scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

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 Stability study of rock slope in fractured quartzite at right side of spillway, Middle Marsyangdi Hydroelectric Project, Nepal

2003 ◽  
Vol 28 ◽  
Author(s):  
Kaustubh Mani Nepal ◽  
Roger Olsson
Keyword(s):  
Rock Slope ◽  
Stability Study ◽  
Cut Slope ◽  
Stability Studies ◽  
Hydroelectric Project ◽  
The Stability ◽  
The Right ◽  
Cut Slopes

A 120 m long and 68 m high rock cut slope is designed at the right side of spillway of Middle Marsyangdi Hydroelectric Project. This paper describes the stability studies performed for the rock cut slopes in jointed quartzite for foundation of spillway.

scholarly journals FORMULATION, CHARACTERIZATION, AND DETERMINATION OF THE DIFFUSION RATE STUDY OF ANTIOXIDANT SERUM CONTAINING ASTAXANTHIN NANOEMULSION

2021 ◽  
pp. 200-204
Author(s):  
LUSI NURDIANTI ◽  
RISNA CLARA ◽  
HENDY SUHENDY ◽  
FAJAR SETIAWAN ◽  
KENI IDACAHYATI
Keyword(s):  
Diffusion Rate ◽  
Topical Administration ◽  
Storage Conditions ◽  
Stability Study ◽  
Gelling Agent ◽  
Rate Study ◽  
Antioxidant Characteristics ◽  
The Stability ◽  
Physical And Chemical ◽  
And Diffusion

Objective: Astaxanthin is one of the natural carotenoids with strong antioxidant characteristics which is widely used in skin care. The aim of this study was developed to formulate and characterize the antioxidant serum containing astaxanthin nanoemulsion and the diffusion rate studies using diffusion Franz method. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using the self-nanoemulsifying method, followed by incorporation into serum preparation with the using carbomer as a gelling agent. Evaluation of serum As-NE was performed by physical, chemical characterizations and diffusion assay. Stability study was carried out in both accelerated (temperature of 40±2 °C/75±5%RH) and non-accelerated (at ambient temperature) conditions. Results: These results suggest that antioxidant serum As-NE had good physical and chemical characteristics that are suitable for topical administration. Conclusion: For the study of diffusion and stability under different storage conditions, it was proven that antioxidant serum As-NE form was packed in a carbomer as a gelling agent that could enhance the stability and diffusion rate of the astaxanthin.

scholarly journals New liquid oral formulations of hydroxychloroquine: a physicochemical stability study

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Vincent Lebreton ◽  
Blandine Bourcier ◽  
Karine Cosson ◽  
Frédéric Lagarce ◽  
Laurence Spiesser-Robelet ◽  
...  
Keyword(s):  
Degradation Products ◽  
Storage Conditions ◽  
Stability Study ◽  
Physical Parameters ◽  
Suspension Stability ◽  
Liquid Form ◽  
Vehicle Suspensions ◽  
Stability Indicating Method ◽  
Oral Liquid ◽  
The Stability

Abstract Objectives Hydroxychloroquine (HCQ) presents many drug properties that increase its therapeutic use. There are, indeed, different research pathways in numerous autoimmune, inflammatory, and infectious diseases, as well as in cancerology. HCQ is only marketed as HCQ sulfate in film-coated or coated tablets for oral use. No pediatric liquid form is currently available on the market. The purpose of the present study is to develop oral liquid formulations for HCQ at 50 mg/mL with two different oral vehicle suspensions, namely ORA-Plus®/ORA-Sweet® (ORA) and Syrspend® SF PH 4 (SYR). Methods The suspension stability was assessed in different storage conditions (4 and 25 °C). A high-pressure liquid chromatography (HPLC) stability-indicating method with UV detection was developed to determine HCQ concentrations in the different formulations, and detect potential degradation products. Physical parameters, e.g. pH and osmolality were also monitored during the period of the stability study. Results HCQ concentration, osmolality, and pH remained stable for 90 days at 4 and 30 °C for HCQ in 50% ORA-Plus®/50% ORA-Sweet®. For HCQ suspension in SYR, the suspension remained stable 90 days at 4 °C and 60 days at 30 °C. Conclusions For all preparations, no significant physical or chemical modification was noticed during the period of the study.

scholarly journals Stability of Cefuroxime Axetil Oral Suspension at Different Temperature Storage Conditions

2008 ◽  
Vol 8 (1) ◽  
pp. 93-96 ◽  
Author(s):  
Alija Uzunović ◽  
Edina Vranić
Keyword(s):  
Drug Release ◽  
Storage Conditions ◽  
Cefuroxime Axetil ◽  
Oral Suspension ◽  
Stability Testing ◽  
Stability Studies ◽  
Concentration Changes ◽  
The Stability ◽  
Temperature Storage

Stability testing of an active substance or finished product provides information of the variation of drug substance or final product with time influenced by a variety of environmental factors such as temperature, humidity and light. Knowledge gained from stability studies enables understanding of the effects of the environment on the drugs.The aim of our study was to determine the stability of cefuroxime axetil oral suspension at different temperature storage conditions (stored at room /20°C/ and refrigerated /5°C/ conditions). Determination of cefuroxime (as cefuroxime axetil) was performed by dissolution testing.Fractions of the released cefuroxime axetil were compared usingJ2 value. After interpolating data for dissolution profiles at room and refrigerated conditions the following f2values were obtained: 62,56; 56,32 and 36,18 on 3rd, 6th and 10th day, respectively. These values indicate similarities in drug release from analyzed cefuroxime axetil oral suspension on 3rd, 6th day, and differences on 10th day.Based on our results, we may assume that cefuroxime axetil oral suspension preserves its stability for 10 days after reconstitution under room and refrigerated conditions. It is obvious, according to the f2 value obtained on the 10th day, that there is a difference between the released ceforoxime axetil from oral suspension at room (87,68%) and refrigerated (92,35%) conditions. Concentration changes can be caused by the mechanisms associated with drug release and hydrolytical decomposition of the sample and higher temperatures during longer period of storage.

