Development and Validation of a Discriminatory Dissolution Model for an Immediately Release Dosage Form by DOE and Statistical Approaches.

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Abstrakt

Tytuł:: Development and Validation of a Discriminatory Dissolution Model for an Immediately Release Dosage Form by DOE and Statistical Approaches.
Autorzy:: Fu M; Sunovion Pharmaceuticals, 84 Waterford Dr, Marlborough, Massachusetts, 01752, USA. .
Conroy E; Sunovion Pharmaceuticals, 84 Waterford Dr, Marlborough, Massachusetts, 01752, USA.
Byers M; Quality Chemical Laboratories, 3220A Corporate Dr, Wilmington, North Carolina, 28405, USA.
Pranatharthiharan L; Sunovion Pharmaceuticals, 84 Waterford Dr, Marlborough, Massachusetts, 01752, USA.
Bilbault T; Sunovion Pharmaceuticals, 84 Waterford Dr, Marlborough, Massachusetts, 01752, USA.
Źródło:: AAPS PharmSciTech [AAPS PharmSciTech] 2021 Apr 21; Vol. 22 (4), pp. 140. Date of Electronic Publication: 2021 Apr 21.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: New York : Springer
Original Publication: Arlington, VA : American Association of Pharmaceutical Scientists, c2000-
MeSH Terms:: Models, Chemical*
Tablets*
Linear Models ; Multivariate Analysis ; Reproducibility of Results ; Solubility ; Water
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Contributed Indexing:: Keywords: DOE; discriminatory; dissolution; statistic
Substance Nomenclature:: 0 (Tablets)
059QF0KO0R (Water)
Entry Date(s):: Date Created: 20210422 Date Completed: 20210520 Latest Revision: 20210520
Update Code:: 20231215
DOI:: 10.1208/s12249-021-02011-z
PMID:: 33884530
: Czasopismo naukowe

Full Text Finder

A discriminatory dissolution model was built through DOE with multivariate analysis of variance (MANOVA) and multiple linear regression (MLR) modeling to assess dissolution operational space for a highly water soluble immediate-release solid dosage drug product. The dissolution was utilized in the following five aspects: (1) understand the impact of individual variables and their interactions on dissolution performance through effect analysis; (2) explain the lack of discriminatory power of the initial dissolution condition used in early phase development by prediction profiler; (3) predict discriminatory dissolution operational space to differentiate photo degraded drug products from control with contour profiler analysis; (4) validate by the external experimental data acquired with the initial nondiscriminatory dissolution condition and the predicted discriminatory dissolution condition, followed by model independent statistical analysis (e.g., f2); and (5) establish correlation of the discriminatory dissolution with disintegration. The selected discriminatory dissolution method was validated by demonstrating accuracy, precision and linearity, specificity, repeatability, intermediate precision, stability, filter verification, and robustness.

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