Oral solids content uniformity

Each of the aforementioned techniques is capable of measuring powder that would be used in low-dose, solid oral dosage formulations. The technique must be compatible with the drug substance, and must be capable of producing the information that is needed. For example, if the particle size distribution is needed to ensure dose content uniformity, photon correlation spectroscopy can only provide an average particle size. In this instance, laser diffraction or image analysis would be more suitable techniques. Table 13.1 contains a comparison of the techniques that have been discussed. 

In the critical variables analysis phase, a statistical experimental design is created (e.g., factorial, Box-Behnken) intended to assess critical formulation and process variables in relatively small-scale manufacture. In these studies, the ranges of composition variables are chosen to at least encompass those noted in the recommendations of the AAPS-FDA Workshop on Scale-up of Immediate Release Oral Solid Dosage Forms or SUP AC. This phase is usually preceded by a development phase during which variables and levels to be studied are determined and the exact method of manufacture is established. Experimental formulations are assessed at least in terms of dissolution performance, content uniformity, and weight variation. On the basis of these studies, the specific formulations to be manufactured for biostudy are selected. 

Rosen, J. M., O Leary, M., Eotino, W, Ryall, R. R., and Gehrlein, L. PyTechnology robotic sample preparation procedures for potency and content uniformity analysis of ceflxime, an orally active cephalosporin solid dosage form. Adv. Lab. Autom. Rob. 5 363-379, 1989. 

Cachet Capsule Herbal tea Powder Formulation Preparation Solid dosage form Tablet Content uniformity Excipients Adapting oral dosage forms... 

H. Mark, G. E. Ritchie, R. W. Roller, E. W. Ciurczak, C. Tso, and S. A. MacDonald, Validation of a Near-Infrared Transmission Spectroscopic Procedure. Part A. Validation Protocols, /. Pharm. Biomed. Anal, 28,251 (2002). G. E. Ritchie, R. W. Roller, E. W. Ciurczak, H. Mark, C. Tso, and S. A. MacDonald, Validation of a Near-Infrared Transmission Spectroscopic Procedure. Part B. Application to Alternate Content Uniformity and Release Assay Methods for Pharmaceutical Solid Dosage Forms, /. Pharm. Biomed. Anal, 29,159 (2002). M. Blanco, M. Bautista, and M. Alcala, API Determination by NIR Spectroscopy across Pharmaceutical Production Process, AAPS PharmSciTech, 9,1130 (2008). A. Peinado, J. Hammond, and A. Scott, Development, Validation and Transfer of a Near Infrared Method to Determine In-Line the End Point of a Fluidised Drying Process for Commercial Production Batches of an Approved Oral Solid Dose Pharmaceutical Product, /. Pharm. Biomed. Anal, 54,13 (2011). 

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