Glibenclamide nanosuspension inhaler: development, in vitro and in vivo assessment

References

• Hernandez-Kirstein N. Development and characterisation of buparvaquone nanosuspensions for pulmonary delivery in the treatment of Pneumocystis pneumonia [Dissertation]. The Department of Biology, Chemistry and Pharmacy, Freie Universität Berlin; 2006.
   Google Scholar
• Vandana KR, Yalavarthi PR, Vadlamudi HC, et al. Process, physicochemical characterization and in-vitro assessment of albendazole microcrystals. Adv Pharm Bull. 2017;7:419–425.
   PubMed Web of Science ®Google Scholar
• Keservani RK, Sharma AK. Nanodispersions for drug delivery. Boca Raton (FL):CRC Press; 2018.
   Google Scholar
• Skiba M, Bounoure F, Barbot C, et al. Development of cyclo-dextrin microspheres for pulmonary drug delivery. J Pharm Pharmaceut Sci. 2005;8:409–418.
   PubMed Web of Science ®Google Scholar
• Patil OA, Patil IS, Mane RU, et al. Formulation optimization and evaluation of Cefdinir nanosuspension using 23 Factorial design. Marmara Pharm J. 2018;22:587–598.
   Google Scholar
• Agarwal V, Rathore DS, Bajpai M. Investigation of effect of non-ionic stabilizers on the physical stability of drug nanosuspension prepared by bottom up approach. Int J Pharm Sci Drug Res. 2016;8:189–198.
   Google Scholar
• McComiskey KPM. The production, characterisation, stabilization and isolation of azole anti-fungal nanoparticles [dissertation]. Ireland: Trinity College Dublin, the University of Dublin; 2019.
   Google Scholar
• Sadikot RT, Kolanjiyil AV, Kleinstreuer C, et al. Nanomedicine for treatment of acute lung injury and acute respiratory distress syndrome. Biomed Hub. 2017;2:1–12.
   PubMedGoogle Scholar
• Mortensen NP, Hickey AJ. Targeting inhaled therapy beyond the lungs. Respiration. 2014;88:353–364.
   PubMed Web of Science ®Google Scholar
• Hillery AM, Park K. Drug delivery: fundamentals and applications. 2nd ed. Boca Raton (FL): CRC Press; 2016.
   Google Scholar
• Xi J, Longest PW. Effects of oral airway geometry characteristics on the diffusional deposition of inhaled nanoparticles. J Biomech Eng. 2008;130:8–11.
   Web of Science ®Google Scholar
• Malamatari M, Somavarapu S, Bloxham M, et al. Preparation of theophylline inhalable particles by wet milling and spray drying; the influence of mannitol as a co-milling agent. Int. J. Pharm. 2016;514 (1):200–211.
   Google Scholar
• Rahimkhani S, Ghanbarzadeh S, Nokhodchi A, et al. An in vitro aerosolization efficiency comparison of generic and branded salbutamol metered dose inhalers. Pharm Sci. 2017;23:77–81.
   Web of Science ®Google Scholar
• USP/NF. General chapters: <601> Inhalation and nasal drug products: aerosols, sprays, and powders-performance quality tests. U.S. Pharmacopeia National Formulary. 39th ed. Rockville (MD): Pharmacopeial Convention; 2016.
   Google Scholar
• Webmd [Internet]: Available from: https://www.webmd.com/diabetes/guide/types-of-diabetes-mellitus#2
   Google Scholar
• Elsayed AM. Formulation and dissolution kinetics of fast-release glibenclamide tablets. Saudi J Health Sci. 2013;2:42.
   Google Scholar
• Gutiérrez-Rodelo   Roura-Guiberna   Olivares-Reyes   Mecanismos moleculares de la resistencia a la insulina: una actualización. Gac Med Mex. 2017;153:214–228.
