharmaceutical field have gained considerable attention in the last decades. Due to this fact, the aim was to execute a long-term stability study of a previously developed, nanosized lamotrigine (LAM) containing nasal powder (NP) formulation. The results of the stability test showed that the NP formulation preserved its key properties (particle size, morphology, structure and in vitro drug release) after 6 months of storage.

The Stability of the WHO Reference Thromboplastin NIBS & C 67/40

1979 ◽  
Vol 42 (04) ◽  
pp. 1135-1140 ◽  
Author(s):  
G I C Ingram
Keyword(s):  
Human Brain ◽  
Collaborative Study ◽  
Calibration Constant ◽  
Long Term Stability ◽  
Freeze Dried ◽  
Show Evidence ◽  
Human Material ◽  
Reference Preparation ◽  
The Stability

SummaryThe International Reference Preparation of human brain thromboplastin coded 67/40 has been thought to show evidence of instability. The evidence is discussed and is not thought to be strong; but it is suggested that it would be wise to replace 67/40 with a new preparation of human brain, both for this reason and because 67/40 is in a form (like Thrombotest) in which few workers seem to use human brain. A �plain� preparation would be more appropriate; and a freeze-dried sample of BCT is recommended as the successor preparation. The opportunity should be taken also to replace the corresponding ox and rabbit preparations. In the collaborative study which would be required it would then be desirable to test in parallel the three old and the three new preparations. The relative sensitivities of the old preparations could be compared with those found in earlier studies to obtain further evidence on the stability of 67/40; if stability were confirmed, the new preparations should be calibrated against it, but if not, the new human material should receive a calibration constant of 1.0 and the new ox and rabbit materials calibrated against that.The types of evidence available for monitoring the long-term stability of a thromboplastin are discussed.

Preparation and Long-Term Stability Study of Steel Fiber/Graphite Conductive Concrete

2016 ◽  
Vol 680 ◽  
pp. 361-364 ◽  
Author(s):  
Jun Du ◽  
Cheng Tang ◽  
Bo Jia ◽  
De Zhang ◽  
Qiang Miao
Keyword(s):  
Corrosion Resistance ◽  
Steel Fiber ◽  
Stability Study ◽  
Soil Resistivity ◽  
Grounding Resistance ◽  
Term Stability ◽  
Long Term Stability ◽  
Conductive Fillers ◽  
The Common

The steel fiber/graphite conductive concrete is applied in power system grounding. In high soil resistivity regions, the common methods for reducing the grounding resistance are not practical. It is difficult for grounding resistance of substations to meet the requirements of working earthing and safety earthing. In order to solve this problem, a steel fiber/graphite conductive concrete is developed in this paper. Steel fiber and graphite are added as conductive fillers. The long-term stability of the steel fiber/graphite conductive concrete is studied. The experiment results show that steel fiber/graphite conductive concrete not only maintains excellent conductivity, but also has good mechanical strength and corrosion resistance in 300 days.

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