Stability of diazepam rectal gel in ambulance-like environments.

The objective of the present study was to evaluate the stability of diazepam rectal gel (Diastat) in various conditions of temperature and light exposure as might be found in ambulances. Three lots of Diastat (Xcel Pharmaceuticals, San Diego, CA) in various fill/syringe configurations were evaluated in controlled conditions of a freeze-thaw cycle, hard freeze (-30 degrees C for 72 hours), extreme light exposure (1,000 ft candles for 1 month), and long-term evaluation at either 30 degrees C or 40 degrees C. In the various configurations and tests, diazepam concentration always exceeded 95% of label, with no changes of note in excipients or physicochemical properties.

Identification of antioxidants for prevention of peroxide-mediated oxidation of recombinant human ciliary neurotrophic factor and recombinant human nerve growth factor.

Peroxides present in non-ionic surfactants used to stabilize certain recombinant protein formulations (e.g. polysorbate 80) can result in the oxidative degradation of proteins.

Stability of interleukin 1 beta (IL-1 beta) in aqueous solution: analytical methods, kinetics, products, and solution formulation implications.

The thermal stability of IL-1 beta in aqueous solution as a function of temperature (5-60 degrees C), pH (2-9), buffer (acetate, citrate, tris, and phosphate), and cyroprotectants (sugars, HSA) was investigated in this study. The analytical methodologies included RP-HPLC, SEC, ELISA, IEF-PAGE, SDS-PAGE, and bioassay. The degradation and inactivation of IL-1 beta at or above 39 degrees C were attributed to autoxidation of the two cysteine residues in the denatured protein, followed by hydrophobic/covalent aggregation and precipitation.

Quantitative evaluation of the stability and delivery of interleukin-1B by infusion.

The stability and delivery of IL-1 beta has been characterized in a polypropylene based syringe pump infusion system and in polyvinyl chloride based infusion bags, at concentrations ranging from 100 ng/mL to 1 microgram/mL. At higher concentrations (1 microgram/mL), minimal drug loss was observed in both systems. At low doses (100 ng/mL) in the syringe-pump system, the addition of 1% human serum albumin was necessary to prevent significant drug absorption to the polypropylene drug reservoir.

Development and characterization of a lyophilized dosage form of IL-1 beta.

The development and characterization of a lyophilized dosage form for recombinant Interleukin-1 beta is described. Included in the evaluation of the drug product are accelerated and long-term stability studies utilizing a number of biophysical techniques (reverse-phase HPLC, SDS-PAGE, isoelectric focusing and ELISA). Data collected with these methods were examined for correlations with biological activity assessments provided by an in-vitro cell culture system (mouse thymocyte proliferation).