Excipient process AIDS

Formulation of dry powders for inhalation must rely on a very short list of excipients to fulfill the customary roles of diluent, stabilizer, solubilizer, processing aid, and property modifier (e.g., flow enhancer). In the United States, only a few materials are approved for use in inhalation products, and of those (e.g., propellants, surfactants) many are of little help in dry powder formulation. 

The vast majority of medicinal products are manufactured by high-speed, largely automated processes for reasons that are related as much to safety and quality as to cost of goods. Excipients that aid in processing include the following ... 

Process aids do not usually contribute to the performance of the dosage form in terms of quality or in vivo performance. Indeed, lubricants, because of their hydrophobic nature, can hinder disintegration and dissolution of solid dosage forms unless the level and mode of incorporation is carefully characterized and controlled. Thus, in addition to drug-excipient interactions, the potential for interexcipient competition and incompatibility must be considered and studied. 

A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling materials. 

In order to develop a reproducible manufacturing process, attention must be given to particular instructions and screening procedures. For instance, excipients should be free of lumps and proper screening will aid raw material dispersion. Additionally, one should specify the size and design of containers and all equipment to be used. 

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