Quality assessment and stability study of compounded furosemide syrup

Alfred-Ugbenbo, Deghinmotei; Zdoryk, O. A.; Georgiyants, V. A.

doi:10.15587/2519-4852.2017.113517

Cited by 3 publications

(4 citation statements)

References 8 publications

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“…Compounded formulations are regarded as being chemically, physically and microbiologically stable when they contain  90 % www.scienceworldjournal.org ISSN: 1597-6343 (Online), ISSN: 2756 Published by Faculty of Science, Kaduna State University of the original amount of the active ingredient, there is no apparent change in physical property and there is no microbial growth (Belayneh and Tessema, 2021). Alfred-Ugbenbo et al (2017) and Belayneh and Tessema (2021) also reported that most extemporaneous formulations were stable at ICH recommended storage conditions and duration, but only when compounded in Syrup USP or other standardized compounding vehicles. It is important to state that none of the previously reported studies used vitamin syrups in preparation of extemporaneous formulations.…”

Section: Discussionmentioning

confidence: 99%

“…A volume equivalent to 50 ml of the compounded batches was measured, placed in a volumetric flask, covered and kept for 30 days and after the 30-day period, the sample was shaken vigorously and allowed to stand for 5 minutes (Alfred-Ugbenbo et al, 2017). The volume of sedimentation was observed and recorded.…”

Section: Sedimentation Testmentioning

confidence: 99%

“…Drugs are compounded as suspensions in order to meet the needs of special patients such as pediatric, geriatric and tube-fed patients (Cutaia et al, 2018;Allen, 2019). Studies have reported variations in pH, viscosity, particle size distribution, API content and microbial contamination of extemporaneous preparations, and suggested that such preparations were suitable for use only for a specified period of time, thus leading to the introduction of beyond-use-dates (BUD), after which the preparation cannot be consumed (Alfred-Ugbenbo et al, 2017;Silva et al, 2020;Soares Rodrigues Costa et al, 2020). However, the bioavailability and palatability of such preparations can still not be proven, even though they have been found to be physically, chemically or microbiologically stable, until they are supported by evidenced based data (Belayneh and Tessema, 2021).…”

Section: Introductionmentioning

confidence: 99%

“…Excipients present in tablet formulations and vitamin syrups can change the pH, viscosity, and other characteristics of the dispersion medium in which they are compounded, which can lead to emergence of undesirable products and/or decrease in API content, thus compromising the safety and efficacy of the extemporaneous mixture. (Alfred-Ugbenbo et al, 2017). Therefore, it is important to study the stability of commonly compounded suspensions in order to determine their BUD in commonly used commercially available vitamin syrups.…”

Section: Introductionmentioning

confidence: 99%

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Insights into folic acid mixtures compounded with commercially available vitamin syrups

Anslem,

Oloyede,

Kassim

et al. 2024

SWJ

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Stability assessments are crucial in determining the shelf-life and quality of compounded pharmaceutical products. Folic acid, an essential B-vitamin, is widely used to prevent and treat folate deficiency-related conditions. However, because of patient-specific demands or customised dose requirements, compounded folic acid syrups are frequently used in pediatric patients. This study aims to examine the stability of compounded folic acid mixtures prepared with some commercially available vitamin syrups. Three commercially available vitamin syrups were utilized as compounding vehicles for folic acid tablets, ensuring a representative sample of products commonly used in compounding practices in hospitals when conventional compounding vehicles are not available. The compounded folic acid mixtures were stored under ambient (21- 25 ºC) and refrigerated conditions (2-8 ºC), to simulate real-life scenarios, and tested using parameters such as, organoleptic characteristics, sedimentation rate, pH, microbial growth and drug content determination at day 7, 14 and 30. The extemporaneous preparations of the compounded folic acid in vitamin syrups generally maintained their physical characteristics over the 30-day study period. However, there was either decrease in folic acid concentration or microbial contamination of the preparations at day 7. Therefore, folic acid compounded in vitamin syrups are generally stable for less than seven days. The data obtained will aid healthcare professionals and compounding pharmacies in decision making concerning the choice of vehicle, compounding practices and strategies to ensure the preparation of wholesome extemporaneous products.