   PubMed Web of Science ®Google Scholar
• Sant’Anna JRd, Franco C, Mathias P, et al. Assessment of in vivo and in vitro genotoxicity of glibenclamide in eukaryotic cells. PLoS One. 2015;10:e0120675.
   PubMed Web of Science ®Google Scholar
• Indian Pharmacopoeia. on behalf of Ministry of health and family welfare Government of India. Vol I. 2018.
   Google Scholar
• Drugbank [Internet]: Available from: http://www.drugbank.ca/drugs/DB01016
   Google Scholar
• Ashwini M, Mangesh B, Prachi K. Nanoparticulates of fenofibrate for solubility enhancement: ex-vivo evaluation. J Drug Deliv Ther. 2019;9:155–163.
   Google Scholar
• Davis AN. Insulin, oral hypoglycemic agents, and the pharmacology of the endocrine pancreas. In: Hardman JG, Limbird LE, editors. Goodmans and gilmans the pharmacological basis of therapeutics. New York: McGrow-Hill; 2002. p. 1487.
   Google Scholar
• Gajra B, Dalwadi C, Patel R. Formulation and optimization of itraconazole polymeric lipid hybrid nanoparticles (Lipomer) using box behnken design. DARU J Pharm Sci. 2015;23:1–15.
   Web of Science ®Google Scholar
• El-Say KM, Abd-Allah FI, Lila AE, et al. Diacerein niosomal gel for topical delivery: development, in vitro and in vivo assessment. J Liposome Res. 2016;26:57–68.
   PubMed Web of Science ®Google Scholar
• Shinde AJ, More HN. Formulation, development and characterization of Simvastatin nanoparticles by solvent displacement method. Der Pharmacia Lettre. 2014;6:145–155.
   Google Scholar
• Abdelbary AA, Al-Mahallawi AM, Abdelrahim ME, et al. Preparation, optimization, and in vitro simulated inhalation delivery of carvedilol nanoparticles loaded on a coarse carrier intended for pulmonary administration. Int J Nanomedicine. 2015;10:6339–6353.
   PubMed Web of Science ®Google Scholar
• Sandhya J, Pavani A, Reddy RR. Formulation and evaluation of nanosuspension of nisoldipine. Int J Pharm Sci Rev Res. 2014;24:177–181.
   Google Scholar
• Liu P. Nanocrystal formulation for poorly soluble drugs [dissertation]. Finland: Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki; 2013.
   Google Scholar
• Saraswathi TS, Mothilal M, Jaganathan MK. Niosomes as an emerging formulation tool for drug delivery – a review. Int J App Pharm. 2019;11:7–15.
   Google Scholar
• Andronescu‏ E, Mihai A. Nanostructure in therapeutic medicine series: nanostructures for drug delivery. Netherlands: Elsevier; 2017.
   Google Scholar
• Yeo PL, Lim CL, Chye SM, et al. Niosomes: a review of their structure, properties, methods of preparation, and medical applications. Asian Biomed (Res Rev News). 2018;11:301–314.
   Google Scholar
• Kassem MA, El-Sawy HS, Abd-Allah FI, et al. Maximizing the therapeutic efficacy of imatinib mesylate-loaded niosomes on human colon adenocarcinoma using Box-Behnken design. J Pharm Sci. 2017;106:111–122.
   PubMed Web of Science ®Google Scholar
• Bhakay A, Rahman M, Dave RN, et al. Bioavailability enhancement of poorly water-soluble drugs via nanocomposites: formulation–processing aspects and challenges. Pharmaceutics. 2018;10:86.
   PubMed Web of Science ®Google Scholar
• Rodriguez Amado JR, Lafourcade Prada A, Duarte JL, et al. Development, stability and in vitro delivery profile of new loratadine-loaded nanoparticles. Saudi Pharm J. 2017;25:1158–1168.
   PubMed Web of Science ®Google Scholar
• Kumar BP, Chandiran IS, Jayaveera KN. Formulation development and evaluation of Glibenclamide loaded Eudragit RLPO microparticles. Int Curr Pharm J. 2013;2:196–201.
