Development of canagliflozin nanocrystals sublingual tablets in the presence of sodium caprate permeability enhancer: formulation optimization, characterization, in-vitro, in silico, and in-vivo study

References

• Abdelmonem R , Elhabal SF , Abdelmalak NS , et al. ( 2021). Formulation and characterization of acetazolamide/carvedilol niosomal gel for glaucoma treatment: in vitro, and in vivo study. Pharmaceutics 13: 1–16. doi: 10.3390/pharmaceutics13020221.
   Web of Science ®Google Scholar
• Abdeltawab H , Svirskis D , Sharma M. ( 2020). Formulation strategies to modulate drug release from poloxamer based in situ gelling systems. Expert Opin Drug Deliv 17: 495–509. doi: 10.1080/17425247.2020.1731469.
   PubMed Web of Science ®Google Scholar
• Bolourchian N , Hadidi N , Foroutan S , Shafaghi B. ( 2009). Development and optimization of a sublingual tablet formulation for physostigmine salicylate. Acta Pharm 59: 301–12. doi: 10.2478/v10007-009-0028-5.
   PubMed Web of Science ®Google Scholar
• Charoonsuk P , Vittayakorn N. ( 2013). Perovskite phase formation of monosized lead zirconate (PbZrO3) nanoparticles prepared by the sono-assisted co-precipitation method. J Nanosci Nanotechnol 13: 3529–34. doi: 10.1166/jnn.2013.7239.
   PubMed Web of Science ®Google Scholar
• Chung YJ , Park KC , Tokar S , et al. ( 2021). Off-target effects of sodium-glucose co-transporter 2 blockers: empagliflozin does not inhibit Na+/H + exchanger-1 or lower [Na+]i in the heart. Cardiovasc Res 117: 2794–806. doi: 10.1093/cvr/cvaa323.
   PubMed Web of Science ®Google Scholar
• Convention USP. ( 2012). The United States Pharmacopeia 2014: USP 37.Rockville (MD): United States Pharmacopeial Convention.
   Google Scholar
• Convention USP. ( 2014). USP 37. Rockville (MD): United States Pharmacopeial Convention.
   Google Scholar
• Council of Europe. ( 2017). European pharmacopoeia. 9th ed. Strasbourg (France): Council of Europe.
   Google Scholar
• Council of Europe. ( 2019). European pharmacopoeia. 9th ed. Strasbourg (France): Council of Europe.
   Google Scholar
• di Prima G , Angellotti G , Scarpaci AG , et al. ( 2021). Improvement of resveratrol permeation through sublingual mucosa: chemical permeation enhancers versus spray drying technique to obtain fast-disintegrating sublingual mini-tablets. Pharmaceutics 13: 1370. doi: 10.3390/pharmaceutics13091370.
   PubMed Web of Science ®Google Scholar
• EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) ; Younes M , Aggett P , Aguilar F , et al. ( 2018). Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives. EFSA J 16: e05180. doi: 10.2903/j.efsa.2018.5180.
   PubMed Web of Science ®Google Scholar
• El-Gizawy S , Osman M , Ibrahim S. ( 2018). Effect of cosolvents on the absorptive clearance of ketotifen fumarate from rabbit intestine, in-situ. J Adv Pharm Res 2: 168–179. doi: 10.21608/aprh.2018.3450.1055.
   Google Scholar
• Fuguet E , Subirats X , Ràfols C , et al. ( 2021). Ionizable drug self-associations and the solubility dependence on PH: detection of aggregates in saturated solutions using mass spectrometry (ESI-Q-TOF-MS/MS). Mol Pharm 18: 2311–2321. doi: 10.1021/acs.molpharmaceut.1c00131.
   PubMedGoogle Scholar
• Gajera BY , Shah DA , Dave RH. ( 2019). Development of an amorphous nanosuspension by sonoprecipitation-formulation and process optimization using design of experiment methodology. Int J Pharm 559: 348–359. doi: 10.1016/j.ijpharm.2019.01.054.
