Respirable controlled release polymeric colloid (RCRPC) of bosentan for the management of pulmonary hypertension: in vitro aerosolization, histological examination and in vivo pulmonary absorption

References

• Abd-Elbary A, El-Laithy H, Tadros M. (2008). Sucrose stearate-based proniosome-derived niosomes for the nebulisable delivery of cromolyn sodium. Int J Pharm 357:189–98
   PubMed Web of Science ®Google Scholar
• Alex R, Bodmeier R. (1990). Encapsulation of water-soluble drugs by a modified solvent evaporation method. I. Effect of process and formulation variables on drug entrapment. J Microencapsul 7:347–55
   PubMed Web of Science ®Google Scholar
• Basalious EB, El-Sebaie W, El-Gazayerly O. (2011). Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS PharmSciTech 12:799–810
   PubMed Web of Science ®Google Scholar
• Basalious EB, Shawky N, Badr-Eldin SM. (2010). SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: Development and optimization. Int J Pharm 391:203–11
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Gauss J, Packhaeuser CB, et al. (2009). Pulmonary drug delivery with aerosolizable nanoparticles in an ex vivo lung model. Int J Pharm 367:169–78
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Kleimann P, Gessler T, et al. (2012a). Nebulization performance of biodegradable sildenafil-loaded nanoparticles using the Aeroneb Pro: formulation aspects and nanoparticle stability to nebulization. Int J Pharm 422:398–408
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Schmehl T, Gessler T, et al. (2012b). Development of a biodegradable nanoparticle platform for sildenafil: formulation optimization by factorial design analysis combined with application of charge-modified branched polyesters. J Control Release 157:469–77
   PubMed Web of Science ®Google Scholar
• Benza RL, Miller DP, Barst RJ, et al. (2012). An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest 142:448–56
   PubMed Web of Science ®Google Scholar
• British Pharmacopia. (2014). Appendix XII C. Consistency of formulated preparations, electronic version 18. UK: TSO
   Google Scholar
• Chacon M, Molpeceres J, Berges L, et al. (1999). Stability and freeze-drying of cyclosporine loaded poly(d, l lactide–glycolide) carriers. Eur J Pharm Sci 8:99–107
   PubMed Web of Science ®Google Scholar
• Channick RN, Simonneau G, Sitbon O, et al. (2001). Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomized placebocontrolled study. The Lancet 358:1119–23
   PubMed Web of Science ®Google Scholar
• Clozel M, Breu V, Gray GA, et al. (1994). Pharmacological characterization of bosentan, a new potent orally active nonpeptide endothelin receptor antagonist. J Pharmacol Exp Ther 270:228–35
   PubMed Web of Science ®Google Scholar
• Das S, Ng WK, Kanaujia P, et al. (2011). Formulation design, preparation and physicochemical characterizations of solid lipid nanoparticles containing a hydrophobic drug: effects of process variables. Colloids Surf B: Biointerfaces 88:483–9
   PubMed Web of Science ®Google Scholar
• Dillen K, Vandervoort J, Van den Mooter G, et al. (2004). Factorial design, physicochemical characterization and activity of ciprofloxacin-PLGA nanoparticles. Int J Pharm 275:171–87
   PubMed Web of Science ®Google Scholar
• Dingemanse J, van Giersbergen PL. (2004). Clinical pharmacology of bosentan, a dual endothelin receptor antagonist. Clin Pharm 43:1089–115
   Google Scholar
• Enna SJ, Schanker LS. (1972). Absorption of saccharides and urea from the rat lung. Am J Physiol 222:409–14
   PubMed Web of Science ®Google Scholar
• Esmaeili F, Atyabi F, Dinarvand R. (2007). Preparation of PLGA nanoparticles using TPGS in the spontaneous emulsification solvent diffusion method. J Exp Nanosci 2:183–92
   Web of Science ®Google Scholar
• European Public Assessment Report of Tracleer. (2004). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000401/WC500041457.pdf [last accessed 10 Apr 2016]
   Google Scholar
• Fernandes CA, Vanbever R. (2009). Preclinical models for pulmonary drug delivery. Expert Opin Drug Deliv 6:1231–45
   PubMed Web of Science ®Google Scholar
• Fouad SA, Basalious EB, El-Nabarawi MA, et al. (2013). Microemulsion and poloxamer microemulsion-based gel for sustained transdermal delivery of diclofenac epolamine using in-skin drug depot: in vitro/in vivo evaluation. Int J Pharm 453:569–78
   PubMed Web of Science ®Google Scholar
• Galindo-Rodriguez S, Allemann E, Fessi H, et al. (2004). Physicochemical parameters associated with nanoparticle formation in the salting-out, emulsification-diffusion, and nanoprecipitation methods. Pharm Res 21:1428–39
