Engleski

  • Sanja Stanković Apotekarska ustanova Neven, Bulevar Nemanjica 33l, 18000 Nis
  • Marija Tasić Kostov
DOI: https://doi.org/10.5937/afmnai39-35426
Ključne reči: biološki lekovi, alternativni putevi primene

Sažetak


Sažetak

Biološki lekovi (biofarmaceutici) predstavljaju novu, obećavajuću terapiju za mnoge bolesti kao što su karcinomi, hronične inflamatorne bolesti i današnji najveći izazov - COVID-19. Danas se većina bioloških lekova dobija savremenim metodama biotehnologije, a pre svega tehnikom rekombinantne DNK. Biofarmaceutici tipa proteina/peptida se uglavnom primenjuju parenteralno, zbog nestabilnosti i veličine molekula. Međutim, mnoge kompanije rade na razvoju adekvatnih farmaceutskih oblika biofarmaceutika za alternativne neinvazivne puteve primene, između ostalog i radi poboljšanja terapijske komplijanse. Cilj ovog rada je sumiranje trenutnih motivacija, ali i problema u formulacijama biofarmaceutika za alternativne, neparenteralne puteve administracije i pregled pokušaja da se isti prevazidju. Akcenat je na težnjama da se monoklonska antitela stabilizuju u specijalne formulacije i sisteme za isporuku leka čija bi primena bila komfornija, pouzdana i bezbedna. Što se tiče hormona, vakcina i manjih peptida, neke kompanije već su registrovale nazalne sprejeve ili oralne oblike za njihovu primenu.

Reference

References



  1. Savić S, Milić J. Biološki lekovi: farmaceutsko-tehnološke specifičnosti. Arh Farm. 2012; 62:374-391.

  2. Crommelin D, Bermejo T, Bisssig M et al.Pharmaceutical evaluation of biosimilars: important differenceas from generic low molekul-weight pharmaceuticals. Eur J Hosp; Pharm. 2005; 11: 11-17.

  3. Savić S, Pantelić I, Savić M. Farmaceutski oblici bioloških i drugih lekova u terapiji multiple skleroze. Arh Farm. 2015; 65: 237 – 255.

  4. Savić S, Vuleta G, Savić M. Hormoni kao biotehnološki lekovi: humani insulin i analozi. Arhiv Farm. 2010; 60(2): 207-225.

  5. Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015; 44 (6): S2-S8.

  6. International alliance of patients organizations. Biologics Introduction. 2017. iapo.org.uk/sites/default/files/files/factsheet1.pdf

  7. Nagel KM. Therapeutic Proteins. In Introduction to Biologic and Biosimilar Product Development and Analysis 2018 (pp. 31-54). Springer, Cham.

  8. Emami F, Vatanara A, Park EJ, Na DH. Drying technologies for the stability and bioavailability of Biopharmaceuticals. Pharmaceutics. 2018; 10(3):131.

  9. Awwad S, Angkawinitwong U. Overview of antibody drug delivery. Pharmaceutics. 2018; 10 (3), 83.

  10. Madani F, Hsein H, Busignies V, Tchoreloff P. An overview on dosage forms and formulation strategies for vaccines and antibodies oral delivery. Pharm.Dev.Technol.S.2020; 25(2),133-148.

  11. Anselmo AC, Gokarn Y, Mitragotri S. Non-invasive delivery strategies for biologics. Nat.Rev. Drug Discov. 2019; 18: 19-40.

  12. Knowles SP, Printz MA, Kang DW, LaBarre MJ, Tannenbaum RP. Safety of recombinant human hyaluronidase PH20 for subcutaneous drug delivery. Expert Opinion on Drug Delivery. 2021 Oct 1:1-3.

  13. Nirnoy D, Kamalika S, Hassan A. An Update on Pharmaceutical Strategies for Oral Delivery of Therapeutic Peptides and Proteins in Adults and Pediatrics. Children. 2020; 7(12): 307.

  14. Viswanathan P, Muralidaran Y, Ragavan G. Challenges in oral drug delivery: a nano-based strategy to overcome. In Nanostructures for oral medicine 2017 Jan 1 (pp. 173-201). Elsevier.

  15. Morcol T, Nagappan P, Nerenbaum L, Mitchell A, Bell S J. Calcium phosphate–PEG–insulin–casein (CAPIC) particles as oral delivery systems for insulin. J. Pharm. 2004; 277(1-2): 91–97.

  16. Eldor R, Neutel J, Homer K, Kidron M. Efficacy and safety of 28‐day treatment with oral insulin (ORMD‐0801) in patients with type 2 diabetes: A randomized, placebo‐controlled trial. Diabetes, Obesity and Metabolism. 2021 Nov;23(11):2529-38.

  17. Oramed Pharmaceuticals. Oramed Initiates Second Phase 3 Oral Insulin Study Under the FDA’s Approved Dual Concurrent Protocol. PRNewswire: Oramed Pharmaceuticals-press releases 2021 March 23. Available from: https://www.oramed.com/oramed-initiates-second-phase-3-oral-insulin-study-under-the-fdas-approved-dual-concurrent-protocol/Last accessed 22.05.2021.

