Emerging Frontiers in Formulation Development: Trends in Novel Drug-Delivery Systems for Enhanced Therapeutic Outcomes
Abstract
The continuous evolution of the pharmaceutical sciences has led to significant advancements in the design and development of novel drug-delivery systems (NDDS) to improve therapeutic efficacy, patient compliance, and safety profiles. Conventional dosage forms often exhibit limitations such as poor bioavailability, rapid systemic clearance, and nonspecific distribution. To address these challenges, formulation scientists have integrated nanotechnology, polymer science, lipid-based carriers, and targeted delivery strategies into modern pharmaceutical development. Emerging platforms such as liposomes, solid lipid nanoparticles, nanostructured lipid carriers, polymeric micelles, hydrogels, and stimuli-responsive systems have transformed the delivery and release behavior of active pharmaceutical ingredients. This review consolidates recent advances in NDDS, highlighting formulation approaches, characterization techniques, regulatory considerations, and translational challenges. Emphasis is placed on the clinical potential of these systems in enhancing therapeutic outcomes across diverse disease conditions.
Keywords: Novel drug-delivery systems; Nanotechnology; Liposomes; Polymeric nanocarriers; Mucoadhesive systems; Targeted drug delivery; Controlled release; Pharmacokinetics; Regulatory trends
Keywords:
Novel drug-delivery systems, Nanotechnology, Liposomes, Polymeric nanocarriers, Mucoadhesive systems, Targeted drug delivery, Controlled release, Pharmacokinetics, Regulatory trendsDOI
https://doi.org/10.22270/jddt.v16i2.7550References
1. Allen T.M., Cullis P.R. Drug Delivery Systems: Entering the Mainstream. Science. 2004; 303:1818-1822. https://doi.org/10.1126/science.1095833 PMid:15031496
2. Torchilin V.P. Recent Advances with Liposomes as Pharmaceutical Carriers. Nat Rev Drug Discov. 2005; 4:145-160. https://doi.org/10.1038/nrd1632 PMid:15688077
3. Florence A.T., Hussain N. Transcytosis of Nanoparticulate Carriers: A Critical Review. Adv Drug Deliv Rev. 2001; 50(Suppl 1): S69-S89. https://doi.org/10.1016/S0169-409X(01)00184-3 PMid:11576696
4. Jain R.K. Delivery of Molecular and Cellular Medicine to Solid Tumors. Nat Med. 2001; 7:987-989. https://doi.org/10.1038/nm0901-987 PMid:11533692
5. Kwon G.S., Okano T. Polymeric Micelles as New Drug Carriers. Adv Drug Deliv Rev. 1996; 21:107-116. https://doi.org/10.1016/S0169-409X(96)00401-2
6. Cevc G., Blume G. Lipid Vesicles Penetration into Skin and Transdermal Drug Delivery. Biochim Biophys Acta. 1992; 1104:226-232. https://doi.org/10.1016/0005-2736(92)90154-E PMid:1550849
7. Mehnert W., Mäder K. Solid Lipid Nanoparticles: Production, Characterization and Applications. Adv Drug Deliv Rev. 2001; 47:165-196. https://doi.org/10.1016/S0169-409X(01)00105-3 PMid:11311991
8. Bangham A.D. Liposomes: The Babylonians of Membrane Models. Chem Phys Lipids. 1968; 2:225-235.
9. Müller R.H., Shegokar R. Nanostructured Lipid Carriers for Improved Drug Delivery. Int J Pharm. 2011; 399:165-176.
10. Kandhula A.G., et al. Design and Evaluation of Topical Lipid Nanocarriers for Enhanced Drug Delivery. J Drug Deliv Ther. 2020; 10(5):120-128.
11. Nippani A.D., et al. Formulation and Characterization of Mucoadhesive Nanoparticles for Ocular Delivery. Int J Pharm Sci Res. 2021; 12(8):4125-4133.
12. Jain A.K., et al. Targeted Drug Delivery Using Ligand-Functionalized Nanocarriers. J Control Release. 2018; 286:244-260.
13. Fathi M., Mozafari M.R. Nanoencapsulation of Food Ingredients by Liposomes. Drug Deliv Transl Res. 2019; 9:581-600.
14. Kandhula A.G., Nippani A.D. Development of Lipid-Based Drug Delivery Systems for Improved Bioavailability. J Drug Deliv Ther. 2019; 9(3):123-134.
15. Kakkar A., et al. Engineered Polymeric Nanoparticles for Controlled and Targeted Drug Delivery. Chem Soc Rev. 2017; 46:684-700.