   PubMed Web of Science ®Google Scholar
• Ganachaud F, Katz JL. (2005). Nanoparticles and nanocapsules created using the ouzo effect: spontaneous emulsification as an alternative to ultrasonic and high‐shear devices. ChemPhysChem 6:209–16
   PubMed Web of Science ®Google Scholar
• Gonda I. (1985). Development of a systematic theory of suspension inhalation aerosols. I. A framework to study the effects of aggregation on the aerodynamic behavior of drug particles. Int J Pharm 27:99–116
   Web of Science ®Google Scholar
• Granton J, Mercier O, De Perrot M. (2013). Management of severe pulmonary arterial hypertension. Semin Respir Crit Care Med 34:700–13
   PubMed Web of Science ®Google Scholar
• Hara K, Tsujimoto H, Tsukada Y, et al. (2008). Histological examination of PLGA nanospheres for intratracheal drug administration. Int J Pharm 356:267–73
   PubMed Web of Science ®Google Scholar
• Hong PD, Chou CM, He CH. (2001). Solvent effects on aggregation behavior of polyvinyl alcohol solutions. Polymer 42:6105–12
   Web of Science ®Google Scholar
• Hu L, Tang X, Cui F. (2004). Solid lipid nanoparticles (SLNs) to improve oral bioavailability of poorly soluble drugs. J Pharm Pharmacol 56:1527–35
   PubMed Web of Science ®Google Scholar
• Kawashima Y, Yamamoto H, Takeuchi H, et al. (1998). Properties of a peptide containing dl-lactide/glycolide copolymer nanospheres prepared by novel emulsion solvent diffusion methods. Eur J Pharm Biopharm 45:41–8
   PubMed Web of Science ®Google Scholar
• Khowessah O, Amin M, Basalious EB. (2009). Development of ocular delivery systems containing aceclofenac nanoparticles. Part I: Optimization of nanoparticles formulations using full factorial design. Egypt J Biomed Sci 31:25–47
   Google Scholar
• Kleemann E, Schmehl T, Gessler T, et al. (2007). Iloprost-containing liposomes for aerosol application in pulmonary arterial hypertension: formulation aspects and stability. Pharm Res 24:277–87
   PubMed Web of Science ®Google Scholar
• Kodani M, Sakata N, Takano Y, et al. (2000). Intratracheal administration of anaphylatoxin C5a potentiates antigen-induced pulmonary reactions through the prolonged production of cysteinyl–leukotrienes. Immunopharmacology 49:263–74
   PubMed Web of Science ®Google Scholar
• Krum H, Charlon V, Widmann T, et al. (1999). Long-term, open-label experience with an endothelin receptor antagonist, bosentan, in patients with severe chronic heart failure. Circulation 100:646–47
   Web of Science ®Google Scholar
• Kumbhar DD, Pokharkar VB. (2013). Engineering of a nanostructured lipid carrier for the poorly water-soluble drug, bicalutamide: physicochemical investigations. Colloids Surf A: Physicochem Eng Aspects 416:32–42
   Web of Science ®Google Scholar
• Lewandowska K, Staszewska DU, Bohdanecký M. (2001). The Huggins viscosity coefficient of aqueous solution of poly(vinyl alcohol). Eur Polym J 37:25–32
   Web of Science ®Google Scholar
• Li H, Zhang W, Xu W, et al. (2000). Hydrogen bonding governs the elastic properties of poly(vinyl alcohol) in water: single-molecule force spectroscopic studies of PVA by AFM. Macromolecules 33:465–9
   Web of Science ®Google Scholar
• Liu J, Gong T, Fu H, et al. (2008). Solid lipid nanoparticles for pulmonary delivery of insulin. Int J Pharm 356:333–44
   PubMed Web of Science ®Google Scholar
• Lyoo WS, Seo IS, Ji BC, et al. (2003). Role of the stereosequences of poly(vinyl alcohol) in the rheological properties of syndiotacticity‐rich poly (vinyl alcohol)/water solutions. J Appl Polym Sci 88:1858–63
   Web of Science ®Google Scholar
• Moldestad O, Karlsen P, Molden S, et al. (2009). Tracheotomy improves experiment success rate in mice during urethane anesthesia and stereotaxic surgery. J Neurosci Methods 176:57–62
   PubMed Web of Science ®Google Scholar
• Nahar K, Absar S, Patel B, et al. (2014). Starch-coated magnetic liposomes as an inhalable carrier for accumulation of fasudil in the pulmonary vasculature. Int J Pharm 464:185–95
   PubMed Web of Science ®Google Scholar
• Nasr M, Nawaz S, Elhissi A. (2012). Amphotericin B lipid nanoemulsion aerosols for targeting peripheral respiratory airways via nebulization. Int J Pharm 436:611–16
   PubMed Web of Science ®Google Scholar
• Nasr M, Taha I, Hathout RM. (2013). Suitability of liposomal carriers for systemic delivery of risedronate using the pulmonary route. Drug Deliv 20:311–18
   PubMed Web of Science ®Google Scholar
• Niwa T, Takeuchi H, Hino T, et al. (1993). Preparations of biodegradable nanospheres of water-soluble and insoluble drugs with d, l-lactide/glycolide copolymer by a novel spontaneous emulsification solvent diffusion method, and the drug release behavior. J Control Release 25:89–98
