Stability studies of Hollow Microspheres at Refrigerated, Normal and Accelerated Conditions

2021 ◽  
pp. 5351-5354
Author(s):  
Surbhi Rohilla ◽  
Dinesh Chandra Bhatt
Keyword(s):  
Drug Release ◽  
Chemical Structure ◽  
Room Temperature ◽  
Hollow Microsphere ◽  
Hollow Microspheres ◽  
Ftir Analysis ◽  
Stability Studies ◽  
Drug Content ◽  
Pharmaceutical Properties ◽  
The Stability

In the present investigation an attempt was made to focus on the stability aspects of itraconazole hollow microsphere at refrigerated condition, room temperature and at accelerated condition. In stability studies, more emphasis given on the effect of different temperature conditions on appearance, % drug content, % buoyancy and % drug release of formulation over a period of 6 months. Apart from above studies, SEM and FTIR analysis was done to determine any change in morphology or chemical structure. The results showed non-significant changes in pharmaceutical properties. From result findings, it can be concluded that the itraconazole hollow microspheres are stable formulation to sustain the drug in upper GIT for prolonged period of time.

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 Design and evaluation of Pulsatile drug delivery of Losartan Potassium

2014 ◽  
Vol 12 (2) ◽  
pp. 119-123
Author(s):  
MS Ashwini ◽  
Mohammed Gulzar Ahmed
Keyword(s):  
In Vitro Release ◽  
Losartan Potassium ◽  
Stability Studies ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Weight Variation ◽  
Release Studies ◽  
The Stability ◽  
Vitro Release

The study was designed for the investigation of pulsatile device to achieve time or site specific release of Losartan potassium based on chronopharmaceutical considerations. The basic design involves the preparation of cross linked hard gelatin capsules by using formaldehyde, then the drug diluent mixture were prepared and loaded in, which was separated by using hydrogel plugs of different polymers of different viscosities. Prepared formulations were subjected to evaluation of various parameters like weight variation, percentage drug content, in vitro drug release and stability studies. Weight variation and percentage drug content results showed that they were within the limits of official standards. The in-vitro release studies revealed that the capsules plugged with polymer HPMC showed better pulsatile or sustained release property as compared to the other formulations. The stability studies were carried out for all the formulations and formulations F1 & F2 were found to be stable. Dhaka Univ. J. Pharm. Sci. 12(2): 119-123, 2013 (December) DOI: http://dx.doi.org/10.3329/dujps.v12i2.17610

scholarly journals Stability Studies of Twenty-Four Analytes in Human Plasma and Serum

2002 ◽  
Vol 48 (12) ◽  
pp. 2242-2247 ◽  
Author(s):  
Bobby L Boyanton ◽  
Kenneth E Blick
Keyword(s):  
Blood Cells ◽  
Repeated Measures ◽  
Room Temperature ◽  
Stability Studies ◽  
Pump Failure ◽  
Glucose Depletion ◽  
Prolonged Contact ◽  
Biochemical Mechanisms ◽  
Clinically Significant ◽  
The Stability

Abstract Background: The stability and stoichiometric changes of analytes in plasma and serum after prolonged contact with blood cells in uncentrifuged Vacutainer® tubes were studied. Methods: We simultaneously investigated the stability of 24 analytes (a) after prolonged contact of plasma and serum with blood cells and (b) after immediate separation of plasma and serum (centrifuged twice at 2000g for 5 min). We verified biochemical mechanisms of observed analyte change by concomitant measurement of pH, Pco2, and Po2. Hemolysis was qualitatively and semiquantitatively assessed. All specimens were maintained at room temperature (25 °C) and analyzed in duplicate 0.5, 4, 8, 16, 24, 32, 40, 48, and 56 h after collection. Statistically significant changes from the 0.5 h mean were determined using repeated-measures ANOVA. The significant change limit was applied to determine clinically significant changes in measured analytes. Results: Fifteen of 24 analytes in plasma and serum maintained in contact with cells showed clinically relevant changes, with the degree of change more pronounced in most plasma specimens. All analytes in plasma and serum immediately separated from cells after collection were stable. Conclusion: Storage of uncentrifuged specimens beyond 24 h caused significant changes in most analytes investigated because of (a) glucose depletion and Na+,K+-ATPase pump failure; (b) the movement of water into cells, causing hemoconcentration; and (c) leakage of intracellular constituents and metabolites. Immediate separation of plasma or serum from cells provides optimal analyte stability at room temperature. When prolonged contact of plasma or serum with cells is unavoidable, use of serum is recommended because of the higher instability of plasma analytes.

