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Research Article

Preformulation characterization and in vivo absorption in beagle dogs of JFD, a novel anti-obesity drug for oral delivery

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Pages 801-811 | Received 29 Nov 2013, Accepted 06 Mar 2014, Published online: 02 Apr 2014

References

  • Heal DJ, Gosden J, Smith SL. What is the prognosis for new centrally-acting anti-obesity drugs? Neuropharmacology 2012;63:132–46
  • Kennett GA, Clifton PG. New approaches to the pharmacological treatment of obesity: can they break through the efficacy barrier? Pharmacol Biochem Behav 2010;97:63–83
  • Kushner RF. Weight Loss strategies for treatment of obesity. Prog Cardiovasc Dis 2014;56:465–72
  • Hossen N, Kajimoto K, Akita H, et al. A comparative study between nanoparticle-targeted therapeutics and bioconjugates as obesity medication. J Control Release 2013;171:104–12
  • Colon-Gonzalez F, Kim GW, Lin JE, et al. Obesity pharmacotherapy: what is next? Mol Aspects Med 2013;34:71–83
  • Zhao SQ, Wen SM, Ding H, et al. Phenylcyclobutylamide derivatives and their stereoisomers, the preparation processes and uses thereof. Patent no. PCT/CN2009/000310; 2012
  • Chen XP, Wen SM, Yan YS, et al. Aryl cyclobutyl compound and application thereof in preparing weight-losing medicine. Patent no.CN101648891; 2010
  • Bharate SS, Vishwakarma RA. Impact of preformulation on drug development. Expert Opin Drug Deliv 2013;10:1239–57
  • Sigfridsson K, Lundqvist R, Ohlson K. Preformulation evaluation of AZD1305, an oxabispidine intended for oral and intravenous treatment. Drug Dev Ind Pharm 2012;38:19–31
  • Ki DH, Jung HC, Noh YW, et al. Preformulation and formulation of newly synthesized QNT3-18 for development of a skin whitening agent. Drug Dev Ind Pharm 2013;39:526–33
  • Dutta AK, Stodghill SP, Wyandt CM. Physicochemical characterization of NPC 1161C, a novel Antimalarial 8-aminoquinoline, in solution and solid state. AAPS PharmSciTech 2011;12:177–91
  • Liltorp K, Larsen TG, Willumsen B, Holm R. Solid state compatibility studies with tablet excipients using non thermal methods. J Pharm Biomed Anal 2011;55:424–8
  • Shah AK, Agnihotri SA. Recent advances and novel strategies in pre-clinical formulation development: an overview. J Control Release 2011;156:281–6
  • Kawabata Y, Wada K, Nakatani M, et al. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int J Pharm 2011;420:1–10
  • Takács-Novák K, Box KJ, Avdeef A. Potentiometric pKa determination of water-insoluble compounds: validation study in methanol/water mixtures. Int J Pharm 1997;151:235–48
  • Völgyi G, Ruiz R, Box K, et al. Potentiometric and spectrophotometric pKa determination of water-insoluble compounds: validation study in a new cosolvent system. Anal Chim Acta 2007;583:418–28
  • Avdeef A. pH-metric log P. Part 1. Difference plots for determining ion-pair octanol-water partition coefficients of multiprotic substances. Quant Struct-Act Relat 1992;11:510–17
  • Avdeef A. pH-metric log P. II: refinement of partition coefficients and ionization constants of multiprotic substances. J Pharm Sci 1993;82:183–90
  • Avdeef A, Comer JE, Thomson SJ. pH-Metric log P. 3. Glass electrode calibration in methanol-water, applied to pKa determination of water-insoluble substances. Anal Chem 1993;65:42–9
  • Box K, Comer JE, Gravestock T, Stuart M. New ideas about the solubility of drugs. Chem Biodivers 2009;6:1767–88
  • Stuart M, Box K. Chasing equilibrium: measuring the intrinsic solubility of weak acids and bases. Anal Chem 2005;77:983–90
  • Akaike H. Likelihood of a model and information criteria. J Econom 1981;16:3–14
  • Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev 2001;46:3–26
  • Sun N, Avdeef A. Biorelevant pKa (37 °C) predicted from the 2D structure of the molecule and its pKa at 25 °C. J Pharm Biomed Anal 2011;56:173–82
  • Hsie YL, Ilevbare GA, Van Eerdenbrugh B, et al. pH-Induced precipitation behavior of weakly basic compounds: determination of extent and duration of supersaturation using potentiometric titration and correlation to solid state properties. Pharm Res 2012;29:2738–53
  • Li XL, Jasti BR. Design of controlled release drug delivery systems. New York: McGraw-Hill; 2005
  • Hörter D, Dressman JB. Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Adv Drug Deliv Rev 2001;46:75–87
