Development of Sustained Release Formulations Based on Lipid-Liquid Crystal to Control the Release of Deoxycholate: In Vitro and In Vivo Assessment.
lipid-liquid crystal
sodium deoxycholate
spectrofluorometric method
sustained release
validation
Journal
AAPS PharmSciTech
ISSN: 1530-9932
Titre abrégé: AAPS PharmSciTech
Pays: United States
ID NLM: 100960111
Informations de publication
Date de publication:
10 Nov 2023
10 Nov 2023
Historique:
received:
24
07
2023
accepted:
12
10
2023
medline:
13
11
2023
pubmed:
10
11
2023
entrez:
9
11
2023
Statut:
epublish
Résumé
Subcutaneous injections of phosphatidylcholine (PC), sodium deoxycholate (NADC), and a mixture of them were found to be an effective option for treating cellulite. However, it is noteworthy that the injection of NADC may result in inflammation as well as necrosis in the injection area. The preparation of a sustained release formulation based on lipid-liquid crystal that controls the release of NADC could be a potential solution to address the issue of inflammation and necrosis at the site of injection. To present a practical and validated approach for accurately determining the concentration of NADC in LLC formulations, spectrofluorimetry was used based on the International Council for Harmonization (ICH) Q2 guidelines. Based on the validation results, the fluorometric technique has been confirmed as a reliable, efficient, and economical analytical method for quantifying NADC concentrations. The method demonstrated favorable attributes of linearity, precision, and accuracy, with an r
Identifiants
pubmed: 37946092
doi: 10.1208/s12249-023-02677-7
pii: 10.1208/s12249-023-02677-7
doi:
Substances chimiques
Delayed-Action Preparations
0
Deoxycholic Acid
005990WHZZ
Lipids
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
224Informations de copyright
© 2023. The Author(s).
Références
Mohammed MS, Sendra S, Lloret J, Bosch I. Systems and WBANs for controlling obesity. J Healthc Eng. 2018;2018:1–21.
Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clin Cosmet Investig Dermatol. 2017;10:17.
pubmed: 28123311
pmcid: 5234561
doi: 10.2147/CCID.S95830
Hexsel D, Dal T, Hexsel C, Schilling-Souza J, Bastos FN, Siega C. Magnetic resonance imaging of cellulite depressed lesions successfully treated by subcision. Dermatol Surg. 2016;42(5):693–6.
pubmed: 27082058
doi: 10.1097/DSS.0000000000000679
Piansay-Soriano ME. Assisted liposuction (ultrasound-assisted, power-assisted, and laser-assisted). Dermatol Rev. 2021;2(4):188–95.
doi: 10.1002/der2.71
Kamalpour S, Leblanc K Jr. Injection adipolysis: mechanisms, agents, and future directions. J Clin Aesthet Dermatol. 2016;9(12):44.
pubmed: 28210398
pmcid: 5300726
Kara Ö, Kara M. Lipolysis of a painful lipoma with ozone: the role of ultrasound in the diagnosis and quantification of the treatment. Med Gas Res. 2019;9(3):168.
pubmed: 31552883
pmcid: 6779005
doi: 10.4103/2045-9912.267000
Sykes JM, Allak A, Klink B. Future applications of deoxycholic acid in body contouring. J Drugs Dermatol. 2017;16(1):43–6.
pubmed: 28095531
Li MK, Mazur C, McDaniel DH, DaSilva D, Canfield D. Use of 3-dimensional imaging in submental fat reduction after deoxycholic acid injection. Dermatol Surg. 2018;44(4):599–602.
pubmed: 29059140
doi: 10.1097/DSS.0000000000001342
Thomas MK, D’Silva JA, Borole AJ. Injection lipolysis: a systematic review of literature and our experience with a combination of phosphatidylcholine and deoxycholate over a period of 14 years in 1269 patients of Indian and South East Asian origin. J Cutan Aesthet Surg. 2018;11(4):222.
