Liposomes are lipid bilayer vesicles that are utilized to transport chemicals to particular locations within the body. They can encapsulate both hydrophilic and lipophilic medicines. Since their development, liposomes have been the focus of in-depth research on medication delivery and are thought to be the most effective type of nanocarrier. Liposomes are superior to typical drug delivery systems in that they have site-targeting, controlled or prolonged release, protection against drug degradation and clearance, better therapeutic effects, and less harmful side effects. Compared to conventional small molecule medications and biologics, liposomal formulations confront significantly more characterisation and regulatory review hurdles since they are an inherently complex delivery method. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer regulatory guidelines for new liposomal drug application evaluations as a result of the rapid development of liposomal drugs. Liposomal drugs are categorized as complex drug products by the FDA in the United States, meaning that they must follow particular regulatory guidelines covering formulation, manufacturing, and clinical evaluation. The European Medicines Agency (EMA) handles liposome drug products in the same way, emphasizing the need for comprehensive characterization and validation. This study presents a thorough analysis of the regulatory environment surrounding the development of liposome drugs, emphasizing the crucial elements of compliance with US and EU regulations.
RizviSASalehAM. Applications of nanoparticle systems in drug delivery technology. Saudi Pharm J2018; 26(1): 64–70.
2.
BarenholzY. Doxil® - the first FDA-approved nano-drug: lessons learned. J Contr Release2012; 160: 117–134.
3.
GiordaniSMarassiVZattoniA, et al.Liposomes characterization 612 for market approval as pharmaceutical products: analytical methods, guidelines and 613 standardized protocols. J Pharm Biomed Anal2023; 236: 115751.
4.
EugsterROrsiMButtittaG, et al.“Leveraging machine learning to streamline the development of liposomal drug delivery systems” SP - 2024.07.01.600773, 2024/01/01.
5.
Prachi AtreSyedRizviA. A., “A brief overview of quality by design approach for developing pharmaceutical liposomes as nano-sized parenteral drug delivery systems” Pharm RSC, 2024; 1: 675.
6.
ShuklaTUpmanyuNPrakash PandeyS, et al.Lipid nanocarriers, lipid nanocarriers for drug targeting. Elsevier, 2018.
7.
YamauchiMTsutsumiKAbeM, et al.Release of drugs from liposomes varies with particle size. Biol Pharm Bull2007; 30(Issue 5): 963–966.
8.
NsairatHKhaterDSayedU, et al.Liposomes: structure, composition, types, and clinical applications. Heliyon2022; 8: e09394, [CrossRef] [PubMed].
9.
MatosCM. Special issue “Application Progress of Liposomes in Drug Development”. Int J Mol Sci2024; 25: 3454.
10.
MishraHChauhanVKumarK, et al.A comprehensive review on liposomes: a novel drug delivery system. J Drug Deliv Therapeut2018; 8(6): 400–404.
11.
TiwariDTalrejaSPandeyMS. A review on use of novel drug delivery systems in herbal medicines. Science and Engineering Journal2020; 24(8): 190–197.
12.
LiposomeADB. The babraham connection. Chem Phys Lipids1993; 64: 1–3.
13.
DwivediCYadavRTiwariS, et al.Role of liposome in novel drug delivery systems. J Drug Deliv Therapeut2014; 4(2): 116–129.
14.
FarooqueFWasiMMugheesMM. Liposomes as drug delivery system: an updated review. J Drug Deliv Therapeut2021; 11(5–S): 149–158.
15.
FDA Guidance Document. Liposome drug products chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability; and labeling documentation. Available from. https://www.fda.gov/media/70837/download
16.
ÇağdaşMSezerADBucakS, et al.Liposomes as potential drug carrier systems for drug delivery. Application of nanotechnology in drug delivery. 2014-07-25, Ch. 1, IntechOpen, Rijeka From the Edited Volume.
17.
NsairatHKhaterDSayedU, et al.Liposomes: structure, composition, types, and clinical applications. Heliyon2022; 8(5): e09394.
18.
DianaGCavaco-PauloANogueiraE. Design of liposomes as drug delivery system for therapeutic applications. Int J Pharm2021; 601: 120571.