  • Box KJ, Comer J, Taylor R, Mole J. Supersaturation and precipitation behaviour of ionizabledrugs in the presence of cellulose polymers. 2012. Available at: http://www.sirius-analytical.com/system/files/private/Cellulose%20Study.pdf [last accessed 28 Nov 2013]
  • Bi V, Box K, Comer J, et al. In-situ solubility measurements of ionizable drugs and precipitation behavior in the presence and absence of Plasdone™ Povidone and Copovidone crystallization inhibitors. 2011. Available at: http://www.sirius-analytical.com/system/files/private/In-situ%20Solubility%20Measurements%20of%20Ionizable%20Drugs_0.pdf [last accessed 28 Nov 2013].
  • Kim MS, Kim JS, Cho W, et al. Supersaturatable formulations for the enhanced oral absorption of sirolimus. Int J Pharm 2013;445:108–16
  • Tran TT, Tran PH, Choi HG, et al. The roles of acidifiers in solid dispersions and physical mixtures. Int J Pharm 2010;384:60–6
  • Tran PH, Tran HT, Lee BJ. Modulation of microenvironmental pH and crystallinity of ionizable telmisartan using alkalizers in solid dispersions for controlled release. J Control Release 2008;129:59–65
  • Niazi SK. Handbook of preformulation: chemical, biological and botanical drugs. New York: Informa Healthcare; 2007
  • Box KJ, Comer JE. Using measured pKa, logP and solubility to investigate supersaturation and predict BCS class. Curr Drug Metab 2008;9:869–78
  • Nachaegari SK, Bansal AK. Coprocessed excipients for solid dosage forms. Pharm Technol 2004;28:52–64
  • Yalkowsky SH. Solubility and partitioning V: dependence of solubility on melting point. J Pharm Sci 1981;70:971–3
  • Ambrogi V, Perioli L, Pagano C, et al. Use of SBA-15 for furosemide oral delivery enhancement. Eur J Pharm Sci 2012;46:43–8
  • Zhang GG, Law D, Schmitt EA, Qiu Y. Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv Drug Deliv Rev 2004;56:371–90
  • Khomane K, Kumar L, Meena CL, et al. NP-647, a novel TRH analogue: investigating physicochemical parameters critical for its oral and parenteral delivery. Int J Pharm 2011;406:21–30
  • Vora KL, Buckton G, Clapham D. The use of dynamic vapour sorption and near infra-red spectroscopy (DVS-NIR) to study the crystal transitions of theophylline and the report of a new solid-state transition. Eur J Pharm Sci 2004;22:97–105
  • Wirth DD, Baertschi SW, Johnson RA, et al. Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine. J Pharm Sci 1998;87:31–9
  • Soares-Sobrinho JL, de La Roca Soares MF, Lopes PQ, et al. A preformulation study of a new medicine for chagas disease treatment: physicochemical characterization, thermal stability, and compatibility of benznidazole. AAPS PharmSciTech 2010;11:1391–6
  • Bharate SS, Bharate SB, Bajaj AN. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. J Excipients Food Chem 2010;1:3–26
  • Fukui E, Miyamura N, Kobayashi M. Effect of magnesium stearate or calcium stearate as additives on dissolution profiles of diltiazem hydrochloride from press-coated tablets with hydroxypropylmethylcellulose acetate succinate in the outer shell. Int J Pharm 2011;216:137–46
  • Mora PC, Cirri M, Mura P. Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations. J Pharm Biomed Anal 2006;42:3–10
  • Verma RK, Garg S. Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility testing. J Pharm Biomed Anal 2005;38:633–44
  • Rowe RC, Sheskey PJ, Quinn ME. Handbook of pharmaceutical excipients. 6th ed. London/Chicago: PhP and APhA; 2009
  • Gift AD, Luner PE, Luedeman L, Taylor LS. Manipulating hydrate formation during high shear wet granulation using polymeric excipients. J Pharm Sci 2009;98:4670–83
  • Wikström H, Carroll WJ, Taylor LS. Manipulating theophylline monohydrate formation during high-shear wet granulation through improved understanding of the role of pharmaceutical excipients. Pharm Res 2008;25:923–35
  • Gao C, Huang J, Jiao Y, et al. In vitro release and in vivo absorption in beagle dogs of meloxicam from Eudragit® FS 30 D-coated pellets. Int J Pharm 2006;322:104–12
  • Lim HT, Balakrishnan P, Oh DH, et al. Development of novel sibutramine base-loaded solid dispersion with gelatin and HPMC: physicochemical characterization and pharmacokinetics in beagle dogs. Int J Pharm 2010;397:225–30
  • Park JY, Kim KA, Park PW, et al. Relative bioavailability and pharmacokinetics of a new sibutramine formulation in healthy male subjects: a randomized, open-Label, two-period, comparative crossover study. Clin Ther 2004;26:2092–101

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