   Google Scholar
• Thakur V, Kush P, Pandey RS, et al. Vincristine sulfate loaded dextran microspheres amalgamated with thermosensitive gel offered sustained release and enhanced cytotoxicity in THP-1, human leukemia cells: In vitro and in vivo study. Mater Sci Eng. 2016;61:113–122.
   Google Scholar
• Chen Z. The use of excipients to stabilise pressurised metered dose inhalers [dissertation]. Cardiff: Cardiff University; 2017.
   Google Scholar
• Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005;50:1177–1190.
   PubMedGoogle Scholar
• Myrdal PB, Sheth P, Stein SW, et al. Modeling and understanding combination pMDI formulations with both dissolved and suspended drugs. Mol Pharm. 2015;12:3455–3467.
   PubMed Web of Science ®Google Scholar
• Kinnunen H, Hebbink G, Peters H, et al. Extrinsic lactose fines improve dry powder inhaler formulation performance of a cohesive batch of budesonide via agglomerate formation and consequential co-deposition. Int J Pharm. 2015;478:53–59.
   PubMed Web of Science ®Google Scholar
• British Pharmacopiea. Appendix XII C, Consistency of formulated preparations, Aerodynamic assessment of fine particles. The stationery office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2019.
   Google Scholar
• Muralidharan P, Malapit M, Mallory E, et al. Inhalable nanoparticulate powders for respiratory delivery. Nanomedicine. 2015;11:1189–1199.
   PubMed Web of Science ®Google Scholar
• Aly AM, Al-Akhali KM, Alrefaey H, et al. Formulation and evaluation of fast dissolving Gliclazide tablets by complexation with hydroxy propyl-B-cyclodextrin. Int J Pharm Sci Nanotech. 2014;7:2399–2405.
   Google Scholar
• Elmowafy E, Osman R, El-Shamy AA, et al. Nasal polysaccharides-glucose regulator microparticles: Optimization, tolerability and antidiabetic activity in rats. Carbohydr Polym. 2014;108:257–265.
   PubMed Web of Science ®Google Scholar
• Moureq RA, Amal JF, Ahmed TA, et al. In vivo assessment of combined effects of glibenclamide and losartan in diabetic rats. Med Princ Pract. 2019;28:178–185.
   PubMed Web of Science ®Google Scholar
• Candasamy MK, Murthy TE, Gubiyappa KS, et al. Alteration of glucose lowering effect of glibenclamide on single and multiple treatments with fenofibrate in experimental rats and rabbit models. J Basic Clin Pharma. 2014;5:62.
   PubMedGoogle Scholar
• Ahire E, Thakkar S, Darshanwad M, et al. Parenteral nanosuspensions: a brief review from solubility enhancement to more novel and specific applications. Acta Pharm Sin B. 2018;8:733–755.
   PubMed Web of Science ®Google Scholar
• Attari Z, Bhandari A, Jagadish PC, et al. a, Enhanced ex vivo intestinal absorption of olmesartan medoxomil nanosuspension: Preparation by combinative technology. Saudi Pharm J. 2016;24:57–63.
   PubMed Web of Science ®Google Scholar
• Amin MA, Elbakry A, Zayed G, et al. Preparation and evaluation of nanosuspension for poorly soluble drug to improve the in vitro and in vivo efficacy. JLM. 2013;1:99–107.
   Google Scholar
• Mauludin R. Nanosuspension of poorly soluble drugs for oral administration [dissertation]. The Free University of Berlin; 2008.
   Google Scholar
• Sahoo RK, Biswas N, Guha A, et al. Development and in vitro/in vivo evaluation of controlled release provesicles of a nateglinide-maltodextrin complex. Acta Pharm Sin B. 2014;4:1–9.
