scholarly journals EFFECT OF STERILIZATION BY HEATING IN THE PRESENCE OF BACTERICIDE AND BACTERIAL FILTERED MEMBRANE ON THE STABILITY OF EYE DROPS CONTAINING 0.5% CHLORAMPHENICOL AT VARIOUS pH

Author(s):  
SRI AGUNG FITRI KUSUMA ◽  
MARLINE ABDASSAH

Objective: The purpose of this study was to determine a sterile 0.5% chloramphenicol eye drop formula with the best potency of antibacterial by determining the appropriate sterilization method and the supporting pH. Methods: 0.5% chloramphenicol was formulated with 0.01% thimerosal, which act as a bactericide and combines with borate buffer to produce eye drop formulas with variations in pH (6.8, 7.0 and 7.4). All formulas were stored at room temperature for 28 d and were evaluated, including: organoleptic of the preparations, sterility, pH stability, and the antibacterial potency of chloramphenicol in eye drops. Results: All dosage formulas did not undergo photodegradation reactions which were marked by no change in color until the end of the storage period. However, the formula with pH 6.8 which was sterilized by heating in a presence of bactericide, showed the presence of more particulate precipitates than in the pH 6.8 formula which was sterilized using membrane filter bacteria. However, both methods of sterilization produced sterile chloramphenicol eye drops. The preparation using a method of heat sterilization with bactericide decreased the pH greater than the preparation using a sterile bacterial filter sterilization method. C2 preparations at pH 7.0 and sterilized using the bacterial filter membrane sterilization method were more stable because they had the smallest pH change of 0.05 and the percentage reduction in antibacterial potential was smaller at 1.15%. Conclusion: The best treatment for the chloramphenicol eye drop was kept the pH formula at pH 7 and sterilized using bacterial filter membrane sterilization method.

Biomedicines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 210
Author(s):  
Arleta Waszczykowska ◽  
Dominik Żyro ◽  
Justyn Ochocki ◽  
Piotr Jurowski

The use of silver preparations in medicine is becoming increasingly popular. The basic aim of this evaluation was to review the literature on the clinical (in vivo) and antibacterial potential of silver preparations in ophthalmic diseases. The second goal was to summarize the results of experimental research on the use of silver preparations in ophthalmology. The third objective was to present a method for stabilizing eye drops containing silver (I) complex. Analysis of the pH stability of the silver (I) complex with metronidazole in the prepared dosage form (eye drops) was carried out. Most silver preparations are clinically used for topical application. Few experimental results indicate the usefulness of intraocular or systemic administration of silver (I) preparations as an alternative or additional therapy in infectious and angiogenic eye diseases. The development of a new formulation increases the stability of the dosage form. New forms of silver (I) products will certainly find application in the treatment of many ophthalmic diseases. One of the most important features of the silver (I) complex is its capacity to break down bacterial resistance. The new eye drops formula can significantly improve comfort of use. Due to their chemical nature, silver (I) compounds are difficult to stabilize, especially in the finished dosage form.