Study on Effect of the Modified Hollow Microspheres on the Foam Ability and Stability of Fire Fighting Foam

2012 ◽  
Vol 455-456 ◽  
pp. 1612-1617 ◽  
Author(s):  
Bao Hua Tang
Keyword(s):  
Hollow Microsphere ◽  
Fire Fighting ◽  
Hollow Microspheres ◽  
Reaction Conditions ◽  
Surface Modifier ◽  
Three Phase ◽  
Optimum Reaction ◽  
The Stability

In this paper, fluoroalkylsilane (F3C-(CF2)5-(CH2)2-Si (OC2H5)3, F-8261) was successfully used as surface modifier to prepare oleophobic hollow microspheres. Three-phase foam was directly fabricated by oleophobic hollow microspheres. The result shows that outstanding improvement in the stability and anti-burning properties of three-phase foam on oil were achieved through the oleophobic modification. The optimum reaction conditions were 12% of fire fighting protein，the addition of 50% of hollow microsphere and0.5% F-8261.

Fabrication and Characterization of Ocular Phase Transition Systems for Blepharitis: A Novel Approach

2020 ◽  
Vol 10 (1) ◽  
pp. 24-37
Author(s):  
Deepali Verma ◽  
Shreya Kaul ◽  
Neha Jain ◽  
Upendra Nagaich
Keyword(s):  
Drug Release ◽  
Ex Vivo ◽  
Eye Drops ◽  
Stability Studies ◽  
In Vitro Drug Release ◽  
In Situ Gel ◽  
Drug Content ◽  
Erythromycin Estolate

Introduction: In the present research, erythromycin estolate loaded in-situ gel was formulated and evaluated for blepharitis in order to improve its therapeutic efficacy, precorneal residence time of the system and to enhance the ocular bioavailability. Material and Methods: The developed formulation was characterized by several parameters viz. FTIR, clarity, pH, gelation temperature, rheological studies, drug content, in vitro drug release studies, transcorneal permeation studies, bioadhesion studies, isotonicity and stability studies. Results: The optimized formulation exhibited non-fickian release diffusion with a sustained release of drug 82.76 ± 0.94% up to 8h and drug content 93.64%. Isotonicity revealed that the formulation was isotonic in nature and there was no shrinkage and busting of cells. Bioadhesion study was performed to check the adherence of the prepared in situ gel to the corneal surface for 4h. Ex vivo transcorneal permeation was observed to be significantly higher when compared with market eye drops. Histopathological studies were conducted to confirm the presence of normal ocular surface tissues by maintaining their morphological structures without causing damage to the tissues. The formulation was nonirritant as confirmed by the HET-CAM test. Stability studies and accelerated stability studies were conducted for 13 weeks and 26 weeks respectively and formulations were analyzed for the visual appearance, pH, viscosity, gelling capacity, drug content and in vitro drug release and results showed no change in the formulations. Conclusion: The formulation was therapeutically efficacious, sterile, stable and provided controlled release over a period of time. The developed system could be a viable alternative to conventional eye drops for treatment of various ocular diseases.

scholarly journals A NOVEL NANOGEL FORMULATION OF FINASTERIDE FOR TOPICAL TREATMENT OF ANDROGENETIC ALOPECIA: DESIGN, CHARACTERIZATION AND IN VITRO EVALUATION

2021 ◽  
pp. 228-240
Author(s):  
DIVYA SANGANABHATLA ◽  
R. SHYAM SUNDER
Keyword(s):  
Particle Size ◽  
Drug Release ◽  
Drug Loading ◽  
In Vitro Release ◽  
Entrapment Efficiency ◽  
Androgenetic Alopecia ◽  
Stability Studies ◽  
Drug Content ◽  
Release Study

Objective: The present paper describes the development and evaluation of a Novel Finasteride (FSD) nanogel topical delivery for the treatment of Androgenetic Alopecia. Nano-based topical formulation was chosen to enhance the solubility, permeability, biocompatibility of drug and to overcome the problems associated with the oral delivery of finasteride. Methods: Various trails batches were prepared by using probe sonication method. Based on stability studies and particle size, NP4 trail was optimized which exhibited a spherical shape with a mean diameter of 113.80±0.72, the polydispersity of 0.28±0.01, zeta potential of-25.2 mV, drug entrapment efficiency of 92.67±0.47 %, and drug loading of 6.15±0.02 %. Storage stability studies demonstrated that the particle size and entrapment efficiency were not changed during 3 mo both at 4 °C and room temperature. Finasteride (FSD) NLCs were characterized for particle size by scanning electron microscope (SEM), chemical state by X-Ray diffraction (XRD), physical stability by centrifugation and thermodynamic stability by Freeze-thaw method. These prepared nanoparticles were transformed into topical nanogel and further evaluated. Results: Among the different trails, C2 trail of NLC gel has shown excellent gelling capacity, clear appearance, good viscosity characteristics and was selected for further evaluation studies. Batches of topical nanogel were characterized through pH, homogeneity, spreadability, viscosity, drug content and in vitro drug release study. Based on pH (6.5-6.8), drug content (91.25±0.9%), spreadability (6.7 cm/sec), C2 batch was subjected to In vitro skin occlusivity study, in-vitro release study and In vitro heamolysis study. Conclusion: The percent cumulative drug release for Finasteride (FSD) gel was found to be 758.52±1.49 µg at 24 h which is quite higher than plain gel and Finasteride (FSD) gel showed maximum occlusiveness and excellent spreadability and found to be stable. In conclusion, prepared Finasteride (FSD) Nanogel could be used with promising potential for the treatment of Androgenetic Alopecia.

