Self-Assembled Lipid Polymer Hybrid Nanoparticles Using Combinational Drugs for Migraine Via Intranasal Route.
ergotamine
hybrid nanoparticles
lipid/polymer weight ratio
nanoprecipitation
serotonin syndrome
serum stability
Journal
AAPS PharmSciTech
ISSN: 1530-9932
Titre abrégé: AAPS PharmSciTech
Pays: United States
ID NLM: 100960111
Informations de publication
Date de publication:
16 Dec 2022
16 Dec 2022
Historique:
received:
10
10
2022
accepted:
29
11
2022
entrez:
16
12
2022
pubmed:
17
12
2022
medline:
21
12
2022
Statut:
epublish
Résumé
The objective of the current research study was to formulate the PEGylated lipid polymer hybrid nanoparticles of ergotamine and caffeine for intranasal administration with higher entrapment efficiency, better permeability, desirable controlled release pattern, and significant brain uptake in animal studies. A single-step nanoprecipitation method was employed in the processing of self-assembled hybrid nanoparticles constituting polymer PLGA, lipids soya lecithin, and DPPC with PEGylation using polyethylene glycol (PEG-2000). The optimal lipid/polymer weight ratio of 15% w/w showed lower particle size of 239.46 ± 2.31 nm with good colloidal stability depicted by zeta potential (- 18.36 ± 6.59 mV), higher entrapment efficiency of 86.88 ± 1.67%, and controlled release profile when evaluated for in vitro and ex vivo studies as 97.12 ± 2.79% and 75.13 ± 5.62% release, respectively, for 48 h. The formulation showed long-term serum stability when incubated in bovine serum albumin and displayed high brain uptake (4.35-fold) offering significant permeability in the brain post-intranasal administration via olfactory route. Histopathological investigations and serotonin toxicity studies in animals confirmed the safe and non-toxic nature of the formulation while the acetic acid writhing test proved the anti-hyperalgesic activity. The PEGylated lipid polymer hybrid nanoparticles of ergotamine and caffeine showed synergistic activity with efficacious higher anti-migraine potential.
Identifiants
pubmed: 36526821
doi: 10.1208/s12249-022-02479-3
pii: 10.1208/s12249-022-02479-3
doi:
Substances chimiques
Polymers
0
Delayed-Action Preparations
0
Caffeine
3G6A5W338E
Lipids
0
Polyethylene Glycols
3WJQ0SDW1A
Ergotamines
0
Drug Carriers
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
20Informations de copyright
© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
Références
Dave V, Tak K, Sohgaura A, Gupta A, Sadhu V, Reddy KR. Lipid-polymer hybrid nanoparticles: synthesis strategies and biomedical applications. J Microbiol Methods. 2019;160:130–42. https://doi.org/10.1016/j.mimet.2019.03.017 .
doi: 10.1016/j.mimet.2019.03.017
Ferreira Soares DC, Domingues SC, Viana DB, Tebaldi ML. Polymer-hybrid nanoparticles: current advances in biomedical applications. Biomed Pharmacotherapy. 2020;131:110695. https://doi.org/10.1016/j.biopha.2020.110695 .
doi: 10.1016/j.biopha.2020.110695
Mohanty A, Uthaman S, Park IK. Utilization of polymer-lipid hybrid nanoparticles for targeted anti-cancer therapy. Molecules. 2020;25(19):4377. https://doi.org/10.3390/molecules25194377 . (Published 2020 Sep 23.).
doi: 10.3390/molecules25194377
Raman S, Mahmood S, Rahman A. A review on lipid- polymer hybrid nanoparticles and preparation with recent update. Mater Sci Forum. 2020;981:322–7.
doi: 10.4028/www.scientific.net/MSF.981.322
Vikulina AS, Skirtach AG, Volodkin DV. Hybrids of polymer multilayers, lipids, and nanoparticles Mimicking the cellular microenvironment. Langmuir. 2019;35(26):8565–73.
doi: 10.1021/acs.langmuir.8b04328
Leng D, et al. Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach. Int J Pharm. 2018;548(2):740–6.
