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

References

• Abdelbary G. (2011). Ocular ciprofloxacin hydrochloride mucoadhesive chitosan-coated liposomes. Pharm Dev Technol 16:44–56.
   PubMed Web of Science ®Google Scholar
• Abdelbary GA, Amin MM, Zakaria MY. (2017). Ocular ketoconazole-loaded proniosomal gels: formulation, ex vivo corneal permeation and in vivo studies. Drug Deliv 24:309–19.
   PubMed Web of Science ®Google Scholar
• Abdelbary G, El-gendy N. (2008). Niosome-encapsulated gentamicin for ophthalmic controlled delivery. AAPS PharmSciTech 9:740–7.
   PubMed Web of Science ®Google Scholar
• Aburahma MH, Abdelbary GA. (2012). Novel diphenyl dimethyl bicarboxylate provesicular powders with enhanced hepatocurative activity: preparation, optimization, in vitro/in vivo evaluation. Int J Pharm 422:139–50.
   PubMed Web of Science ®Google Scholar
• Aburahma MH, Mahmoud AA. (2011). Biodegradable ocular inserts for sustained delivery of brimonidine tartarate: preparation and in vitro/in vivo evaluation. AAPS PharmSciTech 12:1335–47.
   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, Haider M, Ibrahim M, El Hoffy NM. (2017). In vitro and in vivo investigation for optimization of niosomal ability for sustainment and bioavailability enhancement of diltiazem after nasal administration. Drug Deliv 24:414–21.
   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
• Barse RK, Tagalpallewar AA, Kokare CR, et al. (2018). Formulation and ex vivo–in vivo evaluation of pH-triggered brimonidine tartrate in situ gel for the glaucoma treatment using application of 32factorial design. Drug Dev Indu Pharm 44:800–7.
   PubMed Web of Science ®Google Scholar
• Blazek-Welsh AI, Rhodes DG. (2001). Maltodextrin-based proniosomes. AAPS PharmSci 3:1.
   PubMed Web of Science ®Google Scholar
• Dai W, Zhang D, Duan C, et al. (2010). Preparation and characteristics of oridonin-loaded nanostructured lipid carriers as a controlled-release delivery system. J Microencapsul 27:234–41.
   PubMed Web of Science ®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
• Dubey B, Dhangar R, Bhowmick M, et al. (2014). Design and evaluation of proniosomes as drug carrier for ocular delivery of levofloxacin. J Drug Deliv Ther 4:182–9.
   Google Scholar
• Essa E. (2010). Effect of formulation and processing variables on the particle size of sorbitan monopalmitate niosomes. Asian J Pharm 4:227.
   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.
   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
• Flanner M. (1996). Mathematical comparison of dissolution profiles. Pharm Technol 20:64–74.
   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.
   PubMed Web of Science ®Google Scholar
• Gan L, Han S, Shen J, et al. (2010). Self-assembled liquid crystalline nanoparticles as a novel ophthalmic delivery system for dexamethasone: improving preocular retention and ocular bioavailability. Int J Pharm 396:179–87.
   PubMed Web of Science ®Google Scholar
• Gandolfi SA, Cimino L, Mora P. (2003). Effect of brimonidine on intraocular pressure in normal tension glaucoma: a short term clinical trial. Eur J Ophthalmol 13:611–5.
   PubMed Web of Science ®Google Scholar
• Ghate D, Edelhauser HF. (2006). Ocular drug delivery. Exp Opin Drug Deliv 3:275–87.
   PubMed Web of Science ®Google Scholar
• Habib, B.A., Sayed, S., & Elsayed, G.M. 2018. Enhanced transdermal delivery of ondansetron using nanovesicular systems: fabrication, characterization, optimization and ex-vivo permeation study-Box-Cox transformation practical example. Eur J Pharm Sci 115:352–61.
   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
• Hundekar YR, Saboji DJK, Patil SM, Nanjwade DBK. (2014). Preparation and evaluation of diclofenac sodium cubosomes for percutaneous administration. World J Pharm Pharm Sci 3(5):523–39.
   Google Scholar
• Ishii F, Takamura A, Ishigami Y. (1995). Procedure for preparation of lipid vesicles (liposomes) using the coacervation (phase separation) technique. Langmuir 11:483–6.
   Web of Science ®Google Scholar
• Janoria KG, Gunda S, Boddu SHS, Mitra AK. (2007). Novel approaches to retinal drug delivery. Expert Opin Drug Deliv 4:371–88.