pubmed: 30886477
pmcid: 6371720
doi: 10.4103/JCAS.JCAS_117_18
Walker PS, Lee DR, Toth BA, Bowen B. Histological analysis of the effect of ATX-101 (deoxycholic acid injection) on subcutaneous fat: results from a phase 1 open-label study. Dermatol Surg. 2020;46(1):70–7.
pubmed: 30883481
doi: 10.1097/DSS.0000000000001851
Talathi A, Talathi P. Fat busters: lipolysis for face and neck. J Cutan Aesthet Surg. 2018;11(2):67.
pubmed: 30210208
pmcid: 6128158
doi: 10.4103/JCAS.JCAS_59_18
Amore R, Amuso D, Leonardi V, Leva F, Sibaud AC, Guida A, et al. Evaluation of safe and effectiveness of an injectable solution acid deoxycholic based for reduction of localized adiposities. Plast Reconstr Surg GlobOpen. 2018;6(6):e1794.
Jung TW, Kim ST, Lee JH, Chae SI, Hwang KW, Chung YH, et al. Phosphatidylcholine causes lipolysis and apoptosis in adipocytes through the tumor necrosis factor alpha-dependent pathway. Pharmacology. 2018;101(3–4):111–9.
pubmed: 29186713
doi: 10.1159/000481571
El Kamshoushy A, Abel Maksoud R, El Mahdy N. Evaluation of the efficacy of injection lipolysis using phosphatidylcholine/deoxycholate versus deoxycholate alone in treatment of localized fat deposits. J Clin Exp Dermatol. 2012;3(2):1–9.
Salti G, Ghersetich I, Tantussi F, Bovani B, Lotti T. Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study. Dermatol Surg. 2008;34(1):60–6.
pubmed: 18053049
doi: 10.1097/00042728-200801000-00010
Chavda VP, Dawre S, Pandya A, Vora LK, Modh DH, Shah V, et al. Lyotropic liquid crystals for parenteral drug delivery. J Control Release. 2022;349:533–49.
pubmed: 35792188
doi: 10.1016/j.jconrel.2022.06.062
Silvestrini AVP, Caron AL, Viegas J, Praca FG, Bentley MVLB. Advances in lyotropic liquid crystal systems for skin drug delivery. Expert Opin Drug Deliv. 2020;17(12):1781–805.
pubmed: 32886531
doi: 10.1080/17425247.2020.1819979
Milak S. Ocular drug delivery systems for vancomycin/vorgelegt von Spomenka Milak, Mag. pharm: Karl-Franzens-Universität Graz; 2018.
Shiadeh SNR, Khodaverdi E, Maleki MF, Eisvand F, Boujaran H, Zarei H, et al. Lipid-liquid crystals for 2 months controlled risperidone release: In-vitro evaluation and pharmacokinetics in rabbits. Int J Pharm. 2022;618: 121649.
pubmed: 35278600
doi: 10.1016/j.ijpharm.2022.121649
Nilsson C, Edwards K, Eriksson J, Larsen SW, Østergaard J, Larsen C, et al. Characterization of oil-free and oil-loaded liquid-crystalline particles stabilized by negatively charged stabilizer citrem. Langmuir. 2012;28(32):11755–66.
pubmed: 22831645
doi: 10.1021/la3021244
Gairola S, Gautam M, Patil D, Kumar KM, Shinde P, Jana S, et al. Development and application of HPLC-RI and HPLC-MS/MS based methods for quantification of residual deoxycholate levels in pneumococcal polysaccharides. Biologicals. 2016;44(6):517–25.
pubmed: 27666435
doi: 10.1016/j.biologicals.2016.08.004
Danese E, Negrini D, Pucci M, De Nitto S, Ambrogi D, Donzelli S, et al. Bile acids quantification by liquid chromatography–tandem mass spectrometry: method validation, reference range, and interference study. Diagnostics. 2020;10(7):462.
