Lipid-coated mannitol core microparticles for sustained release of protein

Wang, Bifeng; Frieß, Wolfgang

doi:10.1016/j.ejpb.2018.04.022

Cited by 5 publications

(2 citation statements)

References 32 publications

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“…242,243 Moreover, FIM techniques may be used for the detection of cell aggregates occurring postthaw. 221,244 Other Biopharmaceutical Microparticulate Formulations Other biopharmaceutical microparticulate formulations are, e.g., antibody crystals 245,246 and depot formulations containing proteins or peptides 247,248 . Characterization of antibody crystals as well as depot formulations is commonly performed with techniques suitable for the required size range as has been shown by several groups.…”

Section: Cell-based Medicinal Products (Cbmp)mentioning

confidence: 99%

Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Roesch

Zölls²,

Stadler³

et al. 2022

Journal of Pharmaceutical Sciences

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Particles in biopharmaceutical formulations remain a hot topic in drug product development. With new product classes emerging it is crucial to discriminate particulate active pharmaceutical ingredients from particulate impurities. Technical improvements, new analytical developments and emerging tools (e.g., machine learning tools) increase the amount of information generated for particles. For a proper interpretation and judgment of the generated data a thorough understanding of the measurement principle, suitable application fields and potential limitations and pitfalls is required. Our review provides a comprehensive overview of novel particle analysis techniques emerging in the last decade for particulate impurities in therapeutic protein formulations (protein-related, excipient-related and primary packaging material-related), as well as particulate biopharmaceutical formulations (virus particles, virus-like particles, lipid nanoparticles and cellbased medicinal products). In addition, we review the literature on applications, describe specific analytical approaches and illustrate advantages and drawbacks of currently available techniques for particulate biopharmaceutical formulations.

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Section: Cell-based Medicinal Products (Cbmp)mentioning

confidence: 99%

Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Roesch

Zölls²,

Stadler³

et al. 2022

Journal of Pharmaceutical Sciences

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“…This observation was confirmed in vivo with a 5-h extended analgesic effect of the polymer-lipid hybrids over the polymeric nanoparticles. The influence of different lipid types on core-shell particle systems was demonstrated using mannitol microparticle cores with embedded monoclonal antibody IgG 1 [163]. Glyceryl stearate as a coating showed an incomplete in vitro release of IgG 1 , whereas the release profile was prolonged up to 6 weeks with increasing amounts of hard fat as the lipid shell and the initial burst decreased.…”

Section: Solid Particles and Implantsmentioning

confidence: 99%

Injectable Lipid-Based Depot Formulations: Where Do We Stand?

Rahnfeld

Luciani

2020

Pharmaceutics

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The remarkable number of new molecular entities approved per year as parenteral drugs, such as biologics and complex active pharmaceutical ingredients, calls for innovative and tunable drug delivery systems. Besides making these classes of drugs available in the body, injectable depot formulations offer the unique advantage in the parenteral world of reducing the number of required injections, thus increasing effectiveness as well as patient compliance. To date, a plethora of excipients has been proposed to formulate depot systems, and among those, lipids stand out due to their unique biocompatibility properties and safety profile. Looking at the several long-acting drug delivery systems based on lipids designed so far, a legitimate question may arise: How far away are we from an ideal depot formulation? Here, we review sustained release lipid-based platforms developed in the last 5 years, namely oil-based solutions, liposomal systems, in situ forming systems, solid particles, and implants, and we critically discuss the requirements for an ideal depot formulation with respect to the used excipients, biocompatibility, and the challenges presented by the manufacturing process. Finally, we delve into lights and shadows originating from the current setups of in vitro release assays developed with the aim of assessing the translational potential of depot injectables.

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Development of thermo/pH-responsive chitosan coated pectin-graft-poly(N,N-diethyl acrylamide) microcarriers

Işıklan

Tokmak

2019

Carbohydrate Polymers

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Lipid-coated mannitol core microparticles for sustained release of protein

Cited by 5 publications

References 32 publications

Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells

Injectable Lipid-Based Depot Formulations: Where Do We Stand?

Development of thermo/pH-responsive chitosan coated pectin-graft-poly(N,N-diethyl acrylamide) microcarriers

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