   PubMed 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. Available at:
   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
• 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
• Khatoon M, Shah KU, Din FU, et al. (2017). Proniosomes derived niosomes: recent advancements in drug delivery and targeting. Drug Deliv 24:56–69.
   PubMed Web of Science ®Google Scholar
• Lal S, Manna PK, Mohanta GP, et al. (2011). Nanoparticle: an overview of preparation and characterization. J Appl Pharm Sci 1:228–34.
   Google Scholar
• Lalu L, Tambe V, Pradhan D, et al. (2017). Novel nanosystems for the treatment of ocular inflammation: current paradigms and future research directions. J Control Release 268:19–39.
   PubMed Web of Science ®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
• Louis D. (2018). An overview on niosomes: a drug nanocarrier. Drug Des Intellect Prop Int J 143–51.
   Google Scholar
• Manconi M, Sinico C, Valenti D, et al. (2002). Niosomes as carriers for tretinoin. I. Preparation and properties. Int J Pharm 234:237–48.
   PubMed Web of Science ®Google Scholar
• Marques MRC, Loebenberg R, Almukainzi M. (2011). Simulated biological fluids with possible application in dissolution testing.
   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
• Mokhtar M, Sammour OA, Hammad MA, Megrab NA. (2008). Effect of some formulation parameters on flurbiprofen encapsulation and release rates of niosomes prepared from proniosomes. Int J Pharm 361:104–11.
   PubMed Web of Science ®Google Scholar
• Morsi NM, Abdelbary GA, Ahmed MA. (2014). Silver sulfadiazine based cubosome hydrogels for topical treatment of burns: development and in vitro/in vivo characterization. Eur J Pharm Biopharm 86:178–89.
   PubMed Web of Science ®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
• Natesan S, Pandian S, Ponnusamy C, et al. (2017). Co-encapsulated resveratrol and quercetin in chitosan and peg modified chitosan nanoparticles: for efficient intra ocular pressure reduction. Int J Biol Macromol 104:1837–45.
   PubMed Web of Science ®Google Scholar
• Perrett S, Golding M, Williams WP. (1991). A simple method for the preparation of liposomes for pharmaceutical applications: characterization of the liposomes. J Pharm Pharmacol 43:154–61.
   PubMed Web of Science ®Google Scholar
• Prasannan A, Tsai HC, Hsiue GH. (2018). Formulation and evaluation of epinephrine-loaded poly(acrylic acid-co-N-isopropylacrylamide) gel for sustained ophthalmic drug delivery. React Funct Polym 124:40–7.
   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
• Radha GV, Rani TS, Sarvani B. (2013). A review on proniosomal drug delivery system for targeted drug action. J Basic Clin Pharm 4:42.
   PubMedGoogle Scholar
• Rajabalaya R, Leen G, Chellian J, et al. (2016). Tolterodine tartrate proniosomal gel transdermal delivery for overactive bladder. Pharmaceutics 8:27.
   Web of Science ®Google Scholar
• Ramkanth S. (2018). Development, characterization & in vivo evaluation of proniosomal based transdermal delivery system of Atenolol. Future J Pharm Sci 4:80–7.
   Web of Science ®Google Scholar
• Razeghinejad MR, Lee D. (2019). Managing normal tension glaucoma by lowering the intraocular pressure. Surv Ophthalmol 64:111–6.
   PubMed Web of Science ®Google Scholar
• Rowe RC, Sheskey PJ, Quinn ME. 2009. Handbook of pharmaceutical excipients. 6th ed. London: The Pharmaceutical Press; Washington (DC): American Pharmaceutical Association.
   Google Scholar
• Sambhakar S, Paliwal S, Sharma S, Singh B. (2017). Formulation of risperidone loaded proniosomes for effective transdermal delivery: an in-vitro and in-vivo study. Bull Fac Pharm Cairo Univ 55:239–47
   Google Scholar
• Saylor M, McLoon LK, Harrison AR, Lee MS. (2009). Experimental and clinical evidence for brimonidine as an optic nerve and retinal neuroprotective agent. Arch Ophthalmol 127:402–26.
   PubMed Web of Science ®Google Scholar
• Shivakumar HN, Desai BG, Subhash PG, et al. (2007). Design of ocular inserts of brimonidine tartrate by response surface methodology. J Drug Deliv Sci Technol 17:421–30.
