scholarly journals Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension

Molecules ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 301
Author(s):  
Lisa Foley ◽  
Jennifer Toney ◽  
James W. Barlow ◽  
Maura O’Connor ◽  
Deirdre Fitzgerald-Hughes ◽  
...  
Keyword(s):  
Shelf Life ◽  
Storage Conditions ◽  
Losartan Potassium ◽  
Microbial Count ◽  
E Coli ◽  
Physical Chemical ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Stability Data

Extemporaneous oral liquid preparations are commonly used when there is no commercially available dosage form for adjustable dosing. In most cases, there is a lack of stability data to allow for an accurately assigned shelf life and storage conditions to give greater confidence of product safety and efficacy over its shelf life. The aim of this study was to evaluate the physical, chemical and microbiological stability of an extemporaneous oral liquid suspension of losartan potassium, 5 mg/mL, used to treat paediatric hypertension in Our Lady’s Children’s Hospital Crumlin, Ireland. The losartan content of extemporaneous oral suspensions, prepared with and without addition of water, was measured by UV and confirmed by HPLC analysis. Suspensions were stored at 4 °C and room temperature (RT) and were monitored for changes in; pH, colour, odour, re-dispersibility, Total Aerobic Microbial Count, Total Yeast and Mould Count and absence of E. coli. Results showed that suspensions prepared by both methods, stored at 4 °C and RT, were physically and microbiologically stable over 28 days. Initial losartan content of all suspensions was lower than expected at 80–81% and did not change significantly over the 28 days. HPLC and NMR did not detect degradation of losartan in the samples. Suspensions prepared in water showed 100% losartan content. The reduced initial losartan content was confirmed by HPLC and was related to the acidic pH of the suspension vehicle. Physiochemical properties of the drug are important factors for consideration in the selection of suspension vehicle for extemporaneous compounding of oral suspensions as they can influence the quality, homogeneity and efficacy of these preparations.

scholarly journals Fruit Waste as Natural Pectin Source for Jam Production in Rural Communities

2020 ◽  
Vol 9 (3) ◽  
pp. 71
Author(s):  
Ariane M. Kluczkovski ◽  
Augusto Kluczkovski-Junior ◽  
Arine V. Lopes ◽  
Samir C. B. Pinto ◽  
Diana C. Monteiro
Keyword(s):  
Rural Communities ◽  
Shelf Life ◽  
Rural Community ◽  
Passion Fruit ◽  
Alternative Source ◽  
Legal Standards ◽  
Physical Chemical ◽  
Fruit Waste ◽  
Microbiological Stability ◽  
Amazonas State

A study was carried out to elaborate and monitor the shelf life of a pineapple jam with ingredients using, as “gelatinizing agent”, the pectin extracted from passion fruit residues from a rural community of Amazonas State, Brazil. The product was always maintained at a temperature of 25 °C and studied for 4 months, with the results showing physical-chemical and microbiological stability. We concluded that passion fruit residue can be used in pineapple jam production while still meeting legal standards for commercialization, reducing environmental waste, and being an alternative source of income in rural communities.

scholarly journals Evaluation of Physical-Chemical and Microbiological Stability of Fluconazole Oral Suspensions for Hospital Use

2020 ◽  
Vol 4 (1) ◽  
pp. 39-43
Author(s):  
Camilo Marques D'Amore ◽  
Elisa De Saldanha Simon ◽  
Martin Steppe
Keyword(s):  
Analytical Method ◽  
High Performance ◽  
Active Pharmaceutical Ingredient ◽  
Oral Formulation ◽  
Porto Alegre ◽  
Pet Bottles ◽  
Physical Chemical ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
New Formulation

