Establishing a Relationship between Disintegration and Dissolution

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ICH Q6A decision tree #7 criteria are met No modified release dosage form Solubility is high throughout the physiological range pH 1.2 to 6.8 Dissolution is rapid and complete. Under all experimental conditions > 80 % in 15 min No analogous data result form dissolution and disintegration No linear stochastical relationship is feasible A relationship of disintegration as the rate limiting step for dissolution was described The findings for the dissolution tester were confirmed for the disintegration tester (data not shown) Disintegration was found to be the more variable process The data generated for actual production lots represent the properties of the drug product (historical data) As a consequence: The dissolution test may be waived for batch release testing for all formulations included in the study © PHAST GmbH, www.phast.de 31 Finally: Setting Specifications Dissolution testing as a biopharmaceutically relevant test procedure may be waived! • Disintegration is prerequisite for dissolution recommended for batch release testing • Comparison of the disintegration results together with the dissolution results for the disintegration apparatus allows tightening of spec’s to 5 min (Ph,Eur. / USP: 15 min) For all immediate release dosage strengths of that M containing product, the spec’s for disintegration time were set: NMT 5 min © PHAST GmbH, www.phast.de 32 12/18/2009 16
Thank you www www.artofdissolution.com artofdissolution com © PHAST GmbH, www.phast.de 33 12/18/2009 17
Page 1 and 2: Establishing a Relationship between
Page 3 and 4: Prediction of Bioperformance based
Page 5 and 6: Dissolution Spec’s … IR Dosage
Page 7 and 8: Relationship between disintegration
Page 9 and 10: Relationship between disintegration
Page 11 and 12: Methods: chemical analysis, data ev
Page 13 and 14: Establishing a relationship: Result
Page 15: Findings • MDgT MDgT_Disint Disin

Establishing a Relationship between Disintegration and Dissolution

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