19.
GabrijelcicVSentjureMKristlJ. Evaluation of liposomes as drug carriers into the skin by one di-mensional EPR imaging. Int J Pharm1990; 62: 75–79.
20.
NalawadeVPatilK. Liposome: A Novel Drug Delivery System. International Journal of Publication and Review. 2023; 4(1): 1795–1801.
21.
AtoleASBargeVU. A review on liposomes: a promising technique for drug delivery system. International Journal of Scientific Research in Science and Technology(IJSRST)2023; 10(6): 439–461, Online ISSN : 2395-602X, Print ISSN : 2395-6011.
22.
BhupathyraajMMaheswaranABrindhaP, et al.Liposomal drug delivery systems – a review. Int J Pharmaceut Sci Rev Res2013; 23(1): 295–301.
23.
SrivastavaAGuptaASinghA. Liposomal drug delivery system – a review. J App Pharm Sci Res2020; 3(3): 7–10.
24.
Mohammad Shoaib Shaikh HamidHatwar *PRBakalRLKohaleNB. A comprehensive review on liposomes: as a novel drug delivery system. GSC Biol Pharm Sci2024; 27(01): 199–210.
25.
PradhanBKumarNSahaS, et al.Liposome: method of preparation, advantages, evaluation and its application. Journal of Applied Pharmaceutical Research2015; 3(3): 01–08.
26.
VyasSP.VyasSPKharRK (eds). In: Targeted and controlled drug delivery: novel carrie.r systems. CBS publishers, 2002, vol 173, p. 248.
27.
LasicDD. The mechanism of vesicle formation. Biochem J1988; 256: 1–11.
28.
LasicDDJoannicRKellerBC, et al.Spontaneous vesiculation. Adv Colloid Interface Sci2001; 89–90: 337–349.
29.
SercombeLVeeratiTMoheimaniF, et al.Advances and challenges of liposome assisted drug delivery. Front Pharmacol2015; 6: 286.
FilipczakNPanJYalamartySSK, et al.Recent advancements in liposome technology. Adv Drug Deliv Rev2020; 156: 4–22.
32.
Shankar Sawant1GVilas Sutar2KKanekarAS. Liposome: a novel drug delivery system. Pharmaceutical Nanotechnology, Recent Advances in Liposomal Drug Delivery: A Review, Author(s): Vijaykumar Nekkanti and Sandeep Kalepu2015; 3(Issue 1): 35–55.
33.
MalutaSMVinessPYahyaEC, et al.A review on composite liposomal technology for specialized drug delivery. J Drug Delivery2011: 1–19.
34.
SlootenMBoermanORomrenK, et al.Liposome as sustained released system for human interferon-gamma: biopharmaceutical aspects. Biochim Biophys2001; 1530(2–3): 134–145.
35.
AbolfazlASoodabehDYounesH, et al.Liposome: classification, preparation, and application. Nanoscale Res Lett2013; 8: 102.
36.
DivyasreeRDivyaKAartiS, et al.A comprehensive review on liposomes: a novel drug delivery system. Int J Pharma Sci Res2022; 13(2): 628–644.
37.
SharmaVK. Liposomes present prospective and future challenges. International Journal of current pharmaceutical review and Research2010; 1(2): 15–19.
38.
DeshmukhRGawaleSVBhagwaMK, et al.Review on liposomal drug delivery system and its applications. World J Pharm Pharmaceut Sci2016; 5(03): 506–517.
39.
PandeS. Liposomes for drug delivery: review of vesicular composition, factors affecting drug release and drug loading in liposomes. Artif Cells, Nanomed Biotechnol2023; 51(1): 428–440.
40.
ChoudhuryASonowalKLaskarRE, et al.Liposome: a carrier for effective drug delivery. Journal of Applied Pharmaceutical Research2020; 8(1): 22–28.
AditiGSharmaAPanditD, et al.A review on liposomal drug delivery and its applications. World J Pharmaceut Res2019; 8(11): 1377–1385.
43.
BanerjeeRTyagiPLiS, et al.Anisamide‐targeted stealth liposomes: a potent carrier for targeting doxorubicin to human prostate cancer cells. Int J Cancer2004; 112(4): 693–700.
