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Recent Advances of Nanocarriers for Effective Delivery of Therapeutic Open Access Review Precis. Nanomed. 2020 July;3(3):549-576 Recent Advances of Nanocarriers for Effective Delivery of Therapeutic Peptides Mona Atabakhshi-Kashi1#, Marzieh Geranpayehvaghei1,2#, Yazhou Wang1, Hamidreza Akhbariyoon3, Mohammad Taleb1, Yinlong Zhang1, Khosro Khajeh2,3*, Guangjun Nie1,4* 1CAS Key Laboratory for Biomedical Effects of Nanomaterials & Nanosafety, CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology, Beijing 100190, China 2Department of Nanobiotechnology, Faculty of Biological Sciences, Tarbiat Modares University, Tehran, Iran 3Department of Biochemistry, Faculty of Biological Sciences, Tarbiat Modares University, Tehran, Iran 4GBA Research Innovation Institute for Nanotechnology, Guangdong 510700, China Submitted: April 27, 2020 Accepted: June 17, 2020 Published: June 23, 2020 Abstract Precisely selective interactions of peptides with their unique binding partners represent an outstanding starting point for designing novel therapeutics. It is well established that peptides with a variety of critical physiological functions and specific mechanisms of action offer distinct advantages, including excellent safety and higher efficiency over traditional small molecule therapeutics. Certain intrinsic weaknesses of naturally occurring peptides such as negligible plasma half-life, low bioavailability, and potential immunogenicity have limited their administration as medicines. Nanotechnology has ex- panded several promising strategies to address the limitations associated with therapeutic peptides. This review aims to perform a state-of-the-art summary of the strategies that are actively used to develop efficient formulations of nanosystem based peptide medicines. We first focus on the recent advances and updates on peptide-based nanomedicines. Then we indicate how nanosystems improved the func- tionality of therapeutic peptides and what the future opportunities and challenges of developments in the field of therapeutic peptides are. Potential noninvasive delivery platforms for peptide incorporated nanoparticles through alternative administration routes are also discussed. Keywords: Therapeutic peptides; nanoparticles; peptide delivery; noninvasive administration; peptide encapsu- lation Rationale and Purpose summary reporting recent approaches was needed. This review consolidates the current One of the limitations of the therapeutic pep- understanding of nanosystems in the enhance- tides is their inefficient delivery to the site of ment of therapeutic peptide efficiency. Here, action. Since nanoparticles have significant po- we point out the main classes of nanoparticles tential as drug carriers, they can be used to over- that have been introduced for delivery of thera- come this limitation. As the delivery strategies peutic peptides, and after that, we mention re- of peptide drugs using nanocarriers are not cent advances in each class. comprehensively discussed in many articles, a * Correspondence should be addressed to: Prof. Guangjun Nie: [email protected], or Prof. Khosro Khajeh: [email protected] # These authors contributed equally to this work. Prnano.com, https://doi.org/10.33218/001c.13444 549 Andover House, Andover, MA USA The official Journal of CLINAM – ISSN:2639-9431 (online) License: CC BY-NC-SA 4.0 Summary of relevant literature compared with chemo drugs or protein thera- peutics13. However, the number of available New insights into the therapeutic appli- side chains, needed for possible peptide confor- cations of peptides mations and strong target binding, is limited by Peptide-based therapeutics constituting a the short length of polypeptides14. Advance- unique class of biopharmaceuticals have at- ments in biotechnological techniques and re- tracted great interest in the pharmaceutical in- combinant DNA engineering lead to the crea- dustry since the advent of insulin therapy in the tion of several new artificial bioactive peptides 1920s1. Therapeutic peptides have been used and the establishment of new strategies to con- for treatments of a wide assortment of diseases, formationally stabilize these peptides15. Addi- from metabolic and immunologic disorders to tionally, this new class of therapeutics is asso- cancer and infectious diseases2–4. From the late ciated with lower production complexity and is 20th century, over 60 therapeutic peptides have more cost-efficient16. Through the development been approved for clinical usage in the United and manufacturing processes of peptide pro- States, Europe, and Japan5, and the global sales duction, the quality of final products must be of therapeutic peptides exceeded USD 70 bil- assessed and their lot-to-lot consistency must lion in 20196. According to the “Global Peptide be