Stability of Omeprazole Mixtures: Implications for Paediatric Prescribing

Abstract

Background: Commercial omeprazole paediatric mixtures are not available. The stability of omeprazole mixtures prepared from Probitor capsules or omeprazole powder has not been established. Aim: To determine the physicochemical stability of two omeprazole mixtures, prepared from Probitor capsules or omeprazole powder BP, over a 45-day period under refrigeration or at room temperature, shaken or unshaken. Method: Omeprazole 2 mg/mL mixtures were prepared using standard procedures by either emptying the contents of Probitor capsules or by adding omeprazole powder to preserved sodium bicarbonate 8.4% solution. Each formulation was stored in 100 mL amber glass bottles under refrigeration (2-8

Comparative Stability of Compounded Omeprazole Suspension Versus Commercial Omeprazole Kit When Stored in Oral Syringes Under Refrigerated Conditions

“…25 The only published study looking at a compounded preparation stability with a preservative (1% methyl hydroxybenzoate) noted a 45-day refrigerated stability in bulk amber glass bottles. 10 Furthermore, the inclusion of agents in the kit meant to maximize particle dispersion may have also positivity affected stability, as products with nonuniform drug distribution have been shown to reflect lower API recover following compounding. 10 The use of clear oral syringes may have negatively affected omeprazole stability, as exposure to ambient light did occur during syringe filling and sampling.…”

“…10 Furthermore, the inclusion of agents in the kit meant to maximize particle dispersion may have also positivity affected stability, as products with nonuniform drug distribution have been shown to reflect lower API recover following compounding. 10 The use of clear oral syringes may have negatively affected omeprazole stability, as exposure to ambient light did occur during syringe filling and sampling. Several investigators who utilized amber container systems note a 45-day refrigerated stability, [9][10][11] and general light sensitivity has been reported by Phillips et al 26 Furthermore, several investigators report a color change in compounded suspensions (yellow, brown) that may develop with extended storage or exposure to light.…”

“…10 The use of clear oral syringes may have negatively affected omeprazole stability, as exposure to ambient light did occur during syringe filling and sampling. Several investigators who utilized amber container systems note a 45-day refrigerated stability, [9][10][11] and general light sensitivity has been reported by Phillips et al 26 Furthermore, several investigators report a color change in compounded suspensions (yellow, brown) that may develop with extended storage or exposure to light. [8][9][10][11]24,26 Design of the NG tube experiment was modeled after published studies for NG tube administration of fidaxomicin, tedizolid, and rivaroxaban.…”

“…7 Specific findings of previous studies are found in Table 1. [8][9][10][11][12][13] Nasogastric tube administration adds another layer of complexity. Suspensions containing PPIs are often formulated as intact granules or granulates for suspension to overcome acid degradation in the stomach.…”

Paedpharm: Paediatric Pharmacy Network

“…Discussion on the stability and suitability of liquid formulations are often posted and has led to the undertaking of stability studies. 5 Other queries included: clindamycin suspension, cysteamine eye drops and expiry dates for oral formulations. Information was shared on formulations licensed overseas, in short supply or discontinued in Australasia, e.g.…”