doi: 10.1016/j.ijpharm.2017.08.094
Chan Juliana M, Zhang Liangfang, Yuet Kai P, Liao Grace, Rhee June-Wha, Langer Robert, Farokhzad Omid C. PLGA–lecithin–PEG core–shell nanoparticles for controlled drug delivery. Biomaterials. 2009;30(8):1627–34. https://doi.org/10.1016/j.biomaterials.2008.12.013 .
doi: 10.1016/j.biomaterials.2008.12.013
Thevenot Julie, Troutier Anne-Lise, David Laurent, Delair Thierry, Ladavière Catherine. Steric stabilization of lipid/polymer particle assemblies by poly (ethylene glycol)-lipids. Biomacromolecules. 2007;8(11):3651–60. https://doi.org/10.1021/bm700753q .
doi: 10.1021/bm700753q
Tahir N, Haseeb MT, Madni A, Parveen F, Khan MM, Khan S, Jan N, Khan A. Lipid polymer hybrid nanoparticles: a novel approach for drug delivery. In: Tyagi, RK, Garg N, Shukla R, Bisen PS editors. Role of Novel Drug Delivery Vehicles in Nanobiomedicine [Internet]. London: IntechOpen; 2019 [cited 2022 Nov 01]. Available from: https://www.intechopen.com/chapters/69735 . https://doi.org/10.5772/intechopen.88269
Mortar G. Hybrid Lipid-polymer nanoparticulate delivery, The invention relates to a nanoparticulate colloidal delivery vehicle comprising a biodegradable polymer. 2007;1–17.
Liu Yutao, Pan Jie, Feng Si-Shen. Nanoparticles of lipid monolayer shell and biodegradable polymer core for controlled release of paclitaxel: effects of surfactants on particles size, characteristics and in vitro performance. Int J Pharm. 2010;395(1–2):243–50. https://doi.org/10.1016/j.ijpharm.2010.05.008 . (ISSN 0378-5173).
doi: 10.1016/j.ijpharm.2010.05.008
Moon J James, et al. Antigen-displaying lipid-enveloped PLGA nanoparticles as delivery agents for a Plasmodium vivax malaria vaccine. PloS one. 2012;7.2:e31472.
doi: 10.1371/journal.pone.0031472
Mieszawska AJ, Gianella A, Cormode DP, Zhao Y, Meijerink A, Langer R, et al. Engineering of lipid-coated PLGA nanoparticles with a tunable payload of diagnostically active nanocrystals for medical imaging. Chem Commun. 2012;48:5835–7. https://doi.org/10.1039/C2CC32149A .
doi: 10.1039/C2CC32149A
Zhang L, Chan JM, Gu FX, Rhee J-W, Wang AZ, Radovic-Moreno AF, Alexis F, Langer R, Farokhzad OC. Self-assembled lipid polymer hybrid nanoparticles: a robust drug delivery platform. ACS Nano. 2008;2:1696–702.
doi: 10.1021/nn800275r
Ali S, Amin MU, Tariq I, Sohail MF, Ali MY, Preis E, et al. Lipoparticles for synergistic chemo-photodynamic therapy to ovarian carcinoma cells: in vitro and in vivo assessments. Int J Nanomedicine. 2021;16:951–76.
doi: 10.2147/IJN.S285950
Valencia PM, Basto PA, Zhang L, Rhee M, Langer R, Farokhzad OC, Karnik R. Single-step assembly of homogenous lipid-polymeric and lipid-quantum dot nanoparticles enabled by microfluidic rapid mixing. ACS Nano. 2010Mar 23;4(3):1671–9. https://doi.org/10.1021/nn901433u .
doi: 10.1021/nn901433u
Hadinoto K, Sundaresan A, Cheow WS. Lipid-polymer hybrid nanoparticles as a new generation therapeutic delivery platform: a review. Eur J Pharm Biopharm. 2013;85(3 Pt A):427–43. https://doi.org/10.1016/j.ejpb.2013.07.002 .
doi: 10.1016/j.ejpb.2013.07.002
Arnold AC, Ramirez CE, Choi L, Okamoto LE, Gamboa A, Diedrich A, et al. Combination ergotamine and caffeine improves seated blood pressure and pre-syncopal symptoms in autonomic failure. Front Physiol. 2014;5:1–7.