  18. Nagaraju R, Madan S, Arora K, Arora NM, Kundu PK, Greenberg-Shushlav Y, Kidron M, Hershko A. Recombinant Protease Inhibitor Enhances Oral Insulin Pharmacodynamics in Pigs. 2018; 67(1).

  19. Traverso G, Schoellhammer CM, Schroeder A, Maa R, Lauwers GY, Polat BE, Anderson DG, Blankschtein D, Langer R. Microneedles for drug delivery via the gastrointestinal tract. Journal of pharmaceutical sciences. 2015;104(2):362-7.

  20. Tiziana Life Science. Tiziana Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated in Healthy Volunteers. Businesswire: Tiziana Life Science;cited 2020 Jan 09. Available from:https://www.businesswire.com/news/home/20200109005415/en/. Last accessed 18.03.2021.

  21. Tiziana Life Science. Corporate Presentation.Tiziana Life Sience:published 2021 Jan. Available from: https://www.tizianalifesciences.com/cms/resources/tlsa-non-confidential-jan-2021.pdf Last accessed 18.03.2021.

  22. Ilan Y, Shailubhai K, Sanyal A. Immunotherapy with oral administration of humanized anti‐CD3 monoclonal antibody: a novel gut‐immune system‐based therapy for metaflammation and NASH. Clinical & Experimental Immunology. 2018 Sep;193(3):275-83.

  23. Vass P, Démuth B, Hirsch E, Nagy B, Andersen SK, Vigh T. et al. Drying technology for colon-targeted oral delivery of biopharmaceuticals. J Controled Release, 2019; 296:162-178.

  24. Chourasia MK, Jain SK. Pharmaceutical approaches to colon targeted drug delivery systems. J Pharm Pharm Sci. 2003;6(1):33-66.

  25. Maurer JM, Hofman S, Schellekens RC, Tonnis WF, Duboi AO, Woerdenbag HJ et al. Development and potential application of an oral ColoPulse infliximab tablet with colon specific release: A feasibility study. Int. J.Pharm.2016; 505(1-2): 175–18

  26. Intract Pharma. Intract Pharma Limited and Celltrion Group announce collaboration for development of oral Infliximab. Biosimilar development: Intract Pharma: cited 2020 Aug 20. Available from: https://www.biosimilardevelopment.com/doc/intract-pharma-limited-and-celltrion-development-of-oral-infliximab-0001. Last accessed 16.04.2021.

  27. Intract Pharma. Intract Pharma Enters into Research Collaboration with Ferring Pharmaceuticals to Evaluate Oral delivery of Monoclonal Antibodies for Treatment of Chronic Gastrointestinal Diseases-Intract Pharma: cited 2021 Apr 01. Available from : https://www.intractpharma.com/2021/04/01/intract-pharma-enters-into-research-collaboration-with-ferring-pharmaceuticals-to-evaluate-oral-delivery-of-monoclonal-antibodies-for-treatment-of-chronic-gastrointestinal-diseases/. Last accessed 16.04.2021.

  28. Intract Pharma. Enabling Technologies for Precision Drug Delivery in the GI Tract. Available from: https://www.intractpharma.com/ Last accessed 16.04.2021.

  29. Annabestani Z, Sharghi S, Shahbazi S, Karimi F, Taheri E, Heshmat R, Larijani B. Insulin buccal spray (Oral-Lyn) efficacy in type 1 diabetes. Journal of Diabetes and Metabolic Disorders. 2010;9:18.

  30. Generex Biotechnology Corp. Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin, ClinicalTrials.gov Identifier: NCT00668850, 2008.Available from:gov/ct2/show/NCT00668850?term=NCT00668850&draw=2&rank=1.

  31. Bajracharya R, Song JG, Back SY, Han HK. Recent advancements in non-invasive formulations for protein drug delivery. Computational and structural biotechnology journal. 2019;17:1290-308.

  32. Tiziana Life Science. Tiziana Reports Positive Data from the Clinical Study of Nasal Administration with Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, in COVID-19 Patients in Brazil. GlobeNewswire: Tiziana Life Science:cited 2021 Feb 02. Available from: https://www.globenewswire.com/news-release/2021/02/02/2167825/0/en/Tiziana-Reports-Positive-Data-from-the-Clinical-Study-of-Nasal-Administration-with-Foralumab-its-proprietary-fully-human-anti-CD3-monoclonal-antibody-in-COVID-19-Patients-in-Brazil.html,Last accessed 18.03.2021.

  33. Zhang H, Yang Z, Xiang J, Cui Z, Liu J, Liu C. Intranasal administration of SARS-CoV-2 neutralizing human antibody prevents infection in mice. bioRxiv. 2020 Jan 1.

  34. Diomics Corporation, US, 2020. Diomics aims to nose out coronavirus ahead of vaccines with nasal spray that delivers monoclonal antibody protection. Available at: https://www.businesswire.com/news/home/20200908005196/en/Diomics-Aims-Nose-Coronavirus-Vaccines-Nasal-Spray (Last Accessed March 24, 2021).

