Tablet formulations dissolution test methods

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

Recently, Yoshikawa et al. [70] reported a new in vitro dissolution test, called the rotating beads method, for drugs formulated in pressure-controlled colon delivery capsules. This dissolution method was applied to acetominophen sustained-release tablets and two other drugs having low solubility in the colon, tegafur and 5-ASA. There was good correlation between the in vitro dissolution rates and the in vivo absorption rates. 

The outcome of dissolution tests on pharmaceutical formulations can be influenced by a nnmber of factors including the nature of the excipients and lubricants, blending method and granulation procedure used. When the solubility of the API is not the limiting factor, the compaction pressure used to produce tablets is inversely proportional to their dissolution rate and, as noted in the previous section, directly proportional to the slope of the NIR spectra for intact tablets. Blanco et have developed various approaches for... 

Dissolution testing was performed on the five aberrant tablet formulations (n = 6 per formulation) and the target tablet formulation (n = 6) using the small volume dissolution method previously described. As shown in Table 10.6 and Fig. 10.6, the dissolution profiles for the aberrant tablet formulations with additional lubricant, diluent substitution, additional binder, and high tablet hardness differ from the profile... 

Polymers are widely used in various pharmaceutical formulations, such as traditional oral formulations (tablets and capsule) and complex parenteral formulations (such as microspheres, nanoparticles, implants, and in situ forming gels). Dissolution testing is used in formulation development, quality control for batch release of product, and in vitro-in vivo correlations. FDA has a database listing dissolution methods for around 1000 formulations such as tablets, capsules, granules, and injectable suspensions. These methods provide information about the standardized USP apparatus used, testing speed, type and volume of release medium, and the recommended sampling points. For detailed informadon abont the seven standardized dissolution apparatuses, method development, and validation of compendial methods, the reader is referred to USP Chapters 711,... 

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