Particle size specification of pharmaceutical powders is important in the manufacture of solid oral dosage forms due to significant impact of particle size on the safety and efficacy of the drug product so it should meet the regulatory requirement. In the manufacture of solid oral dosage forms, control of particle sizes is only taken into consideration for the drug substances with low solubility. Particle sizes of powders have clear influences on, not only drug product performance (e.g., dissolution, content uniformity and stability etc.) but also drug product manufacturability (e.g., flowability, blend uniformity, compactibility etc.). This Review article gives detailed information about how the particle size specifications are helpful in establishing drug product quality and manufacturing consistency, about the various methods for particle size specification such as Analytical Procedures, Method Validation, and Acceptance Criteria.
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