Chemical Stability of Telavancin in Elastomeric Pumps

Publication date: Available online 22 October 2015 Source:Current Therapeutic Research Author(s): Patrick Sand, Traci Aladeen, Paul Kirkegaard, Dennis LaChance, Christine Slover Purpose To evaluate the chemical stability of telavancin ([VIBATIV®] – Theravance Biopharma US, Inc.), a lipoglycopeptide antibiotic with activity against methicillin-resistant Staphylococcus aureus, in 2 types of elastomeric pumps, the Intermate® Infusion System (Baxter International Inc.) and the Homepump Eclipse® (I-Flow Corporation). Methods Different sizes of the Baxter (105 mL and 275 mL) and I-Flow (100 mL and 250 mL) pumps were compared with glass controls. Telavancin drug product was reconstituted and diluted to concentrations of 0.6 mg/mL and 8.0 mg/mL using either A) 0.9% saline, B) 5% dextrose in water, or C) sterilized water for injection (0.6 mg/mL telavancin) or saline (8.0 mg/mL telavancin) followed by lactated Ringer’s solution. Pumps were filled and stored at 2–8°C, protected from light. Aliquots from both pump types and for all telavancin reconstitution/dilution schemes and concentrations were taken over a period of 8 days and analyzed for appearance, pH, telavancin concentration and purity, and degradation products. Findings The pH of all pump solutions remained consistent throughout the 8-day analysis period, within a range of 4.6–5.7 for the 0.6 mg/mL and 4.4–4.9 for the 8.0 mg/mL telavancin solutions. There was no significant change in the chromat...
Source: Current Therapeutic Research - Category: Drugs & Pharmacology Source Type: research