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Section: Discussionmentioning

confidence: 99%

Section: Sedimentation Testmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Insights into folic acid mixtures compounded with commercially available vitamin syrups

Anslem,

Oloyede,

Kassim

et al. 2024

SWJ

View full text Add to dashboard Cite

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Quality Assessment and Stability Studies of Metronidazole Tablets Formulations Obtained via Crystallo Co-Agglomeration Technique

Adullahi,

Olowosulu,

Allagh

2024

FJS

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Stability studies are essential for assessing the quality, safety, and efficacy of pharmaceutical products, ensuring they maintain their properties over time. This study aimed to assess the stability of metronidazole tablets stored in a desiccator with charged silica gel following the International council for harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines. Metronidazole tablets were formulated from metronidazole co-agglomerates using different excipients by direct compression method and stored for 6 and 12 months at 25±2°C/60±5% relative humidity. Quality parameters such as weight variation, diameter, thickness, hardness, friability, content uniformity, and dissolution rate were evaluated at intervals using the United States Pharmacopeia – National Formulary and British Pharmacopeia specifications. The tablets maintained uniformity in weight, diameter, thickness and content over 12 months, meeting pharmacopeial standards. They exhibited high crushing strength, low friability, and consistent disintegration times (<5 min), across formulations and storage durations with no significant changes after storage, indicating stable performance. The sustained high crushing strength, friability ratio (CSFR) and crushing strength, friability, disintegration time (CSFR/Dt) ratios suggested high tablet strength and quality. In-vitro dissolution studies showed release rates of 87.31 – 100.81 %, with a significant decrease at 6 months within pharmacopeial standards but no change at 12 months. Content uniformity was maintained throughout storage. Metronidazole tablets formulated from crystallo co-agglomerates demonstrated good stability and mechanical strength over 12 months of storage. Storage in air-tight containers with desiccants at controlled room temperature (25±2°C) or below their relative humidities is recommended for maintaining tablet quality

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Estimation of shelf-life of Balachaturbhadrika syrup containing different sweetening agents

Goyal

Bhatt

Rawat

et al. 2022

RJPT

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Background: Stability being the potential of any particular preparation in a noteworthy container/closure set up to abide within its physical, microbiological, chemical, toxicological, therapeutic stipulations which is invariably manifested in respect of shelf-life. Main aim of present analysis is to ascertain the shelf-life of Balachaturbhadrika Syrup prepared with different sweetening agent viz. Sugar (Sample I), Jaggery (Sample II), Honey (Sample III) and Stevia (Sample IV). The study was performed under accelerated storage conditions. Methods: Accelerated stability study was conducted for 3 months as per ICH guideline QA1 (R2) and the changes in physico-chemical traits viz. pH, refractive index, specific gravity, alcohol content and sedimentation rate were inscripted for quadruple alliance of 0, 15, 30 and 90 days. The statistical analysis was done using mean ± SEM, student paired t- test and Analysis of Variance (ANOVA). Results: Remarkable changes were found in both organoleptic and physico-chemical traits. Extrapolated shelf-life of Sample I, II, III and IV from physico-chemical attributes in conformity with the weather conditions prevailing in India were 73.514 month (6.12 year), 76.080 month (6.340 year), 58.05 month (4.83 year) and 37.05 month (3.09 year) respectively. Conclusion: The syrups prepared using Sugar, Jaggery and Honey were found to be more stable than those prepared using Stevia as the value of physical parameters was found more prominent for honey, jaggery and sugar.

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Quality assessment and stability study of compounded furosemide syrup

Cited by 3 publications

References 8 publications

Insights into folic acid mixtures compounded with commercially available vitamin syrups

Insights into folic acid mixtures compounded with commercially available vitamin syrups

Quality Assessment and Stability Studies of Metronidazole Tablets Formulations Obtained via Crystallo Co-Agglomeration Technique

Estimation of shelf-life of Balachaturbhadrika syrup containing different sweetening agents

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