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Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage

Andre Hermans1, Andreas M Abend2, Filippos Kesisoglou1

  • 1Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.

The AAPS Journal
|August 24, 2017
PubMed
Summary
This summary is machine-generated.

Developing clinically relevant dissolution specifications (CRS) for immediate release products is challenging. This work proposes a roadmap using mechanistic understanding and pharmacokinetic data to guide CRS development for oral dosage forms.

Keywords:
BCSPBPK modelingSUPACbiowaiversclinically relevant dissolution specifications

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Product Development
  • Regulatory Science

Background:

  • Establishing clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms presents significant challenges.
  • Current regulatory landscapes, including the US Food and Drug Administration (FDA), generally support the development of CRS, though perspectives are evolving.
  • The IQ Consortium's Dissolution Analytical Working Group offers insights into this developing field.

Purpose of the Study:

  • To highlight challenges and recommend a strategy for developing clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms.
  • To present a roadmap for CRS development, integrating mechanistic dissolution understanding with in-human pharmacokinetic (PK) data for active ingredients with a non-narrow therapeutic window.
  • To discuss the implications of CRS development, including benefits and challenges, in the context of regulatory expectations and evolving industry practices.

Main Methods:

  • Development of a roadmap for creating CRS for IR products, emphasizing mechanistic dissolution insights and in-human PK data.
  • Analysis of two case studies illustrating potential outcomes, benefits, and challenges of implementing the CRS roadmap.
  • Review of current regulatory positions, particularly from the FDA, regarding the use of PK data in setting dissolution specifications.

Main Results:

  • The proposed roadmap facilitates the development of CRS based on pivotal clinical study batch dissolution data, potentially reducing the need for extensive additional PK studies.
  • Case studies demonstrate both advantages and difficulties encountered when pursuing CRS with supplementary PK data.
  • The approach acknowledges the risk of overly stringent manufacturing controls if PK studies are omitted.

Conclusions:

  • A structured approach, integrating mechanistic dissolution understanding and PK data, can guide the development of clinically relevant dissolution specifications for IR products.
  • While not all IR product developments necessitate additional PK studies, strategic investment in in vivo data at specific lifecycle stages is recommended.
  • Opportunities exist for leveraging CRS in post-approval changes, modeling and simulation (M&S), and biowaiver applications, further optimizing drug product development and regulatory processes.