An alternative approach to adjustment of the level of incorporation of boundary lubricants to accommodate changes in granule or blend characteristics

摘要

A method is proposed whereby the determination of the level of incorporation of a boundary lubricant is based on the surface area of the blend or granulation and the shape of the lubricant particles. This is a more logical approach to the lubrication of blends and granulations for the manufacture of solid oral dosage forms than the percentage by weight approach that has traditionally been used. Equations are provided to allow the adjustment of the level of incorporation of the boundary lubricant based on the variation in the surface area of the granulation or blend. This method has potential application in the manufacture of solid oral dosage forms by both batch and continuous processing. The concept of lubricant coverage is relevant to the development of solid oral dosage forms using Quality by Design principles, since certain changes in the granulation or blend characteristics on scale-up would be compensated for, and the use of grade bracketing strategies would be facilitated.