Author(s):  
SRI AGUNG FITRI KUSUMA ◽  
MARLINE ABDASSAH ◽  
FITASARY MARYATI

Objective: The aim of this study was to compare the preservative efficacy of benzalkonium chloride, thimerosal and benzyl alcohol in eye drops formulation containing chloramphenicol as the active agents for producing the sterile and effective eye drops.Methods: The efficacy of preservatives was assayed by evaluating the physical appearance, pH stability, sterility and the antibacterial effectivity of the formulated eye drops. Each of 0.5% chloramphenicol was formulated with different preservatives of benzalkonium chloride, thimerosal and benzyl alcohol at its recommended concentration, 0.01%; 0.01% and 1%, respectively. The in vitro stability was examined periodically for the eye drops formulation stored at room temperature during the 28-day period. The effectiveness of the antibacterial effect of chloramphenicol in eye drops was assayed by using the agar diffusion method against Escherichia coli and evaluated for the diameter of inhibition zones. Result: The clarity of the eye drops formula produced clear solutions. The eye drops formula exhibited relatively stabile on pH. All the formulated eye drops were sterile during the storage time. The appropriate of the sterilization method was thought to contribute to the sterility of eye drops which did not contain preservatives. In addition, it was assumed that the pre-reaction of chloramphenicol in inhibiting the contaminants in the eye drop may occur during the storage time. This hypothesis was confirmed by the inhibitory diameter stability produced by the eye drop formulas containing preservatives compared to that of not. The decrease in inhibition diameter occurred during the storage period (28 d) of each formula was as follows: F0 (51.58%), F1 (35.76%), F2 (31.86%), and F3 (35.35%). The best stability based on the antibacterial activity of the chloramphenicol eye drops was produced by F2 which used 0.01% thimerosal as its preservative. The differences in inhibition diameter were significantly influenced by the presence and the type of preservatives. Conclusion: 0.01% thimerosal indicated the best improvement on the efficacy of 0.5% chloramphenicol eye drop.


2006 ◽  
Vol 19 (5) ◽  
pp. 282-285 ◽  
Author(s):  
Weeranuj Yamreudeewong ◽  
Eric Kurt Dolence ◽  
Deborah Pahl

The stability of donepezil in an extemporaneously prepared oral liquid was studied. An aqueous liquid formulation of donepezil was prepared by reconstituting the powder from triturated 5-mg tablets with equal amounts of deionized water and 70% sorbitol solution with an expected donepezil concentration of 1 mg/mL. Polyethylene terephthalate plastic bottles containing donepezil liquid preparation were stored at ambient room temperature (22° C-26° C) and in the refrigerator (4° C-8° C). After a storage time of 1, 2, 3, and 4 weeks, donepezil liquid samples were analyzed in triplicate for donepezil concentrations by high-performance liquid chromatography. The concentrations of donepezil were found to be within the acceptable limit (± 10% of the initial concentration) in all test samples, which indicated that donepezil liquid preparation was stable at room temperature and in the refrigerator for up to 4 weeks. In addition, our study findings indicated that there was no microbial growth in the extemporaneously prepared donepezil liquid preparation after a storage period of 4 weeks in the refrigerator. In summary, the results of our study revealed that donepezil is stable (no significant loss of donepezil concentration and no microbial growth) in an extemporaneously prepared oral liquid when stored in the refrigerator for up to 4 weeks.


2020 ◽  
Vol 30 (2) ◽  
pp. 234-241
Author(s):  
Lara Milevoj Kopcinovic ◽  
Marija Brcic ◽  
Jelena Culej ◽  
Marijana Miler ◽  
Nora Nikolac Gabaj ◽  
...  

Introduction: Our aim was to investigate the stability of clinically relevant analytes in pleural and peritoneal fluids stored in variable time periods and variable storage temperatures prior to analysis. Materials and methods: Baseline total proteins (TP), albumin (ALB), lactate dehydrogenase (LD), cholesterol (CHOL), triglycerides (TRIG), creatinine (CREA), urea, glucose and amylase (AMY) were measured using standard methods in residual samples from 29 pleural and 12 peritoneal fluids referred to our laboratory. Aliquots were stored for 6 hours at room temperature (RT); 3, 7, 14 and 30 days at - 20°C. At the end of each storage period, all analytes were re-measured. Deviations were calculated and compared to stability limits (SL). Results: Pleural fluid TP and CHOL did not differ in the observed storage periods (P = 0.265 and P = 0.170, respectively). Statistically significant differences were found for ALB, LD, TRIG, CREA, urea, glucose and AMY. Peritoneal fluid TP, ALB, TRIG, urea and AMY were not statistically different after storage, contrary to LD, CHOL, CREA and glucose. Deviations for TP, ALB, CHOL, TRIG, CREA, urea and AMY in all storage periods tested for both serous fluids were within the SL. Deviations exceeding SL were observed for LD and glucose when stored for 3 and 7 days at - 20°C, respectively. Conclusions: TP, ALB, CHOL, TRIG, CREA, urea and AMY are stable in serous samples stored up to 6 hours at RT and/or 30 days at - 20°C. Glucose is stable up to 6 hours at RT and 3 days at - 20°C. The stability of LD in is limited to 6 hours at RT.