Fluconazole is an important drug in the treatment of cutaneous and systemic mycoses. The Hospital de Clínicas de Porto Alegre performs a derivation of fluconazole capsules to obtain an oral liquid formulation that is easily administered and whose dose can be adjusted. In order to replace the derivation for a formulation produced from an active pharmaceutical ingredient, this study sought to develop a liquid oral formulation, evaluate its physical chemical and microbiological stability and demonstrate suitability of the analytical method for the formulation assay. Seven different formulations of pharmaceutical suspension form were produced and evaluated for pH, viscosity, sedimentation volume and assay. The analytical method by High Performance Liquid Chromatography was demonstrated. Two most promising formulations were manipulated in the Farmácia Semi-Industrial do Hospital de Clínicas de Porto Alegre and stored in amber PET bottles under three different conditions: room temperature, under refrigeration (2 to 8 ºC) and in an oven (40 ° C). Samples were collected after 0, 7 and 14 days to evaluate physical-chemical stability, assay, pH and macroscopic aspects. Samples were collected after 0 and 21 days to evaluate microbiological stability. It was possible to demonstrate stability for one of the formulations for a 14-day period. Throughout the study, the chosen formulation presented adequate quantification of fluconazole, constant pH, no organoleptic changes and no microbial growth. The results suggest the incorporation of a new formulation for fluconazole to the Farmacia Semi-Industrial portfolio).

scholarly journals Physical-chemical and microbiological stability of biotherapy Candida albicans RC in different potencies

2021 ◽  
Vol 10 (36) ◽  
pp. 155-157
Author(s):  
Fortune Honsani ◽  
Cristiane Larosa ◽  
Flavia Gonçalves ◽  
Danielle Avellar ◽  
Helena Toma ◽  
...  
Keyword(s):  
Electrical Conductivity ◽  
Candida Albicans ◽  
Oral Candidiasis ◽  
Colony Growth ◽  
Storage Conditions ◽  
Physical Chemical ◽  
Significant Difference ◽  
Immunosuppressed Patients ◽  
Microbiological Stability ◽  
Microbiological Analyses

Introduction: Oral Candidiasis is an opportunist fungal infection, with high incidence in HIV and immunosuppressed patients and Candida albicans is the most common causing agent. In some cases, it can evolve to resistant injuries to antifungal conventional therapy. According to Brazilian Homeopathic Pharmacopeia (BHP) [1], biotherapic medicines are prepared from chemically undefined biological products. Biotherapics created by Brazilian doctor Roberto Costa (RC) have a different homeopathic compounding technique, as its dynamization starts from the ethiologic agent of the illness in its alive form, which present higher capability to stimulate the host immunological system [2,3]. Aim: The goal of this study was evaluate the physical-chemical and microbiological stability of Candida albicans RC potencies under different conditions of storage. Methodology: To prepare the biotherapics, one part of Candida albicans yeast suspension (109 cell/ml) was diluted in 9 parts of sterile distillated water. After preparing this 1:10 dilution, the sample was undergone 100 succussions, resulting in the first decimal dilution (1x). Then, one part of this solution was diluted in 9 parts of sterile distillated water and submitted to 100 succussions, generating the 2x. This process was successively repeated following BHP, until 30x. Water 30x was prepared by the same technique, as control. All the solutions were prepared in aseptic and sterile conditions. Biotherapics 6x, 12x, 18x, 24x, 30x and water 30x were storage under refrigeration (2 to 8°C) and at room temperate (25°C) during 8 weeks. Every 15 days, the following parameters were analyzed: pH, electrical conductivity, UV absorbance (260 and 280 nm). Microbiological analyses were performed after 3 weeks by colony forming unit (CFU) method [4]. Results: The preliminary analyses performed at times zero, 15, 30 and 45 days suggest that electrical conductivity of these solutions tend to increase proportionally to storage time without significant differences due to temperature storage conditions. There was no statistically significant difference detected in pH values. Measures of absorbance of different biotherapic potencies under both conditions of storage are in course. Microbiological analyses showed no colony growth, but in the 1x sample analyzed at time zero, indicating the viability of the fungus. Conclusion: Further experiments are being carried out in order to confirm the preliminary data obtained.

Changes in the Microbiological Quality of Mangrove Oysters (Crassostrea brasiliana) during Different Storage Conditions

2015 ◽  
Vol 78 (1) ◽  
pp. 164-171 ◽  
Author(s):  
MAIKE TAÍS MAZIERO MONTANHINI ◽  
ROBERTO MONTANHINI NETO
Keyword(s):  
Shelf Life ◽  
Microbiological Quality ◽  
Storage Condition ◽  
Storage Conditions ◽  
Effect Of Temperature ◽  
Total Coliforms ◽  
E Coli ◽  
Different Temperatures ◽  
Contamination Levels

