Homogeneity of pharmaceutical dispersed systems

Abstract

Abstract Pharmaceutical dispersions include an extremely important group of formulations for the administration of drugs. A consideration of the homogeneity or dose uniformity requirements of some pharmaceutical dispersions, including tablets, capsules, ointments, suspensions, lotions, emulsions and suppositories is given. Assessment of homogeneity, assuming possible required limits of dose conformity, enables a calculation of the particle size requirements. These may be limited by parameters other than homogeneity, for example, sedimentation in suspensions and physical stability of emulsions. The concept of homogeneity applied to these systems is useful for following the progress of powder mixing or other dispersion operations. It is also useful in examining the feasibility of achieving the desired degree of dispersion. Dose conformity could be an extremely important problem in some cases, where standards do not exist.