2019 ◽  
Vol 55 (3) ◽  
pp. 188-192
Author(s):  
M. L. Colsoul ◽  
A. Breuer ◽  
N. Goderniaux ◽  
J. D. Hecq ◽  
L. Soumoy ◽  
...  

Background and Objective: Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Method: Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Results: Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Conclusion: Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.


2021 ◽  
Vol 48 (5) ◽  
pp. 143-151
Author(s):  
E. E. Adomeh

Meat is very nutritious and as such can easily be contaminated with microorganisms especially when stored under conditions where temperature cannot be controlled. This study was conducted to assess the storage stability of the processed meat type chicken. Differently processed chicken samples were carefully packaged in sterile high density polythene bags. The samples were stored at room temperature (25± 2 C), fridge temperature (4 C), and freezer temperature (-18 C) for 28 days. In each case, a detailed microbial analysis was carried out on the samples. The three treatment samples and the control were packaged separately according to the number of period they would be analyzed. Each of the treatment samples were withdrawn and analyzed for microbiological quality. Samples were taken at 7 days interval, namely, day 1, day 7, day 14, day 21, and day 28. The effect of storage period on microbiological status was also determined. The microbial isolates of meat stored under room temperature increased with increased storage period from day 14 through day 21 to day 28 (Day 14 = 71, Day 21 =81 and Day 28 =86 for smoked chicken; Day 14 = 72, Day 21 =81 and Day 28 =89 for oven dried chicken; Day 14 = 65, Day 21 = 77 and Day 28 =86 for fried chicken). While the isolates of meat stored under condition decreased with storage period from day 14 through day 21 to day 28 (Day 14 = 49, Day 21 = 42 and Day 28 = 21 for smoked chicken; Day 14 = 44, Day 21 = 35 and Day 28 = 20 for oven dried chicken; Day 14 = 44, Day 21 = 39 and Day 28 =27 for fried chicken). The meat stored under freezing condition did not only decrease from day 14 through day 21 to day 28, it also had the least number of isolates at day 28 of storage (Day 14 = 36, Day 21 = 25 and Day 28 = 20 for smoked chicken; Day 14 = 40, Day 21 = 25 and Day 28 = 20 for oven dried chicken; Day 14 = 46, Day 21 = 31 and Day 28 =17 for fried chicken).     La viande est très nutritive et, en tant que telle, peut facilement être contaminée par des micro-organismes, en particulier lorsqu'elle est stockée dans des conditions où la température ne peut pas être contrôlée. Cette étude a été menée pour évaluer la stabilité au stockage du poulet de type viande transformée. Des échantillons de poulet traités différemment ont été soigneusement emballés dans des sacs stériles en polyéthylène haute densité. Les échantillons ont été conservés à température ambiante (25±2oC), au réfrigérateur (4oC) et au congélateur (-18oC) pendant 28 jours. Dans chaque cas, une analyse microbienne détaillée a été réalisée sur les échantillons. Les trois échantillons de traitement et le contrôle ont été emballés séparément selon le nombre de période où ils seraient analysés. Chacun des échantillons de traitement a été prélevé et analysé pour la qualité microbiologique. Des échantillons ont été prélevés à 7 jours d'intervalle, à savoir le jour 1, le jour 7, le jour 14, le jour 21 et le jour 28. L'effet de la période de stockage sur l'état microbiologique a également été déterminé. Les isolats microbiens de viande conservée à température ambiante ont augmenté avec l'augmentation de la période de stockage du jour 14 au jour 21 jusqu'au jour 28 (jour 14 = 71, jour 21 = 81 et jour 28 = 86 pour le poulet fumé ; jour 14 = 72, jour 21 = 81 et Jour 28 = 89 pour le poulet séché au four ; Jour 14 = 65, Jour 21 = 77 et Jour 28 = 86 pour le poulet frit). Alors que les isolats de viande conservés dans des conditions ont diminué avec la période de stockage du jour 14 au jour 21 jusqu'au jour 28 (jour 14 = 49, jour 21 = 42 et jour 28 = 21 pour le poulet fumé ; jour 14 = 44, jour 21 = 35 et Jour 28 = 20 pour le poulet séché au four; Jour 14 = 44, Jour 21 = 39 et Jour 28 = 27 pour le poulet frit). La viande stockée dans des conditions de congélation n'a pas seulement diminué du jour 14 au jour 21 jusqu'au jour 28, elle avait également le moins d'isolats au jour 28 de stockage (jour 14 = 36, jour 21 = 25 et jour 28 = 20 pour poulet ; Jour 14 = 40, Jour 21 = 25 et Jour 28 = 20 pour le poulet séché au four ; Jour 14 = 46, Jour 21 = 31 et Jour 28 = 17 pour le poulet frit).