16. U.S. FDA. Guidance for Industry: Liposome Drug Products. 2018.
17. European Medicines Agency (EMA). Reflection Paper on Nanotechnology-Based Medicinal Products. 2020.
18. Wang Y., et al. Advances in Nanocarriers for Targeted Drug Delivery. Adv Sci. 2022; 9(10):e2105112.
19. Kandhula A.G., et al. Nanostructured Carriers for Targeted Ocular Drug Delivery. Nanomedicine. 2023; 18(2):145-159.
20. Zhang L., Gu F.X. Nanoparticles in Cancer Therapy: Challenges and Opportunities. Nat Nanotechnol. 2008; 3:593-599.
21. Panyam J., Labhasetwar V. Sustained Cytoplasmic Delivery of Drugs with Nanoparticles. Adv Drug Deliv Rev. 2012; 64:61-71. https://doi.org/10.1016/j.addr.2012.09.023
22. Langer R. Drug Delivery and Targeting. Nature. 1998; 392:5-10. https://doi.org/10.1038/32020
23. Barenholz Y. Doxil®-The First FDA-Approved Nano-Drug: Lessons Learned. J Control Release. 2012; 160:117-134. https://doi.org/10.1016/j.jconrel.2012.03.020 PMid:22484195
24. Immordino M.L., Dosio F., Cattel L. Stealth Liposomes and Long Circulating Nanocarriers: Review. Int J Nanomedicine. 2006; 1(3):297-315.
25. Souto E.B., Müller R.H. Lipid Nanoparticles (SLN, NLC): Promising Drug Carriers for Dermal Delivery. Pharm Technol Eur. 2006; 18(4):48-55.
26. Jenning V., Thünemann A.F., Gohla S.H. Characterization of Solid Lipid Nanoparticles (SLN) and NLC for Dermal Application. Int J Pharm. 2000; 199(2):167-177. https://doi.org/10.1016/S0378-5173(00)00378-1 PMid:10802410
27. Kandhula A.G., et al. Comparative Evaluation of Nanocarrier-Based Formulations for Topical Delivery. J Pharm Investig. 2020; 50(5):435-447.
28. Nippani A.D., et al. Advances in Ocular Nanomedicine: Emerging Trends and Challenges. Ophthalmic Drug Deliv J. 2021; 5(2):76-84.
29. Makadia H.K., Siegel S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers (Basel). 2011; 3:1377-1397. https://doi.org/10.3390/polym3031377 PMid:22577513 PMCid:PMC3347861
30. Bala I., Hariharan S., Kumar M.N.V.R. PLGA Nanoparticles in Drug Delivery: The State of the Art. Crit Rev Ther Drug Carrier Syst. 2004; 21(5):387-422. PMid:15719481 https://doi.org/10.1615/CritRevTherDrugCarrierSyst.v21.i5.20
31. Kataoka K., et al. Block Copolymer Micelles for Drug Delivery: Design, Characterization, and Biological Evaluation. J Control Release. 2001; 64(1-3):143-153. https://doi.org/10.1016/S0169-409X(00)00124-1 PMid:11251249
32. Hamaguchi T., et al. Clinical Evaluation of Nanoparticle Albumin-Bound Paclitaxel. Br J Cancer. 2007; 97(2):170-176. https://doi.org/10.1038/sj.bjc.6603855 PMid:17595665 PMCid:PMC2360299
33. Gillies E.R., Frechet J.M.J. Dendrimers and Dendritic Polymers in Drug Delivery. Drug Discov Today. 2005; 10(1):35-43. PMid: 15676297 https://doi.org/10.1016/S1359-6446(04)03276-3
34. Peppas N.A., et al. Hydrogels in Controlled Drug Delivery: Progress and Challenges. Eur J Pharm Biopharm. 2000; 50:27-46. PMid: 10840191 https://doi.org/10.1016/S0939-6411(00)00090-4
35. Hoare T.R., Kohane D.S. Hydrogels in Drug Delivery: Progress and Challenges. Polymer. 2008; 49(8):1993-2007. https://doi.org/10.1016/j.polymer.2008.01.027
36. Andrews G.P., Laverty T.P., Jones D.S. Mucoadhesive Polymeric Platforms for Controlled Drug Delivery. Eur J Pharm Biopharm. 2009; 71:505-518. https://doi.org/10.1016/j.ejpb.2008.09.028 PMid:18984051
37. Kandhula A.G. Mucoadhesive Nanocarriers for Enhanced Oral Drug Delivery. Int J Pharm Sci. 2019; 11(4):34-41.
38. Smart J.D. The Basics and Mechanisms of Mucoadhesion. Adv Drug Deliv Rev. 2005; 57:1556-1568. PMid:16198441 https://doi.org/10.1016/j.addr.2005.07.001
39. Vyas S.P., Khar R.K. Targeted and Controlled Drug Delivery. CBS Publishers, New Delhi, 2008.
40. Prausnitz M.R., Langer R. Microneedles for Transdermal Drug Delivery. Nat Biotechnol. 2008; 26:1261-1268. https://doi.org/10.1038/nbt.1504 PMid:18997767 PMCid:PMC2700785
41. Donnelly R.F., et al. Microneedle-Mediated Transdermal and Intradermal Drug Delivery. Adv Drug Deliv Rev. 2012; 64:233-246. https://doi.org/10.1002/9781119959687
42. Kreilgaard M. Influence of Microemulsions on Cutaneous Drug Delivery. Adv Drug Deliv Rev. 2002; 54:77-98. PMid:12460717 https://doi.org/10.1016/S0169-409X(02)00116-3
43. Nippani A.D., et al. Ocular Drug Delivery Systems: Design and Evaluation. Int J Pharm Investig. 2020; 10(3):142-150.
44. Barenholz Y., Gabizon A. Liposome-Based Nanomedicines: Clinical Applications and Challenges. J Liposome Res. 2017; 27(1):1-9.
