The Physicochemical, Biopharmaceutical, and In Vitro Efficacy Properties of Freeze-Dried Dexamethasone-Loaded Lipomers

Pharmaceutics - Tập 13 Số 8 - Trang 1322
Eloy Pena-Rodríguez1, Aida Mata-Ventosa2,3,4, Laura García‐Vega3,4, Sandra Pérez‐Torras2,3,4, Francisco Fernández-Campos1
1Topical & Oral Development R+D Reig Jofre Laboratories, 08970 Sant Joan Despi, Spain
2Biomedical Research Networking Center in Hepatic and Digestive Diseases (CIBEREHD), Carlos III Health Institute, 28029 Madrid, Spain
3Molecular Pharmacology and Experimental Therapeutics, Department of Biochemistry and Molecular Biomedicine, Institute of Biomedicine, University of Barcelona (IBUB), 08028 Barcelona, Spain
4Sant Joan de Déu Research Institute (IR SJD-CERCA) Esplugues de Llobregat, 08950 Barcelona, Spain

Tóm tắt

Dexamethasone-loaded polymer hybrid nanoparticles were developed as a potential tool to treat alopecia areata due to their follicular targeting ability. Freeze drying (FD) is a common technique used to improve nanoparticle stability; however, there are few studies focused on its effect on ethyl cellulose lipid-core nanoparticles. Nanoparticles were lyophilized with different cryoprotectants. Sucrose was selected because it allowed for a good resuspension and provided acceptable physicochemical parameters (374.33 nm, +34.7 mV, polydispersion 0.229%, and 98.87% encapsulation efficiency). The nanoparticles obtained were loaded into a pleasant xanthan gum hydrogel, and the rheological, release, and skin permeation profiles of different formulations were studied. The FD formulation significantly modified the particle size, and the drug release and permeation properties were also altered. In addition, analyses of the cytotoxicity and anti-inflammatory efficacy of FD and non-FD particles on human keratinocytes indicated no differences.

Từ khóa


Tài liệu tham khảo

Kaul, 2018, Role of Nanotechnology in Cosmeceuticals: A Review of Recent Advances, J. Pharm., 2018, 420204

Fang, 2014, Delivery and targeting of nanoparticles into hair follicles, Ther. Deliv., 5, 991, 10.4155/tde.14.61

Wosicka, 2010, Targeting to the hair follicles: Current status and potential, J. Dermatol. Sci., 57, 83, 10.1016/j.jdermsci.2009.12.005

2017, Alopecia areata. Actualidad y perspectivas, Arch. Argent. Pediatr., 115, e404

Hordinsky, 2013, Overview of Alopecia Areata, J. Investig. Dermatol. Symp. Proc., 16, S13, 10.1038/jidsymp.2013.4

Lee, 2017, Management of alopecia areata: Updates and algorithmic approach, J. Dermatol., 44, 1199, 10.1111/1346-8138.13933

Pena-Rodríguez, E., Lajarin-Reinares, M., Mata-Ventosa, A., Pérez-Torras, S., and Fernández-Campos, F. (2021). Dexamethasone-Loaded Lipomers: Development, Characterization, and Skin Biodistribution Studies. Pharmaceutics, 13.

Abdelwahed, 2006, Freeze-drying of nanoparticles: Formulation, process and storage considerations, Adv. Drug Deliv. Rev., 58, 1688, 10.1016/j.addr.2006.09.017

Mohammady, 2020, Freeze-Drying of Pharmaceutical and Nutraceutical Nanoparticles: The Effects of Formulation and Technique Parameters on Nanoparticles Characteristics, J. Pharm. Sci., 109, 3235, 10.1016/j.xphs.2020.07.015

Holzer, 2009, Physico-chemical characterisation of PLGA nanoparticles after freeze-drying and storage, Eur. J. Pharm. Biopharm., 72, 428, 10.1016/j.ejpb.2009.02.002

Fonte, 2014, Stability Study Perspective of the Effect of Freeze-Drying Using Cryoprotectants on the Structure of Insulin Loaded into PLGA Nanoparticles, Biomacromolecules, 15, 3753, 10.1021/bm5010383

Srihaphon, 2021, Influence of stabilizers and cryoprotectants on the characteristics of freeze-dried plga nanoparticles containing morus alba stem extract, Songklanakarin J. Sci. Technol., 43, 72

Gajra, 2015, Formulation and optimization of itraconazole polymeric lipid hybrid nanoparticles (Lipomer) using box behnken design, DARU J. Pharm. Sci., 23, 1, 10.1186/s40199-014-0087-0