  35. Understanding Nanobody Technology.Available from: https://www.ablynx.com/technology-innovation/understanding-the-nanobody-technology/. Last accessed 09.04.2021

  36. Esparza TJ, Martin NP, Anderson GP, Goldman ER, Brody DL. High affinity nanobodies block SARS-CoV-2 spike receptor binding domain interaction with human angiotensin converting enzyme. Scientific reports. 2020;10(1):1-3.

  37. Liang W, Pan HW, Vllasaliu D, Lam JK. Pulmonary delivery of biological drugs. Pharmaceutics. 2020; (11):1025.

  38. Nambulli S, Xiang Y, Tilston-Lunel NL, Rennick LJ, Sang Z, Klimstra WB, Reed DS, Crossland NA, Shi Y, Duprex WP. Inhalable Nanobody (PiN-21) prevents and treats SARS-CoV-2 infections in Syrian hamsters at ultra-low doses. Science Advances. 2021 May 1;7(22):eabh0319.

  39. Ghadiri M, Young PM, Traini D. Strategies to Enhance Drug Absorption via Nasal and Pulmonary Routs. Pharmaceutics. 2019; 11(3):E113.

  40. Hoyer H, Perera G, Bernkop-Schnürch A. Hoyer H, Perera G, Bernkop-Schnürch A. Noninvasive delivery systems for peptides and proteins in osteoporosis therapy: a retroperspective. Drug development and industrial pharmacy. 2010;36(1):31-44.

  41. Zheng J, Zhang G, Lu Y, Fang F, He J, Li N et al. Effect of Pulmonary Surfactant and Phospholipid Hexadecanol Tyloxapol on Recombinant Human-Insulin Absorption from Intratracheally Administered Dry Powders in Diabetic Rats. Chem. Pharm. Bull, 2010; 58(12):1612–1616.  

  42. Rendell M. Technosphere inhaled insulin (Afrezza). Drugs of today (Barcelona, Spain: 1998). 2014;50(12):813-27.

  43. Ma H, Zeng W, Meng X, Huang X, Yang Y, Zhao D, Zhou P, Wang X, Zhao C, Sun Y, Wang P. Potent Neutralization of SARS-CoV-2 by Hetero-bivalent Alpaca Nanobodies Targeting the Spike Receptor-Binding Domain. Journal of Virology. 2021; 95(10):e02438-20.

  44. Martinez-Delgado G. Inhaled nanobodies against COVID-19. Nature Reviews Immunology. 2020;(10):593.

  45. Hasan M, Khatun A, Fukuta T, Kogure K. Noninvasive transdermal delivery of liposomes by weak electric current. Advanced Drug Delivery Reviews. 2020; 154-155: 227-235.

  46. An YH, Park MJ, Lee J, Ko J, Kim SH, Kang DH, Hwang NS. Recent advances in the transdermal delivery of protein therapeutics with a combinatorial system of chemical adjuvants and physical penetration enhancements. Advanced Therapeutics. 2020 Feb;3(2):1900116.

  47. Kirkby M, Hutton AR, Donnelly RF. Microneedle mediated transdermal delivery of protein, peptide and antibody based therapeutics: current status and future considerations. Pharmaceutical Research. 2020;37:1-8.

  48. Yu J, Zhang Y, Ye Y, DiSanto R, Sun W, Ranson D, Ligler FS, Buse JB, Gu Z. Microneedle-array patches loaded with hypoxia-sensitive vesicles provide fast glucose-responsive insulin delivery. Proceedings of the National Academy of Sciences. 2015;112(27):8260-5.

  49. Courtenay AJ, McCrudden MTC, McAvoy KJ, Helen McCarthy HO, Donnelly RF. Microneedle-mediated transdermal delivery of Bevacizumab. Mol. Pharmaceutics. 2018; 15(8):3545-3556.

  50. Peña-Juárez MC, Guadarrama-Escobar OR, Escobar-Chávez JJ. Transdermal Delivery Systems for Biomolecules. Journal of Pharmaceutical Innovation. 2021:1-4.

  51. Bajracharya R, Song JG, Back SY, Han HK. Recent advancements in non-invasive formulations for protein drug delivery. Computational and structural biotechnology journal. 2019 Jan 1;17:1290-308.

  52. Bialik M, Kuras M, Sobczak M, Oledzka E. Achievements in Thermosensitive Gelling Systems for Rectal Administration. International Journal of Molecular Sciences. 2021 Jan;22(11):5500.

  53. Aprodu A, Mantaj J, Raimi-Abraham B, Vllasaliu D. Evaluation of a Methylcellulose and Hyaluronic Acid Hydrogel as a Vehicle for Rectal Delivery of Biologics. Pharmaceutics. 2019; 11(3): 127.


 

Objavljeno
2025/12/21
Broj časopisa
Vol. 39 Br. 4 (2022): Acta facultatis medicae Naissensis
Rubrika
Pregledni rad / Review article