Post-reconstitution Stability of Telavancin with Commonly Used Diluents and Intravenous Infusion Solutions

Publication date: Available online 5 November 2015 Source:Current Therapeutic Research Author(s): Zhengtian Gu, Carlos Parra, Anissa Wong, Alice Nguyen, Ronnie Cheung, Thomas Catalano Purpose The post-reconstitution chemical stability and microbial challenge hold-time of nonpreserved telavancin for injection was determined using common reconstitution diluents and intravenous (IV) infusion solutions stored at room temperature with light (ambient) or at 2°C–8°C without light (refrigeration). Methods Telavancin was reconstituted with 5% dextrose (D5W), 0.9% normal saline (NS), or sterile water (15 mg/mL). Infusion solutions at 0.6 mg/mL and 8.0 mg/mL were prepared in ViaFlex (polyvinyl chloride) IV bags using D5W, NS, or Lactated Ringer’s. Chemical stability was evaluated for up to 14 days under refrigeration and for up to 3 days under ambient conditions. Telavancin concentration and degradant levels were determined using a stability-indicating high-performance liquid chromatography method. Solutions were subjected to microbial-challenge testing for up to 48 hours (ambient) or for up to 6 days (refrigeration). Findings All reconstituted or infused telavancin solutions met the prespecified stability acceptance criteria after 2 days under ambient and minimum 7 days under refrigeration. Following inoculation with Gram-positive and -negative microorganisms, telavancin infusion solutions stored under ambient reduced or inhibited populations of all organisms ...
Source: Current Therapeutic Research - Category: Drugs & Pharmacology Source Type: research