44.
GillPSEspinaBMMuggiaF, et al. Phase I/II clinical and pharmacokinetic evaluation of liposomal daunorubicin. Journal of clinical oncology: official journal of the American Society of Clinical Oncology. 1995; 13:(4) 996–1003.
45.
GuaglianonePChanKDelaFlor-WeissE, et al.Phase I and pharmacologic study of liposomal daunorubicin (DaunoXome). Invest N Drugs1994; 12: 103–110, Journal of clinical Oncology. 1995 Apr;13(4):996-1003.
46.
EckardtJRCampbellEBurrisHA, et al.A phase II trial of DaunoXome, liposome-encapsulated daunorubicin, in patients with metastatic adenocarcinoma of the colon. Am J Clin Oncol1994; 17(6): 498–501.
47.
SchurmannDDormannAGrunewaldT, et al.Successful treatment of AIDS-related pulmonary kaposi's sarcoma with liposomal daunorubicin. Eur Respir J1994; 7(4): 824–825.
48.
DaraeeHAliEKouhiM, et al.Application of liposomes in medicine and drug delivery, artificial cells. Nanomedicine, and Biotechnology2016; 44(1): 381–391.
49.
BulbakeUDoppalapudiSKommineniN, et al.Liposomal formulations in clinical use: an updated review. Pharmaceutics2017; 9: 12.
SawantRRTorchilinVP. Challenges in development of targeted liposomal therapeutics. AAPS J2012; 14: 303–315.
54.
WangYGraingerDW. Regulatory considerations specific to liposome drug development as complex drug products. Front Drug Deliv2022; 2: 901281–902850.
55.
United States Government Accountability Office (2017). U.S. government accountability office (GAO). Report to congressional requesters on generic drugs — FDA should make public its plans to issue and revise guidance on nonbiological complex drugs.
56.
LionbergerRA. Innovation for generic drugs: science and research under the generic drug user fee amendments of 2012. Clin Pharmacol Ther2019; 105(4): 878–885.
57.
Center for Drug Evaluation and Research. Liposome drug products: chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability, and labeling documentation. U.S. Food and Drug Administration. 2018. https://www.fda.gov/media/70837/download.
58.
U.S. Food and Drug Administration. Liposome drug products chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability; and labeling documentation. FDA Draft Guidance, 2002.
59.
Center for Drug Evaluation and Research; U.S. Food and Drug Administration. Draft guidance on doxorubicin hydrochloride. U.S. Food and Drug Administration, 2014.
AndraVVSN.PammiSVNBhatrajuLVKP, et al.A comprehensive review on novel liposomal methodologies, commercial formulations, clinical trials and patents. BioNanoScience2022; 12: 274–291.
62.
BagmarNAHatwarPRBakalRL. A review on targeted drug delivery system. WJPR2023; 12(19): 288–298.
63.
WeissigV. Liposomes came first. The early history of liposomology. Methods Mol Biol2017; 1522: 1–15, [16] Taglietti, M. Hawkins, C. N. Rao, J. Novel Topical Drug Delivery Systems and Their Potential Use in Acne Vulgaris. Skin Ther. Lett. 2008; 13: 2.6-8.
64.
VermaRKGargS. Current status of drug delivery technologies and future directions. Pharmaceutical Technology On-Line2001; 25(2): 1–14.
65.
RamkrishnaSSunitKSSoumyaranjanS. Liposome as drug delivery system: a brief review. Int J Res Pharm Sci2014; 5(4): 309–321.
66.
AtroozOM. Efects of alkylresorcinolic lipids obtained from acetonic extract of Jordanian wheat grains on liposome properties. Int J Biol Chem2011; 5(5): 314–321.
67.
LasicDD. Novel applications of liposomes. Trends Biotechnol1998; 16(7): 307–321.
68.
WillisMForssenE. Ligand-targeted liposomes. Adv Drug Deliv Rev1998; 29: 249–271.
69.
LiuPChenGZhangJ. AReview of liposomes as a drug delivery system: current status of approved products, regulatory environments, and future perspectives. Molecules2022; 27: 1372.
