Development and characterization of an organic solvent free, proliposomal formulation of Busulfan using quality by design approach

Allen, 2013, Liposomal drug delivery systems: from concept to clinical applications, Adv. Drug Deliv. Rev., 65, 36, 10.1016/j.addr.2012.09.037 Almgren, 2000, Cryo transmission electron microscopy of liposomes and related structures, Colloids Surf. A, 174, 3, 10.1016/S0927-7757(00)00516-1 Andersson, B.S., Bhagwatwar, H.P., Chow, D.S., 1995. Parenteral busulfan for treatment of malignant disease. Google Patents. Andersson, 2000, Acute safety and pharmacokinetics of intravenous busulfan when used with oral busulfan and cyclophosphamide as pretransplantation conditioning therapy: a phase I study, Biol. Blood Marrow Transplant., 6, 548, 10.1016/S1083-8791(00)70064-4 Bertholle-Bonnet, 2007, Influence of underlying disease on busulfan disposition in pediatric bone marrow transplant recipients: a nonparametric population pharmacokinetic study, Ther. Drug Monit., 29, 177, 10.1097/FTD.0b013e318039b478 Bhagwatwar, 1996, Formulation and stability of busulfan for intravenous administration in high-dose chemotherapy, Cancer Chemother. Pharmacol., 37, 401, 10.1007/s002800050404 Buggia, 1994, Busulfan, Ann. Pharmacother., 28, 1055, 10.1177/106002809402800911 Dalle, 2003, Intravenous busulfan for allogeneic hematopoietic stem cell transplantation in infants: clinical and pharmacokinetic results, Bone Marrow Transplant., 32, 647, 10.1038/sj.bmt.1704209 Drummond, 1999, Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors, Pharmacol. Rev., 51, 691 Ehninger, 1995, Use of a water-soluble busulfan formulation-pharmacokinetic studies in a canine model, Blood, 85, 3247, 10.1182/blood.V85.11.3247.bloodjournal85113247 Feit, 1973, 4-Methanesulfonyloxybutanol: hydrolysis of busulfan, J. Pharm. Sci., 62, 1007, 10.1002/jps.2600620634 Goyal, 2005, Liposomal drug delivery systems-clinical applications, Acta Pharm., 55, 1 Hassan, 1999, The role of busulfan in bone marrow transplantation, Med. Oncol., 16, 166, 10.1007/BF02906128 Hassan, 1983, Gas chromatographic determination of busulfan in plasma with electron-capture detection, J. Chromatogr. B: Biomed. Sci. Appl., 277, 374, 10.1016/S0378-4347(00)84861-6 Hassan, 1986, Degradation of busulfan in aqueous solution, J. Pharm. Biomed. Anal., 4, 95, 10.1016/0731-7085(86)80027-9 Hassan, 1998, Pharmacokinetics and distribution of liposomal busulfan in the rat: a new formulation for intravenous administration, Cancer Chemother. Pharmacol., 42, 471, 10.1007/s002800050847 Hassan, 1994, Busulfan bioavailability, Blood, 84, 2144, 10.1182/blood.V84.7.2144.2144 Hassan, 2001, Conditioning regimens pharmacokinetics of liposomal busulphan in man, Bone Marrow Transplant., 27, 479, 10.1038/sj.bmt.1702823 Hudson, 1958, A physico-chemical investigation into the biological action of myleran and related sulphonic acid esters, Biochem. Pharmacol., 1, 48, 10.1016/0006-2952(58)90007-8 Immordino, 2006, Stealth liposomes: review of the basic science, rationale, and clinical applications, existing and potential, Int. J. Nanomed., 1, 297 Janga, 2012, Bioavailability enhancement of zaleplon via proliposomes: role of surface charge, Eur. J. Pharm. Biopharm., 80, 347, 10.1016/j.ejpb.2011.10.010 Jenke, 2005, Accidental busulfan overdose during conditioning for stem cell transplantation, Bone Marrow Transplant., 35, 125, 10.1038/sj.bmt.1704697 Layre, 2006, Busulfan loading into poly (alkyl cyanoacrylate) nanoparticles: physico‐chemistry and molecular modeling, J. Biomed. Mater. Res. B: Appl. Biomater., 79, 254, 10.1002/jbm.b.30536 Lee, 2005, Decreased incidence of hepatic veno-occlusive disease and fewer hemostatic derangements associated with intravenous busulfan vs oral busulfan in adults conditioned with busulfan+ cyclophosphamide for allogeneic bone marrow transplantation, Ann. Hematol., 84, 321, 10.1007/s00277-004-0982-4 Liu, 2014, Preparation of 10-hydroxycamptothecin proliposomes by the supercritical CO2 anti-solvent process, Chem. Eng. J., 243, 289, 10.1016/j.cej.2014.01.023 Marcelino, 2007, Assessing the effects of surfactants on the physical properties of liposome membranes, Chem. Phys. Lipids, 146, 94, 10.1016/j.chemphyslip.2006.12.008 Nguyen, 2006, Intravenous busulfan in adults prior to haematopoietic stem cell transplantation: a population pharmacokinetic study, Cancer Chemother. Pharmacol., 57, 191, 10.1007/s00280-005-0029-0 Park, 1994, The pharmacokinetics of methotrexate after intravenous administration of methotrexate‐loaded proliposomes to rats, Biopharm. Drug Dispos., 15, 391, 10.1002/bdd.2510150506 Patil-Gadhe, 2013, Single step spray drying method to develop proliposomes for inhalation: a systematic study based on quality by design approach, Pulm. Pharmacol. Ther., 27, 197, 10.1016/j.pupt.2013.07.006 Petros, 2010, Strategies in the design of nanoparticles for therapeutic applications, Nat. Rev. Drug Discov., 9, 615, 10.1038/nrd2591 Ranade, 1989, Drug delivery systems. 1. Site‐specific drug delivery using liposomes as carriers, J. Clin. Pharmacol., 29, 685, 10.1002/j.1552-4604.1989.tb03403.x Rojanarat, 2011, Isoniazid proliposome powders for inhalation—preparation, characterization and cell culture studies, Int. J. Mol. Sci., 12, 4414, 10.3390/ijms12074414 Samad, 2007, Liposomal drug delivery systems: an update review, Curr. Drug Deliv., 4, 297, 10.2174/156720107782151269 Sercombe, 2015, Advances and challenges of liposome assisted drug delivery, Front. Pharmacol., 6, 286, 10.3389/fphar.2015.00286 Shaiji, 2013, Proliposomes: a brief overview of novel delivery system, Int. J. Pharma Bio Sci., 4 Yamashita, 2003, Establishment of new preparation method for solid dispersion formulation of tacrolimus, Int. J. Pharm., 267, 79, 10.1016/j.ijpharm.2003.07.010