Ramesh, 2019, Lyophilization and stability study of noscapine-loaded polycaprolactone nanoparticles, Drug Invent. Today, 12, 2516

Choi, 2004, Effect of Freeze-Drying Process Conditions on the Stability of Nanoparticles, Dry. Technol., 22, 335, 10.1081/DRT-120028238

Banlunara, 2014, Ethyl cellulose nanoparticles: Clarithomycin encapsulation and eradication of H. pylori, Carbohydr. Polym., 109, 22, 10.1016/j.carbpol.2014.03.025

Mirabedini, 2012, Preparation and characterization of ethyl cellulose-based core–shell microcapsules containing plant oils, Colloids Surf. A Physicochem. Eng. Asp., 394, 74, 10.1016/j.colsurfa.2011.11.028

Ahmed, 2009, Thermal Degradation Kinetics and Geometrical Stability of D-Sucrose, Int. J. Polym. Mater., 58, 322, 10.1080/00914030902859273

Zhang, 2010, DDSolver: An Add-In Program for Modeling and Comparison of Drug Dissolution Profiles, AAPS J., 12, 263, 10.1208/s12248-010-9185-1

Starciuc, 2020, Trehalose or Sucrose: Which of the Two Should be Used for Stabilizing Proteins in the Solid State? A Dilemma Investigated by In Situ Micro-Raman and Dielectric Relaxation Spectroscopies During and After Freeze-Drying, J. Pharm. Sci., 109, 496, 10.1016/j.xphs.2019.10.055

Kumar, 2017, Role of freeze-drying in the presence of mannitol on the echogenicity of echogenic liposomes, J. Acoust. Soc. Am., 142, 3670, 10.1121/1.5017607

Almalik, 2017, Effect of cryoprotection on particle size stability and preservation of chitosan nanoparticles with and without hyaluronate or alginate coating, Saudi Pharm. J., 25, 861, 10.1016/j.jsps.2016.12.008

Bonaccorso, 2017, Revisiting the role of sucrose in PLGA-PEG nanocarrier for potential intranasal delivery, Pharm. Dev. Technol., 23, 265, 10.1080/10837450.2017.1287731

Kannan, 2014, Effect of sucrose as a lyoprotectant on the integrity of paclitaxel-loaded liposomes during lyophilization, J. Liposome Res., 25, 270, 10.3109/08982104.2014.992023

Nail, 2002, Fundamentals of Freeze-Drying, Pharm. Biotechnol., 14, 281, 10.1007/978-1-4615-0549-5_6

Meister, 2009, Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data, AAPS PharmSciTech, 10, 582, 10.1208/s12249-009-9245-y

Ward, K.R., and Matejtschuk, P. (2016). The use of microscopy, thermal analysis, and impedance measurements to establish critical formulation parameters for freeze-drying cycle development. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, CRC Press. [3rd ed.].

Meister, 2009, Freeze-Dry Microscopy of Protein/Sugar Mixtures: Drying Behavior, Interpretation of Collapse Temperatures and a Comparison to Corresponding Glass Transition Data, J. Pharm. Sci., 98, 3072, 10.1002/jps.21586

Pikal, 1990, The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase, Int. J. Pharm., 62, 165, 10.1016/0378-5173(90)90231-R

Pauline, M.D. (2013). Chapter 11—Unit Operations, Bioprocess Engineering Principles, Academic Press. [2nd ed.].

Talik, 2021, DSC study of hydration and water-holding behaviour of cultured in vitro mycelium and naturally grown fruiting bodies of freeze-dried Boletus badius, Agaricus bisporus and Cantharellus cibarius, J. Therm. Anal. Calorim., 143, 3525, 10.1007/s10973-020-09654-3

Strohm, C. (2014). Generalized Newtonian Fluid (GNF) Models. Polymer Rheology: Fundamentals and Applications, Hanser Publications.

Obach, 2017, Pharmaceutical development of a generic corticoid semisolid formulation, J. Drug Deliv. Sci. Technol., 42, 227, 10.1016/j.jddst.2017.03.016

Tauber, 2014, Alopecia areata occurring during anti-TNF therapy: A national multicenter prospective study, J. Am. Acad. Dermatol., 70, 1146, 10.1016/j.jaad.2014.03.005

Pratt, 2017, Alopecia areata, Nat. Rev. Dis. Primers, 3, 17011, 10.1038/nrdp.2017.11