Tablets disintegration time

Fig. 9 Effect of starch concentration and location on tablet disintegration time. (From Ref. 54.)...

FIGURE 15 Correlation of physical parameters on tablet disintegration time. 

Method for the determination of tablet disintegration time (not collaboratively tested). 

For many years, starch was the disintegrating agent of choice. Recently, however, so-called super disinte-grants have been introduced, which markedly reduce tablet disintegration time. Such substances include croscarmellose, crospovidone, polacrilin potassium, and sodium starch glycolate. ... 

Thus, P i,b/a describes the effect on the response of changing F, from state A to B. In our example, it is the increase of the tablet disintegration time resulting from the replacement of 1% magnesium stearate in the formulation by 2.5% hydrogenated castor oil. This method introduces a certain asymmetry between the 2 levels, which is perhaps not justified. Why choose one level, or one lubricant, as the reference state rather than another ... 

As an example, consider the percentage yield of a chemical reaction, the response y, measured when the factor "reaction temperature", F, can take one of the two levels 25°C and 40°C. The two experiments are represented in the plan below, and a further column has been added for the experimental results. This is a non-pharmaceutical example, but the reasoning would be identical for the case of tablet disintegration times resulting from the use of different lubricants. 

Figure 9.4 Box-Cox transformation study on the tablet disintegration time data.

The lack of correlation between tablet disintegration time and GI absorption of the active ingredient is shown in Table 9.1. 

GACP, GMP and GLP standards. During the industrial manufacturing of herbal medicinal products not only the raw material is subject to rigid quality control, but also the quality of the semi-manufactured and finished product is monitored (in-process controls) and evaluated (end controls on content, identity, purity). Finally a pharmaceutical dosage form should comply with the applicable pharmacopoeial standards (e.g., crush strength of tablets, disintegration time of tablets and capsules, uniformity of mass and content [11-13]). 

Hill PM. Effect of compression force and corn starch on tablet disintegration time. J Pharm Sci 1975 65(11) 1694-1696. 

Donoso, M. and E.S. Ghaly, Prediction of tablets disintegration times using near-infrared diffuse reflectance spectroscopy as a nondestructive method. Pharm. Dev. TechnoL, 10 211-217 (2005). 

Figure 28.3 Fuzzy logic representation of the disintegration time of a tablet as Low or High.

Rocksloh K, Rapp F-R, Abu Abed S, Mueller W, Reher M, Gauglitz G, Schmidt PC. Optimization of crushing strength and disintegration time of a high dose plant extract tablet by neural networks. Drug Dev Ind Pharm 1999 25 1015-25. 

Within the realm of physical reality, and most important in pharmaceutical systems, the unconstrained optimization problem is almost nonexistent. There are always restrictions that the formulator wishes to place or must place on a system, and in pharmaceuticals, many of these restrictions are in competition. For example, it is unreasonable to assume, as just described, that the hardest tablet possible would also have the lowest compression and ejection forces and the fastest disintegration time and dissolution profile. It is sometimes necessary to trade off properties, that is, to sacrifice one characteristic for another. Thus, the primary objective may not be to optimize absolutely (i.e., a maxima or minima), but to realize an overall pre selected or desired result for each characteristic or parameter. Drug products are often developed by teaching an effective compromise between competing characteristics to achieve the best formulation and process within a given set of restrictions. 

Fig. 13 Contour plots for (a) disintegration time (b) tablet hardness (c) dissolution response (%) (d) tablet friability as a function of disintegrant level and compressional force. Dashed lines on ordinate denote limits of experimental range (—1.547 to + 1.547 eu see text for details).

FIG. 7. Maximum axial disintegrating pressure vs. disintegration time of dicatcium phosphate and lactose tablets containing 2% super disintegrants. (O) Dicalcium phosphate r = 0.92, p < 0.05, significant correlation (A) Lactose r = 0.81, p < 0.05, significant correlation. (Replotted from Ref. 27). 

---