assured17. Peptide-related impurities includ- Therapeutics Market & Clinical Trials Insight ing degraded products and residual solvents, 2026” report, there are approximately 800 pep- must be precisely controlled during peptide tide drugs in clinical trials and 197 peptide- drug production based on the guidelines. The based drugs commercially available on the mar- proposed threshold of these impurities usually ket7. It is expected that the peptide drug market depends on the type of clinical application (e.g., will keep continuous 9.1% growth per year un- therapeutic, vaccine, diagnostic) of the pep- til 20268. tide18. Peptides are arbitrarily defined as biopoly- Despite promising therapeutic properties, mers with 2 to 50 amino acid residues and less naturally occurring peptides are facing several than 6 kDa molecular mass9. The length of ther- interrelated pharmaceutical limitations, such as apeutic peptides is determinative for their sec- short plasma half-life and low oral bioavailabil- ondary structure, cytotoxicity, stability, and ity that make them unsuitable for direct use as mode of action10. Most of the previous thera- conventional medicines19. In the most fre- peutic peptides entering the clinical trials stage quently employed methods of administration, contain less than 10 amino acids that 7 to 8 of currently available therapeutic peptides are de- them were used to form amphipathic struc- livered through the parenteral routes20. Lower tures11. However, advances in manufacturing stability and short circulation half-life of pep- technology have provided peptide drugs with- tides in the bloodstream, in comparison with out length related constraints. Depending on protein therapeutics, leads to a low drug con- their amino acid sequences, site-specific modi- centration and consequently, low therapeutic fications, and subsequent spatial confor- efficiency at the site of action. To overcome this mations, peptides retain diverse three-dimen- issue, frequent injections are required. On the sional structures and possess a variety of im- other hand, multiple injections bring about an portant physiological roles which are due to oscillating concentration of drug in the blood their ability to bind with exquisite specificity to and also consume higher doses of drugs, result- the respective biological counterparts. Disrupt- ing in the development of side effects13. Poten- ing the interactions of proteins, propagation or tial unwanted immunogenicity is another draw- inhibition of signaling cascades, and modulat- back that should be taken into account. Immu- ing the plasma membrane integrity are some in- nogenicity of peptide drugs that refer to the un- stances of peptide strategies as therapeutic desirable immune response in patients has been agents12. Furthermore, peptides that mimic nat- associated with the systemic (usually paren- ural peptide hormones are considered as a med- teral) administration of these therapeutics21. ication by compensating hormone deficiencies Over the past decade, several alternative formu- in body8. The intrinsic property of peptides pro- lation routes, including oral, respiratory, trans- vides great benefits such as notably lower side dermal, and ocular, have been established and effects and less toxicity toward normal tissues were considered as notably less invasive routes Prnano.com, https://doi.org/10.33218/001c.13444 550 Andover House, Andover, MA USA The official Journal of CLINAM – ISSN:2639-9431 (online) License: CC BY-NC-SA 4.0 for the administration of peptide medicines. on the development of effective peptide deliv- Nevertheless, these alternative routes are also ery to the extracellular or intracellular targets. limited because of poor membrane permeabil- However, low permeability of peptides through ity, insignificant bioavailability after admin- biological barriers and their inefficacious cellu- istration, intrinsic weakness in front of enzy- lar internalization have hampered the clinical matic digestion of protease, and high clearance translation of peptide-based medicines30. Ther- rate22. apeutic peptides engineered into nanostructures Several techniques have been developed to not only provide opportunities to accelerate overcome these drawbacks and increase the sta- smart transportation to the desired site but also bility of peptides in biological fluids. The most prolong their half-life in the plasma. These commonly used strategy is to add stabilizing nanostructures are stable as colloidal particles agents or a combination of specific antiprote- in aqueous suspensions and are smaller than ases to the formulation of peptide medicines. 1000 nm in diameter that have been developed These stabilizing additives, including heparin, for interaction with biological macromolecules chelating agents, and
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