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Research Article

Formulation and optimization of spray-dried amlodipine solid dispersion for enhanced oral absorption

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Pages 1133-1141 | Received 23 May 2012, Accepted 15 Aug 2012, Published online: 26 Sep 2012

References

  • de Champlain J, Karas M, Nguyen P, Cartier P, Wistaff R, Toal CB et al. (1998). Different effects of nifedipine and amlodipine on circulating catecholamine levels in essential hypertensive patients. J Hypertens, 16:1357–1369.
  • Humphreys A, Boersig C. (2003). Cholesterol drugs dominate. Med Ad News, 22:42–57.
  • Rovnyak GC, Atwal KS, Hedberg A, Kimball SD, Moreland S, Gougoutas JZ, O’Reilly BC, Schwartz J, Malley MF. (1992). Dihydropyrimidine calcium channel blockers. 4. Basic 3-substituted-4-aryl-1, 4-dihydropyrimidine-5-carboxylic acid esters. Potent antihypertensive agents. J Med Chem, 35:3254–3263.
  • Amidon GL, Lennernäs H, Shah VP, Crison JR. (1995). A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res, 12:413–420.
  • Rausl D, Fotaki N, Zanoski R, Vertzoni M, Cetina-Cizmek B, Khan MZ et al. (2006). Intestinal permeability and excretion into bile control the arrival of amlodipine into the systemic circulation after oral administration. J Pharm Pharmacol, 58:827–836.
  • Boetker JP, Savolainen M, Koradia V, Tian F, Rades T, Müllertz A et al. (2011). Insights into the early dissolution events of amlodipine using UV imaging and Raman spectroscopy. Mol Pharm, 8:1372–1380.
  • Meredith PA, Elliott HL. (1992). Clinical pharmacokinetics of amlodipine. Clin Pharmacokinet, 22:22–31.
  • Abernethy DR. (1992). Pharmacokinetics and pharmacodynamics of amlodipine. Cardiology, 80 Suppl 1:31–36.
  • Beresford AP, Macrae PV, Stopher DA. (1988). Metabolism of amlodipine in the rat and the dog: a species difference. Xenobiotica, 18:169–182.
  • Jang DJ, Jeong EJ, Lee HM, Kim BC, Lim SJ, Kim CK. (2006). Improvement of bioavailability and photostability of amlodipine using redispersible dry emulsion. Eur J Pharm Sci, 28:405–411.
  • Meredith PA. (2009). Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms. Curr Med Res Opin, 25:2179–2189.
  • Saigal N, Baboota S, Ahuja A, Ali J. (2008). Fast-dissolving intra-oral drug delivery systems. Exp Opin Ther Pat, 18:769–781.
  • Ragno G, Garofalo A, Vetuschi C. (2002). Photodegradation monitoring of amlodipine by derivative spectrophotometry. J Pharm Biomed Anal, 27:19–24.
  • Ragno G, Cione E, Garofalo A, Genchi G, Ioele G, Risoli A et al. (2003). Design and monitoring of photostability systems for amlodipine dosage forms. Int J Pharm, 265:125–132.
  • Cho SH, Youn YS, Jung YT, Park CS, Lee HK, Lee KH, Jeong EJ, Kim YH, Jin HT, Cheon JH. (2005). Organic acid salt of amlodipine. Patents US6890944.
  • Furlan B, Copar A, Jeriha A. (1995). Process for the preparation of amlodipine benzenesulphonate. Patent US5438145.
  • Lemmens JM, Peters THA, Benneker FBG, Picha F. (2003). Amlodipine fumarate. Patent US6518288.
  • Park YJ, Kang DS, Ju SY. (2005). A composition of fast dissolving tablets containing amlodipine free base. Patent KR2005-0035907.
  • Yang GU, Gil YS, Hong SC, Yuu CH, Ahn KY, Ahn KS. (2006). Composition for oral administration of amlodipine freebase which has improved stability and processability. Patent KR 2005-0052738.
  • Ahuja N, Katare OP, Singh B. (2007). Studies on dissolution enhancement and mathematical modeling of drug release of a poorly water-soluble drug using water-soluble carriers. Eur J Pharm Biopharm, 65:26–38.
  • Aggarwal AK, Singh S. (2011). Physicochemical characterization and dissolution study of solid dispersions of diacerein with polyethylene glycol 6000. Drug Dev Ind Pharm, 37:1181–1191.
  • Fouad EA, EL-Badry M, Mahrous GM, Alanazi FK, Neau SH, Alsarra IA. (2011). The use of spray-drying to enhance celecoxib solubility. Drug Dev Ind Pharm, 37:1463–1472.
