Review Article

A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations

Table 1

The stability of oral liquid extemporaneous preparations compounded from commercially available formulations.

Author, year (references)Study areaMethod of chemical stability testSource drug for extemporaneous formulationStorage conditions of extemporaneous formulationStability result of oral extemporaneous liquid formulation
Chemical stability resultPhysical stability resultMicrobiological stability study

Alemón-Medina et al., 2015 [5]MexicoUPLC-UVMetformin tablet25 ± 2°C by exposing to light and dark, 4°C in the dark, and 40°C in the dark for 30 daysStable at all storage conditions (>90% of the initial amount)
(i) No change in pH
Stable (no change in color, no foreign particles, and no turbidity)
Alemon-Medina et al., 2012 [6]MexicoUPLC-UVGlucophage® tablets (metformin)25 ± 2°C by exposing to light and dark, 4°C in the dark, and 40°C in the dark for 30 daysStable (>90% of its initial content)Physically stable for 30 daysStable (no apparent bacterial or yeast growth)
Ali et al., 2016 [11]The United Arab EmiratesUV-spectrophotometerFurosemide tablet4 and 25°C for 90 daysStable (>98%)Stable (no change in viscosity, color, odour, and dispersibility)Stable (no apparent bacterial)
Boscolo et al., 2020 [12]ArgentinaHPLCOmeprazole pelletsStored in 4°C and 25°C temperature for 150 days(i) At 4°C, stable for at least 150 days
(ii) Stable for 14 days at 25°C
(iii) No change in pH
(i) Physically stable (no change in color, redispersibility, and flavor)Stable (no contamination of E. coli, fungi, and yeast was observed)
Buontempo et al., 2010 [13]ArgentinaHPLCCarvedilol tablet4, 25, and 40°C for 56 days(i) Stable at all temperatures (>99%)
Buontempo et al., 2013 [14]ArgentinaHPLCClobazam tablets4 and 25°C for 56 daysStable (>98%)Stable
Casas et al., 2015 [15]SpainHPLCPure drug of enalapril and captopril5, 25, and 40°C for 90 days(i) Stable only for 50 days at 50C(i) Stable in consistency
Freed et al., 2005 [16]USAHPLCAccupril® tablets (quinapril)−5°C for 28 daysStable (≥90%)
García et al., 2017 [17]ArgentinaUV-spectrophotometryBenznidazole tablets5 and 25°C for 90 daysStable (>99%) and no pH change(i) No detectable changes in color, odour, and viscosityStable
Han et al., 2006 [18]UKTacrolimus pure drug22–26°C for 56 daysStableStable
Helin-Tanninen, 2010 [19]FinlandHPLCNifedipine tabletAt 22°C and 6°C for 28 days(i) Stable when protected from light, whereas on exposure to light, nifedipine degrades rapidly
Juárez Olguín et al., 2008 [20]MexicoHPLCPropafenone tablet15 ± 5°C and at refrigeration (3–5°C) for 90 daysStable (>90%)No color and odour changeStable
Klovrzová, 2016 [21]Czech RepublicHPLCPure sotalolRoom temperature and in a refrigerator for 180 daysStable (>95%)Stable
Klovrzová et al., 2013 [22]Czech RepublicHPLCPropranolol tablet5 ± 3°C and 25 ± 3°C for 180 daysStable at both storage temperaturesStable
Kučerová et al., 2019 [23]Czech RepublicUltra-HPLC method with UV detectionPure omeprazole drug4°C for 15 daysStable
Lafuente et al., 2019 [24]ArgentinaHPLCIndomethacin injectionRoom temperature for 17 daysStableStable (no detectable changes in color, odour, and/or flavor)Stable
Lin et al., 2021 [25]TaiwanHPLCPropafenone hydrochloride tablets2–8°C and room temperature for 90 daysStableStableStable
Mahmoud et al., 2014 [26]SaudiUV-spectrophotometerSpironolactone tabletsRoom temperature for 35 daysStable (>90%)Stable (no appearance change)Stable
Mendes et al., 2013 [27]BrazilHPLCFurosemide, hydrochlorothiazide, and spironolactone tablets25 ± 2°C and 5 ± 3°C for 7 daysStable, except hydrochlorothiazideStableStable
Mohamed‐Ahmed et al., 2017 [28]UKReverse phase HPLC and mass spectrometryPyridoxal 50-phosphate tabletRoom temperature for 24 hoursStable at room temperature (protected from light) after 24 h, but unstable after 4 h when exposed to light.
Pramann et al., 2016 [29]USAUltra-performance liquid chromatography time-of-flight mass spectrometryAripiprazole tablet4°C for 91 daysStable (>90%)No apparent physical changes
Provenza et al., 2014 [30]SpainOptical spectroscopySildenafil tablet4 and 25°C for 90 daysStable (>90%)Stable at 25°C but problem of redispersibility at 4°CStable
Shoosanglertwijit et al., 2011 [31]ThailandHPLCFurosemide tabletGlass bottles are protected from light and stored for 60 days at 4 ± 2°C room temperature (30 ± 2°C) and 3 controlled temperatures of 45°CStable (93%)There was no significant alteration in the appearance (color and consistency) or odour of either formulationStable
Soliman et al., 2014 [32]EgyptHPLCGabapentin tabletAbsence of light at 2–8°C in the refrigerator for 90 daysStable
Sosnowska et al., 2009 [33]PolandHPLCEnalapril tabletAbsence of light at 4 and 25°C for 30 daysStable (98%)No appreciable changes from the initial pH and initial viscosities
Van Der Vossen et al., 2016 [34]NetherlandsHPLC-UVAmlodipine tablet4°C, 25°C, and 40°C for 24 hoursAt 25°C and 40°C, subsequent chemical degradation, but it is stable at 4 0CStable
Zahálka et al., 2018 [35]Czech RepublicHPLCFurosemide25°C ± 3°C or at 40°C ± 0.5°C for 9 monthsStable (>90%)No color, taste, and odour changeStable
Zaid, 2016 [36]PalestineUV-spectrophotometryParacetamol tablet25°C and 40°C for 4 monthsStable (>93%)No change in organoleptic properties was observedStable

NB: dash (—) in the table indicates that data is not available.