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

Foley, Lisa S.; Toney, Jennifer; Barlow, James W.; O’Connor, Maeve; Fitzgerald-Hughes, Deirdre; Ramtoola, Zebunnissa

doi:10.3390/molecules26020301

Cited by 12 publications

(6 citation statements)

References 15 publications

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“…No similar studies were found with test results for storage at oven temperature of 40°C. However, a study carried out in Ireland showed that an extemporaneous suspension of losartan potassium (5 mg/mL) remained stable in the refrigerator and at room temperature for 28 days 13. The same period was determined by Alfagih et al 14.…”

Section: Discussionmentioning

confidence: 79%

“…Few studies related to liquid formulation of losartan potassium have been published,13 14 so the purpose of this study is to develop a liquid formulation containing losartan potassium using the raw material and a simple manufacturing process suitable for reproduction in a University Hospital in Brazil. A high-performance liquid chromatography (HPLC) method was validated in order to carry out stability tests of the developed formulation.…”

Section: Introductionmentioning

confidence: 99%

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Losartan potassium liquid formulation for paediatric hospital use: development and stability evaluation

Corte,

Gobetti,

Carlos

et al. 2024

Eur J Hosp Pharm

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ObjectivesThis study aimed to develop a liquid oral formulation containing losartan potassium, an angiotensin II receptor antagonist drug used for its antihypertensive activity, and to perform a preliminary stability assessment under different temperatures and packages to ensure paediatric therapeutic adherence and facilitate the hospital routine.MethodsA syrup containing losartan potassium (1.0 and 2.5 mg/mL) (excipients: potassium sorbate, sucrose (85%), water, citric acid and raspberry flavouring) was prepared. The packaging was carried out in amber polyethylene terephthalate (PET) and amber glass bottles (in triplicate) under the following conditions: (a) room temperature (15–30°C); (b) refrigeration (2–8°C); and (c) oven temperature (40°C) for 28 days. An analytical method by high performance liquid chromatography using a reverse-phase column was also developed and validated for quantitative determination of the drug in the formulations.ResultsThe analytical method showed satisfactory linearity, detection and quantification limits, precision, accuracy and robustness. Samples at room temperature maintained content values between 90% and 110% for 7 days, while those stored under refrigeration maintained a homogeneous appearance and content between 90% and 110% for a period of 21 days. Values of pH stayed in a narrow range. Viscosity results were between 40.1 and 49.2 centipoise (cp) for glass bottles and 42.4 and 54.7 cp for PET bottles.ConclusionsA simple and economical losartan potassium liquid formulation was produced and was shown to be stable under refrigeration for 21 days in both PET and glass packages.

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Section: Discussionmentioning

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Losartan potassium liquid formulation for paediatric hospital use: development and stability evaluation

Corte,

Gobetti,

Carlos

et al. 2024

Eur J Hosp Pharm

View full text Add to dashboard Cite

show abstract

“…Losartan has an 8 mg/mL water solubility level with a pKa of 5.5. A 5 mg/mL formulation has recently been studied [ 102 ], and directions for the preparation of a 2.5 mg/mL suspension are contained in the package insert [ 103 ].…”

Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Parrish

Ashworth²,

Löbenberg

et al. 2022

Pharmaceutics

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The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

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“…Therefore, extemporaneous compounding of losartan oral suspension is performed in various hospitals globally [8].…”

Section: Introductionmentioning

confidence: 99%

Quality and Stability Evaluation of Extemporaneously Compounded Losartan Potassium Oral Suspension at the Hospital Pharmacy

Alfagih,

Aloraini,

Eltahir

2023

J. Pharm. Res. Int.

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Aims: The purpose of this study was to evaluate the quality of an extemporaneous formulation of losartan potassium oral suspensions from crushed losartan potassium tablets to ensure that the compounded suspension maintained its quality attributes during its storage period. Methodology: Losartan potassium suspensions were compounded extemporaneously in the same way they are prepared for patients at a hospital pharmacy. The suspensions were kept in the refrigerator at 4°C and evaluated immediately and after 9, 18, and 28 days. Suspension ease of redispersion, color, odor, pH, particle size, zeta potential, viscosity, and sedimentation volume were all evaluated. In addition, microbiological stability, drug content, and drug dissolution were assessed. Results: During the study period, the extemporaneously compounded suspension retained its color and odor, and the pH profile remained consistent. Moreover, all suspensions were easily resuspended in a homogeneous liquid with gentle shaking, and no caking was detected. Furthermore, the results of the microbiological test revealed no microbial growth. The content uniformity and dissolution test results met the pharmacopeial requirements. The findings revealed that the losartan potassium compounding procedure was reliable and capable of producing 2.5 mg/mL of losartan potassium suspension using commercially available tablets and Ora-Blend as a suspending vehicle. Furthermore, after 28 days in the refrigerator (4°C), the suspension had acceptable quality features. Conclusion: Extemporaneously compounded suspension allows physicians to prescribe a variable dose that adjusts to each patient’s needs, providing treatment when the liquid dosage form is unavailable.

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

Cited by 12 publications

References 15 publications

Losartan potassium liquid formulation for paediatric hospital use: development and stability evaluation

Losartan potassium liquid formulation for paediatric hospital use: development and stability evaluation

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Quality and Stability Evaluation of Extemporaneously Compounded Losartan Potassium Oral Suspension at the Hospital Pharmacy

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