Modeling and comparison of dissolution profiles

Costa, Paulo; Sousa Lobo, José Manuel

doi:10.1016/s0928-0987(01)00095-1

Cited by 5,509Drug Solubulity and Delivery SystemsAdvanced Drug Delivery SystemsAnalytical Methods in Pharmaceuticals

Modeling and comparison of dissolution profiles

Costa, Paulo, Sousa Lobo, José Manuel·2001·European Journal of Pharmaceutical Sciences

DOI 10.1016/s0928-0987(01)00095-1

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Abstract

Over recent years, drug release/dissolution from solid pharmaceutical dosage forms has been the subject of intense and profitable scientific developments. Whenever a new solid dosage form is developed or produced, it is necessary to ensure that drug dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays, on drug dissolution studies. The quantitative analysis of the values obtained in dissolution/release tests is easier when mathematical formulas that express the dissolution results as a function of some of the dosage forms characteristics are used. In some cases, these mathematic models are derived from the theoretical analysis of the occurring process. In most of the cases the theoretical concept does not exist and some empirical equations have proved to be more appropriate. Drug dissolution from solid dosage forms has been described by kinetic models in which the dissolved amount of drug (Q) is a function of the test time, t or Q=f(t). Some analytical definitions of the Q(t) function are commonly used, such as zero order, first order, Hixson-Crowell, Weibull, Higuchi, Baker-Lonsdale, Korsmeyer-Peppas and Hopfenberg models. Other release parameters, such as dissolution time (tx%), assay time (tx min), dissolution efficacy (ED), difference factor (f1), similarity factor (f2) and Rescigno index (xi1 and xi2) can be used to characterize drug dissolution/release profiles.

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Authors: Costa, P., & Sousa Lobo, J. M.
Affiliations: Universidade do Porto (PT)
Corresponding author: Costa, Paulo
ORCID: Costa, Paulo
Venue: European Journal of Pharmaceutical Sciences
Publisher: Elsevier BV
Published: 2001-05
Volume: 13
Issue: 2
Pages: 123-133
ISSN: 0928-0987 (ISSN-L)
DOI: 10.1016/s0928-0987(01)00095-1
OpenAlex: W2115439624
Cited by: 5,509
References: 69
Citations by year: 2026: 295 · 2025: 278 · 2024: 269 · 2023: 287 · 2022: 299 · 2021: 367 · 2020: 390 · 2019: 335 · 2018: 350 · 2017: 401 · 2016: 324 · 2015: 334 · 2014: 326 · 2013: 273 · 2012: 234
FWCI: 12.45
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: European Journal of Pharmaceutical Sciences (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
Keywords: drug dissolution, dissolution profile, dissolution kinetics, zero-order release, first-order release, Higuchi model, Korsmeyer-Peppas model, Weibull model, Hixson-Crowell model, similarity factor f2, solid dosage forms, drug release
MeSH terms: Chemistry, Pharmaceutical, Drug Industry, Humans, Models, Theoretical, Pharmacokinetics, Solubility

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Modeling and comparison of dissolution profiles

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