   Web of Science ®Google Scholar
• Shokry M, Hathout RM, Mansour S. (2018). Exploring gelatin nanoparticles as novel nanocarriers for Timolol Maleate: augmented in-vivo efficacy and safe histological profile. Int J Pharm 545:229–39.
   PubMed Web of Science ®Google Scholar
• Singh J, Chhabra G, Pathak K. (2014). Development of acetazolamide-loaded, pH-triggered polymeric nanoparticulate in situ gel for sustained ocular delivery: in vitro. ex vivo evaluation and pharmacodynamic study. Drug Dev Ind Pharm 40:1223–32.
   PubMed Web of Science ®Google Scholar
• Singh SA, Chaudhari Y, Singh RR, Kunwarpuriya A. (2015). Proniosomes : a recent advancement in vesicular drug. World J Pharm Res 4:1671–89.
   Google Scholar
• Song Y, Nagai N, Saijo S, et al. (2018). In situ formation of injectable chitosan-gelatin hydrogels through double crosslinking for sustained intraocular drug delivery. Mater Sci Eng C 88:1–12..
   PubMed Web of Science ®Google Scholar
• Sudhamani T, Priyadarisini N, Radhakrishnan M. (2010). Proniosomes - A promising drug carriers. Int J PharmTech Res 2:1446–54.
   Google Scholar
• Tayel SA, El-Nabarawi MA, Tadros MI, Abd-Elsalam WH. (2013). Promising ion-sensitive in situ ocular nanoemulsion gels of terbinafine hydrochloride: design, in vitro characterization and in vivo estimation of the ocular irritation and drug pharmacokinetics in the aqueous humor of rabbits. Int J Pharm 443:293–305.
   PubMed Web of Science ®Google Scholar
• Teodorescu F, Quéniat G, Foulon C, et al. (2017). Transdermal skin patch based on reduced graphene oxide: a new approach for photothermal triggered permeation of ondansetron across porcine skin. J Control Release 245:137–46.
   PubMed Web of Science ®Google Scholar
• Thomas L, Viswanad V. (2012). Formulation and optimization of clotrimazole-loaded proniosomal gel using. Sci Pharm 3:731–48.
   Google Scholar
• Volland C, Wolff M, Kissel T. (1994). The influence of terminal gamma-sterilization on captopril containing poly(d,l-lactide-co-glycolide) microspheres. J Control Release 31:293–305.
   Web of Science ®Google Scholar
• Vora B, Khopade AJ, Jain NK. (1998). Proniosome based transdermal delivery of levonorgestrel for effective contraception. J Control Release 54:149–65.
   PubMed Web of Science ®Google Scholar
• Wang G, Wang T. (2008). Oxidative stability of egg and soy lecithin as affected by transition metal ions and pH in emulsion. J Agric Food Chem 56:11424–31.
   PubMed Web of Science ®Google Scholar
• Weinreb RN, Aung T, Medeiros FA. (2014). The pathophysiology and treatment of glaucoma: a review. J Am Med Assoc 311:1901–11.
   PubMed Web of Science ®Google Scholar
• White B, Banerjee S, O’Brien S, et al. 2007. Zeta-potential measurements of surfactant-wrapped individual single-walled carbon nanotubes.
   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
• Yadav K, Yadav D, Saroha K, Nanda S. (2010). Proniosomal gel: a provesicular approach for transdermal drug delivery. Der Pharm Lett 2:189–98.
   Google Scholar
• Yasam VR, Jakki SL, Natarajan J, Kuppusamy G. (2014). A review on novel vesicular drug delivery: proniosomes. Drug Deliv 21:243–9.
   PubMed Web of Science ®Google Scholar
• Yoshioka T, Sternberg B, Florence AT. (1994). Preparation and properties of vesicles (niosomes) of sorbitan monoesters (Span 20, 40, 60 and 80) and a sorbitan triester (Span 85). Int J Pharm 105:1–6.
   Web of Science ®Google Scholar
• Yousry C, Fahmy RH, Essam T, et al. (2016). Nanoparticles as tool for enhanced ophthalmic delivery of vancomycin: a multidistrict-based mic robiological study, solid lipid nanoparticles formulation and evaluation. Drug Dev Ind Pharm 42:1752–62.
   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
• Zubairu Y, Negi LM, Iqbal Z, Talegaonkar S. (2015). Design and development of novel bioadhesive niosomal formulation for the transcorneal delivery of anti-infective agent: in-vitro and ex-vivo investigations. Asian J Pharm Sci 10:322–30.
   Web of Science ®Google Scholar