   Web of Science ®Google Scholar
• Niwa T, Takeuchi H, Hino T, et al. (1994). In vitro drug release behavior of d, l‐lactide/glycolide copolymer (PLGA) nanospheres with nafarelin acetate prepared by a novel spontaneous emulsification solvent diffusion method. J Pharm Sci 83:727–32
   PubMed Web of Science ®Google Scholar
• Ohlstein EH, Douglas SA. (1993). Endothelin‐1 modulates vascular smooth muscle structure and vasomotion: implications in cardiovascular pathology. Drug Dev Res 29:108–28
   Web of Science ®Google Scholar
• Okumura K, Iwakawa S, Yoshida T, et al. (1992). Intratracheal delivery of insulin absorption from solution and aerosol by rat lung. Int J Pharm 88:63–73
   Web of Science ®Google Scholar
• Rahman Z, Zidan AS, Habib MJ, et al. (2010). Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett–Burman design. Int J Pharm 389:186–94
   PubMed Web of Science ®Google Scholar
• Rao DR, Kankan RN, Phull MS, et al. (2013). Method of synthesis of bosentan, its polymorphic forms and its salts. Google Patents (EP 2248805 A2)
   Google Scholar
• Reis CP, Neufeld RJ, Ribeiro AJ, et al. (2006). Nanoencapsulation. I. Methods for preparation of drug-loaded polymeric nanoparticles. Nanomed: Nanotechnol Biol Med 2:8–21
   PubMed Web of Science ®Google Scholar
• Roux S, Breu V, Ertel SI, et al. (1999). Endothelin antagonism with bosentan: a review of potential applications. J Mol Med 77:364–76
   PubMed Web of Science ®Google Scholar
• Rubin LJ. (1997). Primary pulmonary hypertension. N Engl J Med 336:111–17
   PubMed Web of Science ®Google Scholar
• Saigal A, Ng WK, Tan RB, et al. (2013). Development of controlled release inhalable polymeric microspheres for treatment of pulmonary hypertension. Int J Pharm 450:114–22
   PubMed Web of Science ®Google Scholar
• Song X, Zhao Y, Hou S, et al. (2008). Dual agents loaded PLGA nanoparticles: systematic study of particle size and drug entrapment efficiency. Eur J Pharm Biopharm 69:445–53
   PubMed Web of Science ®Google Scholar
• Song X, Zhao Y, Wu W, et al. (2008). PLGA nanoparticles simultaneously loaded with vincristine sulfate and verapamil hydrochloride: systematic study of particle size and drug entrapment efficiency. Int J Pharm 350:320–9
   PubMed Web of Science ®Google Scholar
• Soppimath KS, Aminabhavi TM, Kulkarni AR, et al. (2001). Biodegradable polymeric nanoparticles as drug delivery devices. J Control Release 70:1–20
   PubMed Web of Science ®Google Scholar
• Sung JC, Pulliam BL, Edwards DA. (2007). Nanoparticles for drug delivery to the lungs. Trends Biotechnol 25:563–70
   PubMed Web of Science ®Google Scholar
• Vachiery JL, Simonneau G. (2010). Management of severe pulmonary arterial hypertension. Eur Respir Rev 19:279–87
   PubMedGoogle Scholar
• Varshosaz J, Minaiyan M, Zaki MR, et al. (2016). In vitro/in vivo evaluation of agar nanospheres for pulmonary delivery of bupropion HCl. Drug Deliv 23:1948–54
   PubMed Web of Science ®Google Scholar
• Williamson DJ, Wallman LL, Jones R, et al. (2000). Hemodynamic effects of bosentan, an endothelin receptor antagonist, in patients with pulmonary hypertension. Circulation 102:411–18
   PubMed Web of Science ®Google Scholar
• Yang YY, Chung TS, Ng NP. (2001). Morphology, drug distribution, and in vitro release profiles of biodegradable polymeric microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. Biomaterials 22:231–41
   PubMed Web of Science ®Google Scholar
• Yu L, Mishra DS, Rigsbee DR. (1998). Determination of the glass properties of d-mannitol using sorbitol as an impurity . J Pharm Sci 87:774–7
   PubMed Web of Science ®Google Scholar
• Yuan H, Li X, Zhang C, et al. (2015). Nanosuspensions as delivery system for gambogenic acid: characterization and in vitro/in vivo evaluation. Drug Deliv 1–8 [Epub ahead of print]. doi: 10.3109/10717544.2015.1077294
   Web of Science ®Google Scholar
• Zhang H, Xu J. (2016). Enhanced oral bioavailability of salmeterol by loaded PLGA microspheres: preparation, in vitro, and in vivo evaluation. Drug Deliv 23:248–53
   PubMed Web of Science ®Google Scholar
• Zhang J, Lv H, Jiang K, Gao Y. (2011). Enhanced bioavailability after oral and pulmonary administration of baicalein nanocrystal. Int J Pharm 420:180–8
   PubMed Web of Science ®Google Scholar
• Zhang Q, Shen Z, Nagai T. (2001). Prolonged hypoglycemic effect of insulin-loaded polybutylcyanoacrylate nanoparticles after pulmonary administration to normal rats. Int J Pharm 218:75–80
   PubMed Web of Science ®Google Scholar