Stability of pantoprazole in an extemporaneously compounded oral liquid

Dentinger, Paul J.; Swenson, Chad F.; Anaizi, Nasr H.

doi:10.1093/ajhp/59.10.953

Cited by 25 publications

(16 citation statements)

References 0 publications

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“…This was superior to the findings of Dentinger et al 56 who studied pantoprazole 2 mg/mL oral suspensions extemporaneously prepared from tablets, sterile water and sodium bicarbonate.…”

Section: Resultsmentioning

confidence: 55%

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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“…This was superior to the findings of Dentinger et al 56 who studied pantoprazole 2 mg/mL oral suspensions extemporaneously prepared from tablets, sterile water and sodium bicarbonate.…”

Section: Resultsmentioning

confidence: 55%

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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“…Crushing the medications subverts the intention of the formulators because the drug is then inactivated by gastric acid. 51 , 52 …”

Section: Biopharmaceutical Considerationsmentioning

confidence: 99%

Oral drug therapy in elderly with dysphagia: between a rock and a hard place!

Logrippo¹,

Ricci²,

Sestili

et al. 2017

CIA

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Demographic indicators forecast that by 2050, the elderly will account for about one-third of the global population. Geriatric patients require a large number of medicines, and in most cases, these products are administered as solid oral solid dosage forms, as they are by far the most common formulations on the market. However, this population tends to suffer difficulties with swallowing. Caregivers in hospital geriatric units routinely compound in solid oral dosage forms for dysphagic patients by crushing the tablets or opening the capsules to facilitate administration. The manipulation of a tablet or a capsule, if not clearly indicated in the product labeling, is an off-label use of the medicine, and must be supported by documented scientific evidence and requires the patient’s informed consent. Compounding of marketed products has been recognized as being responsible for an increased number of adverse events and medical errors. Since extemporaneous compounding is the rule and not the exception in geriatrics departments, the seriousness and scope of issues caused by this daily practice are probably underestimated. In this article, the potential problems associated with the manipulation of authorized solid oral dosage forms are discussed.

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“…58,59 Coadministration with food has no effect on pantoprazole pharmacokinetics. [57][58][59] Neither food nor antacids altered the bioavailability of pantoprazole. The t max is highly variable and may increase when pantoprazole is given with meals.…”

Section: Moxifloxacinmentioning

confidence: 99%