Impact of formulation design and lyophilisation on the physicochemical characteristics of finasteride nanosystems

References

• Abdelwahed, W., et al., 2006. Freeze-drying of nanoparticles: formulation, process and storage considerations. Advanced drug delivery reviews, 58 (15), 1688–1713.
   PubMed Web of Science ®Google Scholar
• Ahmadi, F., et al., 2015. Chitosan based hydrogels: characteristics and pharmaceutical applications. Research in pharmaceutical sciences, 10 (1), 1–16.
   PubMed Web of Science ®Google Scholar
• Akrawi, S.H., et al., 2020. Development and optimization of naringenin-loaded chitosan-coated nanoemulsion for topical therapy in wound healing. Pharmaceutics, 12 (9), 893.
   PubMed Web of Science ®Google Scholar
• Almalik, A., et al., 2017. Effect of cryoprotection on particle size stability and preservation of chitosan nanoparticles with and without hyaluronate or alginate coating. Saudi pharmaceutical journal, 25 (6), 861–867.
   PubMed Web of Science ®Google Scholar
• Amiri, A., et al., 2020. Fabrication of cumin loaded-chitosan particles : characterized by molecular, morphological, thermal, antioxidant and anticancer properties as well as its utilization in food system. Food chemistry, 310, 125821.
   PubMed Web of Science ®Google Scholar
• Anhorn, M.G., Mahler, H.C., and Langer, K., 2008. Freeze drying of human serum albumin (HSA) nanoparticles with different excipients. International journal of pharmaceutics, 363 (1–2), 162–169.
   PubMed Web of Science ®Google Scholar
• Argimón, M., et al., 2016. Development and characterization of vitamin A-loaded solid lipid nanoparticles for topical application. Journal of the Brazilian chemical society, 28 (7), 1177–1184.
   Web of Science ®Google Scholar
• Balabathula, P., et al., 2020. Lyophilized iron oxide nanoparticles encapsulated in amphotericin B: a novel targeted nano drug delivery system for the treatment of systemic fungal infections. Pharmaceutics, 12 (3), 247.
   PubMed Web of Science ®Google Scholar
• Bexiga, N.M., et al., 2018. Freeze-drying of ovalbumin-loaded carboxymethyl chitosan nanocapsules: impact of freezing and annealing procedures on physicochemical properties of the formulation during dried storage. Drying technology, 36 (4), 400–417.
   Web of Science ®Google Scholar
• Bhakay, A., et al., 2018. Bioavailability enhancement of poorly water-soluble drugs via nanocomposites: formulation–processing aspects and challenges. Pharmaceutics, 10 (3), 86.
   PubMed Web of Science ®Google Scholar
• Caon, T., et al., 2014. Chitosan-decorated polystyrene-b-poly(acrylic acid) polymersomes as novel carriers for topical delivery of finasteride. European journal of pharmaceutical sciences, 52 (1), 165–172.
   PubMedGoogle Scholar
• Caserini, M., et al., 2016. Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia. International journal of clinical pharmacology and therapeutics, 54 (1), 19–27.
   PubMed Web of Science ®Google Scholar
• Chaudhari, A.A., et al., 2016. A novel covalent approach to bio‑conjugate silver coated single walled carbon nanotubes with antimicrobial peptide. Journal of nanobiotechnology, 14 (1), 1–15.
   PubMedGoogle Scholar
• Chaudhury, A., et al., 2012. Lyophilization of cholesterol-free PEGylated liposomes and its impact on drug loading by passive equilibration. International journal of pharmaceutics, 430 (1–2), 167–175.
   PubMed Web of Science ®Google Scholar
• Chezanoglou, E., and Goula, A.M., 2021. Trends in food science & technology co-crystallization in sucrose : a promising method for encapsulation of food bioactive components. Trends in food science & technology, 114 (February), 262–274.
   Google Scholar
• Crowe, L.M., Reid, D.S., and Crowe, J.H., 1996. Is trehalose special for preserving dry biomaterials? Biophysical journal, 71 (4), 2087–2093.
   PubMed Web of Science ®Google Scholar
• da Silva, B.D., et al., 2022. Essential oil nanoemulsions : properties, development, and application in meat and meat products trends in food science & technology essential oil nanoemulsions : properties, development, and application in meat and meat products. Trends in food science & technology, 121, 1–13.
   Web of Science ®Google Scholar
• Dave, V., et al., 2017. Lipid-polymer hybrid nanoparticles: development & statistical optimization of norfloxacin for topical drug delivery system. Bioactive materials, 2 (4), 269–280.
