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

Abstract

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.

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

“…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.…”

“…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. [27][28][29] Passage of the omeprazole products through the various NG tubes did not have a statistically significant impact on omeprazole concentration versus that of samples that were not exposed to the tubes.…”

Stability data of extemporaneous oral suspension of pentobarbital in Syrspend SF Alka for imaging sedation procedure

“…The suspension was thoroughly mixed to obtain a uniform suspension. The method for suspension preparation was based on the general protocol indicated by the vehicle manufacturer [10] . Three identical samples of the formulation were prepared in the original vehicle container with a safety cap and stored at room temperature (25 ± 3 °C) and at refrigerated temperature (5 ± 3 °C).…”

Simultaneous Quantitative Analysis of Six Proton-Pump Inhibitors with a Single Marker and Evaluation of Stability of Investigated Drugs in Polypropylene Syringes for Continuous Infusion Use

“…LPZ is the only PPI with no substitutions on the benzimidazole ring; it has the chemically name 2-[[ Literature survey revealed that there are several HPLC methods available for simultaneous determination of two to five PPIs but there seem to be no reports concerning methods for the simultaneous determination of all six PPIs using HPLC in the commercial pharmaceutical preparations. [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] At present, the simultaneous determination of multi-components by the external standard methods needs many expensive standard substances, lower selectivity, and a lot of time, thereby limiting its application. Quantitative analysis of multi-components by a single marker (QAMS), is an economical, convenient and environmentally sound method that simultaneously determines the concentrations of multi-components by a single reference standard.…”