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.

Stability Study of Epirubicin in Nacl 0.9% Injection

1997 ◽  
Vol 31 (9) ◽  
pp. 992-995 ◽  
Author(s):  
Montserrat Pujol ◽  
Montserrat Muñoz ◽  
Josefina Prat ◽  
Victoria Girona ◽  
Jordi De Bolós
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Degradation Kinetics ◽  
Storage Conditions ◽  
Hplc Method ◽  
Stability Study ◽  
Chemistry Laboratory ◽  
Maximum Decrease ◽  
Different Temperatures ◽  
The Stability

Objective To determine the stability of epirubicin in NaCl 0.9% injection under hospital storage conditions. Methods NaCl 0.9% solution was added to epirubicin iyophilized powder to make a final concentration of 1 mg/mL to study the degradation kinetics and 2 mg/mL to study the stability in polypropylene syringes under hospital conditions. Setting Physical chemistry laboratory, Unitat de Fisicoquímica, Universitat de Barcelona. Main outcome Measures Solutions of epirubicin at 2 mg/mL in NaCl 0.9% solutions stored in plastic syringes were studied under hospital conditions at room temperature (25 ± 1 °C) and under refrigeration (4 ± 1 °C) both protected from light and exposed to room light (~50 lumens/m2). All samples were studied in triplicate and epirubicin concentrations were obtained periodically throughout each storage/time condition via a specific stability-indicating HPLC method. To determine the degradation kinetics, solutions of epirubicin in NaCl 0.9% at 1 mg/mL were stored at different temperatures (40, 50, and 60 °C) to obtain the rate degradation constant and the shelf life at room temperature and under refrigeration. Results The degradation of epirubicin in NaCl 0.9% solutions follows first-order kinetics. The shelf life was defined as the time by which the epirubicin concentration had decreased by 10% from the initial concentration. In this study, epirubicin was stable in NaCl 0.9% injection stored in polypropylene containers for all time periods and all conditions. That results in a shelf life of at least 14 and 180 days at 25 and 4 °C, respectively. The maximum decrease in epirubicin concentration observed at 25 °C and 14 days was 4%, and at 4 °C and 180 days was 8%. The predicted shelf life obtained from the Arrhenius equation was 72.9 ± 0.2 and 3070 ± 15 days at 25 and 4 °C, respectively, in both dark and illuminated conditions. Conclusions Solutions of epirubicin in NaCl 0.9% at 2 mg/mL are chemically stable when they are stored in polypropylene syringes under hospital storage conditions. No special precaution is neccessary to protect epirubicin solutions (2 mg/mL) from light.

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.

Estimation of the Stability of the Assembly of the Dump of Technological Soil, Obtained from Open Works for the Recultivation of the Career Extract

2020 ◽  
Vol 24 (3) ◽  
pp. 51-53
Author(s):  
N.V. Kruk ◽  
D.A. Ozerskii
Keyword(s):  
Visual Inspection ◽  
Mechanical Characteristics ◽  
Field Tests ◽  
Laboratory Studies ◽  
Snow Melting ◽  
Safety Factors ◽  
Observation Well ◽  
Regulatory Requirements ◽  
The Stability ◽  
Physical And Mechanical Characteristics

To determine the stability of the ledge of dumps formed on the site being rehabilitated, using the technological soil obtained from the overburden works, the results of field tests and laboratory studies of the physical and mechanical characteristics of the technological soil are used. Numerical simulation of the calculation of stability is performed in a flat-vertical formulation, it is determined that the safety factors of the stability of the overburden slope meet the regulatory requirements. As recommendations, it was proposed to once a month to monitor the water level in the observation well, and especially closely during periods of snow melting (spring) and rains (autumn) and to conduct a visual inspection in the zone of obtaining the minimum curve for the occurrence of cracks and floods of the soil massif, in case of their occurrence, develop reinforcing measures.

Research on Support Technology in Deep Roadway of Huafeng Mine

2013 ◽  
Vol 753-755 ◽  
pp. 831-834
Author(s):  
Jie Kong ◽  
Peng Chen ◽  
Jun Chen ◽  
Qing Shu Liu ◽  
Zhen Ma
Keyword(s):  
Service Life ◽  
Mechanical Characteristics ◽  
Soft Rock ◽  
Surrounding Rock ◽  
Strata Control ◽  
Reference Function ◽  
The Stability ◽  
Inclined Angle ◽  
Roadway Deformation ◽  
Physical And Mechanical Characteristics

Huafeng mine 1141 roadway (the 5th) that the buried depth is nearly 1000m, the angel of roadway is larger, the physical and mechanical characteristics of surrounding rock are poor, belongs to typical large inclined angle soft rock deep roadway. Using the reasonable supporting way is very important to control the deformation of the surrounding rock in roadways. The strata control observation shows that the roadway deformation is in a predictable range, could effectively ensure the stability and service life of 1141 roadway (the 5th) by using combined support of anchor, bolting with band and net, composite U shape shed. It can provide reference function to the supporting way of similar deep roadway.

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