   PubMed Web of Science ®Google Scholar
• Degobert, G., and Aydin, D., 2021. Lyophilization of nanocapsules: Instability sources, formulation and process parameters. Pharmaceutics, 13 (8), 1112.
   PubMed Web of Science ®Google Scholar
• del Pozo-Rodríguez, A., et al., 2009. Short- and long-term stability study of lyophilized solid lipid nanoparticles for gene therapy. European journal of pharmaceutics and biopharmaceutics, 71 (2), 181–189.
   PubMed Web of Science ®Google Scholar
• Espinoza, L.C., et al., 2019. Nanoemulsion strategy of pioglitazone for the treatment of skin inflammatory diseases. Nanomedicine: nanotechnology, biology, and medicine, 19, 115–125.
   PubMed Web of Science ®Google Scholar
• Fagir, W., et al., 2015. Self-microemulsifying systems of Finasteride with enhanced oral bioavailability: multivariate statistical. Nanomedicine, 10 (22), 3373–3389.
   PubMed Web of Science ®Google Scholar
• Fonte, P., et al., 2012. Effect of cryoprotectants on the porosity and stability of insulin-loaded PLGA nanoparticles after freeze-drying. Biomatter, 2 (4), 329–339.
   PubMedGoogle Scholar
• Fonte, P., et al., 2014. Stability study perspective of the effect of freeze-drying using cryoprotectants on the structure of insulin loaded into PLGA nanoparticles. Biomacromolecules, 15 (10), 3753–3765.
   PubMed Web of Science ®Google Scholar
• Franzé, S., et al., 2018. Lyophilization of liposomal formulations: still necessary, still challenging. Pharmaceutics, 10 (3), 139.
   PubMed Web of Science ®Google Scholar
• Gagliardi, A., et al., 2021. Biodegradable polymeric nanoparticles for drug delivery to solid tumors. Frontiers in pharmacology, 12 (February), 1–24.
   Google Scholar
• Giandalia, G., et al., 2001. Trehalose – hydroxyethylcellulose microspheres containing vancomycin for topical drug delivery related papers. European journal of pharmaceutics and biopharmaceutics, 52 (1), 83–89.
   PubMed Web of Science ®Google Scholar
• Glowka, E., Stasiak, J., and Lulek, J., 2019. Drug delivery systems for vitamin D supplementation and therapy. Pharmaceutics, 11 (7), 347.
   PubMed Web of Science ®Google Scholar
• González-Louzao, R., et al., 2020. Encapsulation of finasteride with native and modified γ-cyclodextrins. Extensive characterization of the complexes. International journal of pharmaceutics, 587 (July), 119619.
   PubMedGoogle Scholar
• Hernández-Carrión, M., et al., 2019. Effects of different drying methods on the physicochemical properties of powders obtained from high-oleic palm oil nanoemulsions, 11–14.
   Google Scholar
• Hester, S., et al., 2021. Development of a lyophilization process for long-term storage of albumin-based perfluorodecalin-filled artificial oxygen carriers. Pharmaceutics, 13 (4), 584.
   PubMed Web of Science ®Google Scholar
• Irfan, M.M., et al., 2021. Physicochemical characterization of finasteride nanosystem for enhanced topical delivery. International journal of nanomedicine, 16, 1207–1220.
   PubMed Web of Science ®Google Scholar
• Jelvehgari, M., et al., 2017. Development of a nanoprecipitation method for the entrapment of a very water soluble drug into Eudragit RL nanoparticles. Research in pharmaceutical sciences, 12 (1), 1–14.
   PubMedGoogle Scholar
• Khan, M.Z.U., et al., 2018. Finasteride topical delivery systems for androgenetic alopecia. Current drug delivery, 15 (8), 1100–1111.
   PubMed Web of Science ®Google Scholar
• Klymchenko, A.S., et al., 2012. Highly lipophilic fluorescent dyes in nano-emulsions: towards bright non-leaking nano-droplets. RSC advances, 2 (31), 11876–11886.
   PubMed Web of Science ®Google Scholar
• Kumar, S., Prasad, M., and Rao, R., 2021. Topical delivery of clobetasol propionate loaded nanosponge hydrogel for effective treatment of psoriasis: formulation, physicochemical characterization, antipsoriatic potential and biochemical estimation. Materials science & engineering. C, materials for biological applications, 119, 111605.
   PubMed Web of Science ®Google Scholar
• Leceta, I., Guerrero, P., and De La Caba, K., 2013. Functional properties of chitosan-based films. Carbohydrate polymers, 93 (1), 339–346.