2019 ◽  
pp. 64-75
Author(s):  
А. I. Tykhonov ◽  
T. G. Yarnykh ◽  
S. G. Bobro ◽  
O. S. Shpychak

In modern conditions, the incidence of acne, which is a polymorphic multifactorial disease of the sebaceous glands of the skin, has a tendency to significant growth. Localization of lesions on the face in almost all patients indicates the fact that acne has an effect on their psycho-emotional sphere and social adaptation, which makes this problem urgent and indicates the feasibility of creating new effective domestic medicines for treating this pathology. The aim of the work was to conduct research on the investigation of quality indicators and studying the stability of «Propolis-AK» gel of anti-inflammatory and antimicrobial action for the treatment of acne disease. The objects of research were model test-samples of «Propolis-AK» gel, for which were developed methodic for analyzing the qualitative composition and quantitative content of the active substances – propolis phenolic hydrophobic drug (PPHD) and azelaic acid (AA) in this dosage form, comprehensively allowing to evaluate the quality and criteria for the stability of the gel during the entire storage period for the following indicators: description, identification, homogeneity, tightness of the container, pH, package contents, microbiological purity, quantification. In addition, the requirements for packaging, labeling, transportation, storage conditions and shelf life were included in the draft of quality control methods. According to the results of the study of organoleptic and physical-chemical parameters of the developed «Propolis-AK» gel during storage at two temperature conditions (8‒15 °C and 15‒25 °C), it was found that the test samples of the gel under study remained fairly stable according to the studied indicators for 2 years and 3 months, which allows us to recommend a shelf life of 2 years at room temperature in aluminum tubes for the studied gel. According to the results of research, a specification for «Propolis-AK» gel for external use was developed as a component of the draft of quality control methods for the studied medicine. Studies have been conducted to establish the main indicators and methods of quality control of the developed «Propolis-AK» gel for the treatment of acne disease. According to the results of the tests, a “Specification” was developed, which was included in the draft of quality control methods and experimentally proved the stability of «Propolis-AK» gel prepared in pharmaceutical and industrial conditions for a prescribed shelf life of 24 months when stored in aluminum tubes with an internal lacquer coating in a cool place (8‒15 °C) and at room temperature (15‒25 °C).


2020 ◽  
Vol 859 ◽  
pp. 277-282
Author(s):  
Danuch Panchapornpon ◽  
Sirikarn Pengon ◽  
Nawinda Chinatangkul ◽  
Terachart Chevadisaikul