pubmed: 32645999
pmcid: 7399932
doi: 10.3390/diagnostics10070462
Barbosa FDS, Rodrigues VC, Volpato NM, Schapoval EES, Steppe M, Garcia CV, et al. (2017) UV spectrophotometric method for quantitative determination of Agomelatine in coated tablets. Drug Anal Res Porto Alegre RS. 2017;1(2):24–9.
doi: 10.22456/2527-2616.79219
Bulduk I, Akbel E. A comparative study of HPLC and UV spectrophotometric methods for remdesivir quantification in pharmaceutical formulations. J Taibah Univ Sci. 2021;15(1):507–13.
doi: 10.1080/16583655.2021.1991737
Metias YM, Hosny MM, Ayad MM, Kaji N. High-throughput spectrofluorimetric approach for one-step, sensitive, and green assays of alfuzosin hydrochloride using a 96-well microplate reader: application to tablet formulations and human urine. Talanta Open. 2022;6: 100139.
doi: 10.1016/j.talo.2022.100139
Forman DT, Phillips C, Eiseman W, Taylor CB. Fluorometric measurement of fecal bile acids. Clin Chem. 1968;14(4):348–59.
pubmed: 5642015
doi: 10.1093/clinchem/14.4.348
Bridwell H, Dhingra V, Peckman D, Roark J, Lehman T. Perspectives on method validation: importance of adequate method validation. Qual Assur J. 2010;13(3–4):72–7.
doi: 10.1002/qaj.473
Ozkan SA. Analytical method validation: the importance for pharmaceutical analysis. Pharm Sci. 2018;24(1):1–2.
doi: 10.15171/PS.2018.01
Guideline I. Validation of analytical procedures: text and methodology. Q2 R1. 2005;1:5.
Davoodi J, Majidi S, Jahani M, Tayarani-Najaran Z, Golmohammadzadeh S, Kamali H. Implementation of design of experiments for optimization of forced degradation conditions and development of a stability-indicating high-performance liquid chromatography method for sepiwhite. J Sep Sci. 2021;44(24):4299–312. https://doi.org/10.1002/jssc.202100388 .
doi: 10.1002/jssc.202100388
pubmed: 34669262
Miao Y, Jia B, Chen M, Zhang W. Preparation and characterization of solid lipid microparticles with liquid crystal structure. Mol Cryst Liq Cryst. 2016;633(1):110–22.
doi: 10.1080/15421406.2016.1177899
Usach I, Martinez R, Festini T, Peris J-E. Subcutaneous injection of drugs: literature review of factors influencing pain sensation at the injection site. Adv Ther. 2019;36:2986–96.
pubmed: 31587143
pmcid: 6822791
doi: 10.1007/s12325-019-01101-6
Shiadeh SNR, Khodaverdi E, Maleki MF, Eisvand F, Nazari A, Zarqi J, et al. A sustain-release lipid-liquid crystal containing risperidone based on glycerol monooleate, glycerol dioleate, and glycerol trioleate: in-vitro evaluation and pharmacokinetics in rabbits. J Drug Deliv Sci Technol. 2022;70: 103257.
doi: 10.1016/j.jddst.2022.103257
Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016;7(2):27.
pubmed: 27057123
pmcid: 4804402
doi: 10.4103/0976-0105.177703
Rittes PG, Rittes JC, Amary MFC. Injection of phosphatidylcholine in fat tissue: experimental study of local action in rabbits. Aesthet Plast Surg. 2006;30(4):474–8.
doi: 10.1007/s00266-005-0170-5
Kim GW, Chung SH. The beneficial effect of glycerophosphocholine to local fat accumulation: a comparative study with phosphatidylcholine and aminophylline. Korean J Physiol Pharmacol. 2021;25(4):333–9.
pubmed: 34187950
pmcid: 8255124
doi: 10.4196/kjpp.2021.25.4.333
Ahmad N, Bitar Y, Trefi S. Development and validation of a simple method for the determination of Atorvastatin calcium in pure and pharmaceutical formulations using spectrofluorimetry. Heliyon. 2023;9(3): e13771.
pubmed: 36873484
pmcid: 9981906
doi: 10.1016/j.heliyon.2023.e13771
Namegabe LM, Sarr SO, Diop YM. Development and validation of a spectrofluorimetric method for the assay of tetracycline in capsules. Am J Anal Chem. 2018;9(03):162.
doi: 10.4236/ajac.2018.93014
Rajak P, Nath L, Bhuyan B. Liquid crystals: an approach in drug delivery. Indian J Pharm Sci. 2019;81(1):11–21.
