QbD Approach-Based Preparation and Optimization of Hydrophobic Ion-Pairing Complex of Lysozyme with Sodium Dodecyl Sulphate to Enhance Stability in Lipid-Based Carriers Article Swipe
Alharith A. A. Hassan
,
Tamás Sovány
,
Krisztián Pamlényi
,
M Deák
,
Viktória Hornok
,
Edit Csapó
,
Géza Regdon
,
Ildikó Csóka
,
Katalin Kristó
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3390/pharmaceutics16050589
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3390/pharmaceutics16050589
Hydrophobic ion pairing (HIP) complexation was found to be an efficient approach in modulating the release and enhancing the stability and encapsulation of hydrophilic macromolecules such as proteins in hydrophobic nano/microcarriers. The present work strives to develop and optimize the preparation of the HIP complex of the antimicrobial enzyme lysozyme (LYZ) with the ion-pairing agent (IPA) sodium dodecyl sulphate (SDS) relying on the quality-by-design (QbD) approach. The quality target product profile (QTPP) includes the achievement of maximal lipophilicity in a reversible manner to enable the maintenance of biological activity. The related critical quality attributes (CQAs) were defined as complexation efficacy, complex stability, enzyme recovery and activity. Three risk assessment (RA) tools were used to identify and rank the critical process parameters (CPPs) and critical material attributes (CMAs). From this assessment, the pH of the medium, LYZ:SDS molar ratio and drying conditions were determined as high-risk factors that need to be investigated. To the best of our knowledge, for the first time, electrostatic titration was used as a smart approach to determine the optimum molar ratio at different pH values. Based on the predefined CQAs, pH 8 with an LYZ/SDS molar ratio of 1:8 was found to be the optimal condition for complexation efficiency and recovery (%) of a biologically active enzyme. A cost-effective drying process based on a ventilated oven was developed, which resulted in complex qualities comparable to those obtained by the commonly used freeze-drying method. In a nutshell, the optimum conditions for the preparation of the LYZ/SDS HIP complex were efficiently facilitated by the rational application of QbD principles and the utilization of efficient electrostatic titration and ventilated oven-drying methods.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/pharmaceutics16050589
- OA Status
- gold
- Cited By
- 4
- References
- 33
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4395668639
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4395668639Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.3390/pharmaceutics16050589Digital Object Identifier
- Title
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QbD Approach-Based Preparation and Optimization of Hydrophobic Ion-Pairing Complex of Lysozyme with Sodium Dodecyl Sulphate to Enhance Stability in Lipid-Based CarriersWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-04-26Full publication date if available
- Authors
-
Alharith A. A. Hassan, Tamás Sovány, Krisztián Pamlényi, M Deák, Viktória Hornok, Edit Csapó, Géza Regdon, Ildikó Csóka, Katalin KristóList of authors in order
- Landing page
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https://doi.org/10.3390/pharmaceutics16050589Publisher landing page
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.3390/pharmaceutics16050589Direct OA link when available
- Concepts
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Critical quality attributes, Lysozyme, Chemistry, Chromatography, Lipophilicity, Pulmonary surfactant, Sodium dodecyl sulfate, Chemical engineering, Particle size, Organic chemistry, Biochemistry, Engineering, Physical chemistryTop concepts (fields/topics) attached by OpenAlex
- Cited by
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4Total citation count in OpenAlex
- Citations by year (recent)
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2025: 3, 2024: 1Per-year citation counts (last 5 years)
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33Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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