Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method

Merlo-Mas, Josep; Tomsen-Melero, Judit; Corchero, José-Luis; González‐Mira, Elisabet; Font, Albert; Pedersen, Jan Skov; García‐Aranda, Natalia; Cristóbal-Lecina, Edgar; Alcaina-Hernando, Marta; Mendoza, Rosa; García‐Fruitós, Elena; Lizarraga, T.; Resch, Susanne; Schimpel, Christa; Falk, Andreas; Pulido, Daniel; Royo, Míriam; Schwartz, Simó; Abasolo, Ibane; Pedersen, Jan Skov; Danino, Dganit; Soldevila, Andreu; Veciana, Jaume; Sala, Santiago; Ventosa, Nora; Córdoba, Alba

doi:10.1016/j.supflu.2021.105204

Cited by 24 publications

(13 citation statements)

References 27 publications

(37 reference statements)

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“…Pandey et al applied the QbD method in the development of chitosan-coated, hydrophilic API-enclosing liposomes prepared via a modified ethanol injection method [ 28 ]. Merlo-Mas et al presented the use of the QbD tools and risk analysis in the case of the α-galactosidase-loaded nanoliposomes preparation through the DELOS-susp (depressurisation of an expanded liquid organic solution into aqueous solution) method, a compressed fluid-based technique that results in reproducible and scalable nanovesicular systems [ 29 ]. As the presented list about the diversified applications of the QbD approach shows, this quality management method is useable when complex fields need to be combined to meet the development, therapeutic, authorisation and patient-centred requirements.…”

Section: Introductionmentioning

confidence: 99%

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

et al. 2021

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Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an “intermediate” active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG2000), the type of the hydration media (saline or phosphate-buffered saline solutions) and the cryoprotectants (glucose, sorbitol or trehalose). The characterisation results (size, surface charge, thermodynamic behaviours, formed structure and bonds) of the prepared liposomes supported the outcomes of the updated RA. The findings can be used as a basis for a particular study with specified circumstances.

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Section: Introductionmentioning

confidence: 99%

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

et al. 2021

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“…The high stability, together with their simple and effective (one-step, green, and scalable) manufacturing procedure, makes these sRNA nanocarriers highly attractive for the translation to the clinical phases, compared to other nanocarriers with low stability and with challenging (multistep) scalability [ 126 ]. Recently, the DELOS method has been employed to prepare α-galactosidase-loaded nanoliposomes (nanoGLA) for the treatment of Fabry disease (a lysosomal storage disease that arises from a deficiency of the enzyme α-galactosidase A (GLA)) [ 127 ]. Within the investigation, a nanoformulation for (preclinical) in vivo studies was developed by implementing a Quality by Design (QbD) approach.…”

Section: Novel Technologies For Liposome Preparationmentioning

confidence: 99%

“…This methodology allows for developing efficient drug-manufacturing and control methods. Through a risk analysis and a Design of Experiments (DoE), it was possible to obtain the critical parameters (such as the GLA and lipid concentration) for achieving a stable nanoformulation, and to optimize the production process for in vivo preclinical testing [ 127 ].…”

Section: Novel Technologies For Liposome Preparationmentioning

confidence: 99%

Methods of Liposomes Preparation: Formation and Control Factors of Versatile Nanocarriers for Biomedical and Nanomedicine Application

2022

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Liposomes are nano-sized spherical vesicles composed of an aqueous core surrounded by one (or more) phospholipid bilayer shells. Owing to their high biocompatibility, chemical composition variability, and ease of preparation, as well as their large variety of structural properties, liposomes have been employed in a large variety of nanomedicine and biomedical applications, including nanocarriers for drug delivery, in nutraceutical fields, for immunoassays, clinical diagnostics, tissue engineering, and theranostics formulations. Particularly important is the role of liposomes in drug-delivery applications, as they improve the performance of the encapsulated drugs, reducing side effects and toxicity by enhancing its in vitro- and in vivo-controlled delivery and activity. These applications stimulated a great effort for the scale-up of the formation processes in view of suitable industrial development. Despite the improvements of conventional approaches and the development of novel routes of liposome preparation, their intrinsic sensitivity to mechanical and chemical actions is responsible for some critical issues connected with a limited colloidal stability and reduced entrapment efficiency of cargo molecules. This article analyzes the main features of the formation and fabrication techniques of liposome nanocarriers, with a special focus on the structure, parameters, and the critical factors that influence the development of a suitable and stable formulation. Recent developments and new methods for liposome preparation are also discussed, with the objective of updating the reader and providing future directions for research and development.

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“…Since 2001, DELOS has been applied to the micronization of polymers, surfactan [108] and poorly water-soluble compounds such as naproxen and ibuprofen This process uses less CO2; the filtration takes place at atmospheric pressure, and the la of nozzles improves scalability [112]. A technique for developing unilamellar nanovesic based on DELOS was developed that was similar to the above-mentioned SuperLip [11 Depressurization of an expanded liquid organic solution into aqueous solution (DELO susp) is mainly applied to produce nanovesicles to carry nucleic acids and enzym [50,114,115]. However, loaded liposomes are obtained in aqueous bulk rather than in dried form.…”

Section: Depressurization Of An Expanded Liquid Organic Solution (Delos)mentioning

confidence: 99%

Solid Dosage Forms of Biopharmaceuticals in Drug Delivery Systems Using Sustainable Strategies

et al. 2021

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Drug delivery systems (DDS) often comprise biopharmaceuticals in aqueous form, making them susceptible to physical and chemical degradation, and therefore requiring low temperature storage in cold supply and distribution chains. Freeze-drying, spray-drying, and spray-freeze-drying are some of the techniques used to convert biopharmaceuticals-loaded DDS from aqueous to solid dosage forms. However, the risk exists that shear and heat stress during processing may provoke DDS damage and efficacy loss. Supercritical fluids (SCF), specifically, supercritical carbon dioxide (scCO2), is a sustainable alternative to common techniques. Due to its moderately critical and tunable properties and thermodynamic behavior, scCO2 has aroused scientific and industrial interest. Therefore, this article reviews scCO2-based techniques used over the year in the production of solid biopharmaceutical dosage forms. Looking particularly at the use of scCO2 in each of its potential roles—as a solvent, co-solvent, anti-solvent, or co-solute. It ends with a comparison between the compound’s stability using supercritical CO2-assisted atomization/spray-drying and conventional drying.

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Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method

Cited by 24 publications

References 27 publications

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

Methods of Liposomes Preparation: Formation and Control Factors of Versatile Nanocarriers for Biomedical and Nanomedicine Application

Solid Dosage Forms of Biopharmaceuticals in Drug Delivery Systems Using Sustainable Strategies

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