Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products.

Evaluating the in-use stability of a biological product including its compatibility with administration components allows to define handling instructions and potential hold times that retain product quality during dose preparation and administration. The intended drug product usage may involve the dilution of drug formulation into admixtures for infusion and exposure to new interfaces of administration components like intravenous (iv) bags, syringes, and tubing. In-use studies assess the potential impact on product quality by simulating drug handling throughout the defined in-use period.

Effect of chain length on binding of fatty acids to Pluronics in microemulsions.

We investigated the effect of fatty acid chain length on the binding capacity of drug and fatty acid to Pluronic F127-based microemulsions. This was accomplished by using turbidity experiments. Pluronic-based oil-in-water microemulsions of various compositions were synthesized and titrated to turbidity with concentrated Amitriptyline, an antidepressant drug.

Determination of drug and fatty acid binding capacity to pluronic f127 in microemulsions.

We propose that one can deduce very insightful information regarding the drug and fatty acid binding capacity of microemulsions through simple turbidity experiments. Pluronic F127-based oil-in-water microemulsions of various compositions were synthesized and titrated to turbidity with concentrated amitriptyline, an antidepressant drug. We observed that, above certain Pluronic F127 concentrations, turbidity was never observed, irrespective of how much amitriptyline was added to the microemulsion.

Anesthetic properties of a propofol microemulsion in dogs.

Microemulsions of propofol with nanometer droplet diameter are alternatives to soybean macroemulsions for inducing anesthesia, and may have important advantages. We used a propofol (10 mg/mL) microemulsion (particle diameter 24.5 +/- 0.

Preparation and anesthetic properties of propofol microemulsions in rats.

Background: The lipophilicity of propofol has required dispersion in a soybean macroemulsion. The authors hypothesized that the anesthetic properties of propofol are preserved when reformulated as a transparent microemulsion rather than as a turbid macroemulsion and that the dose-response relation can be selectively modified by altering the microemulsion's surfactant type and concentration.

Methods: Microemulsions of propofol were formulated using purified poloxamer 188 (3%, 5%, 7%), and sodium salt of fatty acids (C(8), C(10), C(12)) in saline and characterized using ternary/binary diagrams, particle sizing, and stability upon dilution.

Process model and economic analysis of itaconic acid production from dimethyl succinate and formaldehyde.

A complete process model and economic analysis has been developed for itaconic acid production via catalytic condensation of dimethyl succinate and formaldehyde. The process model is based on experimental yields and selectivities obtained for the condensation reaction and on recovery schemes for itaconic acid developed in our laboratory. For an 18 million kg/yr (40 million lb/yr) itaconic acid production facility with a 10-year lifetime, the model predicts a capital investment of $40 million and an itaconic acid selling price of $2.