Granulation Particle size distribution

Once the analytical method is validated for accuracy at the laboratory scale, it can be used to obtain extensive information on process performance (blend homogeneity, granulation particle size distribution, and moisture content) under various conditions (blender speed, mixing time, drying air temperature, humidity, volume, etc.). Statistical models can then be used to relate the observable variables to other performance attributes (e.g., tablet hardness, content uniformity, and dissolution) in order to determine ranges of measured values that are predictive of acceptable performance. 

Granulation particle size distribution An extremely important parameter that can affect tablet compressibility, hardness, thickness, disintegration, dissolution, weight variation, and content uniformity. This parameter, which can be done by sieve analysis, should be monitored throughout the tablet validation process. 

Evaluate granulation particle size distribution Manufacturability Particle size analysis or powder flow assessment Powder flow... 

Evaluation of Granulation Particle Size Distribution and Density... 

Similarly, the granulation particle size distribution of Drug B shows a significant increase in the weight percent of material remaining in the 20, 40, and 60 mesh screen... 

Figure 6.6 Comparison of initial blend and final granulation particle size distribution— Drugs A and B.

In contrast, increasing the gap width between the dry granulator rollers decreases the density of the compacted ribbon or briquette (also possible when other factors, such as feed rate or roll force, are changed). This reduced densification process results in a weaker binding of API to carrier excipients, and reduced overall granulation particle size distribution and increased bypass. 

Fig. 5 illustrates the granule particle size distribution as a function of gap size between rotor and stator. As can be seen, the average particle size D(50) is approximately equal to the gap size, and the particle size span (ca. 0.5) is very low and independent of gap size. Typically, the concentration of the binder is 25wt%. In all of the known agglomeration and microencapsulation techniques, the concentration of... 

Steiner G, Patel M, Carstensen JT. Effeet of milling on granulation particle—size distribution. J Pharm Sci 1974 63 1395-1398. 

Fumaric acid is sold as resia-grade and food-grade. The general sales specification under which resia-grade fumaric acid is sold ia the United States specifies white, crystalline granules with a minimum assay of 99.6% and maximum ash content of 0.05%. The moisture specification is 0.3% maximum with < 10 ppm heavy metals. The color of a 5% solution ia methanol is to be less than 10 APHA. Food-grade fumaric acid calls for somewhat lower impurity levels. Particle size and particle size distribution are important ia many appHcations. 

Injection moulding compositions have a number of requirements with regard to granule flow and cure characteristics not always met by conventional formulations. For example, granules should be free-flowing (i.e. of a narrow particle size distribution and not too irregular in shape). There are also certain requirements in terms of viscosity. 

Particle size distribution/physical form, e.g. fine powder, flakes, granules, pellets, prills, lumps Porosity... 

Kristensen, H. G., Holm, P., and Schaefer, T., Mechanical Properties of Moist Agglomerates in Relation to Granulation Mechanisms. Part II Effect of Particle Size Distribution, Powder Technology, 44 239-247 (1985)... 

Figure 24. Effects of conventional dense phase conveying and vibration assisted conveying on the particle size distribution of spray granules (the vertical bars indicate the confidence intervals. (Molerus et al., 1989.)...

Kovacova (1990) describes a method for the batch drying of fruit and vegetable pulp in a fluidized bed in which carrier particles (variously crystalline and caster sugar, dried skim milk, potato and wheat starch, apple powder, semolina or oat flakes), pre-moistened to a solids content of between 55% and 76%, are fed to a preheated fluidized bed and sprayed with the pulp to be dried. A product with a narrow particle size distribution and a uniform pulp content is claimed. Specific foods for which fluidized bed granulation has been used include potato puree (Zelenskaya and Filipenko, 1989) and granulated dried apple (Haida et al, 1994). 

The particle size distribution depends on the type of plant (see Table 5). The size of the potato starch granules is considerably higher than the size of com and tapioca starch granules. Also, the moisture absorption of potato starch is much higher than for com and tapioca starch. Thus, processing of tapioca starch in technical processes like compounding is similar to that of com starch [10]. 

The sorbitol solution produced from hydrogenation is purified in two steps [4]. The first involves passing the solution through an ion-exchange resin bed to remove gluconate and other ions. In the second step, the solution is treated with activated carbon to remove trace organic impurities. The commercial 70% sorbitol solution is obtained by evaporation of the water under vacuum. The solid is prepared by dehydration until a water-free melt is obtained which is cooled and seeded. The crystals are removed continuously from the surface (melt crystallization). The solid is sold as flakes, granules, pellet, and powder forms in a variety of particle size distributions. 

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