Tablet manufacture attributes

TABLE 2.6 Typical Unit Operations, Process Parameters, and Quality Attributes for Tablet Manufacture... 

There are three methods of tablet manufacture designed to confer these essential attributes to a tablet formulation. Wet granulation and direct compression are the most important, with dry granulation (also known as precompression or slugging) used in some circumstances. Fig. 1 shows the processes of wet granulation and direct compression broken down into their constituent stages. 

A powder compact s TS is the stress required to separate its constituent particles in tensile mode. This is measured for the tableting indices by transverse compression of the square compacts, using narrow platens. Stresses build within the sample until it fails in a tensile mode that is perpendicular to the direction of platen movement. Tablets that are manufactured on a traditional tablet press and that have high TS are considered hard and generally robust, and so this is a highly desired attribute for immediate release and other tablet types. 

Given the fact that only a very low amount of dmg is incorporated, its physical and mechanical properties typically do not alter the formulation characteristics and do not influence the downstream manufacturability to a large extent. While it is known for high dmg load formulations that compressibility and tablet attributes such as hardness, friability, and disintegration are in some cases strongly dependant on the characteristics of the API, this is not true for low-dose formulations. The latter formulations... 

Sorbitol can exist in four crystalline forms. Guyot-Hermann, Leblanc, and Draguet-Brugmans compared 11 commercially available varieties of sorbitol, and found three of these four forms to be present. y-Sorbitol was found to be the most useful as a tablet diluent. The method of manufacture has also been shown to affect tabletting properties, differences being attributed to variations in particle shape and surface properties. Spray-dried varieties of sorbitol are available as direct compression diluents which are claimed to have overcome problems associated with the different crystalline forms. ... 

Chemical stability, disintegration rate, dissolution profile, friability, and hardness are the major stability attributes for the tablet dosage form. An unoptimized tablet formulation may become soft or very hard after storage, with altered dissolution profiles, and as a result, its dissolution profile and bioavailability may not be appropriate. If effervescent products are not properly formulated, manufactured, and packaged, the premature acid-base reaction will cause the product s self-destruction. 

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