Systematic Development and Optimization of Teriparatide-Loaded Nanoliposomes Employing Quality by Design Approach for Osteoporosis
Tóm tắt
The present study is aimed at developing liposomal nanovesicular system of teriparatide employing the use of ethanol injection method for providing sustained release in the treatment of osteoporosis. Formulation development was carried out systematically by employing Quality by Design (QbD) approach. The developed system was evaluated for various physicochemical characterizations. The developed liposomal formulation exhibited particle size of approximately 186.9 ± 2.20 nm. Cryogenic field emission scanning electron microscopy (Cryo-FE-SEM) analysis revealed spherical morphology of the liposomes. The % encapsulation efficiency (% EE) was found to be 46.52% and polydispersity index (PDI) to be 0.149 ± 0.02, suggesting narrow particle size distribution of the developed liposomal formulation. Circular dichroism study revealed intact structure of drug in the formulation. Haemolysis assay was performed and the no significant lysis of RBC was observed up to the concentration of 10 µg/ml of formulation. The developed formulation took almost 24 h to release 50% of the encapsulated teriparatide while it took 36 h to release about 90% of the drug. Furthermore, results of cell viability study suggest that encapsulation of teriparatide into the liposomes is not affecting its safety. The implementation of the QbD concept in the development of teriparatide-loaded liposomes enhanced understanding of the manufacturing process and the influence of formulation parameters on the quality attributes of liposomes.
Tài liệu tham khảo
Langdahl B, Ferrari S, Dempster DW. Bone modeling and remodeling: potential as therapeutic targets for the treatment of osteoporosis. Ther Adv Musculoskelet Dis. 2016;8(6):225. https://doi.org/10.1177/1759720X16670154.
Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007;83:509–17. https://doi.org/10.1136/pgmj.2007.057505.
Wei H, Xu Y, Wang Y, Xu L, Mo C, Li L, et al. Identification of fibroblast activation protein as an osteogenic suppressor and anti-osteoporosis drug target. Cell Rep. 2020;33(2): 108252. https://doi.org/10.1016/j.celrep.2020.108252.
Sozen T, Ozisik L, Calik BN. An overview and management of osteoporosis. Eur J Rheumatol. 2017;4(1):46–56. https://doi.org/10.5152/eurjrheum.2016.048.
Föger-Samwald U, Dovjak P, Azizi-Semrad U, Kerschan-Schindl K, Pietschmann P. Osteoporosis: Pathophysiology and therapeutic options. Excli J. 2020;19:1017–37. https://doi.org/10.17179/excli2020-2591.
Chen JS, Sambrook PN. Antiresorptive therapies for osteoporosis: a clinical overview. Nat Rev Endocrinol. 2012;8(2):81–91. https://doi.org/10.1038/nrendo.2011.146.
Quattrocchi E, Kourlas H. Teriparatide: a review. Clin Ther. 2004;26(6):841–54. https://doi.org/10.1016/S0149-2918(04)90128-2.
Salave S, Rana D, Benival D. Peptide functionalised nanocarriers for bone specific delivery of PTH (1–34) in osteoporosis. Curr Nanomedicine. 2021;11:142–8. https://doi.org/10.2174/2468187312666211220112324.
Estell EG, Rosen CJ. Emerging insights into the comparative effectiveness of anabolic therapies for osteoporosis. Nat Rev Endocrinol. 2021;17(1):31–46. https://doi.org/10.1038/s41574-020-00426-5.
Lane NE, Kelman A. A review of anabolic therapies for osteoporosis. Arthritis Res Ther. 2003;5(5):214–22. https://doi.org/10.1186/ar797.
Mahajan A, Narayanan M, Jaffers G, Concepcion L. Hypoparathyroidism associated with severe mineral bone disease postrenal transplantation, treated successfully with recombinant PTH. Hemodial Int. 2009;13(4):547–50. https://doi.org/10.1111/j.1542-4758.2009.00380.x.
