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Doxil® — The first FDA-approved nano-drug: Lessons learned
Abstract
Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available.
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“Among such attempts, polyethylene glycol (PEG) coating on liposomes is a successful attempt to avoid RES recognition of nanocarrier system (Barenholz, 2012; Wong et al., 2012).”
From Nanotechnology: A Promising Approach for Delivery of Neuroprotective Drugs (2020) · cites this paper as Barenholz, 2012
In the citing paper
“The successful listing of pegylated liposome Doxil, the first nanoparticle therapeutic drug, in 1995 proved the feasibility of this technology.292”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [292]
In the citing paper
“Doxil, a PEG functionalized liposomal doxorubicin, was the first nanomedicine that has been approved for anticancer medications (FDA in 1995).292”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [292]
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Self-citationMadden, T. D., Janoff, A. S., & Cullis, P. R. (1990) · Chemistry and Physics of Lipids · doi:10.1016/0009-3084(90)90114-7 · Cited by 30
Barenholz, Y. (2016) · CRC Press eBooks · doi:10.1201/9780849397271-5 · Cited by 30
Self-citationDoxil® — The First FDA-Approved Nano-Drug: From an Idea to a Product
Barenholz, Y. (2020) · doi:10.1201/9781003125259-16 · Cited by 30
Self-citationTirosh, O., Kohen, R., Katzhendler, J., Alon, A., & Barenholz, Y. (1997) · Chemistry and Physics of Lipids · doi:10.1016/s0009-3084(97)00019-4 · Cited by 29
Self-citationRational design of amphiphile-based drug carriers and sterically stabilized carriers
Barenholz, Y., & Cohen, R. (1995) · Journal of Liposome Research · doi:10.3109/08982109509012690 · Cited by 28
Self-citationZhang, B. (2001) · CRC Press eBooks · doi:10.1201/9780203904671-31 · Cited by 28
Wasserman, V., Kizelsztein, P., Garbuzenko, O. B., Kohen, R., Ovadia, H., Tabakman, R., & Barenholz, Y. (2007) · Langmuir · doi:10.1021/la060218k · Cited by 25
Self-citationComplement Activation, Immunogenicity, and Immune Suppression as Potential Side Effects of Liposomes
Szebeni, J., & Barenholz, Y. (2020) · doi:10.1201/9781003125259-12 · Cited by 23
Self-citationStability of anthracycline antitumour agents in infusion fluids.
Beijnen, J. H., Rosing, H., Pa, D. V., & UNDERBERG, W. J. M. (1985) · PubMed · Cited by 19
Investigations on the antitumor efficacy of liposome-associated doxorubicin in murine tumor models.
Gabizón, A., Goren, D., & Barenholz, Y. (1989) · PubMed · Cited by 18
Self-citationTirosh, O., Kohen, R., Katzhendler, J., Gorodetsky, R., & Barenholz, Y. (1997) · Journal of the Chemical Society Perkin Transactions 2 · doi:10.1039/a601955b · Cited by 17
Self-citationBassermann, R. (1986) · Recent results in cancer research/Recent Results in Cancer Research · doi:10.1007/978-3-642-82635-1_32 · Cited by 15
Qualitative aspects of the degradation of mitomycins in alkaline solution
Beijnen, J. H., den Hartigh, J., & Underberg, W. J. M. (1985) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/0731-7085(85)80008-x · Cited by 15
(2018) · CRC Press eBooks · doi:10.1201/9781420005875-27 · Cited by 12
Design, Characterization and Anti-Tumor Activity of Adriamycin-Containing Phospholipid Vesicles
Gabizón, A., Goren, D., Ramu, A., & Barenholz, Y. (1986) · Springer eBooks · doi:10.1007/978-1-4684-5185-6_17 · Cited by 9
Self-citationZhang, Y., eh, B. C., & Lasiç, D. D. (2001) · CRC Press eBooks · doi:10.1201/9780203904671.ch29 · Cited by 6
From fusion to magic bullets: The influence of dimitri papahadjopoulos
Allen, T. M. (1995) · Journal of Liposome Research · doi:10.3109/08982109509012671 · Cited by 2
Flagged first, then by citations
13 of the 140 references couldn’t be matched to a known paper.
Research works printed but not linked: 3
- Amselem, 1993, A large-scale method for the preparation of sterile and nonpyrogenic liposomal formulations of defined size distributions for clinical use, vol. 1, 501
- Barenholz, 1993, Quality control assays in the development and clinical use of liposome-based formulations, vol. 1, 527
- Poste, 1983, Liposome targeting in vivo: problems and opportunities, Biol. Cell, 47, 19
Cited by
Sorted by citations
Principles of nanoparticle design for overcoming biological barriers to drug delivery
Blanco, E., Shen, H., & Ferrari, M. (2015) · Nature Biotechnology · doi:10.1038/nbt.3330 · Cited by 7,002
Nano based drug delivery systems: recent developments and future prospects
Patra, J. K., Das, G., Fraceto, L. F., Campos, E. V. R., Rodríguez-Torres, M. D. P., Acosta‐Torres, L. S., Diaz-Torres, L. A., Grillo, R., Swamy, M. K., Sharma, S., et al. (2018) · Journal of Nanobiotechnology · doi:10.1186/s12951-018-0392-8 · Cited by 7,038
Cancer nanomedicine: progress, challenges and opportunities
Shi, J., Kantoff, P. W., Wooster, R., & Farokhzad, O. C. (2017) · Nature Reviews Cancer · doi:10.1038/nrc.2016.108 · Cited by 5,873
Analysis of nanoparticle delivery to tumours
Wilhelm, S., Tavares, A. J., Dai, Q., Ohta, S., Audet, J., Dvorak, H. F., & Chan, W. C. W. (2016) · Nature Reviews Materials · doi:10.1038/natrevmats.2016.14 · Cited by 5,218
Liposomal drug delivery systems: From concept to clinical applications
Allen, T. M., & Cullis, P. R. (2013) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2012.09.037 · Cited by 4,839
Metadata
- Authors
- Barenholz, Y. (.
- Affiliations
- Hebrew University of Jerusalem (IL)
- Corresponding author
- Barenholz, Yechezkel (Chezy)
- Venue
- Journal of Controlled Release
- Publisher
- Elsevier BV
- Published
- 2012-06
- Volume
- 160
- Issue
- 2
- Pages
- 117-134
- ISSN
- 0168-3659 (ISSN-L)
- OpenAlex
- W1989230986
- Cited by
- 4,792
- References
- 140
- Citations by year
- 2026: 415 · 2025: 541 · 2024: 462 · 2023: 405 · 2022: 444 · 2021: 441 · 2020: 436 · 2019: 303 · 2018: 324 · 2017: 284 · 2016: 243 · 2015: 188 · 2014: 174 · 2013: 106 · 2012: 23
- FWCI
- 8.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Controlled Release (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Physical Sciences › Engineering › Biomedical Engineering › Ultrasound and Hyperthermia Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- pegylated liposomal doxorubicin, PEGylated liposomes, nanotherapeutics, doxorubicin, enhanced permeability and retention effect, passive tumor targeting, liposome circulation time, remote loading, phosphatidylcholine, cholesterol, drug release, generic drug availability
- MeSH terms
- Antibiotics, Antineoplastic, Chemistry, Pharmaceutical, Delayed-Action Preparations, Doxorubicin, Drug Carriers, Drug Compounding, Humans, Liposomes, Solubility, United States, United States Food and Drug Administration, Drug Design, Drug Approval, Nanoparticles
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