Residual Solvents in Nanomedicine and Lipid-Based Drug Delivery Systems: a Case Study to Better Understand Processes

Dikpati, Amrita; Mohammadi, Farzad; Greffard, Karine; Queant, Caroline; Arnaúd, Philippe; Bastiat, Guillaume; Rudkowska, Iwona; Bertrand, Nicolas

doi:10.1007/s11095-020-02877-x

Cited by 23 publications

(15 citation statements)

References 33 publications

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“…Lecithin nanovesicles were prepared using a solvent-free hydration method recently developed [ 30 ]. Briefly, oxygen was removed from ultrapure water by bubbling nitrogen.…”

Section: Methodsmentioning

confidence: 99%

C57bl/6 Mice Show Equivalent Taste Preferences toward Ruminant and Industrial Trans Fatty Acids

2023

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Two distinct types of trans fatty acids (TFA) are found in the diet. Industrial TFA such as elaidic acid (EA) have deleterious effects on metabolic risk factors, and oppositely ruminant TFA including trans-palmitoleic acid (TPA) may have beneficial effects. The objective is to evaluate the taste preference between EA, TPA, lecithin or water. In this study, 24 female C57BL/6 mice were microchipped and placed in two separate IntelliCages®. Nano encapsulated TFA or lecithin were added to drinking water in different corners of the cage with normal diet. The study was carried out over 5 weeks, during which mice were exposed to water only (weeks 1 and 3), TFA or lecithin (week 2), and EA or TPA (weeks 4 and 5). Mice weights, corner visits, nose pokes (NP), and lick number were measured each week. The results demonstrated that mice consume more TFA, either EA or TPA, compared with lecithin. In addition, the mice licked more EA compared with TPA in one cage; conversely, in the other cage they licked more TPA compared with EA. However, when TFA positions were swapped, mice had equal licks for EA and TPA. In sum, mice preferred TFA, in equal matter compared with controls; therefore, the results demonstrate the potential for TFA-type substitution in diet.

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“…Lecithin nanovesicles were prepared using a solvent-free hydration method recently developed [ 30 ]. Briefly, oxygen was removed from ultrapure water by bubbling nitrogen.…”

Section: Methodsmentioning

confidence: 99%

C57bl/6 Mice Show Equivalent Taste Preferences toward Ruminant and Industrial Trans Fatty Acids

2023

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“…Residual solvents can be toxic and affect drug particle size, dissolution, and wettability. The need to measure residual solvents was highlighted at various preparation and purification stages of liposomes and polymeric NPs for development of efficacious and safe NDDS (Dikpati et al, 2020).…”

Section: In Vitro Dissolution Considerations For Nddsmentioning

confidence: 99%

“…Safety of nanomaterials in cosmetic products guidance (FDA, 2014b) also necessitates the thorough understanding of manufacturing process to identify residual additives and impurities. Dikpati et al (2020) have provided useful recommendations to minimize the residual solvents in the NDDS. First, the use of class III solvents (e.g., acetone, ethyl acetate, dimethyl sulfoxide) or solvent-free/solvent-limiting preparation methods (e.g., supercritical fluid technology, microfluidics, and extrusion for polymer based NDDS or high-pressure homogenization for lipid based NDDS) (Anton et al, 2012;Paliwal et al, 2014).…”

Section: Biocompatibilitymentioning

confidence: 99%

In vitro dissolution considerations associated with nano drug delivery systems

Gupta

Chen

Xie

2021

WIREs Nanomed Nanobiotechnol

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Nano drug delivery systems (NDDS) offer promising solution for the translation of future nanomedicines. As bioavailability and therapeutic outcomes can be improved by altering the drug release from these NDDS, it becomes essential to thoroughly understand their drug release kinetics. Moreover, U.S. Food and Drug Administration requires critical evaluation of potential safety, efficacy, and public health impacts of nanomaterials. Spiraling up market share of NDDS has also stimulated the pharmaceutical industry to develop their cost‐effective generic versions after the expiry of patent and associated exclusivity. However, unlike the conventional dosage forms, the in vivo disposition of NDDS is highly intricate and different from their in vitro behavior. Significant challenges exist in the establishment of in vitro–in vivo correlation (IVIVC) due to incomplete understanding of nanoparticles' in vivo biofate and its impact on in vitro experimental protocols. A rational design of dissolution may serve as quality and quantity control tool and help develop a meaningful IVIVC for favorable economic implications. Clinically relevant drug product specifications (critical quality attributes) can be identified by establishing a link between in vitro performance and in vivo exposure. In vitro dissolution may also play a pivotal role to understand the dissolution‐mediated clearance and safety of NDDS. Prevalent in vitro dissolution methods for NDDS and their limitations are discussed in this review, among which USP 4 is gaining more interest recently. Researchers are working diligently to develop biorelevant in vitro release assays to ensure optimal therapeutic performance of generic versions of these NDDS. This article focuses on these studies and presents important considerations for the future development of clinically relevant in vitro release methods. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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“…These techniques are especially useful for nanoparticles that cannot be sedimented because of their small size and/or low density. They are also particularly efficient to remove small molecular weight solutes . Drawbacks of these methods include the tedious validation necessary with each individual system, the low throughput of extraction, and, with biological samples, the difficulty of adequately separating small nanoparticles from larger lipoproteins or protein complexes.…”

Section: Introductionmentioning

confidence: 99%

“…They are also particularly efficient to remove small molecular weight solutes. 16 Drawbacks of these methods include the tedious validation necessary with each individual system, the low throughput of extraction, and, with biological samples, the difficulty of adequately separating small nanoparticles from larger lipoproteins or protein complexes. Finally, rapid, specific, and sensitive isolation methods using magnetic fields have also been reported, but are only applicable to magnetic/paramagnetic systems (e.g., iron oxide nanoparticles).…”

Section: ■ Introductionmentioning

confidence: 99%

Isolating Nanoparticles from Complex Biological Media by Immunoprecipitation

et al. 2021

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Polyethylene glycol (PEG) is considered the gold standard to prepare long circulating nanoparticles. The hydrophilic layer that sterically protects PEGylated nanomedicines also impedes their separation from biological media. In this study, we describe an immunoprecipitation method using AntiPEG antibodies cross-linked to magnetic beads to extract three types of radiolabeled PEGylated systems: polymeric nanoparticles, liposomes, and therapeutic proteins. The potential of the method is emphasized by isolating these systems after in vivo administration and ex vivo incubation in human biological fluids. Immunoprecipitation also allows a unique perspective on the size distribution of nanoparticles in the bloodstream after intravenous and intraperitoneal administrations. Further, we highlight the potential of the approach to inform on nanomaterial-associated drug in plasma as well as help characterize the protein corona. Altogether, we believe this method answers an unmet need in nanomedicine research and will contribute a fresh perspective on the interactions of nanomedicines with biological systems.

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Residual Solvents in Nanomedicine and Lipid-Based Drug Delivery Systems: a Case Study to Better Understand Processes

Cited by 23 publications

References 33 publications

C57bl/6 Mice Show Equivalent Taste Preferences toward Ruminant and Industrial Trans Fatty Acids

C57bl/6 Mice Show Equivalent Taste Preferences toward Ruminant and Industrial Trans Fatty Acids

In vitro dissolution considerations associated with nano drug delivery systems

Isolating Nanoparticles from Complex Biological Media by Immunoprecipitation

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