Bridging the gap between fundamental research and product development of long acting injectable PLGA microspheres

Li, Xun; Zhang, Zhanpeng; Harris, Alice C.; Yang, Lin

doi:10.1080/17425247.2022.2105317

Cited by 11 publications

(7 citation statements)

References 118 publications

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“…Now, the manufacturing conditions of microspheres have also improved with the development of preparation technology, which has achieved in the manufacturing technology platforms of microspheres production and novel upstream and downstream facilities. 135 Moreover, some researchers have proposed developing long-acting injectable PLGA/PLA-based microspheres through quality by design thinking and taking the approved Bydureon s as a typical example to prove its feasibility. 125 It is believed that with the deepening of research and the improvement of production and preparation technology, more microsphere injections will enter the market and bring good news to patients suffering from pain.…”

Section: Review Materials Advancesmentioning

confidence: 99%

Application of biodegradable microsphere injections: an anticancer perspective

Cai,

Li,

et al. 2024

Mater. Adv.

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Section: Review Materials Advancesmentioning

confidence: 99%

Application of biodegradable microsphere injections: an anticancer perspective

Cai,

Li,

et al. 2024

Mater. Adv.

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“…This optimization is an iterative journey, marked by systematic adjustments based on initial results, ultimately fine-tuning the fabrication process to achieve an efficient and biomimetic platform tailored to the specific requirements of bone tissue regeneration applications. 158,159 The implementation of quality control measures is a critical component to ensure the reliability, safety, and effectiveness of the final product. The first step involves a detailed characterization of the morphology, encompassing an assessment of size, shape, and surface characteristics.…”

Section: Translational Considerationsmentioning

confidence: 99%

Nanofibrous Microspheres: A Biomimetic Platform for Bone Tissue Regeneration

Desai,

Pande,

Vora

et al. 2024

ACS Appl. Bio Mater.

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Bone, a fundamental constituent of the human body, is a vital scaffold for support, protection, and locomotion, underscoring its pivotal role in maintaining skeletal integrity and overall functionality. However, factors such as trauma, disease, or aging can compromise bone structure, necessitating effective strategies for regeneration. Traditional approaches often lack biomimetic environments conducive to efficient tissue repair. Nanofibrous microspheres (NFMS) present a promising biomimetic platform for bone regeneration by mimicking the native extracellular matrix architecture. Through optimized fabrication techniques and the incorporation of active biomolecular components, NFMS can precisely replicate the nanostructure and biochemical cues essential for osteogenesis promotion. Furthermore, NFMS exhibit versatile properties, including tunable morphology, mechanical strength, and controlled release kinetics, augmenting their suitability for tailored bone tissue engineering applications. NFMS enhance cell recruitment, attachment, and proliferation, while promoting osteogenic differentiation and mineralization, thereby accelerating bone healing. This review highlights the pivotal role of NFMS in bone tissue engineering, elucidating their design principles and key attributes. By examining recent preclinical applications, we assess their current clinical status and discuss critical considerations for potential clinical translation. This review offers crucial insights for researchers at the intersection of biomaterials and tissue engineering, highlighting developments in this expanding field.

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“…Among the emulsion-based PLGA microsphere-manufacturing technologies, including solvent extraction, solvent evaporation (SE), coacervation, and spray drying to achieve this drug release control purpose [ 3 , 12 , 13 , 14 , 15 ], recent research on poly (lactic/glycolic) acid (PLGA) microsphere manufacturing using a new technology called supercritical fluid extraction of emulsions (SFEEs) has been pioneered by several leading teams [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ]. Typically, the SFEE process for the preparation of PLGA microspheres involves two major steps: the preparation of the emulsion and the fabrication/solidification of PLGA via organic solvent removal [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

Exploring the Effects of Process Parameters during W/O/W Emulsion Preparation and Supercritical Fluid Extraction on the Protein Encapsulation and Release Properties of PLGA Microspheres

Park

2024

Pharmaceutics

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In this study, protein-loaded poly(lactic-co-glycolic acid) (PLGA) microspheres were prepared via supercritical fluid extraction of emulsion (SFEE) technology. To understand the correlation between process parameters and the main quality characteristics of PLGA microspheres, a comprehensive prior study on the influence of process variables on encapsulation efficiency (EE), initial drug burst release (IBR), morphology, surface property, and particle size distribution (PSD) was conducted within a wide process condition range of each unit process step, from the double-emulsion preparation step to the extraction step. Bovine serum albumin (BSA), a high-molecular weight-protein that is difficult to control the IBR and EE of PLGA microspheres with, was used as a model material. As double-emulsion manufacturing process parameters, the primary (W/O) and secondary emulsion (W/O/W) homogenization speed and secondary emulsification time were evaluated. In addition, the effect of the SFEE process parameters, including the pressure (70–160 bar), temperature (35–65 °C), stirring rate (50–1000 rpm), and flow rate of supercritical carbon dioxide, SC-CO2 (1–40 mL/min), on PLGA microsphere quality properties were also evaluated. An increase in the homogenization speed of the primary emulsion resulted in an increase in EE and a decrease in IBR. In contrast, increasing the secondary emulsification speed resulted in a decrease in EE and an increase in IBR along with a decrease in microsphere size. The insufficient secondary emulsification time resulted in excessive increases in particle size, and excessive durations resulted in decreased EE and increased IBR. Increasing the temperature and pressure of SFEE resulted in an overall increase in particle size, a decrease in EE, and an increase in IBR. It was observed that, at low stirring rates or SC-CO2 flow rates, there was an increase in particle size and SPAN value, while the EE decreased. Overall, when the EE of the prepared microspheres is low, a higher proportion of drugs is distributed on the external surface of the microspheres, resulting in a larger IBR. In conclusion, this study contributes to the scientific understanding of the influence of SFEE process variables on PLGA microspheres.

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Bridging the gap between fundamental research and product development of long acting injectable PLGA microspheres

Cited by 11 publications

References 118 publications

Application of biodegradable microsphere injections: an anticancer perspective

Application of biodegradable microsphere injections: an anticancer perspective

Nanofibrous Microspheres: A Biomimetic Platform for Bone Tissue Regeneration

Exploring the Effects of Process Parameters during W/O/W Emulsion Preparation and Supercritical Fluid Extraction on the Protein Encapsulation and Release Properties of PLGA Microspheres

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