Kim D-H, Jahn A, Cho S-J, Kim JS, Ki M-H, Kim D-D. Lyotropic liquid crystal systems in drug delivery: a review. J Pharm Investig. 2015;45:1–11.
doi: 10.1007/s40005-014-0165-9
Ki M-H, Lim J-L, Ko J-Y, Park S-H, Kim J-E, Cho H-J, et al. A new injectable liquid crystal system for one month delivery of leuprolide. J Control Release. 2014;185:62–70.
pubmed: 24794897
doi: 10.1016/j.jconrel.2014.04.034
Boyd BJ, Whittaker DV, Khoo S-M, Davey G. Hexosomes formed from glycerate surfactants—formulation as a colloidal carrier for irinotecan. Int J Pharm. 2006;318(1–2):154–62.
pubmed: 16621358
doi: 10.1016/j.ijpharm.2006.03.010
Kamali H, Karimi M, Abbaspour M, Nadim A, Hadizadeh F, Khodaverdi E, et al. Comparison of lipid liquid crystal formulation and Vivitrol® for sustained release of Naltrexone: in vitro evaluation and pharmacokinetics in rats. Int J Pharm. 2022;611: 121275.
pubmed: 34748809
doi: 10.1016/j.ijpharm.2021.121275
Wang X, Zhang Y, Gui S, Huang J, Cao J, Li Z, et al. Characterization of lipid-based lyotropic liquid crystal and effects of guest molecules on its microstructure: a systematic review. AAPS PharmSciTech. 2018;19(5):2023–40.
pubmed: 29869308
doi: 10.1208/s12249-018-1069-1
Wadsater M, Barauskas J, Nylander T, Tiberg F. Formation of highly structured cubic micellar lipid nanoparticles of soy phosphatidylcholine and glycerol dioleate and their degradation by triacylglycerol lipase. ACS Appl Mater Interfaces. 2014;6(10):7063–9.
pubmed: 24779728
doi: 10.1021/am501489e
Permanadewi I, Kumoro A, Wardhani D, Aryanti N, editors. Modelling of controlled drug release in gastrointestinal tract simulation. Journal of Physics: Conference Series: IOP Publishing; 2019;1295:12063.
Rose PT, Morgan M. Histological changes associated with mesotherapy for fat dissolution. J Cosmet Laser Ther. 2005;7(1):17–9.
pubmed: 16020211
doi: 10.1080/14764170510037743
Reeds DN, Mohammed BS, Klein S, Boswell CB, Young VL. Metabolic and structural effects of phosphatidylcholine and deoxycholate injections on subcutaneous fat: a randomized, controlled trial. Aesthet Surg J. 2013;33(3):400–8.
pubmed: 23439063
doi: 10.1177/1090820X13478630
Liang X, Chen Y, Wu L, Maharjan A, Regmi B, Zhang J, et al. In situ hexagonal liquid crystal for intra-articular delivery of sinomenine hydrochloride. Biomed Pharmacother. 2019;117: 108993.
pubmed: 31228805
doi: 10.1016/j.biopha.2019.108993
Hara E. Relationship between obesity, gut microbiome and hepatocellular carcinoma development. Dig Dis. 2015;33(3):346–50.
pubmed: 26045268
doi: 10.1159/000371679
Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS biol. 2010;8(6): e1000412.
pubmed: 20613859
pmcid: 2893951
doi: 10.1371/journal.pbio.1000412