Abstract

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

Page(s): 432-436

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  • In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Page 1
  • In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Page 2
  • In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Page 3
  • In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Page 4
  • In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Page 5

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

  • 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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