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Figure 2. The utility of the Raman method was demonstrated by evaluating the effect of these conditions on the Quantitative Analysis of Crystallization During Tablet physical stability of the amorphous SDI of ibipinabant Stability Studies after manufacture in the form of a low dose tablet The current International Conference on Harmoniza- for 6 months.

Bottom Calculated degree of crys- tallinity of intact tablet with a 1. Percent- ing the conversion to the crystalline form. Middle RMSECV values calculated for crystallinity tallinity in the tablet at 3 and 6 months by using the modeling in tablets based on Raman spectra.

In general, increases in crystallinity were observed correlating to increases in temperature and humidity. A significant increase in crystallinity amorphous form in the tablet.

Higher RH and tempera- cess. The intact tablet samples were tested after 3 and ture accelerated the transformation even though the 6 months in both closed induction sealed containers compound is very hydrophobic. In contrast, the SDI and open dish conditions. This difference in the crystallization Typical domain sizes range from about 5—20 :m. In general, the tablet, XY 2D micro-Raman spectroscopy map- the micro-Raman results are consistent with the ob- ping was conducted at drug-rich locations on the sur- served trends observed from FT Raman analysis and face of the tablet for each stability storage condition.

The data were analyzed based on the band po- detecting the crystalline form in the product. All these attributes can be affected by solid- served for the pure amorphous and crystalline spec- state phase transformation processes such as crystal- tra.

Figure 5 shows the results of XY Raman map- lization of an amorphous phase. There were no significant dif- talline form evidenced by only seeing the green areas. In addition, no significant increases be explained on the basis of the amount of the recrys- in chemical degradation or presence of impurities tallization, which occurred after 3 months storage as were observed.

A discriminating dissolution method determined by the Raman spectroscopy method. Figure 6 shows the dissolution profiles at each stabil- The recrystallization kinetics of ibipinabant in the ity storage condition after 3 months and is compared formulation was conducted as follows. A ground tablet the crystalline form of ibipinabant. The FT Raman spectrum of the with decreasing release profiles correlating with in- SDI showed no significant change during the duration creasing levels of crystalline conversion.

The fastest of the experiment, suggesting that it remained as a and most complete dissolution profiles were seen for stable amorphous form. Crystallization usually involves RH closed , significant changes in the dissolution pro- a two-step process of nucleation and growth.

Recrys- Figure 6. Calculated degree of crystallinity and dissolution profile of intact tablet with a 1. Various nucleation mechanisms are known such as sporadic random nucleation and in- stantaneous nucleation. In sporadic nucleation ther- mal , the nuclei are formed continuously linearly with first-order time dependence. In instantaneous nucleation athermal , all the nuclei that are to ap- pear will appear at one time with zero-order time dependence. Crystal growth proceeds on the nuclei as soon as they are formed.

Crystal growth dimen- sion, m, is either, one, two, or three corresponding to rod-like unidimensional , disk-like bidimensional , and spherulitic tridimensional crystal habitat, re- spectively.

According to the model, the rate of crystallization growth rate and the dimensionality of the growth in the model are assumed to be lin- ear and constant.

The parameters n and k can be used to interpret qualitatively the nucleation mech- anism, morphology, and overall crystallization rate of the drug in the formulation. Table 3 describes the crystal growth dimensions for different values of n for sporadic and instantaneous nucleation mechanisms.

The values of k and n can graphically be determined by the classical double-logarithm expression of Eq. Figure 7. Bottom Calculated crystallization profile, conversion ver- The slope corresponds to the Avrami exponent, n. In contrast, the SDI showed no detectable increase in re- crystallization over the duration of the experiment.

A lag time between the beginning of the experiment and the first detection of recrystallization was observed and is estimated to be between 50 and 60 h. The total time for the water vapor absorption process was deter- mined to be complete within 10 h for the sample and does not fully account for the observation. Therefore, we define this period as the induction time tind as- sociated with the actual nucleation process random mechanism or the slow growth of germ nuclei in- stantaneous mechanism.

This is the time required for the generation of nuclei that will be transformed into fully active growth nuclei and identified here as the time interval prior to conforming to the Avrami kinetics.

The crystal growth behavior of amorphous ibipinabant in the tablet formulation and in the SDI can be followed by spectral changes in the FT Ra- man spectra. To clarify the kinetic mechanism of re- crystallization of amorphous ibipinabant, the fraction of crystallization was evaluated based on the Raman method and kinetic parameters were evaluated based on the Avrami solid-state kinetic equation.

In Figure 8 top , the crys- tallized fraction was plotted against time using the linear expression of the JMA equation Eq. The value of the Avrami exponent, n, was found from the slope. Figure 8 middle shows the experimental data and fit of Eq 3 using the derived value of n, for crystal- lization at room temperature in the conversion range 0. The value of the rate constant, k, was found from the slope.

The results are shown in Table 4. Figure 8. Top Crystallization data plotted using the The correlation coefficients R2 were greater than classical double logarithm Avrami plot for determination 0. Bottom Comparison between experimen- tal data and model prediction during crystallization. Figure 8 bottom shows changes in crystallinity over time corrected by the recrystallization of amorphous ibipinabant solubi- induction time.

The solid line represents the fitted lized in a lipid based semisolid microemulsion system Avrami curve according to Eq. Optical microscopy observation of the bant in the low dose drug product. Table 4. Thorough characterization of the kinetics can also en- hance the fundamental understanding of the underly- ing crystallization process.

These results demonstrate the utility of Raman spectroscopy and multivariate analysis for detection and monitoring the physical stability of ibipinabant in a very low dose product during stability storage. This installment of Progressive Grind features classics with a dash of current progressive flavor. This episode made it's resurgence from the archives.

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