   PubMed Web of Science ®Google Scholar
• Li, X., et al., 2021. Microencapsulation of poorly water-soluble finasteride in polyvinyl alcohol/chitosan microspheres as a long-term sustained release system for potential embolization applications. Engineered science, 13, 105–120.
   Google Scholar
• Lima, S.G.B., et al., 2018. Preformulation studies of finasteride to design matrix systems for topical delivery. Journal of pharmaceutical and biomedical analysis, 161, 273–279.
   PubMed Web of Science ®Google Scholar
• Luesakul, U., et al., 2020. Quaternized chitosan-coated nanoemulsions: a novel platform for improving the stability, anti-inflammatory, anti-cancer and transdermal properties of Plai extract. Carbohydrate polymers, 230 (November), 115625.
   PubMedGoogle Scholar
• Madheswaran, T., et al., 2014. Enhanced topical delivery of finasteride using glyceryl monooleate-based liquid crystalline nanoparticles stabilized by cremophor surfactants. American association of pharmaceutical scientist, 15 (1), 44–51.
   Google Scholar
• Mady, F.M., and Aly, U.F., 2017. Experimental, molecular docking investigations and bioavailability study on the inclusion complexes of finasteride and cyclodextrins. Drug design, development and therapy, 11, 1681–1692.
   PubMed Web of Science ®Google Scholar
• Mohammady, M., Mohammadi, Y., and Yousefi, G., 2020. Freeze-drying of pharmaceutical and nutraceutical nanoparticles : the effects of formulation and technique parameters on nanoparticles characteristics. Journal of pharmaceutical sciences, 109 (11), 3235–3247.
   PubMed Web of Science ®Google Scholar
• Morais, A. R. d V., et al., 2016. Freeze-drying of emulsified systems: a review. International journal of pharmaceutics, 503 (1–2), 102–114.
   PubMed Web of Science ®Google Scholar
• Morand, D., et al., 2015. Active nanofibrous membrane effects on gingival cell inflammatory response. Materials, 8 (10), 7217–7229.
   PubMed Web of Science ®Google Scholar
• Moretton, M.A., Chiappetta, D.A., and Sosnik, A., 2012. Cryoprotection-lyophilization and physical stabilization of rifampicin-loaded flower-like polymeric micelles. Journal of the royal society, interface, 9 (68), 487–502.
   PubMed Web of Science ®Google Scholar
• Naskar, S., Sharma, S., and Kuotsu, K., 2019. Chitosan-based nanoparticles: An overview of biomedical applications and its preparation. Journal of drug delivery science and technology, 49, 66–81.
   Web of Science ®Google Scholar
• Patra, J.K., et al., 2018. Nano based drug delivery systems: recent developments and future prospects 10 technology 1007 nanotechnology 03 chemical sciences 0306 physical chemistry (incl. Structural) 03 chemical sciences 0303 macromolecular and materials chemistry 11 medical and he. Journal of nanobiotechnology, 16 (1), 1–33.
   PubMed Web of Science ®Google Scholar
• Queiroz, M.B., et al., 2022. Co-crystallized sucrose-soluble fiber matrix: physicochemical and structural characterization. LWT, 154 (October 2021), 112685.
   Google Scholar
• Rampino, A., et al., 2013. Chitosan nanoparticles: preparation, size evolution and stability. International journal of pharmaceutics, 455 (1–2), 219–228.
   PubMed Web of Science ®Google Scholar
• Rao, Y., et al., 2015. Penetration profile and human cadaver skin distribution of finasteride from vesicular nanocarriers. Drug delivery, 22 (8), 1003–1009.
   PubMed Web of Science ®Google Scholar
• Rey, L., and May, J. C., 2004. Freeze drying/Lyophilization of Pharmaceutical and Biological Products, Drugs and the Pharmaceutical Sciences.
   Google Scholar
• Roque, L.V., et al., 2017. Design of finasteride-loaded nanoparticles for potential treatment of alopecia. Skin pharmacology and physiology, 30 (4), 197–204.
   PubMed Web of Science ®Google Scholar
• Rouco, H., et al., 2021. A traffic light system to maximize carbohydrate cryoprotectants’ effectivity in nanostructured lipid carriers’ lyophilization. Pharmaceutics, 13 (9), 1330.
   PubMed Web of Science ®Google Scholar
• Santagapita, P.R., et al., 2012. Invertase stability in alginate beads. Effect of trehalose and chitosan inclusion and of drying methods. Food research international, 47 (2), 321–330.
   Web of Science ®Google Scholar
• Sethi, A., et al., 2021. Evaluation of low molecular weight cross linked chitosan nanoparticles, to enhance the bioavailability of 5-flourouracil. Dose-Response, 19 (2), 1–12.
