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In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers

Author(s):  Bhattacharya Sisir,Parekh Satish,Dedhiya Mahendra

Issue:  Sep/Oct 2015 - Volume 19, Number 5
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Abstract:  The objective of this study was to determine in-use stability of ceftaroline fosamil infusion solution of concentrations up to 12 mg/mL in elastomeric home infusion system prefilled with 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP and MINI-BAG Plus Container delivery devices prefilled with 0.9% sodium chloride injection. In-use ceftaroline fosamil infusion solution (12 mg/mL) was prepared for elastomeric home infusion systems (Homepump Eclipse, Baxter Intermate, and AccuRx Elastomeric Pump) prefilled with either 0.9% sodium chloride injection or 5% dextrose; or Baxter MINI-BAG Plus Containers pre-filled with 0.9% Sodium Chloride Injection USP (4 mg/mL to 12 mg/mL ceftaroline fosamil in final solution). The systems were stored refrigerated for 24 hours followed by up to 6 hours of storage at room temperature. Samples were analyzed at various time points for assay and degradation product by a validated stability-indicating high-performance liquid chromatography method. In-use ceftaroline fosamil infusion solution, ranging from 4-mg/mL to a maximum of 12-mg/mL concentration, in elastomeric home infusion systems prefilled with 0.9% sodium chloride injection or 5% dextrose, and MINI-BAG Plus Containers prefilled with 0.9% sodium chloride injection were chemically stable for up to 24 hours refrigerated at 2°C to 8°C (36°F to 46°F) and up to 6 hours at room temperature and had acceptable compatibility with material used. Ceftaroline fosamil (4 mg/mL to 12 mg/mL) maintains its potency for up to 24 hours refrigerated at 2°C to 8°C (36°F to 46°F) and up to 6 hours of storage at room temperature upon reconstitution in infusion solution with 0.9% sodium chloride or 5% dextrose when used in elastomeric home infusion system and MINI-BAG Plus Containers delivery devices prefilled with 0.9% sodium chloride injection.

Related Keywords: Sisir Bhattacharya, PhD, Satish Parekh, MS, Mahendra Dedhiya, PhD, ceftaroline fosamil, elastomeric home infusion system, MINI-BAG Plus containers, skin infections, acute bacterial skin and skin structure infections, ABSSSI, cephalosporin ceftaroline prodrug, antimicrobial agent, antibacterial agent, difficult-to-treat pathogens, beta-lactam antibiotic, continuous infusion, in-use stability, storage temperature, diluent

Related Categories: INFUSION, PACKAGING, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, INFECTIOUS DISEASE, STORAGE

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