   PubMed Web of Science ®Google Scholar
• Kumar S, Sangwan P, Lather V, et al. Biocompatible PLGA-oil hybrid nanoparticles for high loading and controlled delivery of resveratrol. J Drug Deliv Sci Technol. 2015;30:54–62.
   Web of Science ®Google Scholar
• Tejaa SB, Patila SP, Shete G, et al. Drug-excipient behavior in polymeric amorphous solid dispersions. J Excip Food Chem. 2013;4:70–94.
   Google Scholar
• Sukmawati A, Utami W, Yuliani R, et al. Effect of tween 80 on nanoparticle preparation of modified chitosan for targeted delivery of combination doxorubicin and curcumin analogue. IOP Conf Ser Mater Sci Eng. 2018;311:012024.
   Google Scholar
• Kuk DH, Ha ES, Ha DH, et al. Development of a resveratrol nanosuspension using the antisolvent precipitation method without solvent removal based on a quality by design (QbD) approach. Pharmaceutics. 2019;11:688.
   Web of Science ®Google Scholar
• Naha A, Sai K, Rai I, et al. Preparation and evaluation of polymeric nanoparticles of glibenclamide. J Drug Deliv Ther. 2014;4:190–192.
   Google Scholar
• Nada A, Bandarkar F, Al-Basarah Y. Formulation of ibuprofen nanoparticles and nanosuspensions with enhanced dissolution rate using ultra homogenization technique. Asian J Pharm. 2017;11:14–23.
   Web of Science ®Google Scholar
• Dias RJ, Ranjan S, Mali KK, et al. Liquisolid compacts of meloxicam: in-vitro and in-vivo evaluation. Egypt Pharmaceut J. 2017;16:112–120.
   Google Scholar
• Ha E, Baek I, Yoo J, et al. Improving dissolution and oral bioavailability of pranlukast hemihydrate by particle surface modification with surfactants and homogenization. Drug Des Devel Ther. 2015;9:3257–3266.
   PubMed Web of Science ®Google Scholar
• Rashid R, Kim DW, Din FU, et al. Effect of hydroxypropylcellulose and Tween 80 on physicochemical properties and bioavailability of ezetimibe-loaded solid dispersion. Carbohydr Polym. 2015;130:26–31.
   PubMed Web of Science ®Google Scholar
• Shah Sunny R. Studies in dissolution enhancement of anti diabetic drug of sulfonylurea class by novel drug delivery strategy [dissertation]. Saurashtra University; 2008.
   Google Scholar
• Mir KB, Khan NA. Preparation of solid dispersions of glibenclamide for in-vitro dissolution enhancement. J Drug Deliv Ther. 2019;9:82–87.
   Google Scholar
• Abdul Q, Faiyazuddin Hussain T, et al. Critical steps and energetics involved in a successful development of a stable nanoemulsion. J Mol Liq. 2016;214:7–18.
   Web of Science ®Google Scholar
• Hl R, Kumar G P. Development and evaluation of polymer-bound glibenclamide oral thin film. J Bioequiv Availab. 2016;09:324–330.
   Google Scholar
• Ramazani F. Formulation and characterization of glibenclamide micro- and nano-particles using acrylic polymers [master’s thesis]. Tabriz University of Medical Sciences; 2007.
   Google Scholar
• Rosière R, Berghmans T, De Vuyst P, et al. The position of inhaled chemotherapy in the care of patients with lung tumors: clinical feasibility and indications according to recent pharmaceutical progresses. Cancers. 2019;11:329.
   Web of Science ®Google Scholar
• Mansour HM. Inhaled medical aerosols by nebulizer delivery in pulmonary hypertension. Pulm Circ. 2018;8.
   PubMed Web of Science ®Google Scholar
• Emetere ME, Sanni SE, Okoro EE, et al. Aerosol loading and its effect on respiratory dysfunction disorder over Dapaong-Togo. Sci Rev Eng Env Sci. 2019;27:410–424.
   Google Scholar