Tablets drug physical stability

The hydration state of risedronate sodium was monitored continuously in a fluidized bed dryer and correlated to data on the physical stability of tablets made from the monitored material [275]. The final granulation moisture was found to affect the solid-state form, which in turn dictated the drug s physical stability over time. The process of freeze-drying mannitol was monitored continuously with in-line Raman and at-line NIR spectroscopies [276]. The thin polymer solvent coatings, such as poly(vinyl acetate) with toluene, methanol, benzene, and combinations of the solvents, were monitored as they dried to generate concentra-tion/time profiles [277]. 

D.S. Hausman, R.T. Cambron and A. Sakr, Application of on-line Raman spectroscopy for characterizing relationships between drug hydration state and tablet physical stability, Int. J. Pharm., 299, 19-33 (2005). 

David, S.T. Galhan, C.E. The effect of environmental moisture and temperature on the physical stability of effervescent tablets in foil laminate package containing minute imperfections. Drug Dev. Ind. Pharm. 1986,12, 2541-2550. 

P.K. Shiromani and J.F. Bavitz, Effect of moisture on the physical and chemical stability of granulations and tablets of the angiotensin converting enzyme inhibitor, enalapril maleate. Drug Dev. Ind. Pharm., 12 (1986) 2467. 

Formulation design is based on the physical, chemical, and biopharmaceutical properties of a drug substance. A formulation for direct compression is composed of active pharmaceutical ingredients and other inactive ingredients such as fillers, binders, dis-integrants, flow aids, and lubricants. Simplicity is the basis of good formulation design. Minimally, a direct compression tablet formulation must meet requirements for manufacturability, uniformity of dose, physical and chemical stability, appropriate dmg release profiles, and bioavailability. In addition, the formulation must meet many quality standards and special requirements to ensure the efficacy and safety of the product. 

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