ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2017
A quality by design approach for the development of lyophilized liposomes with simvastatin.
Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Liposomal Nanosystems Versus Hydrogels in the Prevention and Treatment of Metabolic Diseases.Gels (Basel, Switzerland) · 2025Review
- Influence of Formulation Composition on the Characteristic Properties of 5-fluorouracil-loaded Liposomes.Turkish journal of pharmaceutical sciences · 2025Article
- From lab to industrial development of lipid nanocarriers using quality by design approach.International journal of pharmaceutics: X · 2024Review
- The Effect of Cryoprotectants and Storage Conditions on the Transfection Efficiency, Stability, and Safety of Lipid-Based Nanoparticles for mRNA and DNA Delivery.Advanced healthcare materials · 2023Article
- Long-Circulating and Fusogenic Liposomes Loaded with Paclitaxel and Doxorubicin: Effect of Excipient, Freezing, and Freeze-Drying on Quality Attributes.Pharmaceutics · 2022Article
- Quality by Design Approach in Liposomal Formulations: Robust Product Development.Molecules (Basel, Switzerland) · 2022Review
- Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method.The Journal of supercritical fluids · 2021Article
- Article
- Protective Effect of Saccharides on Freeze-Dried Liposomes Encapsulating Drugs.Frontiers in bioengineering and biotechnology · 2019Article
- Lyophilization of Liposomal Formulations: Still Necessary, Still Challenging.Pharmaceutics · 2018Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the T
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