<p>An investigation of the stability of meropenem in elastomeric infusion devices</p>

Abstract

Purpose To evaluate the stability of meropenem trihydrate in elastomeric infusion devices at a range of selected concentrations (6, 12, 20 and 25 mg/mL) at ambient, refrigeration and freezing temperatures. Methods Meropenem Ranbaxy ® (meropenem trihydrate equivalent to anhydrous meropenem 1 g) vials for injection were reconstituted with 0.9% sodium chloride and adjusted to pH 6.5 using 1 M hydrochloric acid. Following preparation, solutions were stored for 7 days at either 6.7°C in elastomeric infusion devices or at −19°C in glass vials; samples of each concentration were removed from the infusion devices at specific time-points and stored for 24 hrs at 22.5°C. All solutions were assayed at specific time-points using high-performance liquid chromatography. Forced degradation in hydrochloric acid, sodium hydroxide and hydrogen peroxide was carried out at 40°C. Results The lowest concentration of meropenem (6 mg/mL) displayed the highest stability. It maintained >90% of its initial concentration for up to 144 hrs when stored at 6.7°C and 72 hrs following 24 hrs storage at 22.5°C, having been initially refrigerated for 48 hrs. Meropenem 20 mg/mL required immediate administration following preparation under ambient temperatures, whilst meropenem 25 mg/mL did not remain stable following 24 hrs storage at ambient temperatures. Frozen meropenem solutions displayed good stability in all concentrations but were physically unstable due to the formation of a precipitate. Conclusion At lower concentrations, meropenem showed suitable stability for storage and administration in elastomeric infusion devices, at refrigerated temperatures. To enhance the stability of lower concentration solutions when exposed to ambient temperatures by ambulatory patients, a more adept method of maintaining lower temperatures that reflect refrigerated conditions for elastomeric infusion devices should be devised.

Stability of Antimicrobials in Elastomeric Pumps: A Systematic Review

“…The principal characteristics of each antimicrobial group, such as drug, reference [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ], main conditions (composition of the elastomeric device chosen, concentration, diluent, temperature, and duration of storage), chemical and physical stability obtained, and the most relevant comments for the systematic review, are summarized in Table 1 , Table 2 , Table 3 , Table 4 , Table 5 , Table 6 , Table 7 and Table 8 .…”

An investigation of reconstituted terlipressin infusion stability for use in hepatorenal syndrome

“…The second vial was kept in the stability chamber at 22.5 °C for 24 h prior to assay to determine the concentration after 24 h in the chamber. The temperature used for the stability chamber was 22.5 °C and was determined in a previous study by measuring average temperature when an www.nature.com/scientificreports/ infusor was worn by several members of the research team, in a carrying pouch for 24 h, with ice packs changed every 8 h 16 . The same procedure (without pH measurement) was adopted on Days 2 and 3 (24 and 48 h).…”

“…High Performance Liquid Chromatography (HPLC) used a mobile phase consisting of acetonitrile (lot 180372; Fisher Chemical, USA), potassium dihydrogen orthophosphate (batch number 1809274114, expiry 09/2021; Ajax Finechem, VIC, Australia) and orthophosphoric acid 85% (batch number 1076916; Thermo Fisher Scientific, WA, Australia). Water was accessed through a MilliQ Ultrapure Water System (Merck, VIC, Australia) consisting of a four-bowl ultrapure cartridge kit with a conductivity of 0.05 µS, and was used to prepare buffers and standards 16 .…”

“…The HPLC was a Shimadzu Prominence LC-20AT consisting of a Shimadzu Prominence SIL-20ACHT Auto Sampler, a Shimadzu Prominence SPD20A UV Wavelength Detector (Shimadzu Corp, Kyoto, Japan), a Shimadzu DGU-20AC5R Degassing Unit, an Apollo C18 reverse phase column (150 × 4.6 mm, 5 µ particle size; lot 50629864), and Lab Solutions Version 5.85 analytical software (Shimadzu Corp, Kyoto, Japan) 16 .…”

“…Forced degradation studies used hydrochloric acid 36% analytical reagent (Fisher Scientific, UK), hydrogen peroxide 30% analytical-grade (batch number 16082255558; Ajax Finechem Pty Ltd, NSW, Australia), sodium hydroxide pellets (Chem Supply Pty Ltd, SA, Australia) and pH 7 buffer prepared from sodium dihydrogen orthophosphate monohydrate (batch number 16256; Meck, VIC, Australia), and di-sodium hydrogen orthophosphate anhydrous (batch number 11747; BDH Chemicals, VIC, Australia) to test the stability of commercial terlipressin. A Werke EH4.2 water bath (IKA, Germany) was used to maintain water at a constant temperature 50 °C (± 0.2 °C); temperature was measured by a Brannan 76 mm immersion thermometer (Brannan, UK) 16 .…”