title: A freeze-stable formulation for DTwP and DTaP vaccines.
abstract: Inadvertent vaccine freezing often occurs in the cold chain and may cause damage to freeze‑sensitive vaccines. Liquid vaccines that contain aluminum salt adjuvants are particularly vulnerable. Polyol cryoprotective excipients have been shown to prevent freeze damage to hepatitis B vaccine. In this study, we examined the freeze-protective effect of propylene glycol on diphtheria-tetanus-pertussis-whole-cell (DTwP) and acellular (DTaP) vaccines. Pilot lots of DTwP and DTaP formulated with 7.5% propylene glycol underwent 3 freeze-thaw treatments. The addition of propylene glycol had no impact on pH, particle size distribution, or potency of the vaccines prior to freeze-thaw treatment; the only change noted was an increase in osmolality. The potencies and the physical properties of the vaccines containing cryoprotectant were maintained after freeze-thawing and for 3 months in accelerated stability studies. The results from this study indicate that formulating vaccines with propylene glycol can protect diphtheria-tetanus-pertussis vaccines against freeze damages.
authors: a Wuhan Institute of Biological Products ; Wuchang , Wuhan , People's Republic of China.
authors: Honggang
authors: H
authors: Xue
authors: Bangling
authors: B
authors: Yang
authors: Debra D
authors: DD
authors: Kristensen
authors: Dexiang
authors: D
authors: Chen
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000737:chemistry*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000737:chemistry*; D004355:Drug Stability; D005615:Freezing; D010316:Particle Size; D019946:Propylene Glycol / Q000737:chemistry
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D019946:Propylene Glycol
keywords: cold chain; formulation; potency; protection; stability; vaccine freezing