doi: 10.3389/fphys.2014.00270
Dali P, Shende P. Inclusion complex of cyclodextrin with ergotamine and evaluation of cyclodextrin-based nanosponges. J Incl Phenom Macrocycl Chem. 2020;102:S45–S1. https://doi.org/10.1007/s10847-022-01149-y .
doi: 10.1007/s10847-022-01149-y
Nag OK, Awasthi V. Surface engineering of liposomes for stealth behavior. Pharmaceutics. 2013;5:542–69. https://doi.org/10.3390/pharmaceutics5040542 .
doi: 10.3390/pharmaceutics5040542
Ling Guixia, Zhang Peng, Zhang Wenping, Sun Jin, Meng Xiaoxue, Qin Yimeng, Deng Yihui, He Zhonggui. Development of novel self-assembled DS-PLGA hybrid nanoparticles for improving oral bioavailability of vincristine sulfate by P-gp inhibition. J Control Release. 2010;148(2):241–8. https://doi.org/10.1016/j.jconrel.2010.08.010 . (ISSN 0168-3659).
doi: 10.1016/j.jconrel.2010.08.010
Suk JS, Xu Q, Kim N, Hanes J, Ensign LM. PEGylation as a strategy for improving nanoparticle-based drug and gene delivery. Adv Drug Deliv Rev. 2016;99:28–51. https://doi.org/10.1016/j.addr.2015.09.012 .
doi: 10.1016/j.addr.2015.09.012
García-González CA, et al. Production of hybrid lipid-based particles loaded with inorganic nanoparticles and active compounds for prolonged topical release. Int J Pharm. 2009;382(1–2):296–304.
doi: 10.1016/j.ijpharm.2009.08.033
Ma P, Li T, Xing H, et al. Local anesthetic effects of bupivacaine loaded lipid-polymer hybrid nanoparticles: in vitro and in vivo evaluation. Biomed Pharmacother. 2017;89:689–95. https://doi.org/10.1016/j.biopha.2017.01.175 .
doi: 10.1016/j.biopha.2017.01.175
Wang Y, Yang X, Yang J, Wang Y, Chen R, Jing Wu, Liu Y, Zhang N. Self-assembled nanoparticles of methotrexate conjugated O-carboxymethyl chitosan: preparation, characterization and drug release behavior in vitro. Carbohyd Polym. 2011;86(4):1665–70.
doi: 10.1016/j.carbpol.2011.06.080
Masjedi M, Azadi A, Heidari R, Mohammadi-Samani S. Nose-to-brain delivery of sumatriptan-loaded nanostructured lipid carriers: preparation, optimization, characterization and pharmacokinetic evaluation. J Pharm Pharmacol. 2020;72(10):1341–51. https://doi.org/10.1111/jphp.13316 .
doi: 10.1111/jphp.13316
Haberzett R, et al. Animal models of the serotonin syndrome: a systematic review. Behav Brain Res. 2013;256:328–45.
doi: 10.1016/j.bbr.2013.08.045
Chiew AL, Buckley NA. The serotonin toxidrome: shortfalls of current diagnostic criteria for related syndromes. Clin Toxicol (Phila). 2022;60:143.
doi: 10.1080/15563650.2021.1993242
FDA. Guidance for Industry: Q1A(R2) Stability testing of new drug substances and products, U.S. Department of Health and Human Services, Food and Drug Administration. Substance. 2003;1–22
Jurišić Dukovski B, Mrak L, Winnicka K, Szekalska M, Juretić M, Filipović-Grčić J, et al. Spray-dried nanoparticle-loaded pectin microspheres for dexamethasone nasal delivery. Dry Technol [Internet]. Taylor & Francis; 2019;37:1915–25. Available from: https://doi.org/10.1080/07373937.2018.1545783
Khair R, Shende P, Kulkarni YA. Nanostructured polymer-based cochleates for effective transportation of insulin. J Mol Liq [Internet]. Elsevier B.V.; 2020;311:113352. Available from. https://doi.org/10.1016/j.molliq.2020.113352
Tahir N, Madni A, Balasubramanian V, et al. Development and optimization of methotrexate-loaded lipid-polymer hybrid nanoparticles for controlled drug delivery applications. Int J Pharm. 2017;533(1):156–68. https://doi.org/10.1016/j.ijpharm.2017.09.061 .
