The dispersion releaser technology is an effective method for testing drug release from nanosized drug carriers

Janas, Christine; Mast, Marc-Phillip; Kirsamer, Li; Angioni, Carlo; Gao, Fiona; Mäntele, Werner; Dressman, Jennifer B.; Wacker, Matthias G.

doi:10.1016/j.ejpb.2017.02.006

Cited by 40 publications

(62 citation statements)

References 36 publications

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“…When assessing drug release from nanoparticulate dosage forms, the main concern is to quantify the released moiety of drug substance in the presence of the carrier bound moiety, which may require physical separation. Physical separation methods based on filtration and centrifugation are used besides physicochemical methods (solid phase extraction [SPE]) (26,(50)(51)(52).…”

Section: Separation Techniquesmentioning

confidence: 99%

“…The versatility of the sample and separate methods is overcome by the difficulty of the separation step and lack of precision. Dialysis membrane-based methods compensate for this drawback by integrating the separation step into the release test, with the necessity to determine the diffusion rate of the drug in solution through the dialysis membrane (13,26).…”

Section: Separation Techniquesmentioning

confidence: 99%

“…Computation of the release kinetics may need additional membrane permeation experiments for drug solutions, combined with mathematical deconvolution if needed (26).…”

Section: Use Of Membranesmentioning

confidence: 99%

“…Thus, the term in vitro release testing can be used for performance testing of nanoparticulate drug products (25). Numerous methods have been described in the literature for testing in vitro release from nanoparticulate drug products, among which membrane diffusion methods, sampling and separation methods, and continuous flow methods are most frequently employed (26)(27)(28). This review article intends to give an overview of current concepts and methods for testing in vitro release of parenteral nanoparticulate drug products, describing suitability and limitations of the present methodology.…”

Section: Introductionmentioning

confidence: 99%

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In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

Fecioru¹,

Klein²,

Krämer³

et al. 2019

Dissolution Technol.

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The parenteral administration route is most effective for the delivery of drug substances with poor oral bioavailability. Nanoparticulate drug delivery systems were developed with the specific purpose of overcoming the obstacles met by conventional drug therapy for parenteral administration in case of drug targeting or passing biobarriers. Today, in vitro performance tests are a prerequisite for formulation development and quality control of nanoparticulate dosage forms, focusing on drug release and stability of the release rate in particular if the release should extend to days. As a consequence of the diverse technologies of these novel dosage forms, at present there is no standardized in vitro release test available. With a focus on parenterally administered formulations, this review describes published methods used for in vitro drug release testing of nanoparticulate drug products. Some of the techniques may be applicable to nanoparticulate dosage forms for oral application.

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Section: Separation Techniquesmentioning

confidence: 99%

Section: Separation Techniquesmentioning

confidence: 99%

“…Computation of the release kinetics may need additional membrane permeation experiments for drug solutions, combined with mathematical deconvolution if needed (26).…”

Section: Use Of Membranesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

Fecioru¹,

Klein²,

Krämer³

et al. 2019

Dissolution Technol.

Self Cite

View full text Add to dashboard Cite

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“…The nanoparticles effectively induced neurite outgrowth without exhibiting significant cytotoxicity. Drug release was investigated using the dispersion releaser technology [26,27] The transport of NGF into the brain was confirmed in vitro in bEnd3 cells. Finally, a combination of the nanocarriers with the small-molecular mitogen-activated protein kinase (MEK) inhibitor U0126 was tested in an in vivo model of stroke.…”

Section: Introductionmentioning

confidence: 99%

Stimulating brain recovery after stroke using theranostic albumin nanocarriers loaded with nerve growth factor in combination therapy

Feczkó

Piiper

Ansar

et al. 2019

Journal of Controlled Release

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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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The dispersion releaser technology is an effective method for testing drug release from nanosized drug carriers

Cited by 40 publications

References 36 publications

In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

Stimulating brain recovery after stroke using theranostic albumin nanocarriers loaded with nerve growth factor in combination therapy

In vitro dissolution considerations associated with nano drug delivery systems

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