The Dissolution Procedure: Development and …

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The Dissolution Procedure: Development and ValidationBased on: <1092> as published in PharmacopoeialForum, Vol. 31 (5), 2005Dr. Elisabeth KrugLilly ForschungGmbHGermanyDr. Elisabeth Krug25. Jan. 2006 -SAQCompany ConfidentialCopyright 2000 Eli Lilly and Company2Dissolution OutlineGeneral considerations for Dissolution proceduresMediumIn vivo In vitro correlationApparatusAgitationSinkersStud y DesignObservations SamplingFiltersAssayValidationAnalysisAc ceptance CriteriaDr. Elisabeth Krug25. Jan. 2006 -SAQCompany ConfidentialCopyright 2000 Eli Lilly and Company3Dissolution General Considerations Dissolution is a performance test, applicable to manydosage forms It yields data to allow an accept/reject decision One test amongst a series of others The USP provides the following General Chapters:Disintegration <701>Drug Release <724> Dissolution <711>MediumApparatus/Agitation RateStudy DesignAssayAcceptance CriteriaDr. Elisabeth Krug25.

The Dissolution Procedure: Development and Validation Based on: <1092> as published in Pharmacopoeial Forum, Vol. 31 (5), 2005 Dr. Elisabeth Krug Lilly Forschung GmbH Germany

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