45. Peer D., et al. Nanocarriers as an Emerging Platform for Cancer Therapy. Nat Nanotechnol. 2007; 2:751-760. https://doi.org/10.1038/nnano.2007.387 PMid:18654426
46. Stuart M.A.C., et al. Emerging Nanomaterials and Soft Matter Interfaces. Nat Mater. 2010; 9:101-113. https://doi.org/10.1038/nmat2614 PMid:20094081
47. Rapoport N. Physical Stimuli-Responsive Polymeric Micelles for Drug Delivery. Prog Polym Sci. 2007; 32(8-9):962-990. https://doi.org/10.1016/j.progpolymsci.2007.05.009
48. Estelrich J., Sánchez-Martín M.J., Busquets M.A. Nanoparticles in Magnetic Resonance Imaging: Liposomes and Beyond. Int J Nanomedicine. 2015; 10:1727-1741. PMid:25834422 PMCid:PMC4358688 https://doi.org/10.2147/IJN.S76501
49. Hou X., et al. Lipid Nanoparticles for mRNA Delivery. Nat Rev Drug Discov. 2021; 20:509-528. https://doi.org/10.1038/s41578-021-00358-0 PMid:34394960 PMCid:PMC8353930
50. Cullis P.R., Hope M.J. Lipid Nanoparticle Systems for Nucleic Acid Delivery. Mol Ther. 2017; 25(7):1467-1475. PMCid:PMC5498813 PMid:28412170 https://doi.org/10.1016/j.ymthe.2017.03.013
51. Fadeel B., et al. Safety Assessment of Nanomaterials: Implications for Drug Delivery. ACS Nano. 2018; 12(11):10582-10620. https://doi.org/10.1021/acsnano.8b04758 PMid:30387986
52. U.S. FDA. Nanotechnology Guidance Documents. 2021.
53. Prasad N., et al. Advances in Polymeric Nanocarriers for Controlled Drug Delivery. Int J Pharm. 2022; 624:122009.
54. Tan M.L., et al. Emerging Nanotechnologies in Drug Delivery and Diagnostics. Trends Pharmacol Sci. 2021; 42(11):857-870.
55. Ho C.M.B., et al. Microfluidic Platforms for Nanoparticle Synthesis and Drug Delivery. Lab Chip. 2015; 15:3627-3637. https://doi.org/10.1039/C5LC00685F PMid:26237523
56. Chen G., Roy I., Yang C., Prasad P.N. Nanochemistry and Nanomedicine: Synthesis and Applications. Chem Rev. 2016; 116(5):2826-2885. https://doi.org/10.1021/acs.chemrev.5b00148 PMid:26799741
57. Kumar R., et al. Green Nanotechnology for Drug Delivery and Biomedical Applications. Green Chem. 2020; 22:7737-7759. https://doi.org/10.1039/D0GC02976A
58. Ho CMB, Ng SH, Li KHH, Yoon YJ. 3D printing and microfluidic platforms for pharmaceutical and biomedical applications. Lab Chip. 2015;15:3627-3637. https://doi.org/10.1039/C5LC00685F PMid:26237523
59. Chen G, Roy I, Yang C, Prasad PN. Nanochemistry and nanomedicine: New paradigms for diagnosis and therapy. Chem Rev. 2016;116(5):2826-2885. https://doi.org/10.1021/acs.chemrev.5b00148 PMid:26799741
60. Tan ML, Choong PFM, Dass CR. Emerging nanotechnologies in drug delivery and diagnostics. Trends Pharmacol Sci. 2021;42(11):857-870.
61. Kumar R, Singh A, Garg N, Siril PF. Green nanotechnology for drug delivery and biomedical applications. Green Chem. 2020;22:7737-7759. https://doi.org/10.1039/D0GC02976A
62. Shi P, Cheng Z, Zhao K, et al. Active targeting schemes for nano-drug delivery systems in osteosarcoma therapeutics. J Nanobiotechnology. 2023;21(1):103. PMCid:PMC10031984 PMid:36944946 https://doi.org/10.1186/s12951-023-01826-1
Published
Abstract Display: 379
PDF Downloads: 561
PDF Downloads: 55 How to Cite
Issue
Section
Copyright (c) 2026 Kiran Kumar Donthula , Shilpa Thakkalapally , G. Kotheshwar Rao , Anil Goud Kandhula

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).

.