Manufacturing of Formulations and Dosage Forms

Agere manufactures a variety of liquid and solid dosage forms. Our capabilities include spray drying, melt extrusion, lipid based formulations, milling and other standard processes. We offer a complete set of solid dosage form manufacturing services including suspensions, capsules, tablets, and liquid formulations. Our detailed attention to quality is paramount to all of our manufacturing processes and associated analytical methodologies.

Manufacturing of Solid Dispersions

Agere uses a standard, broadly applicable spray drying process to manufacture the majority of customer API into solid dispersions. In some cases, based on API physical properties or Customer preference, a melt-extrusion process is utilized as well.

Spray drying is a standard highly scalable, commercially demonstrated process in the pharmaceutical industry. Agere uses standard USP/NF excipients and ICH Class II /III solvents for all formulation manufacturing. Process design begins with a detailed understanding of the solubility of API in a range of organic solvents with the goal of selection of the preferred solvent system to obtain maximum yield and particle size and morphology. Agere then uses standard process engineering design methods to select spray drying process variables, such as input temperature, spray solution flow rates, and nozzle selection. This methodology results in a robust process leading to a robust formulation.