Quality requirements disintegration

The quality requirements of a substance in bulk and those of a pharmaceutical formulation are compiled in specifications. In these documents the requirements on the various quality parameters are given as minimum or maximum limits or ranges. Formulations often have requirements on technical properties such as dissolution rate, disintegration, and hardness for tablets. All those requirements are the result of... 

Pharmacopoeia Quality requirements Assay Identity Content Purity Content uniformity Disintegration Dissolution Particles FRC Analytical validation... 

Ph. Eur. 2.9.1 Disintegration of tablets and capsules describes the equipment and the method of analysis. The disintegration medium that has to be used as well as the quality requirements are specific for the dosage form and can be fotmd in the appropriate monographs. The requirement for solid capsules is for example disintegration in water within 30 min. 

These quality requirements are mainly tested in the design phase and probably repeated as a release control. Disintegration may however decrease on storage and hence it is recommended to include it in stability testing of the product. The quality requirements of the Ph. Eur. apply up to the expiry date. 

Specifications used by quality control to release drug A are found in a laboratory procedure. In addition to the previously discussed hardness and disintegration time requirements, the procedure calls for determining the average tablet weight by the United States Pharmacopeia (USP) procedure that is, 20 individual tablets are weighed. 

However, some excipients have multiple functions. For example, microcrystalline cellulose can function as a filler, a binder, and a disintegrant. As seen in Table 7.3, a typical low-dose formulation could include more than 85% filler—binders. Thus, physical and chemical properties for these specialty excipients are extremely important in a low-dose formulation for manufacturability, product performance, and longterm stability. Because the poor physicomechanical properties of components are not altered during manufacture as they are in the wet or dry granulation process, critical material properties and their impact on product quality attributes should be well characterized and understood.23 Discussion in this section will focus on fillers-binders. For those requiring more information on excipients, several excellent books and review articles are available in the literature.24-27... 

The performance requirements of a tablet were discussed in the previous section, and it is clear that most tablets will contain several ingredients. The drug substance, probably a filler, a disintegrant and a lubricant will be common to most formulations, while glidants, colourants and wetting agents may also be included. The quality of the final product will be as dependent on the way in which the components are combined as it is on the components selected. Traditionally, tablet formulations have been prepared by one of two methods direct compression or granulation. 

The second standard however, ASTM D6400-99, is much more specific and precise with regard to the requirements which must be met by compostable plastics. In that sense, it is comparable to the EN 13432 [5] and DIN V 54900 [4] and as a matter of fact is also built around the same three basic requirements (biodegradation, disintegration and compost quality). Although the basic philosophy and rationale is similar to the European and German norm, the detailed figures and requirements show some differences. 

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