Physical stability of tablets

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]. 

THE USE OF A FACTORIAL DESIGN TO EVALUATE THE PHYSICAL STABILITY OF TABLETS AFTER STORAGE UNDER TROPICAL CONDITIONS... 

The studies described in this chapter are restricted to the physical stability of tablets. Physical properties that are of interest are e.g. crushing strength, friability, disintegration time and dissolution profile. One of the causes of... 

Section 8.2 describes the feasibility of the use of the Storage to Initial Ratio as a measure to express the physical stability of tablets. By expressing the stability as the relative value after storage related to the initial value, it is... 

Since the aim of this study was to evaluate the use of the change in the tablet properties during storage as a parameter to express the physical stability of tablet formulations, the Storage to Initial Ratio of the crushing strength (SIR(S)) and of the disintegration time (SIR(D)) were calculated and used as response values for equation (2). The calculations of SIR(S) and SIR(D) were performed as in equation (1). The mean of the measurements directly after preparation were used as initial value. 

Since the SIR of disintegration time after storage depends on the compression load as well as on the disintegrant concentration, these factors should both be taken into account, when the SIR of disintegration time is used as a measure for the physical stability of tablets after storage, in the developing stage of tablet formulations. 

P. York, A preliminary study of the physical stability of tablets prepared from powders stored under tropical conditions. Pharm., 31 (1976) 383. 

Bos CE, Bolhuis GK, Smilde AK, DeBoer JH. The use of a factorial design to evaluate the physical stability of tablets after storage under topical conditions. In Hendriks MMWB, DeBoer JH, Smilde AK, eds. Robustness of analytical chemical methods and pharmaceutical technological products. Amsterdam Elsevier, 1996 309-341. 

Nokhodchi A, Javadzadeh Y (2007) The effect of storage condition on the physical stability of tablets. Pharm Technol Eur 19 January 1. 

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