UV-Vis spectrophotometric method was validated for the stability assessment of 5% extemporaneous vancomycin eye drops in different vehicles. The eye drops were extemporaneously prepared by dissolving vancomycin in various vehicles, including sterile water for injection (SWI), 0.45% normal saline (0.45%NSS) and artificial tear. The solutions were stored at room temperature and in refrigerator for 30 days. The content of vancomycin was measured by UV-Vis spectrophotometer at 280 nm. UV-Vis Spectrophotometric method was validated according to ICH guideline. The results indicated that the method was precise and accurate. The calibration curve was linear with r2 = 0.9997 in the range of 40-160 μg/mL. LOD and LOQ were 3.39 and 10.26 μg/mL, respectively. The results showed that the percentage of vancomycin residual concentation in SWI and 0.45%NSS was decreased to less than 90% after storage at room temperature for 8 days, whereas the residual concentration of vancomycin in artificial tear was less than 90 % after 10 days in room temperature. Meanwhile the percentage of vancomycin residual concentation in all formulations was remarkably decreased to less than 90% after storage in refrigerator for 17 days. The physical appearance of eye drops in artificial tear remained unchanged. However the observed color of other formulations was gradually changed to yellow in day 7 at room temperature and day 17 in refrigerator. The pH values of all preparations were within the general U.S. pharmacopeia national formulation range of 2.5-4.5. In conclusion, the eye preparations of 5%w/v vancomycin in all selected vehicle were stable for 17 days in refrigerator (2-8°C).


2020 ◽  
Vol 9 (9) ◽  
pp. e884998227
Author(s):  
Josef Gastl Filho ◽  
Millena Almeida Resende ◽  
Flávio Caldeira Silva

Studying the stability of the raw material as a function of the storage time is fundamental to establish the characteristics performance and to determine the period that it should be stored. The objective of the present study was to evaluate the stability of the alcoholic extract for 28 days of storage. It was performed in a completely randomized and split-plot design (3x5) with 3 repetitions and using the following formulation: 500 g of banana components (peel, pulp or peel plus pulp), 1000 mL of cereal alcohol 96 ºGL and maceration process for fifteen days. Filtered alcoholic extracts were stored in a dark place at room temperature for analysis of colorimetric parameters Luminosity, hue, chroma, chromaticity a* and chromaticity b*. Results showed that storage period for 28 days significantly affected stability, promoting notable reduction in Luminosity, hue, chromaticity b* and chroma and also increased the chromaticity value chromaticity a*. It was observed that the banana pulp alcoholic extract showed the highest values for Luminosity and hue, and the banana peel alcoholic extract stood out in relation to the chromaticity chroma, chromaticity a* and chromaticity b*. The information obtained through colorimetric parameters can be used by the food industry to establish procedures that mitigate the effects of the storage period in the raw material, since the characteristics inherent to the raw material are significantly changed over time and result in changes in the quality of the final product.


Author(s):  
ANA PAULA DE CARVALHO ALVES ◽  
ANGELITA DUARTE CORRÊA ◽  
JÉSSICA BORELI DOS REIS LINO ◽  
TAMARA REZENDE MARQUES

The stability of jaboticaba skin fl our was evaluated during 12months of storage, for the purpose of extending the use of this fl ourthroughout the year, because jaboticaba production is seasonal.Ripe Plinia jaboticaba (Vell.) Berg fruits, of the Sabará genotype,were collected and the separated skins were dried at a temperatureof 45 oC. They were then ground and stored in hermetically sealedfl asks and protected from light at room temperature for 0, 3, 6, 9 and12 months. At each storage time, analyses of proximate composition,vitamin C, phenolic compounds, anthocyanins, soluble solids, wateractivity, color, pH and microbiological analysis were conducted.It was possible to observe a signifi cant increase in the followingparameters during the 12 months of storage: humidity, 34 %; wateractivity, 31.23 %; a color coordinates,12.37 % and b colorcoordinates, 24 %; pH, 7.35 %. There was a decrease in phenoliccontent of 9.91 %; anthocyanins 29 % and vitamin C 20 %. Therewas no signifi cant difference in the levels of lipids, protein, ash, fi berand soluble solids, and the presence of microorganisms was notdetected for any storage period. Therefore, it is possible to concludethat the jaboticaba skin fl our did not show signifi cant changes innutritional parameters, and showed a small reduction in antioxidantcompounds when stored for periods up to 12 months. This fl our cantherefore be considered as an alternative for the enrichment of foodproducts throughout the year


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