This study aimed to determine the effect of temperature and period of postharvest storage on the microbiological quality and shelf life of raw mangrove oysters, Crassostrea brasiliana. A total of 150 dozen oysters were collected directly from the points of extraction or cultivation in southern Brazil, and in the laboratory, they were stored raw at 5, 10, 15, 20, and 25°C for 1, 4, 8, 11, and 15 days. On each of these days, the oysters were subjected to microbiological analyses of aerobic mesophilic count, total coliforms, enterococci, Escherichia coli, Staphylococcus aureus, and Salmonella. None of the tested samples under any storage condition showed contamination levels above those allowed by Brazilian legislation for E. coli, S. aureus, and Salmonella, and there was no change (P > 0.05) in the counts of these microorganisms due to the temperature and/or period of oyster storage. Counts of enterococci and total coliforms showed a tendency to increase (P < 0.05) among the different temperatures tested. Raw mangrove oysters remain in safe microbiological conditions for consumption up to 8 days after harvesting, regardless of temperature, and their shelf life may be extended to 15 days if they are stored at temperatures not exceeding 15°C.

scholarly journals Physical, chemical, and microbiological stability study of diluted atropine eye drops

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Jumpei Saito ◽  
Hitomi Imaizumi ◽  
Akimasa Yamatani
Keyword(s):  
Shelf Life ◽  
Package Insert ◽  
Ophthalmic Solution ◽  
Improve Patient Care ◽  
Stability Study ◽  
Eye Drops ◽  
Myopia Progression ◽  
Physical Chemical ◽  
Long Term Treatment ◽  
Microbiological Stability

Abstract Background Atropine eye drops are indicated for juvenile myopia progression, cycloplegia, amblyopia, and strabismus. According to the package insert, 10 mg/mL atropine eye drops must be diluted for pediatric patients to prevent systemic adverse effects. Compounding units in hospital pharmaceutical departments or community pharmacies are compelled to prepare this essential medication; however, validated atropine stability data is limited and the shelf life after preparation is extremely short. As it is a long-term treatment, a longer shelf life is necessary to improve patient care. This study aimed to demonstrate the physical, chemical, and microbiological stability of diluted atropine eye drops over a period of six months. Methods Preparation consists of dilution of a 10 mg/mL atropine solution (Nitten Atropine Ophthalmic Solution 1%; Nitten Pharmaceutical Co., Ltd.) in 0.9% NaCl to concentrations of 0.1, 1.0, 2.5, and 5.0 mg/mL, followed by a sterilizing filtration procedure and then an aseptic filling process of 5 mL in 5 mL polyethylene eyedropper bottles. The entire process is carried out in an overpressure isolator. All concentration products were kept for six months at 25 °C or 5 °C. Visual inspection was conducted and pH, osmolality, and atropine concentration were measured at day 0, day 14, day 28, and every month until six months. Atropine concentration was measured using liquid chromatography tandem mass spectrometry. The sterility was monitored using a method adapted from the Japanese Pharmacopoeia sterility assay. Results Atropine remained within ±5% of the target value in the six batches. Osmolality (285 mOsm/kg) as well as pH (5.88) were kept constant. No variations in solution characteristics (crystallization, discoloration) were noted. Sterility was maintained. Conclusions This study validated the physical, chemical, and microbiological stability of 0.1, 1.0, 2.5, and 5.0 mg/mL atropine sulfate eye drops conserved inside polyethylene eyedroppers for six months at 25 °C or 5 °C.

scholarly journals Formulation and Stability Study of Omeprazole Oral Liquid Suspension for Pediatric Patients

2019 ◽  
Vol 55 (5) ◽  
pp. 314-322
Author(s):  
Oriana Boscolo ◽  
Francesco Perra ◽  
Leandro Salvo ◽  
Fabián Buontempo ◽  
Silvia Lucangioli
Keyword(s):  
High Performance ◽  
Pediatric Patients ◽  
Hplc Method ◽  
Stability Study ◽  
Oral Formulations ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Pediatric Use ◽  
Liquid Suspensions