   PubMed Web of Science ®Google Scholar
• Ghadi R , Dand N. ( 2017). BCS class IV drugs: highly notorious candidates for formulation development. J Control Release 248: 71–95. doi: 10.1016/j.jconrel.2017.01.014.
   PubMed Web of Science ®Google Scholar
• Gulsun T , Ozturk N , Kaynak MS , et al. ( 2017). Preparation and evaluation of furosemide containing orally disintegrating tablets by direct compression. Pharmazie 72: 389–394. doi: 10.1691/ph.2017.6149.
   PubMed Web of Science ®Google Scholar
• Hamza AA , Khasawneh MA , Elwy HM , et al. ( 2022). Salvadora persica attenuates DMBA-induced mammary cancer through downregulation of oxidative stress, estrogen receptor expression and proliferation, and augmenting apoptosis. Biomed Pharmacother 147: 112666. doi: 10.1016/j.biopha.2022.112666.
   PubMed Web of Science ®Google Scholar
• Hoover A , Chitranshi P , Momot M , et al. ( 2021). In vitro evaluation of enteral tube administration of lansoprazole orally disintegrating tablets. Pharm Dev Technol 26: 846–851. doi: 10.1080/10837450.2021.1948567.
   PubMed Web of Science ®Google Scholar
• Jin L , Yang YZ , Fan JF , Xu BS. ( 2020). Effect of surfactant polyvinyl pyrrolidone on the properties of microporous carbon nanospheres reinforced magnesium matrix composites. Nanomaterials 10: 1–21. doi: 10.3390/nano10112281.
   Web of Science ®Google Scholar
• Józó M , Simon N , Yi L , et al. ( 2021). Improved release of a drug with poor water solubility by using electrospun water-soluble polymers as carriers. Pharmaceutics 34: 2022. doi: 10.3390/pharmaceutics.
   Google Scholar
• Leal-Júnior CC , Amorim MMR , Souza GFA , et al. ( 2020). Effectiveness of an oral versus sublingual loading dose of nifedipine for tocolysis. Int J Gynaecol Obstet 148: 310–315. doi: 10.1002/ijgo.13067.
   PubMed Web of Science ®Google Scholar
• Li X , Wang L , She L , et al. ( 2018). Immunotoxicity assessment of ordered mesoporous carbon nanoparticles modified with PVP/PEG. Colloids Surf B Biointerfaces 171: 485–493. doi: 10.1016/j.colsurfb.2018.07.072.
   PubMed Web of Science ®Google Scholar
• Lindmark T , Söderholm JD , Olaison G , et al. ( 1997). Mechanism of absorption enhancement in humans after rectal administration of ampicillin in suppositories containing sodium caprate. Pharm Res 14: 930–935. doi: 10.1023/A:1012112219578.
   PubMed Web of Science ®Google Scholar
• Lippincott Williams & Wilkins. ( 2011). Martin’s physical pharmacy and pharmaceutical sciences: physical chemical and biopharmaceutical principles in the pharmaceutical sciences. 6th ed. Baltimore (MD): Lippincott Williams & Wilkins.
   Google Scholar
• Liu J , Li L , Li S , et al. ( 2020). Sodium-glucose co-transporter-2 inhibitors and the risk of diabetic ketoacidosis in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab 22: 1619–1627. doi: 10.1111/dom.14075.
   PubMed Web of Science ®Google Scholar
• Marilly E , Cottin J , Cabrera N , et al. ( 2022). SGLT2 inhibitors in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials balancing their risks and benefits. Diabetologia 65: 2000–2010. doi: 10.1007/s00125-022-05773-8.
   PubMed Web of Science ®Google Scholar
• Mohamed DI , Abou-Bakr DA , Ezzat SF , et al. ( 2021). Vitamin D3 prevents the deleterious effects of testicular torsion on testis by targeting MiRNA-145 and ADAM17: in silico and in vivo study. Pharmaceuticals 14: 1222. doi: 10.3390/ph14121222.
   Web of Science ®Google Scholar
• Mohamed DI , El-Waseef DAEDA , Nabih ES , et al. ( 2022). Acetylsalicylic acid suppresses alcoholism-induced cognitive impairment associated with atorvastatin intake by targeting cerebral MiRNA155 and NLRP3: in vivo, and in silico study. Pharmaceutics 14: 529. doi: 10.3390/pharmaceutics14030529.
   PubMed Web of Science ®Google Scholar
• Moussa BA , Mahrouse MA , Fawzy MG. ( 2021). Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet. Biomed Chromatogr 35: e5155. doi: 10.1002/bmc.5155.
   PubMed Web of Science ®Google Scholar
• Naguib MJ , Makhlouf AIA. ( 2021). Scalable flibanserin nanocrystal-based novel sublingual platform for female hypoactive sexual desire disorder: engineering, optimization adopting the desirability function approach and in vivo pharmacokinetic study. Drug Deliv 28: 1301–1311. doi: 10.1080/10717544.2021.1938755.
   PubMed Web of Science ®Google Scholar
• Niu Y , Liu R , Guan C , et al. ( 2022). Structural basis of inhibition of the human SGLT2–MAP17 glucose transporter. Nature 601: 280–284. doi: 10.1038/s41586-021-04212-9.
   PubMed Web of Science ®Google Scholar
• Puri V , Froelich A , Shah P , et al. ( 2022). Quality by design guided development of polymeric nanospheres of terbinafine hydrochloride for topical treatment of onychomycosis using a nano-gel formulation. Pharmaceutics 14: 2170. doi: 10.3390/pharmaceutics14102170.
   PubMed Web of Science ®Google Scholar
• Quodbach J , Kleinebudde P. ( 2016). A critical review on tablet disintegration. Pharm Dev Technol 21: 763–774. doi: 10.3109/10837450.2015.1045618.
   PubMed Web of Science ®Google Scholar
• Ramasamy T , Ruttala HB , Shanmugam S , Umadevi SK. ( 2013). Eudragit-coated aceclofenac-loaded pectin microspheres in chronopharmacological treatment of rheumatoid arthritis. Drug Deliv 20: 65–77. doi: 10.3109/10717544.2012.762434.
   PubMed Web of Science ®Google Scholar
• Sabaa M , Sharawy MH , El-Sherbiny M , et al. ( 2022). Canagliflozin interrupts MTOR-mediated inflammatory signaling and attenuates DMBA-induced mammary cell carcinoma in rats. Biomed Pharmacother 155: 113675. doi: 10.1016/j.biopha.2022.113675.
   PubMed Web of Science ®Google Scholar
• Saied EM , El-Maradny YA , Osman AA , et al. ( 2021). A comprehensive review about the molecular structure of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): insights into natural products against COVID-19. Pharmaceutics 13: 1759 doi: 10.3390/pharmaceutics13111759.
   PubMed Web of Science ®Google Scholar
• Salah S , Awad GEA , Makhlouf AIA. ( 2018). Improved vaginal retention and enhanced antifungal activity of miconazole microsponges gel: formulation development and in vivo therapeutic efficacy in rats. Eur J Pharm Sci 114: 255–266. doi: 10.1016/j.ejps.2017.12.023.
   PubMed Web of Science ®Google Scholar
• Salem MG , El-Maaty DMA , El-Deen, et al. ( 2022). Novel 1,3-thiazole analogues with potent activity against breast cancer: a design, synthesis, in vitro, and in silico study. Molecules 27: 4898. doi: 10.3390/molecules27154898.
   PubMed Web of Science ®Google Scholar
• Sammar FE , Hanan Mohamed E , Soha H , et al. ( 2023a). Biosynthesis and characterization of gold and copper nanoparticles from Salvadora persica fruit extracts and their biological properties. Int J Nanomedicine 17: 6095–6112.
   Web of Science ®Google Scholar
• Sammar FE , Shrouk AG , Raghda H , et al. ( 2023b). Development of thermosensitive hydrogel of Amphotericin-B and Lactoferrin combination-loaded PLGA-PEG-PEI nanoparticles for potential eradication of ocular fungal infections: in-vitro, ex-vivo and in-vivo studies. Int J Pharm X 5: 100174. doi: 10.1016/j.ijpx.2023.100174.
   PubMedGoogle Scholar
• Shahinaze AF , Mahmoud HT , Mostafa IG , et al. ( 2023). Progress against cancer in Kuwait: trends in incidence, survival and mortality. Gulf J Oncolog 1: 23–31. doi: 10.1080/10717544.2023.2181747.
   PubMedGoogle Scholar
• Shoman NA , Saady M , Teaima M , et al. ( 2023). Merging konjac glucomannan with other copolymeric hydrogels as a cutting-edge liquid raft system for dual delivery of etoricoxib and famotidine. Drug Deliv 30: 2189630. doi: 10.1080/10717544.2023.2189630.
   PubMed Web of Science ®Google Scholar
• Sherje AP , Kulkarni V , Murahari M , et al. ( 2017). Inclusion complexation of etodolac with hydroxypropyl-beta-cyclodextrin and auxiliary agents: formulation characterization and molecular modeling studies. Mol Pharm 14: 1231–1242. doi: 10.1021/acs.molpharmaceut.6b01115.
   PubMed Web of Science ®Google Scholar
• Singh D , Tiwary AK , Kang TS , Bedi N. ( 2021). Polymeric precipitation inhibitor based supersaturable self-microemulsifying drug delivery system of canagliflozin: optimization and evaluation. Curr Drug Deliv 18: 1352–1367. doi: 10.2174/1567201818666210217155909.
   PubMed Web of Science ®Google Scholar
• Singh D , Singh AP , Singh D , et al. ( 2020). Enhanced oral bioavailability and anti-diabetic activity of canagliflozin through a spray dried lipid based oral delivery: a novel paradigm. Daru 28: 191–208. doi: 10.1007/s40199-020-00330-3.
   PubMed Web of Science ®Google Scholar
• Twarog C , Fattah S , Heade J , et al. ( 2019). Intestinal permeation enhancers for oral delivery of macromolecules: a comparison between salcaprozate sodium (SNAC) and sodium caprate (C10). Pharmaceutics 11: 78. doi: 10.3390/pharmaceutics11020078.
   PubMed Web of Science ®Google Scholar
• Vlad RA , Antonoaea P , Todoran N , et al. ( 2022). Development and evaluation of cannabidiol orodispersible tablets using a 23-factorial design. Pharmaceutics 14: 1467. doi: 10.3390/pharmaceutics14071467.
   PubMed Web of Science ®Google Scholar
• Walsh EG , Adamczyk BE , Chalasani KB , et al. ( 2011). Oral delivery of macromolecules: rationale underpinning Gastrointestinal Permeation Enhancement Technology (GIPET®). Ther Deliv 2: 1595–1610. doi: 10.4155/tde.11.132.
   PubMedGoogle Scholar
• Xia D , Quan P , Piao H , et al. ( 2010). Preparation of stable nitrendipine nanosuspensions using the precipitation–ultrasonication method for enhancement of dissolution and oral bioavailability. Eur J Pharm Sci 40: 325–334. doi: 10.1016/j.ejps.2010.04.006.
   PubMed Web of Science ®Google Scholar
• Younes NF , el Assasy AE-HI , Makhlouf AIA. ( 2021). Microenvironmental PH-modified amisulpride-labrasol matrix tablets: development, optimization and in vivo pharmacokinetic study. Drug Deliv Transl Res 11: 103–117. doi: 10.1007/s13346-019-00706-2.
   PubMed Web of Science ®Google Scholar
• Zhao H , Zhao L , Lin X , Shen L. ( 2022). An update on microcrystalline cellulose in direct compression: functionality, critical material attributes, and co-processed excipients. Carbohydr Polym 278: 118968. doi: 10.1016/j.carbpol.2021.118968.
   PubMed Web of Science ®Google Scholar
• Zhu Y , Kang Y , Zhu L , et al. ( 2021). Investigation of solubility behavior of canagliflozin hydrate crystals combining crystallographic and Hirshfeld surface calculations. Molecules 26: 298. doi: 10.3390/molecules26020298.
   PubMed Web of Science ®Google Scholar