   Web of Science ®Google Scholar
• Shubber, S., et al., 2015. Research paper mechanism of mucosal permeability enhancement of critical Sorb ® (Solutol ® HS15) investigated in vitro in cell cultures. Pharmaceutical research, 32 (2), 516–527.
   PubMed Web of Science ®Google Scholar
• Simona, J., et al., 2021. Edible films from carrageenan/orange essential oil/trehalose—structure. Optical properties, and antimicrobial activity. Polymers, 13, 332.
   PubMed Web of Science ®Google Scholar
• Smith. W.P., 1989. United States Patent (19), 4–7.
   Google Scholar
• Soares, S., et al., 2018. Nanomedicine: principles, properties, and regulatory issues. Frontiers in chemistry, 6 (AUG), 360.
   PubMedGoogle Scholar
• Sukweenadhi, J., et al., 2021. South African journal of chemical engineering scale-up of green synthesis and characterization of silver nanoparticles using ethanol extract of Plantago major L. leaf and its antibacterial potential. South African journal of chemical engineering, 38 (June), 1–8.
   Google Scholar
• Sussich, F., and Cesàro, A., 2008. Trehalose amorphization and recrystallization. Carbohydrate research, 343 (15), 2667–2674.
   PubMed Web of Science ®Google Scholar
• Sylvester, B., et al., 2018. Formulation optimization of freeze-dried long-circulating liposomes and in-line monitoring of the freeze-drying process using an NIR spectroscopy tool. Journal of pharmaceutical sciences, 107 (1), 139–148.
   PubMed Web of Science ®Google Scholar
• Szymańska, E., and Winnicka, K., 2015. Stability of chitosan – a challenge for pharmaceutical and biomedical applications. Marine drugs, 13 (4), 1819–1846.
   PubMed Web of Science ®Google Scholar
• Teng, F., et al., 2020. Effect of ultrasonication on the stability and storage of a soy protein isolate ‑ phosphatidylcholine nanoemulsions. Scientific reports, 10, 14010.
   PubMed Web of Science ®Google Scholar
• Tonnis, W.F., et al., 2015. Size and molecular flexibility of sugars determine the storage stability of freeze-dried proteins. Molecular pharmaceutics, 12 (3), 684–694.
   PubMed Web of Science ®Google Scholar
• Trenkenschuh, E., et al., 2022. Enhancing the stabilization potential of lyophilization for extracellular vesicles. Advanced healthcare materials, 11 (5), 2100538.
   Web of Science ®Google Scholar
• Trenkenschuh, E., and Friess, W., 2021. Freeze-drying of nanoparticles: How to overcome colloidal instability by formulation and process optimization. European journal of pharmaceutics and biopharmaceutics, 165 (May), 345–360.
   PubMedGoogle Scholar
• Verhoeven, N., et al., 2012. Characteristics of dehydration kinetics of dihydrate trehalose to its anhydrous form in ethanol by DSC. Food chemistry, 132 (4), 1638–1643.
   Web of Science ®Google Scholar
• Wang, L., et al., 2018. Cryoprotectant choice and analyses of freeze-drying drug suspension of nanoparticles with functional stabilisers. Journal of microencapsulation, 35 (3), 241–248.
   PubMed Web of Science ®Google Scholar
• Wójcik-Pastuszka, D., et al., 2019. Evaluation of the release kinetics of a pharmacologically active substance from model intra-articular implants replacing the cruciate ligaments of the knee. Materials, 12 (8), 1202.
   PubMed Web of Science ®Google Scholar
• Wolska, E., et al., 2020. Analytical techniques for the assessment of drug-lipid interactions and the active substance distribution in liquid dispersions of solid lipid microparticles (SLM) produced de novo and reconstituted from spray-dried powders. Pharmaceutics, 12 (7), 664.
   PubMed Web of Science ®Google Scholar
• Yang, T.-L., et al., 2022. Oleic acid-based self micro-emulsifying delivery system for enhancing antifungal activities of clotrimazole. Pharmaceutics, 14 (3), 478.
   PubMed Web of Science ®Google Scholar
• Zhang, L., et al., 2008. The effects of cryoprotectants on the freeze-drying of ibuprofen-loaded solid lipid microparticles (SLM). European journal of pharmaceutics and biopharmaceutics, 69 (2), 750–759.
   PubMed Web of Science ®Google Scholar
• Zhao, L., et al., 2021. Effects of different drying methods on the characterization, dissolution rate and antioxidant activity of ursolic acid-loaded chitosan nanoparticles. Foods, 10 (10), 2470.
   PubMed Web of Science ®Google Scholar