Objectives: To develop and to study the physicochemical and microbiological stability of omeprazole liquid oral formulations used as therapeutic agent in many acid-related disorders, for pediatric use. Furthermore, to optimize and validate a stability-indicating high-performance liquid chromatography (HPLC) method for the analysis of omeprazole in the studied formulations. Method: Oral liquid suspensions of omeprazole were prepared at 2 mg/mL using crushed omeprazole pellets (formulation A) and pure omeprazole (formulation B) with a complete vehicle including humectant, suspending, sweetening, antioxidant, and flavoring agents. Samples were stored at 4°C and 25°C. Omeprazole content of each formulation was analyzed in triplicate using micro-HPLC at 0, 3, 7, 14, 30, 60, 90, 120, and 150 days. Other parameters were also determined, such as appearance, pH, resuspendibility, and viscosity. Microbiological studies were conducted according to the United Stated Pharmacopeia (USP) guidelines for non-sterile products. Results: Formulation A stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions during at least 150 days and it only stayed stable during 14 days at 25°C. Formulation B was stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions at least 90 days, but it is not recommended to store at 25°C for more than 1 day. Conclusions: Formulation A and formulation B can be stored for at least 150 and 90 days, respectively, at refrigerated conditions. Formulation A can be stored at room temperature for 14 days. Both formulations are perfectly suitable for pediatric patients who are usually notable to swallow solid oral formulations. The proposed analytical method was suitable for the study of stability of different formulations.

Formulation of Oral Mucoadhesive Tablets using Mucilage Isolated from Buchanania lanzan spreng Seeds

2014 ◽  
Vol 7 (2) ◽  
pp. 2494-2503
Author(s):  
Sudarshan Singh ◽  
Ayaz Ahmad ◽  
Sunil Bothara B
Keyword(s):  
Drug Delivery ◽  
Guar Gum ◽  
Physical Property ◽  
Flow Property ◽  
Relative Effect ◽  
Losartan Potassium ◽  
In Vitro Dissolution ◽  
Wet Granulation ◽  
Microbial Count

The present study was taken to formulate and evaluate mucilage obtained from Buchanania lanzan spreng seeds (BL) belonging to family anacardiacea for oral mucoadhesive drug delivery system containing losartan potassium. Physiochemical characteristics of mucilage, such as swelling index, microbial count, viscosity, hydration capacity, flow property, and pH were studied. The mucilage was evaluated for its mucoadhesive properties in compressed tablet, containing losartan potassium. Granules were prepared by wet granulation process using polyvinylpyrrolidone as binding agent. Mucilage was used in four different concentrations i.e., 21, 42 and 55% w/w. The tablet were prepared and evaluated for its physical property. Further, in vitro dissolution and swelling index was determined. The property of bioadhesive strength of isolated mucilage was compared with Guar gum and HPMC E5LV, which was used as standard mucoadhesive agent concentration. Bioadhesive strength of the tablet was measured on the modified physical balance. Result revealed that tablets had good physiochemical properties, and drug release was retarded as concentration of mucilage was increased. The force of adhesion was obtained 0.1238N, 0.2822N, 0.5175N, 0.8679N and 0.3983N respectively for F1, F2, F3, F4 and F5. Formulations were subjected for study the effect of agitation at different rpm. Formulation showed relative effect on release of drug from formulation. All the formulations were subjected to stability studies for three months, all formulations showed stability with respect to release pattern. In conclusions, these results indicate that the seed mucilage of BL can be a suitable excipient for oral mucoadhesive drug delivery systems.  

scholarly journals Shelf Life Extension of Chilled Pork by Optimal Ultrasonicated Ceylon Spinach (Basella alba) Extracts: Physicochemical and Microbial Properties

Foods ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 1241
Author(s):  
Yuthana Phimolsiripol ◽  
Srirana Buadoktoom ◽  
Pimporn Leelapornpisid ◽  
Kittisak Jantanasakulwong ◽  
Phisit Seesuriyachan ◽  
...  
Keyword(s):  
Shelf Life ◽  
Antioxidant Activities ◽  
Antibacterial Properties ◽  
Meat Products ◽  
Thiobarbituric Acid ◽  
Antibacterial Activities ◽  
Life Extension ◽  
Microbial Count ◽  
Basella Alba ◽  
Chilled Pork

