Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice.

The internal temperature of a passive thermal shipper employing dry ice as the coolant often decreases to less than the equilibrium sublimation point (-78.5°C) during shipment. In this paper, we demonstrate that in many cases, this unexpected phenomenon is due to excessive sublimation cooling by the dry ice.

The effect of inert atmospheric packaging on oxidative degradation in formulated granules.

Purpose: Oxidative degradation of drug substances in pharmaceutical products is well documented and is thought to occur in many cases via autoxidative processes involving headspace molecular oxygen in the primary package. Reducing the headspace oxygen concentration inside a package could thus be an option for reducing oxidative degradation in pharmaceutical products. The purpose of this study is to examine the effect of headspace oxygen concentration and relative humidity (RH) on the oxidative degradation of a model pharmaceutical formulation.

Pharmaceutical and immunological evaluation of a single-shot hepatitis B vaccine formulated with PLGA microspheres.

A single-shot Hepatitis B vaccine formulation using poly(d,l)-lactide-co-glycolide acid (PLGA) microspheres as a delivery system was examined using a variety of biophysical and biochemical techniques as well as immunological evaluation in C3H mice. PLGA microsphere encapsulation of the Hepatitis B surface antigen (HBsAg), a lipoprotein particle, resulted in good recoveries of protein mass, protein particle conformational integrity, and in vitro antigenicity. Some partial delipidation of the HBsAg, however, was observed.