Stability of omeprazole in an extemporaneously prepared oral liquid

Quercia, Robert; Fan, Chunyan; Liu, Xinchun; Chow, Moses S. S.

doi:10.1093/ajhp/54.16.1833

Cited by 44 publications

(32 citation statements)

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“…A correlation was however found between the degree of darkening and decreased drug content in the pellets [1]. In the case of a liquid formulation of omeprazole extemporaneously prepared, the rate of degradation was temperature dependant, with the formulation remaining stable (>90%) for 30 days only at 5 • C, while the drug content declined to below 90% after only 18 days at room temperature (25 • C) [2].…”

Section: Introductionmentioning

confidence: 99%

Physical and thermal characterisation of chiral omeprazole sodium salts

Markovic

Agotonovic-Kustrin

Glass

et al. 2006

Journal of Pharmaceutical and Biomedical Analysis

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Section: Introductionmentioning

confidence: 99%

Physical and thermal characterisation of chiral omeprazole sodium salts

Markovic

Agotonovic-Kustrin

Glass

et al. 2006

Journal of Pharmaceutical and Biomedical Analysis

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“…This confirms that SyrSpend SF Alka could be a viable alternative to commercially available capsules when that dosage form is found to be inappropriate. Quercia et al 45 evaluated omeprazole 8.4% sodium bicarbonate mixtures. In this study omeprazole was stable for 30 days at −20°C and 4°C while the samples stored at room temperature had 8% loss in 14 days and 14% loss in 18 days.…”

Section: Resultsmentioning

confidence: 99%

Compatibility of proton pump inhibitors in a preservative-free suspending vehicle

Polonini¹,

Silva²,

Loures³

et al. 2016

Eur J Hosp Pharm

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ObjectivesTo evaluate the microbiological and physicochemical compatibility of commonly used proton pump inhibitors (PPIs) esomeprazole, lansoprazole, omeprazole and pantoprazole compounded at a single concentration using SyrSpend SF Alka and stored at refrigerated temperatures (omeprazole was also stored at room temperature because it has the most widespread use).MethodsCompatibility was assessed by measuring the per cent recovery at varying time points throughout a 90-day period. Quantification of the APIs was performed by a validated high performance liquid chromatography (HPLC-UV) method. This same assay was also used to determine the dosage content uniformity of the suspensions. Microbiological stability (‘test in use’) was assessed during 60 days and total aerobic microbial count (TAMC), total combined yeasts and moulds count (TYMC), detection of Escherichia coli and pH determination were performed. Antimicrobial effectiveness testing was determined following European Pharmacopoeia guidelines.ResultsBeyond-use dates of maximum 60 days for omeprazole (5 mg/mL), pantoprazole (3 mg/mL) and esomeprazole (3 mg/mL) were established. All suspensions that met the physicochemical criteria for stability also met the content uniformity criteria. The suspensions showed no antimicrobial efficiency against bacteria, yeasts and moulds as SyrSpend SF Alka is an unpreserved vehicle, but the ‘test in use’ showed that the suspensions can remain microbiologically stable for up to 60 days.ConclusionsSyrSpend SF Alka can be used to compound palatable (taste-masking properties) preservative-free oral suspensions with almost all commonly used PPIs.

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“…The preparation formed a milky white suspension with a final omeprazole concentration of 2 mg/mL. The suspension was stable for 14 days at 24˚C and for 30 days at 5˚C and -20˚C, 26 and maintained greater than 90% potency at room temperature for 7 days. 23 Quercia et al 26 recently published a procedure to extemporaneously compound 100 mg (50 mL) of omeprazole liquid.…”

Section: Methods Of Administrationmentioning

confidence: 99%