The effect of ultrasonication on the antioxidant and antibacterial properties of Ceylon spinach (Basella alba) extracts (CE) and the shelf life of chilled pork with CE were studied. The CE were ultrasonicated at different power levels (60–100%) for 10–40 min in an ultrasonic bath with the rise of antioxidant activities (p ≤ 0.05) proportional to the ultrasonication time. The additional investigation of antibacterial activities showed that the ultrasonicated extracts (100 mg/mL) could inhibit and inactivate Staphylococcus aureus and Escherichia coli with the optimal condition of 80% power for 40 min. For shelf-life testing, fresh pork treated with the ultrasonicated extracts at 100 and 120 mg/mL had lower values of thiobarbituric acid reactive substances (TBARS) than the control (without dipping). For food safety as measured by the total microbial count, the fresh pork dipped with 100–120 mg/mL CE extract could be kept at 0 °C for 7 days, 2 to 3 days longer than control meat at 0 and 4 °C, respectively. A sensory evaluation using a nine-point hedonic scale showed that fresh pork dipped with 100-mg/mL CE extracts was accepted by consumers. It is suggested that CE extracts can be applied in the food industry to enhance the quality and extend the shelf life of meat products.

scholarly journals Antimicrobial Edible Films and Coatings for Meat and Meat Products Preservation

2014 ◽  
Vol 2014 ◽  
pp. 1-18 ◽  
Author(s):  
Irais Sánchez-Ortega ◽  
Blanca E. García-Almendárez ◽  
Eva María Santos-López ◽  
Aldo Amaro-Reyes ◽  
J. Eleazar Barboza-Corona ◽  
...  
Keyword(s):  
Shelf Life ◽  
Meat Products ◽  
Barrier Properties ◽  
Storage Conditions ◽  
Edible Films ◽  
Animal Origin ◽  
Chemical Additives ◽  
Processed Meats ◽  
Physicochemical Changes ◽  
Preservation Technology

Animal origin foods are widely distributed and consumed around the world due to their high nutrients availability but may also provide a suitable environment for growth of pathogenic and spoilage microorganisms. Nowadays consumers demand high quality food with an extended shelf life without chemical additives. Edible films and coatings (EFC) added with natural antimicrobials are a promising preservation technology for raw and processed meats because they provide good barrier against spoilage and pathogenic microorganisms. This review gathers updated research reported over the last ten years related to antimicrobial EFC applied to meat and meat products. In addition, the films gas barrier properties contribute to extended shelf life because physicochemical changes, such as color, texture, and moisture, may be significantly minimized. The effectiveness showed by different types of antimicrobial EFC depends on meat source, polymer used, film barrier properties, target microorganism, antimicrobial substance properties, and storage conditions. The perspective of this technology includes tailoring of coating procedures to meet industry requirements and shelf life increase of meat and meat products to ensure quality and safety without changes in sensory characteristics.

scholarly journals Quantifying within- and between-animal variation and uncertainty associated with counts of Escherichia coli O157 occurring in naturally infected cattle faeces

2008 ◽  
Vol 6 (31) ◽  
pp. 169-177 ◽  
Author(s):  
S.E Robinson ◽  
P.E Brown ◽  
E.J Wright ◽  
C.A Hart ◽  
N.P French
Keyword(s):  
Escherichia Coli ◽  
Statistical Model ◽  
Human Infection ◽  
Microbial Count ◽  
Infected Cattle ◽  
Explanatory Variables ◽  
E Coli ◽  
Fixed And Random Effects ◽  
Cattle Faeces ◽  
Multiple Samples

Cattle faeces are considered the most important reservoir for human infection with Escherichia coli O157. We have previously described shedding of E. coli O157 in the faeces of naturally infected cattle cohorts. However, the data require further investigation to quantify the uncertainty and variability in the estimates previously presented. This paper proposes a method for analysing both the presence and the quantity of E. coli O157 in cattle faecal samples, using two isolation procedures, one of which enumerates E. coli O157. The combination of these two measurements, which are fundamentally different in nature and yet measuring a common outcome, has necessitated the development of a novel statistical model for ascertaining the contribution of the various components of variation (both natural and observation induced) and for judging the influence of explanatory variables. Most of the variation within the sampling hierarchy was attributable to multiple samples from the same animal. The contribution of laboratory-level variation was found to be low. After adjusting for fixed and random effects, short periods of increased intensity of shedding were identified in individual animals. We conclude that within-animal variation is greater than between animals over time, and studies aiming to elucidate the dynamics of shedding should focus resources, sampling more within than between animals. These findings have implications for the identification of persistent high shedders and for assessing their role in the epidemiology of E. coli O157 in cattle populations. The development of this non-standard statistical model may have many applications to other microbial count data.

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