Opportunities and challenges in commercial pharmaceutical liposome applications

Jensen, Greg; Hodgson, Donald F.

doi:10.1016/j.addr.2020.07.016

Cited by 63 publications

(46 citation statements)

References 40 publications

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“…The increase of efficacy of the liposomal dosage forms and/or the reduction of toxicity may be linked to the EPR effect, which results in an enrichment of the liposomal cytostatic in tumor tissue and simultaneously avoidance of “tox target” organs, as demonstrated with the Doxil product. J ensen and H odgson [ 241 ] reviewed the properties of DaunoXome in comparison to Doxil and mention the short shelf‐life of the DaunoXome product. In addition, DaunoXome is only applied to treat liquid tumors, whereas Doxil is used for both liquid and solid tumors.…”

Section: Discussionmentioning

confidence: 99%

“…Both have reduced cardiotoxicity, but Doxil is using PEGylated lipids to prolong the circulation time after intravenous administration, whereas Myocet and DaunoXome do not contain PEGylated liposomes. [ 241,339 ]…”

Section: Discussionmentioning

confidence: 99%

“…[ 240 ] The development of an injectable Pharmaceutical Form Line Extension with amikacin sulfate using liposomes was explored by Gilead Sciences Inc. (La Verne, CA) named MiKasome. [ 241 ] MiKasome showed substantially reduced nephrotoxicity and reduced ototoxicity in preclinical studies. In humans, however, it was assumed that therapeutic dose monitoring would virtually eliminate the toxicity in control arms in clinical studies for the cystic fibrosis indication, and so proof of improvement and label claim would be very difficult to obtain.…”

Section: Inhalation Pharmaceutical Form Line Extensionsmentioning

confidence: 99%

“…With these issues, there was less commercial incentive leading to cessation of further development of this product. [ 241 ]…”

Section: Inhalation Pharmaceutical Form Line Extensionsmentioning

confidence: 99%

“…With these issues, there was less commercial incentive leading to cessation of further development of this product. [241] Still, local administration of this product was considered a potentially viable therapeutic strategy, and the company Transave (South Brunswick Township, NJ) decided to develop liposomal amikacin (Arikace, later named Arikayce) originally for treatment of Pseudomonas lung infections and lung infections due to nontuberculous Mycobacteria in cystic fibrosis patients. [242] After obtaining the orphan drug status in the US and EU, Insmed Inc. (Bridgewater Township, NJ) acquired Transave and further developed the product.…”

Section: Amikacinmentioning

confidence: 99%

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The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

Hoogevest

Tiemessen

Metselaar

et al. 2021

Euro J Lipid Sci & Tech

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This review describes the use of phospholipid excipients to make Pharmaceutical Form (Dosage Form) Line Extensions of existing drugs as part of a Product Life Cycle Management. Product examples and development candidates, which show the versatility of phospholipids as key excipients in formulations to develop line extension drug products for any administration route by reformulating existing products, are provided. The resulting patented products enable the application of a drug substance for another administration route or show an increased efficacy and/or reduced toxicity of the formulated drug substances, or enable a more convenient use, through reduction of dosing frequency, or adapt a product for regulatory requirements for specific patient populations. Parenteral line extensions for lipophilic drugs using non‐toxic phospholipid‐based solubilising formulations are clearly an alternative to products with solubilising synthetic detergents with the risk for allergic and anaphylactic reactions. This review draws the attention to academic and industrial formulation scientist to consider using phospholipid excipients to reformulate existing products to improve the product properties by an active product life cycle management. Phospholipids are suitable for this purpose because they are biocompatible, biodegradable, non‐toxic, and available at large scale and of pharmaceutical grade. Besides, they are well known to regulatory authorities.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Inhalation Pharmaceutical Form Line Extensionsmentioning

confidence: 99%

“…With these issues, there was less commercial incentive leading to cessation of further development of this product. [ 241 ]…”

Section: Inhalation Pharmaceutical Form Line Extensionsmentioning

confidence: 99%

Section: Amikacinmentioning

confidence: 99%

See 3 more Smart Citations

The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

Hoogevest

Tiemessen

Metselaar

et al. 2021

Euro J Lipid Sci & Tech

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Liposomes as Targeted Drug‐Delivery Systems

Mundargi

Taneja

Hadia

et al. 2022

Targeted Drug Delivery

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Regulating Size and Charge of Liposomes in Microneedles to Enhance Intracellular Drug Delivery Efficiency in Skin for Psoriasis Therapy

Qu,

Sun,

et al. 2023

Adv Healthcare Materials

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The stratum corneum (SC) and cell membrane are two major barriers that hinder the therapeutic outcomes of transdermal drug delivery for the treatment of skin diseases. While microneedles (MNs) can efficiently penetrate the SC to deliver nanomedicines, the optimization of physicochemical properties of nanomedicines in MNs to enhance their in vivo cellular delivery efficiency remains unclear. Here, we systematically investigated how the size and surface charge of drug‐loaded liposomes in MNs influence the retention time and cellular delivery in psoriatic skin. The results indicated that while 100 nm negatively‐charged liposomes in MNs showed higher cellular uptake in vitro, 250 and 450 nm liposomes could enhance skin retention and the long‐term in vivo cellular delivery efficiency of drugs. Moreover, 250 nm cationic liposomes with a stronger positive charge showed an extraordinarily long skin retention time of 132 h and significantly higher in vivo cellular internalization. In the treatment study, dexamethasone (dex)‐loaded cationic liposomes‐integrated MNs showed better therapeutic outcomes than dex‐loaded anionic liposomes‐integrated MNs in a psoriasis‐like animal model. The design principles of liposomes in MN drug delivery systems explored in the study hold the potential for enhancing the therapeutic outcomes of psoriasis and are instrumental for successful translation.This article is protected by copyright. All rights reserved

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Opportunities and challenges in commercial pharmaceutical liposome applications

Cited by 63 publications

References 40 publications

The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

Liposomes as Targeted Drug‐Delivery Systems

Regulating Size and Charge of Liposomes in Microneedles to Enhance Intracellular Drug Delivery Efficiency in Skin for Psoriasis Therapy

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