  • DiNunzio JC, Schilling SU, Coney AW, Hughey JR, Kaneko N, McGinity JW. (2012). Use of highly compressible Ceolus™ microcrystalline cellulose for improved dosage form properties containing a hydrophilic solid dispersion. Drug Dev Ind Pharm, 38:180–189.
  • Koradia V, Tenho M, Lopez de Diego H, Ringkjøbing-Elema M, Møller-Sonnergaard J, Salonen J et al. (2012). Investigation of solid phase composition on tablet surfaces by grazing incidence X-ray diffraction. Pharm Res, 29:134–144.
  • Chutimaworapan S, Ritthidej G, Oguchi T, Yamamoto K. (2000). Controlled release of nifedipine from microspheres spray dried with eudragit and polyvinylpyrrolidone. J Pharm Sci Tech, 60:196–206.
  • Sheen PC, Khetarpal VK, Cariola CM, Rowlings CE. (1995). Formulation studies of a poorly water-soluble drug in solid dispersions to improve bioavailability. Int J Pharm, 118:221–227.
  • Yamashita K, Nakate T, Okimoto K, Ohike A, Tokunaga Y, Ibuki R et al. (2003). Establishment of new preparation method for solid dispersion formulation of tacrolimus. Int J Pharm, 267:79–91.
  • Lee EJ, Lee SW, Choi HG, Kim CK. (2001). Bioavailability of cyclosporin A dispersed in sodium lauryl sulfate-dextrin based solid microspheres. Int J Pharm, 218:125–131.
  • Saito M, Nozawa Y, Sadzuka Y, Miyagishima A, Sonobe T, Nakajima T. (2001). Preparation and dissolution characteristics of griseofulvin solid dispersions with dextrin or starch. J Pharm Sci Technol, 61:11–20.
  • Saito M, Ugajin T, Nozawa Y, Sadzuka Y, Miyagishima A, Sonobe T. (2002). Preparation and dissolution characteristics of griseofulvin solid dispersions with saccharides. Int J Pharm, 249:71–79.
  • Kawabata Y, Yamamoto K, Debari K, Onoue S, Yamada S. (2010). Novel crystalline solid dispersion of tranilast with high photostability and improved oral bioavailability. Eur J Pharm Sci, 39:256–262.
  • Onoue S, Takahashi H, Kawabata Y, Seto Y, Hatanaka J, Timmermann B et al. (2010). Formulation design and photochemical studies on nanocrystal solid dispersion of curcumin with improved oral bioavailability. J Pharm Sci, 99:1871–1881.
  • Vasconcelos T, Sarmento B, Costa P. (2007). Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov Today, 12:1068–1075.
  • Ambike AA, Mahadik KR, Paradkar A. (2005). Spray-dried amorphous solid dispersions of simvastatin, a low tg drug: in vitro and in vivo evaluations. Pharm Res, 22:990–998.
  • Peltonen L, Valo H, Kolakovic R, Laaksonen T, Hirvonen J. (2010). Electrospraying, spray drying and related techniques for production and formulation of drug nanoparticles. Expert Opin Drug Deliv, 7:705–719.
  • Takeuchi H, Nagira S, Yamamoto H, Kawashima Y. (2004). Solid dispersion particles of tolbutamide prepared with fine silica particles by the spray-drying method. Powder Technol, 141:187–195.
  • Ho PY, Yeh TK, Yao HT, Lin HL, Wu HY, Lo YK et al. (2008). Enhanced oral bioavailability of paclitaxel by D-alpha-tocopheryl polyethylene glycol 400 succinate in mice. Int J Pharm, 359:174–181.
  • Carvalho M, Oliveira CH, Mendes GD, Sucupira M, Moraes ME, De Nucci G. (2001). Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry. Biopharm Drug Dispos, 22:383–390.
  • Rowe RC, Sheskey PJ, Owen SC. Handbook of pharmaceutical excipients. London: Pharmaceutical press, 2003:651–653.
  • Fukushima K, Terasaka S, Haraya K, Kodera S, Seki Y, Wada A et al. (2007). Pharmaceutical approach to HIV protease inhibitor atazanavir for bioavailability enhancement based on solid dispersion system. Biol Pharm Bull, 30:733–738.
  • Patel AR, Joshi VY. (2008). Evaluation of SLS: APG mixed surfactant systems as carrier for solid dispersion. AAPS PharmSciTech, 9:583–590.
  • Aungst BJ. (2000). Intestinal permeation enhancers. J Pharm Sci, 89:429–442.
  • Ganem-Quintanar A, Kalia Y, Falson-Rieg F, Buri P. (1997). Mechanisms of oral permeation enhancement. Int J Pharm, 156:127–142.
  • Mortelmans K, Haworth S, Lawlor T, Speck W, Tainer B, Zeiger E. (1986). Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals. Environ Mutagen, 8 Suppl 7:1–119.
  • Chang Y, