Hyaluronic acid-enriched bilosomes: an approach to enhance ocular delivery of agomelatine via D-optimal design: formulation, in vitro characterization, and in vivo pharmacodynamic evaluation in rabbits

References

• Abd-Elsalam WH, ElKasabgy NA. (2019). Mucoadhesive olaminosomes: a novel prolonged release nanocarrier of agomelatine for the treatment of ocular hypertension. Int J Pharm 560:235–45.
   PubMed Web of Science ®Google Scholar
• Abdelbary AA, Abd-Elsalam WH, Al-mahallawi AM. (2016). Fabrication of novel ultradeformable bilosomes for enhanced ocular delivery of terconazole: in vitro characterization, ex vivo permeation and in vivo safety assessment. Int J Pharm 513:688–96.
   PubMed Web of Science ®Google Scholar
• Abdelbary GA, Aburahma MH. (2015). Oro-dental mucoadhesive proniosomal gel formulation loaded with lornoxicam for management of dental pain. J Liposome Res 25:107–21.
   PubMed Web of Science ®Google Scholar
• Aburahma MH. (2014). Bile salts-containing vesicles: promising pharmaceutical carriers for oral delivery of poorly water-soluble drugs and peptide/protein-based therapeutics or vaccines. Drug Deliv 23:1847–67.
   PubMed Web of Science ®Google Scholar
• Ahmed S, Kassem MA, Sayed S. (2020). Bilosomes as promising nanovesicular carriers for improved transdermal delivery: construction, in vitro optimization, ex vivo permeation and in vivo evaluation. IJN 15:9783–98.
   Web of Science ®Google Scholar
• Al-Mahallawi AM, Abdelbary AA, Aburahma MH. (2015). Investigating the potential of employing bilosomes as a novel vesicular carrier for transdermal delivery of tenoxicam. Int J Pharm 485:329–40.
   PubMed Web of Science ®Google Scholar
• Al-Mahallawi AM, Khowessah OM, Shoukri RA. (2014). Nano-transfersomal ciprofloxacin loaded vesicles for non-invasive trans-tympanic ototopical delivery: in-vitro optimization, ex-vivo permeation studies, and in-vivo assessment. Int J Pharm 472:304–14.
   PubMed Web of Science ®Google Scholar
• Alarma-Estrany P, Pintor J. (2007). Melatonin receptors in the eye: location, second messengers and role in ocular physiology. Pharmacol Ther 113:507–22.
   PubMed Web of Science ®Google Scholar
• Ammar HO, Ghorab M, El-Nahhas SA, Higazy IM. (2011). Proniosomes as a carrier system for transdermal delivery of tenoxicam. Int J Pharm 405:142–52.
   PubMed Web of Science ®Google Scholar
• Ammar HO, Salama HA, Ghorab M, Mahmoud AA. (2009). Nanoemulsion as a potential ophthalmic delivery system for dorzolamide hydrochloride. AAPS PharmSciTech 10:808–19.
   PubMed Web of Science ®Google Scholar
• Aziz DE, Abdelbary AA, Elassasy AI. (2019). Investigating superiority of novel bilosomes over niosomes in the transdermal delivery of diacerein: in vitro characterization, ex vivo permeation and in vivo skin deposition study. J Liposome Res 29:73–85.
   PubMed Web of Science ®Google Scholar
• Basha M, Abd El-Alim SH, Shamma RN, Awad GEA. (2013). Design and optimization of surfactant-based nanovesicles for ocular delivery of Clotrimazole. J Liposome Res 23:203–10.
   PubMed Web of Science ®Google Scholar
• Baydoun L, Furrer P, Gurny R, Müller-Goymann CC. (2004). New surface-active polymers for ophthalmic formulations: evaluation of ocular tolerance. Eur J Pharm Biopharm 58:169–75.
   PubMed Web of Science ®Google Scholar
• Dahiya S, Rani R, Dhingra D, et al. (2018). Conjugation of epigallocatechin gallate and piperine into a zein nanocarrier: implication on antioxidant and anticancer potential. Adv Nat Sci: Nanosci Nanotechnol 9:035011
   Google Scholar
• De Bodinat C, Guardiola-Lemaitre B, Mocaër E, et al. (2010). Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nat Rev Drug Discov 9:628–42.
   PubMed Web of Science ®Google Scholar
• Dhangar R, Bhowmick M, Parihar SS, et al. (2014). Design and evaluation of proniosomes as drug carrier for ocular delivery of levofloxacin. J Drug Delivery Ther 4(5):182–189.
   Google Scholar
• Dora CP, Singh SK, Kumar S, et al. (2010). Development and characterization of nanoparticles of glibenclamide by solvent displacement method. Acta Pol Pharm - Drug Res. 67:283–90.
   PubMed Web of Science ®Google Scholar
• Doshi U, Xu J. (2009). Effect of viscosity, surface tension and mucoadhesion on ocular residence time of lubricant eye drops. Invest Ophthalmol Visual Sci. 85:715–25.
   Google Scholar
• Draize JH, Woodard G, Calvery HO. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther. 82:377–90.
   Web of Science ®Google Scholar
• El-Mahrouk G, Aboul-Einien MH, Elkasabgy NA. (2009). Formulation and evaluation of meloxicam orally dispersible capsules. Asian J Pharm Sci. 4:8–22.
   Google Scholar
• Elazreg R. (2014). Formulation and in vitro evaluation of methazolamide elastic vesicular systems. Al-Azhar J Pharm Sci. 49:75–84.
   Google Scholar
• Elnaggar YSR, Omran S, Hazzah HA, Abdallah OY. (2019). Anionic versus cationic bilosomes as oral nanocarriers for enhanced delivery of the hydrophilic drug risedronate. Int J Pharm 564:410–25.
   PubMed Web of Science ®Google Scholar
• Emad Eldeeb A, Salah S, Ghorab M. (2019). Proniosomal gel-derived niosomes: an approach to sustain and improve the ocular delivery of brimonidine tartrate; formulation, in-vitro characterization, and in-vivo pharmacodynamic study. Drug Deliv 26:509–21. 10.1080/10717544.2019.1609622[Mismatch]
   PubMed Web of Science ®Google Scholar
• Fahmy AM, El-Setouhy DA, Habib BA, Tayel SA. (2019). Enhancement of transdermal delivery of haloperidol via spanlastic dispersions: entrapment efficiency vs. particle size. AAPS PharmSciTech. 20:95.
   PubMed Web of Science ®Google Scholar
• Fahmy AM, El-Setouhy DA, Ibrahim AB, et al. (2018). Penetration enhancer-containing spanlastics (PECSs) for transdermal delivery of haloperidol: in vitro characterization, ex vivo permeation and in vivo biodistribution studies. Drug Deliv 25:12–22. 10.1080/10717544.2017.1410262[Mismatch]
   PubMed Web of Science ®Google Scholar
• Fahmy AM, Hassan M, El-Setouhy DA, et al. (2021). Statistical optimization of hyaluronic acid enriched ultradeformable elastosomes for ocular delivery of voriconazole via Box-Behnken design: in vitro characterization and in vivo evaluation. Drug Deliv 28:77–86. 10.1080/10717544.2020.1858997[Mismatch]
   PubMed Web of Science ®Google Scholar
• Fatouh AM, Elshafeey AH, Abdelbary A. (2017a). Agomelatine-based in situ gels for brain targeting via the nasal route: statistical optimization, in vitro, and in vivo evaluation. Drug Deliv 24:1077–85.
   PubMed Web of Science ®Google Scholar
• Fatouh AM, Elshafeey AH, Abdelbary A. (2017b). Intranasal agomelatine solid lipid nanoparticles to enhance brain delivery: formulation, optimization and in vivo pharmacokinetics. DDDT 11:1815–25.
   PubMed Web of Science ®Google Scholar
• Fouda NH, Abdelrehim RT, Hegazy DA, Habib BA. (2018). Sustained ocular delivery of dorzolamide-HCL via proniosomal gel formulation: in-vitro characterization, statistical optimization, and in-vivo pharmacodynamic evaluation in rabbits. Drug Deliv 25:1340–9. 10.1080/10717544.2018.1477861[Mismatch]
   PubMed Web of Science ®Google Scholar
• Ghate D, Edelhauser HF. (2006). Ocular drug delivery. Expert Opin Drug Deliv 3:275–87.
   PubMed Web of Science ®Google Scholar
• Gupta PN, Mishra V, Rawat A, et al. (2005). Non-invasive vaccine delivery in transfersomes, niosomes and liposomes: a comparative study. Int J Pharm 293:73–82.
   PubMed Web of Science ®Google Scholar
• Hao Y, Zhao F, Li N, et al. (2002). Studies on a high encapsulation of colchicine by a niosome system. Int J Pharm 244:73–80.
   PubMed Web of Science ®Google Scholar
• Hathout RM, Mansour S, Mortada ND, Guinedi AS. (2007). Liposomes as an ocular delivery system for acetazolamide: in vitro and in vivo studies. AAPS PharmSciTech 8:1.
   PubMed Web of Science ®Google Scholar
• Jain S, Harde H, Indulkar A, Agrawal AK. (2014). Improved stability and immunological potential of tetanus toxoid containing surface engineered bilosomes following oral administration. Nanomed Nanotechnol Biol Med. 10:4314–440.
   Web of Science ®Google Scholar
• Järvinen K, Järvinen T, Urtti A. (1995). Ocular absorption following topical delivery. Adv Drug Deliv Rev 16:3–19.
   Web of Science ®Google Scholar
• Kakkar S, Kaur IP. (2011). Spanlastics-A novel nanovesicular carrier system for ocular delivery. Int J Pharm 413:202–10.
   PubMed Web of Science ®Google Scholar
• Kapetanakis VV, Chan MPY, Foster PJ, et al. (2016). Global variations and time trends in the prevalence of primary open angle glaucoma (POAG): a systematic review and meta-analysis. Br J Ophthalmol 100:86–93.
   PubMed Web of Science ®Google Scholar
• Kaur IP, Rana C, Singh M, et al. (2012). Development and evaluation of novel surfactant-based elastic vesicular system for ocular delivery of fluconazole. J Ocul Pharmacol Ther 28:484–96.
   PubMed Web of Science ®Google Scholar
• Khalil RM, Abdelbary GA, Basha M, et al. (2017). Enhancement of lomefloxacin Hcl ocular efficacy via niosomal encapsulation: in vitro characterization and in vivo evaluation. J Liposome Res 27:312–23.
   PubMed Web of Science ®Google Scholar
• Kuno N, Fujii S. (2011). Recent advances in ocular drug delivery systems. Polymers 3:193–221.
   Web of Science ®Google Scholar
• Lee BB, Chan ES, Ravindra P, Khan TA. (2012). Surface tension of viscous biopolymer solutions measured using the du Nouy ring method and the drop weight methods. Polym Bull 69:471–89.
   Web of Science ®Google Scholar
• Lei W, Yu C, Lin H, Zhou X. (2013). Development of tacrolimus-loaded transfersomes for deeper skin penetration enhancement and therapeutic effect improvement in vivo. Asian J Pharm Sci 8:336–45.
   Google Scholar
• Li Q, Li Z, Zeng W, et al. (2014). Proniosome-derived niosomes for tacrolimus topical ocular delivery: in vitro cornea permeation, ocular irritation, and in vivo anti-allograft rejection. Eur J Pharm Sci 62:115–23.
   PubMed Web of Science ®Google Scholar
• Khatoon M, Shah KU, Uddin F, et al. (2017). Proniosomes derived niosomes: recent advancements in drug delivery and targeting. Drug Deliv 24:56–69.
   PubMed Web of Science ®Google Scholar
• Maldonado-Valderrama J, Wilde P, MacIerzanka A, MacKie A. (2011). The role of bile salts in digestion. Adv Colloid Interface Sci 165:36–46.
   PubMed Web of Science ®Google Scholar
• Martínez-Águila A, Fonseca B, De Lara MJP, Pintor J. (2016). Effect of melatonin and 5-methoxycarbonylamino-n-acetyltryptamine on the intraocular pressure of normal and glaucomatous mice. J Pharmacol Exp Ther 357:293–9.
   PubMed Web of Science ®Google Scholar
• Mishra V, Jain NK. (2014). Acetazolamide encapsulated dendritic nano-architectures for effective glaucoma management in rabbits. Int J Pharm 461:380–90.
   PubMed Web of Science ®Google Scholar
• Mohsen AM, Salama A, Kassem AA. (2020). Development of acetazolamide loaded bilosomes for improved ocular delivery: preparation, characterization and in vivo evaluation. J Drug Delivery Sci Technol 59:101910.
   Web of Science ®Google Scholar
• Moore JW, Flanner HH. (1996). Mathematical Comparison of Dissolution Profiles. Pharm Technol. 20:64–74.
   Google Scholar
• Morsi NM, Nabil Shamma R, Osama Eladawy N, Abdelkhalek AA. (2019). Bioactive injectable triple acting thermosensitive hydrogel enriched with nano-hydroxyapatite for bone regeneration: in-vitro characterization, Saos-2 cell line cell viability and osteogenic markers evaluation. Drug Dev Ind Pharm 45:787–804.
   PubMed Web of Science ®Google Scholar
• Nemr AA, El-mahrouk GM, Badie HA. (2021a). Development and evaluation of proniosomes to enhance the transdermal delivery of cilostazole and to ensure the safety of its application. Drug Dev Ind Pharm 47:403–15.
   PubMed Web of Science ®Google Scholar
• Nemr AA, El-mahrouk GM, Badie HA. (2021b). Development and evaluation of surfactant-based elastic vesicular system for transdermal delivery of Cilostazole: ex-vivo permeation and histopathological evaluation studies. J Liposome Res 32:159–71.
   PubMed Web of Science ®Google Scholar
• Niu M, Tan Y, Guan P, et al. (2014). Enhanced oral absorption of insulin-loaded liposomes containing bile salts: a mechanistic study. Int J Pharm 460:119–30.
   PubMed Web of Science ®Google Scholar
• Okamoto N, Ito Y, Nagai N, et al. (2010). Preparation of ophthalmic formulations containing cilostazol as an anti-glaucoma agent and improvement in its permeability through the rabbit cornea. J Oleo Sci 59:423–30.
   PubMed Web of Science ®Google Scholar
• Omerović N, Vranić E. (2020). Application of nanoparticles in ocular drug delivery systems. Health Technol 10:61–78.
   Web of Science ®Google Scholar
• Paul S, Mondol R, Ranjit S, Maiti S. (2010). Anti-glaucomatic niosomal system: recent trend in ocular drug delivery research. Int J Pharm Pharm Sci. 2:15–18.
   Google Scholar
• Pescosolido N, Gatto V, Stefanucci A, Rusciano D. (2015). Oral treatment with the melatonin agonist agomelatine lowers the intraocular pressure of glaucoma patients. Ophthalmic Physiol Opt 35:201–5.
   PubMed Web of Science ®Google Scholar
• Qiao J, Ji D, Sun S, et al. (2018). Oral bioavailability and lymphatic transport of pueraria flavone-loaded self-emulsifying drug-delivery systems containing sodium taurocholate in rats. Pharmaceutics 10:147.
   PubMed Web of Science ®Google Scholar
• Quigley HA. (2005). Glaucoma: macrocosm to microcosm. The Friedenwald Lecture. Invest Ophthalmol Vis Sci. 46:2663–70.
   Web of Science ®Google Scholar
• Rizwanullah ZS, Rizwanullah M, Mir SR, Amin S. (2020). Bilosomes nanocarriers for improved oral bioavailability of acyclovir: a complete characterization through in vitro, ex-vivo and in vivo assessment. J Drug Delivery Sci Technol 57:101634.
   Web of Science ®Google Scholar
• Sayed MM, El-Sabagh HA, Al-Mahallawi AM, et al. (2020). Enhancing tumor targeting efficiency of radiolabeled uridine (via) incorporation into nanocubosomal dispersions. Cancer Biother Radiopharm 35:167–76.
   PubMed Web of Science ®Google Scholar
• Scognamiglio I, De Stefano D, Campani V, et al. (2013). Nanocarriers for topical administration of resveratrol: a comparative study. Int J Pharm 440:179–87.
   PubMed Web of Science ®Google Scholar
• Shahab MS, Rizwanullah M, Alshehri S, Imam SS. (2020). Optimization to development of chitosan decorated polycaprolactone nanoparticles for improved ocular delivery of dorzolamide: in vitro, ex vivo and toxicity assessments. Int J Biol Macromol 163:2392–404.
   PubMed Web of Science ®Google Scholar
• Sultana Y, Jain R, Aqil M, Ali A. (2006). Review of ocular drug delivery. CDD 3:207–17.
   PubMedGoogle Scholar
• Sun J, Zhou Z. (2018). A novel ocular delivery of brinzolamide based on gellan gum: in vitro and in vivo evaluation. DDDT 12:383–9.
   PubMed Web of Science ®Google Scholar
• Tan Y, Qi J, Lu Y, et al. (2013). Lecithin in mixed micelles attenuates the cytotoxicity of bile salts in Caco-2 cells. Toxicol In Vitro 27:714–20.
   PubMed Web of Science ®Google Scholar
• Tawfik MA, Tadros MI, Mohamed MI, El-Helaly SN. (2020). Low-frequency versus high-frequency ultrasound-mediated transdermal delivery of agomelatine-loaded invasomes: development, optimization and in-vivo pharmacokinetic assessment. IJN 15:8893–910.
   Web of Science ®Google Scholar
• Tiffany JM, Winter N, Bliss G. (1989). Tear film stability and tear surface tension. Curr Eye Res 8:507–15.
   PubMed Web of Science ®Google Scholar
• Tran TH, Choi JY, Ramasamy T, et al. (2014). Hyaluronic acid-coated solid lipid nanoparticles for targeted delivery of vorinostat to CD44 overexpressing cancer cells. Carbohydr Polym 114:407–15.
   PubMed Web of Science ®Google Scholar
• Trotta M, Peira E, Debernardi F, Gallarate M. (2002). Elastic liposomes for skin delivery of dipotassium glycyrrhizinate. Int J Pharm 241:319–27.
   PubMed Web of Science ®Google Scholar
• Van Den Bergh BAI, Wertz PW, Junginger HE, Bouwstra JA. (2001). Elasticity of vesicles assessed by electron spin resonance, electron microscopy and extrusion measurements. Int J Pharm 217:13–24.
   PubMed Web of Science ®Google Scholar
• Vicario-de-la-Torre M, Benítez-del-Castillo JM, Vico E, et al. (2014). Design and characterization of an ocular topical liposomal preparation to replenish the lipids of the tear film. Invest Ophthalmol Vis Sci. 55:7839–47.
   PubMed Web of Science ®Google Scholar
• Wadhwa S, Paliwal R, Paliwal SR, Vyas SP. (2010). Hyaluronic acid modified chitosan nanoparticles for effective management of glaucoma: development, characterization, and evaluation. J Drug Target 18:292–302.
   PubMed Web of Science ®Google Scholar
• Weinreb RN, Aung T, Medeiros FA. (2014). The pathophysiology and treatment of glaucoma: a review. JAMA - J Am Med Assoc 311:1901.
   PubMed Web of Science ®Google Scholar
• Wu Y, Liu Y, Li X, et al. (2019). Research progress of in-situ gelling ophthalmic drug delivery system. Asian J Pharm Sci 14:1–15.
   PubMed Web of Science ®Google Scholar
• Younes NF, Abdel-Halim SA, Elassasy AI. (2018). Solutol HS15 based binary mixed micelles with penetration enhancers for augmented corneal delivery of sertaconazole nitrate: optimization, in vitro, ex vivo and in vivo characterization. Drug Deliv 25:1706–17. 10.1080/10717544.2018.1497107[Mismatch]
   PubMed Web of Science ®Google Scholar
• Yue Y, Zhao D, Yin Q. (2018). Hyaluronic acid modified nanostructured lipid carriers for transdermal bupivacaine delivery: in vitro and in vivo anesthesia evaluation. Biomed Pharmacother 98:813–20.
   PubMed Web of Science ®Google Scholar
• Zafar A, Alruwaili NK, Imam SS, et al. (2021). Bioactive Apigenin loaded oral nano bilosomes: formulation optimization to preclinical assessment. Saudi Pharm J 29:269–79.
   PubMed Web of Science ®Google Scholar
• Zeisig R, Shimada K, Hirota S, Arndt D. (1996). Effect of sterical stabilization on macrophage uptake in vitro and on thickness of the fixed aqueous layer of liposomes made from alkylphosphocholines. Biochim Biophys Acta – Biomembr. 1285:237–45.
   PubMed Web of Science ®Google Scholar
• Zeng Y, Chen J, Li Y, et al. (2018). Thermo-sensitive gel in glaucoma therapy for enhanced bioavailability: in vitro characterization, in vivo pharmacokinetics and pharmacodynamics study. Life Sci 212:80–6.
   PubMed Web of Science ®Google Scholar