scholarly journals Development of Nicotinic Acid Controlled Release Tablets with Natural Phenolic Anti-oxidant Polymer by Encapsulation Technique

2021 ◽  
Vol 20 (4) ◽  
pp. 204
Author(s):  
Ravi Manne ◽  
Agilandeswari Devarajan
Keyword(s):  
Drug Release ◽  
Nicotinic Acid ◽  
Encapsulation Efficiency ◽  
Release Kinetics ◽  
Diffusion Mechanism ◽  
Fickian Diffusion ◽  
Wet Granulation ◽  
Stability Studies ◽  
Cholesterol Lowering ◽  
Drug Content

Nicotinic Acid (NA) is a cholesterol lowering agent used to treat dyslipidemia. Proanthocyanidins (PC) was selected as a drug and encapsulation material in which the later has a dual property of being a polymer as well as cholesterol lowering agent. The encapsulation of NA with different concentrations of (PC) was carried out by solvent evaporation technique. The encapsulated NA was converted to granules which were then compressed into tablets by wet granulation method. It was subjected to many pre-compression parameters evaluation such as flow properties, drug content and encapsulation efficiency. The tablets were evaluated for thickness, hardness, friability, <em>in vitro</em> release studies, release kinetics and stability studies. The evaluated parameters of the formulations showed compliance with pharmacopoeial standards. The encapsulation efficiency was 99.73% and 99.52% of drug content. The FT-IR spectrum did not show interaction between drug and polymer. The drug release in pH 1.2 was lesser than in pH 6.8 buffer. The encapsulated product released drug in controlled manner in alkaline medium. The drug release was 97.1% and release was extended up to 12 hrs. The optimized batch underwent stability studies as per ICH guidelines. It can be concluded that among all the formulations the F5 can be considered as optimized formulation. The optimized formulations showed non-fickian diffusion mechanism of release.

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 A laboratory Study On The Effect Of Temperature And pH On The Stability Of Tilmicosin

2007 ◽  
Vol 31 (1) ◽  
pp. 55-61
Author(s):  
Lubna Ahmed Al-Ani
Keyword(s):  
Drinking Water ◽  
Laboratory Study ◽  
Chemical Structure ◽  
Room Temperature ◽  
Summer Season ◽  
Effect Of Temperature ◽  
Assay Method ◽  
Significant Drop ◽  
Ph Values ◽  
The Stability

The effect of temperature and pH on the stability of the antibacterial“tilmicosin” was evaluated in this study. The temperature degrees studied were25 , 45 and 65 oC each for 24 hours , while the pH values studied were 6 , 7 and8 each at room temperature and for 24 hours also.A microbiological assay method was employed for analysis of the collectedsamples.The results of analysis indicate significant drop in activity of the drug as aresults of exposure to temperature or pH.The above mentioned results necessitate the maintenance of drinking water inthe storage depots of the field below 65 oC especially in summer season, so tokeep the chemical structure of the drug and to offer enough therapeuticconcentration to reach the tissue.

scholarly journals Stability Analyses of Guanitoxin Isolated from Sphaerospermopsis torques-reginae by Mass Spectrometry

2021 ◽  
Author(s):  
Kelly Fernandes ◽  
Felipe Augusto Dörr ◽  
Ernani Pinto
Keyword(s):  
Mass Spectrometry ◽  
Chemical Structure ◽  
Room Temperature ◽  
Storage Conditions ◽  
Extraction Yield ◽  
Cyanobacterial Blooms ◽  
Main Degradation Product ◽  
The Stability ◽  
Hydrolysis Of ◽  
Freshwater Monitoring

Guanitoxin (GNT) is a natural organophosphate produced by some species of freshwater cyanobacteria, which inhibits the active site of acetylcholinesterase, preventing the hydrolysis of cholinesterases and consequently causing serious disturbances in the neuromuscular system. Despite having a chemical structure like synthetic organophosphates, there is still no analytical standard available for environmental and freshwater monitoring. Therefore, this study investigated the stability of GNT under different storage conditions, pH, and temperature. The toxin is produced by the cyanobacterium Sphaerospermopsis torques-reginae and monitored by liquid chromatography coupled to mass spectrometry (LC-MS) and LC-MS/MS for the identification and verification of its stability. The main degradation product formed is the hydroxy-amino-guanidinic derivative of the toxin. The results also indicate that GNT is stable in acidic medium (pH = 3.0), but can gradually degrade at room temperature (> 23 ºC) over a period of 96 h. Lyophilized biomass of S. torques-reginae containing GNT remained stable when stored in a refrigerator below 4 ºC. In addition, the extraction yield is higher when prepared from fresh S. torques-reginae cells than from lyophilized material. Thus, the results shown here contribute with valuable information for studies that aim at the isolation, identification, and monitoring of GNT in samples of raw water and cyanobacterial blooms.

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