Liposomal Formulations in Clinical Use: An Updated Review
Abstract
:1. Introduction
2. Liposome Technologies for Delivery of Therapeutics
2.1. Stealth Liposome Technology
2.2. Non-PEGylated Liposome Technology
2.3. DepoFoam™ Liposome Technology
2.4. Lysolipid Thermally Sensitive Liposome (LTSL) Technology
3. Clinically Available Liposome-Based Products
3.1. Liposomes for Cancer Therapy
3.1.1. Doxil®
3.1.2. DaunoXome®
3.1.3. Depocyt®
3.1.4. Myocet®
3.1.5. Mepact®
3.1.6. Marqibo®
3.1.7. Onivyde™
3.2. Liposomes for Fungal Infections
3.2.1. Abelcet®
3.2.2. Ambisome®
3.2.3. Amphotec®
3.3. Liposomes for Photodynamic Therapy
Visudyne®
3.4. Liposomes for Pain Management
3.4.1. DepoDur™
3.4.2. Exparel®
3.5. Liposomes for Viral Infections
3.5.1. Epaxal®
3.5.2. Inflexal® V
4. Liposomal Formulations in Clinical Trials
4.1. Phase III
4.1.1. Arikace™
4.1.2. Stimuvax®
4.1.3. T4N5
4.1.4. Liprostin™
4.1.5. ThermoDox®
4.1.6. Lipoplatin™
4.2. Phase II
4.2.1. Aroplatin™
4.2.2. Liposomal Annamycin
4.2.3. SPI-077
4.2.4. OSI-211
4.2.5. S-CKD602
4.2.6. LE-SN38
4.2.7. LEP-ETU
4.2.8. Endotag-I
4.2.9. Atragen®
4.3. Phase I
5. Conclusions
Conflicts of Interest
References
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SN | Clinical Products (Approval Year) | Administration | Active Agent | Lipid/Lipid:Drug Molar Ratio | Indication | Company |
---|---|---|---|---|---|---|
1. | Doxil® (1995) | i.v. | Doxorubicin | HSPC:Cholesterol:PEG 2000-DSPE (56:39:5 molar ratio) | Ovarian, breast cancer, Kaposi’s sarcoma | Sequus Pharmaceuticals |
2. | DaunoXome® (1996) | i.v. | Daunorubicin | DSPC and Cholesterol (2:1 molar ratio) | AIDS-related Kaposi’s sarcoma | NeXstar Pharmaceuticals |
3. | Depocyt® (1999) | Spinal | Cytarabine/Ara-C | DOPC, DPPG, Cholesterol and Triolein | Neoplastic meningitis | SkyPharma Inc. |
4. | Myocet® (2000) | i.v. | Doxorubicin | EPC:Cholesterol (55:45 molar ratio) | Combination therapy with cyclophosphamide in metastatic breast cancer | Elan Pharmaceuticals |
5. | Mepact® (2004) | i.v. | Mifamurtide | DOPS:POPC (3:7 molar ratio) | High-grade, resectable, non-metastatic osteosarcoma | Takeda Pharmaceutical Limited |
6. | Marqibo® (2012) | i.v. | Vincristine | SM:Cholesterol (60:40 molar ratio) | Acute lymphoblastic leukaemia | Talon Therapeutics, Inc. |
7. | Onivyde™ (2015) | i.v. | Irinotecan | DSPC:MPEG-2000:DSPE (3:2:0.015 molar ratio) | Combination therapy with fluorouracil and leucovorin in metastatic adenocarcinoma of the pancreas | Merrimack Pharmaceuticals Inc. |
8. | Abelcet® (1995) | i.v. | Amphotericin B | DMPC:DMPG (7:3 molar ratio) | Invasive severe fungal infections | Sigma-Tau Pharmaceuticals |
9. | Ambisome® (1997) | i.v. | Amphotericin B | HSPC:DSPG:Cholesterol:Amphotericin B (2:0.8:1:0.4 molar ratio) | Presumed fungal infections | Astellas Pharma |
10. | Amphotec® (1996) | i.v. | Amphotericin B | Cholesteryl sulphate:Amphotericin B (1:1 molar ratio) | Severe fungal infections | Ben Venue Laboratories Inc. |
11. | Visudyne® (2000) | i.v. | Verteporphin | Verteporphin:DMPC and EPG (1:8 molar ratio) | Choroidal neovascularisation | Novartis |
12. | DepoDur™ (2004) | Epidural | Morphine sulfate | DOPC, DPPG, Cholesterol and Triolein | Pain management | SkyPharma Inc. |
13. | Exparel® (2011) | i.v. | Bupivacaine | DEPC, DPPG, Cholesterol and Tricaprylin | Pain management | Pacira Pharmaceuticals, Inc. |
14. | Epaxal® (1993) | i.m. | Inactivated hepatitis A virus (strain RGSB) | DOPC:DOPE (75:25 molar ratio) | Hepatitis A | Crucell, Berna Biotech |
15. | Inflexal® V (1997) | i.m. | Inactivated hemaglutinine of Influenza virus strains A and B | DOPC:DOPE (75:25 molar ratio) | Influenza | Crucell, Berna Biotech |
SN | Products | Administration | Active Agent | Lipid Composition | Indication | Company |
---|---|---|---|---|---|---|
Phase III | ||||||
1. | Arikace | Aerosol delivery | Amikacin | DPPC and cholesterol | Lung infections | Transave Inc. |
2. | Stimuvax | s.c. | Tecemotide | Cholesterol, DMPG, DPPC | Non-small cell lung cancer | Oncothyreon Inc. |
3. | T4N5 liposomal lotion | Topical | T4 endonuclease V | Egg lecithin | Xeroderma pigmentosum | AGI Dermatics Inc. |
4. | Liprostin | i.v. | Prostaglandin E-1 (PGE-1) | Unknown | Restenosis after angioplasty | Endovasc Inc. |