doi: 10.1016/j.ijpharm.2017.09.061
Schubert MA, Schicke BC, Müller-Goymann CC. Thermal analysis of the crystallization and melting behavior of lipid matrices and lipid nanoparticles containing high amounts of lecithin. Int J Pharm. 2005;298:242–54.
doi: 10.1016/j.ijpharm.2005.04.014
Mahmood S, Kiong KC, Tham CS, Chien TC, Hilles AR, Venugopal JR. PEGylated lipid polymeric nanoparticle-encapsulated acyclovir for in vitro controlled release and ex vivo gut sac permeation. AAPS PharmSciTech. 2020;21(7):285. https://doi.org/10.1208/s12249-020-01810-0 .
doi: 10.1208/s12249-020-01810-0
Bonechi C, Martini S, Ciani L, et al. Using liposomes as carriers for polyphenolic compounds: the case of trans-resveratrol. PLoS ONE. 2012;7(8):e41438. https://doi.org/10.1371/journal.pone.0041438 .
doi: 10.1371/journal.pone.0041438
Mohammad HA, Ghareeb MM, Akrami M, Sahib AS. Design and characterization of Tacrolimus monohydrate loaded core shell lipid polymer hybrid nanoparticle. J Complement Med Res. 2020;11(5):204–14.
Mandal B, Bhattacharjee H, Mittal N, Sah H, Balabathula P, Thoma LA, Wood GC. Core-shell-type lipid-polymer hybrid nanoparticles as a drug delivery platform. Nanomed Nanotechnol Biol Med. 2013;9(4):474–91. https://doi.org/10.1016/j.nano.2012.11.010 .
doi: 10.1016/j.nano.2012.11.010
Nguyen TTL, Maeng HJ. Pharmacokinetics and pharmacodynamics of intranasal solid lipid nanoparticles and nanostructured lipid carriers for nose-to-brain delivery. Pharmaceutics. 2022;14.
Garg NK, Tandel N, Bhadada SK, Tyagi RK. Nanostructured lipid carrier–mediated transdermal delivery of aceclofenac hydrogel present an effective therapeutic approach for inflammatory diseases. Front Pharmacol. 2021;12:1–18.
doi: 10.3389/fphar.2021.713616
Bekhti F, Mokhtari-Soulimane N, Bensalah M, Wacila N, Badi Z, Rouigueb K, Tewfik S, Tofail SAM, Helen T, Nanasaheb T. Histological injury to rat brain, liver, and kidneys by gold nanoparticles is dose-dependent. ACS Omega. 2022;7(24):20656–65. https://doi.org/10.1021/acsomega.2c00727 .
doi: 10.1021/acsomega.2c00727
Isbister GK, Buckley NA. The pathophysiology of serotonin toxicity in animals and humans. Clin Neuropharmacol. 2005;28(5):205–14. https://doi.org/10.1097/01.wnf.0000177642.89888.85 .
doi: 10.1097/01.wnf.0000177642.89888.85
Mohammad A, Ghareeb M. Tacrolimus monohydrate loaded lipid polymer hybrid nanoparticles Formulation and stability study. Kerbala J Pharm Sci. 2021;1(19).
Bershteyn A, Chaparro J, Yau R, Kim M, Reinherz E, Ferreira-Moita L, et al. Polymer-supported lipid shells, onions, and flowers. Soft Matter. 2008;4:1787–91.
doi: 10.1039/b804933e
Galgatte UC, Kumbhar AB, Chaudhari PD. Development of in situ gel for nasal delivery: design, optimization, in vitro and in vivo evaluation. Drug Deliv. 2014;21(1):62–73. https://doi.org/10.3109/10717544.2013.849778 .
doi: 10.3109/10717544.2013.849778
Ma Z, Zhang G, Jenney C, Krishnamoorthy S, Tao R. Characterization of serotonin-toxicity syndrome (toxidrome) elicited by 5-hydroxy-l-tryptophan in clorgyline-pretreated rats. Eur J Pharmacol. 2008;588:198–206.
doi: 10.1016/j.ejphar.2008.04.004