What does this research mean for the field?

Particle size specifications must be evaluated in the context of biorelevant dissolution conditions, as interactions between dose, solubility, and diffusivity significantly impact dissolution profile sameness. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

The research aims to determine how interactions between Z-factor, particle size, dose, solubility, and diffusivity affect the similarity of dissolution profiles.

June 3, 2026European Journal of Pharmaceutical Sciences0 citationsOpen Access

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Determinants of Simulated Dissolution Profile Similarity (f2): Interactions of Z-Factor, Particle Size, Dose, Solubility, and Diffusivity

AOAyşe Nur OktayUniversity of Maryland, Baltimore DVDiego Véliz-OtaniUniversity of Maryland, Baltimore JPJames PolliUniversity of Maryland, Baltimore

Key Points

The research aims to determine how interactions between Z-factor, particle size, dose, solubility, and diffusivity affect the similarity of dissolution profiles.
Evaluated various particle sizes under controlled biorelevant dissolution conditions.
Analyzed the impact of dose, solubility, and diffusivity on dissolution profile similarity.
Findings highlight the importance of considering particle size specifications in relation to both solubility and diffusivity for improving dissolution profile similarity.

Abstract

values. These findings emphasize that particle size specifications should be evaluated in the context of biorelevant dissolution conditions when dose, solubility, and diffusivity impact on dissolution profile sameness.

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Cite This Study

Oktay et al. (Fri,) studied this question.

synapsesocial.com/papers/6a1fc394dee9eb8c0dce506a https://doi.org/https://doi.org/10.1016/j.ejps.2026.107571

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