FORTEO (teriparatide) Label. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf. Accessed 01 Apr 2022.
Application to extend duration of treatment for TeriboneTM osteoporosis drug. https://www.asahi-kasei.com/news/2016/e160722.html. Accessed 01 Apr 2022.
Approval to manufacture and sell TeriboneTM autoinjector. 2019. https://www.asahi-kasei.com/news/2019/e190920_2.html. Accessed 01 Apr 2022.
Sugimoto T, Shiraki M, Fukunaga M, Kishimoto H, Hagino H, Sone T, et al. Study of twice-weekly injections of teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study. Osteoporos Int. 2019;30(11):2321–31. https://doi.org/10.1007/S00198-019-05111-6.
Kostenuik PJ, Ferrari S, Pierroz D, Bouxsein M, Morony S, Warmington KS, et al. Infrequent delivery of a long-acting PTH-Fc fusion protein has potent anabolic effects on cortical and cancellous bone. J Bone Miner Res. 2007;22(10):1534–47. https://doi.org/10.1359/JBMR.070616.
Rana D, Salave S, Longare S, Agarwal R, Kalia K, Benival D. Nanotherapeutics in tumour microenvironment for cancer therapy. Nanosci Nanotechnology-Asia. 2021;12. https://doi.org/10.2174/2210681211666210908144839.
Salave S, Rana D, Pardhe R, Bule P, Benival D. Unravelling micro and nano vesicular system in intranasal drug delivery for epilepsy. Pharm Nanotechnol. 2022;10. https://doi.org/10.2174/2211738510666220426115340.
Shah S, Dhawan V, Holm R, Nagarsenker MS, Perrie Y. Liposomes: advancements and innovation in the manufacturing process. Adv Drug Deliv Rev. 2020;154–155:102–22. https://doi.org/10.1016/J.ADDR.2020.07.002.
Barbălată CI, Tomuță I, Achim M, Boșca AB, Cherecheș G, Sorițău O, et al. Application of the QbD approach in the development of a liposomal formulation with EGCG. J Pharm Innov. 2021;2021:1–14. https://doi.org/10.1007/S12247-021-09541-W.
Layek B, Mukherjee B. Tamoxifen citrate encapsulated sustained release liposomes: preparation and evaluation of physicochemical properties. Sci Pharm. 2010;78:507–15. https://doi.org/10.3797/SCIPHARM.0911-11.
Karumanchi DK, Skrypai Y, Thomas A, Gaillard ER. Rational design of liposomes for sustained release drug delivery of bevacizumab to treat ocular angiogenesis. J Drug Deliv Sci Technol. 2018;47:275–82. https://doi.org/10.1016/J.JDDST.2018.07.003.
Sun X, Wei J, Lyu J, Bian T, Liu Z, Huang J, et al. Bone-targeting drug delivery system of biomineral-binding liposomes loaded with icariin enhances the treatment for osteoporosis. J Nanobiotechnology. 2019;17:10. https://doi.org/10.1186/S12951-019-0447-5.
Assil KK, Weinreb RN. Multivesicular liposomes: sustained release of the antimetabolite cytarabine in the eye. Arch Ophthalmol. 1987;105:400–3. https://doi.org/10.1001/ARCHOPHT.1987.01060030120040.
DepoDur ® (morphine sulfate extended-release liposome injection) 2007. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s019lbl.pdf. Accessed 11 May 2022.
Hartrick CT, Hartrick KA. Extended-release epidural morphine (DepoDur): review and safety analysis. Expert Rev Neurother. 2008;8:1641–8. https://doi.org/10.1586/14737175.8.11.1641.
FDA. Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. Guidance for Industry. 2018;(August):1–15.
ICH. Ich Harmonised Tripartite Guideline, Pharmaceutical Development Q8(R2). ICH Harmon Tripart Guidel. 2009;8(August):1–28.
