Dissolution test methods

FW Goodhart, RH McCoy, FC Ninger. New in vitro disintegration and dissolution test method for tablets and capsules. J Pharm Sci 62 304-310, 1973. 

II Low solubility/High Peff IVIVC should be possible to establish provided that in vitro relevant dissolution test method are used and drug absorption is limited by dissolution rate rather than saturation solubility... 

Stippler E. Bioequivalent dissolution test methods to assess bioequivalence of drug products. Ph.D. dissertation, Johann Wolfgang Goethe University, Frankfurt am Main, 2004. 

Table 3 Suitable Dissolution Test Methods for Compounds with Good Solubility11...

Stippler E. Development of BCS-conform Dissolution Testing Methods. Dissertation thesis, University of Frankfurt, 2004. 

Stippler E. Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products. Frankfurt Institute for Pharmaceutical Technology, J. W. Goethe University, 2004 414. 

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. 

Since in this study in vitro dissolution served as the response or objective function for optimizing the level of magnesium stearate, it would appear that the authors of Ref. 8 had a high degree of confidence in this method. The dissolution test method and acceptance criterion in the selected example is fairly common. Its in vivo relevance is assumed by many with a fair degree of confidence, as exemplified by the following perspective expressed in the USP [35] ... 

Several knowrir vitro dissolution/release-rate test methods have been reported for assessing performance of MR dosage forms. The selection of a partidnlaitro dissolution test method for a product is often dependent on the type and/or design ofthe dosage form. These commonly used tests are summarized below ... 

Shaw, J.M. Sullivan, B.M. Bowen, W.E. Martin, G.P. Reed, R.A. Studies Directed Towards the Development of Enzymatic Dissolution Test Methods for Cross-Linked Hard Gelatin Capsule Formulations Containing Poorly Water-Soluble Drug Substances. Abstracts of the AAPS Annual Meeting, New Orleans, LA, Nov 14-18, 1999 American Association of Pharmaceutical Scientists Arlington, VA, 1999 Abstract No. 3358. 

The stability testing requirements for diltiazem hydrochloride include an HPLC assay and dissolution test. The HPLC assay is described in the section for the potency assay (9.2.1.1.) and the dissolution test method is described in Section 9.1. 

It is surprising that there are very limited data on the chemical resistance of various oxide materials. Most of the data are obtained on solid, non-porous materials and with simple dissolution test methods. In the few cases where porous materials are used, hydrodynamic conditions are not or are inadequately taken into account and flow of the aggressive media through the pore network does not occur during the tests. 

The Committee noted that dissolution test methods were being developed and agreed that rifampicin should serve as the marker for dissolution testing in the relevant fixed-dose combinations, as it was the least soluble substance. For other products, standard dissolution test methods could be applied. 

Stippler E, [Dissertation], Biorelevant Dissolution Test Methods to Assess Bioequivaience of Drug Products. Germany, Johann-Wolfgang von Goethe University Frankfurt, 2004. 

Figure 9.9 USP dissolution testing method 3. The United States Pharmacopeial Convention, 2009. All rights reserved. Printed with permission.

IN VITRO DISSOLUTION TESTING METHODS FOR POLYMERIC FORMULATIONS... 

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