5. | ThermoDox | i.v. | Doxorubicin | DPPC, Myristoyl stearyl phosphatidylcholine and DSPE-N-[amino(polyethylene glycol)-2000] | Hepatocellular carcinoma and also recurring chest wall breast cancer | Celsion |
6. | Lipoplatin | i.v. | Cisplatin | DPPG, soy phosphatidyl choline, mPEG-distearoyl phosphatidylethanolamine lipid conjugate and cholesterol | Non-small cell lung cancer | Regulon Inc. |
Phase II | ||||||
7. | Aroplatin | i.v. | Platinum analogue cis-(trans- R,R-1,2-diaminocyclohexane) bis (neodecanoato) platinum (II) | DMPC and DMPG | Metastatic colorectal cancer | Agenus Inc. |
8. | Liposomal annamycin | i.v. | Semi-synthetic doxorubicin analogue annamycin | DMPC and DMPG | Relapsed or refractory acute myeloid leukaemia | Aronex Pharmaceuticals |
9. | SPI-077 | i.v. | Cisplatin | Soybean phosphatidylcholine, cholesterol | Lung, head and neck cancer | Alza Corporation |
10. | OSI-211 | i.v. | Lurtotecan | HSPC and cholesterol | Ovarian, head and neck cancer | OSI Pharmaceuticals |
11. | S-CKD602 | i.v. | Potent topoisomerase I inhibitor | Phospholipids covalently bound to mPEG | Cancer | Alza Corporation |
12. | LE-SN38 | i.v. | Irinotecan’s active metabolite | DOPC, cholesterol and cardiolipin | Advanced colorectal cancer | NeoPharm Labs Ltd. |
13. | LEP-ETU | i.v. | Paclitaxel | DOPC, cholesterol and cardiolipin | Cancer | NeoPharm Labs Ltd. |
14. | Endotag-I | i.v. | Paclitaxel | DOTAP: DOPC: Paclitaxel | Breast and pancreatic cancers | Medigene |
15. | Atragen | i.v. | All-trans retinoic acid | DMPC and soybean oil | Hormone-resistant prostate cancer, renal cell carcinoma and acute myelogenous leukaemia | Aronex Pharmaceuticals |
Phase I | ||||||
16. | LEM-ETU | i.v. | Mitoxantrone | DOPC, cholesterol and cardiolipin | Various cancers | NeoPharm Labs Ltd. |
17. | Liposomal Grb-2 | i.v. | Antisense oligodeoxynucleotide growth factor receptor bound protein 2 (Grb-2) | Unknown | Hematologic malignancies | Bio-Path holdings |
18. | INX-0125 | i.v. | Vinorelbine tartrate | Cholesterol and sphingomyelin | Advanced solid tumours | Inex Pharmaceuticals |
19. | INX-0076 | i.v. | Topotecan | Cholesterol and sphingomyelin | Advanced solid tumours | Inex Pharmaceuticals |
20. | TKM-080301 | Hepatic intra-arterial administration | PLK1 siRNA | Unique LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) | Neuroendocrine tumours | Tekmira Pharmaceuticals |
21. | Atu027 | i.v. | PKN3 siRNA | AtuFECT01 | Pancreatic cancer | Silence Therapeutics |
22. | 2B3-101 | i.v. | Doxorubicin | Glutathione PEGylated liposomes | Solid tumours | 2-BBB therapeutic |
23. | MTL-CEBPA | i.v. | CEBPA siRNA | SMARTICLES® liposomal nanoparticles | Liver cancer | MiNA Therapeutics |
24. | ATI-1123 | i.v. | Docetaxel | Protein stabilizing liposomes (PSL™) | Solid tumours | Azaya therapeutic |
25. | LiPlaCis | i.v. | Cisplatin | The lipid composition of the LiPlasomes is tailored to be specifically sensitive to degradation by the sPLA2 enzyme | Advanced solid tumours | Oncology Venture |
26. | MCC-465 | i.v. | Doxorubicin | DPPC, cholesterol and maleimidated palmitoyl phosphatidyl ethanolamine; immunoliposomes tagged with PEG and the F(ab′)2 fragment of human monoclonal antibody GAH | Metastatic stomach cancer | Mitsubishi Tanabe Pharma Corporation |
27. | SGT-53 | i.v. | p53 gene | Cationic lipids complexed with plasmid DNA encoding wild-type p53 tumour suppressor protein | Various solid tumours | SynerGene Therapeutics |
28. | Alocrest | i.v. | Vinorelbine | Sphingomyelin/cholesterol (OPTISOME™) | Breast and lung cancers | Spectrum Pharmaceuticals |
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Bulbake, U.; Doppalapudi, S.; Kommineni, N.; Khan, W. Liposomal Formulations in Clinical Use: An Updated Review. Pharmaceutics 2017, 9, 12. https://doi.org/10.3390/pharmaceutics9020012
Bulbake U, Doppalapudi S, Kommineni N, Khan W. Liposomal Formulations in Clinical Use: An Updated Review. Pharmaceutics. 2017; 9(2):12. https://doi.org/10.3390/pharmaceutics9020012
Chicago/Turabian StyleBulbake, Upendra, Sindhu Doppalapudi, Nagavendra Kommineni, and Wahid Khan. 2017. "Liposomal Formulations in Clinical Use: An Updated Review" Pharmaceutics 9, no. 2: 12. https://doi.org/10.3390/pharmaceutics9020012