Porfire A, Achim M, Barbalata C, Rus I, Tomuta I, Cristea C. Pharmaceutical development of liposomes using the QbD approach. Liposomes - Adv Perspect. 2019. https://doi.org/10.5772/intechopen.85374.
Bhattacharyya S, Sogali BS. Application of statistical design to assess the critical process parameters of ethanol injection method for the preparation of liposomes. Dhaka Univ J Pharm Sci. 2019;18(1):103–11. https://doi.org/10.3329/dujps.v18i1.41897.
Shaker S, Gardouh A, Ghorab M. Factors affecting liposomes particle size prepared by ethanol injection method. Res Pharm Sci. 2017;12(5):346–52. https://doi.org/10.4103/1735-5362.213979.
Bahari Javan N, Rezaie Shirmard L, Jafary Omid N, Akbari Javar H, Rafiee Tehrani M, Abedin DF. Preparation, statistical optimisation and in vitro characterisation of poly (3-hydroxybutyrate-co-3-hydroxyvalerate)/poly (lactic-co-glycolic acid) blend nanoparticles for prolonged delivery of teriparatide. J Microencapsul. 2016;33(5):460–74. https://doi.org/10.1080/02652048.2016.1208296.
Neves AR, Lúcio M, Martins S, Lima JLC, Reis S. Novel resveratrol nanodelivery systems based on lipid nanoparticles to enhance its oral bioavailability. Int J Nanomedicine. 2013;8:177–87. https://doi.org/10.2147/IJN.S37840.
Goyanes A, Chang H, Sedough D, Hatton GB, Wang J, Buanz A, et al. Fabrication of controlled-release budesonide tablets via desktop (FDM) 3D printing. Int J Pharm. 2015;496(2):414–20. https://doi.org/10.1016/j.ijpharm.2015.10.039.
Narayanan D, Anitha A, Jayakumar R, Chennazhi KP. PTH 1–34 loaded thiolated chitosan nanoparticles for osteoporosis: oral bioavailability and anabolic effect on primary osteoblast cells. J Biomed Nanotechnol. 2014;10(1):166–78. https://doi.org/10.1166/jbn.2014.1700.
Baskaran R, Lee CJ, Kang SM, Oh Y, Jin SE, Lee DH, et al. Poly(lactic-co-glycolic acid) microspheres containing a recombinant parathyroid hormone (1–34) for sustained release in a rat model. Indian J Pharm Sci. 2018;80(5):837–43. https://doi.org/10.4172/pharmaceutical-sciences.1000429.
Siswanto A, Fudholi A, Nugroho AK, et al. In vitro release modeling of aspirin floating tablets using DDSolver. Indones. J Pharm. 2015:4;26(2):94. https://doi.org/10.14499/indonesianjpharm26iss2pp94.
Altaani BM, Almaaytah AM, Dadou S, Alkhamis K, Daradka MH, Hananeh W. Oral delivery of teriparatide using a nanoemulsion system: design, in vitro and in vivo evaluation. Pharm Res. 2020;37(4):80. https://doi.org/10.1007/s11095-020-02793-0.
Pallagi E, Jójárt-Laczkovich O, Németh Z, Szabó-Révész P, Csóka I. Application of the QbD-based approach in the early development of liposomes for nasal administration. Int J Pharm. 2019;562:11–22. https://doi.org/10.1016/j.ijpharm.2019.03.021.
Fukuda IM, Pinto CFF, Moreira CDS, Saviano AM, Lourenço FR. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Brazilian J Pharm Sci. 2018;54. https://doi.org/10.1590/s2175-97902018000001006.
Amani N, Javar HA, Dorkoosh FA, Rouini MR, Amini M, Sharifzadeh M, et al. Preparation and pulsatile release evaluation of teriparatide-loaded multilayer implant composed of polyanhydride-hydrogel layers using spin coating for the treatment of osteoporosis. J Pharm Innov. 2020;1(3)–22. https://doi.org/10.1007/s12247-020-09453-1.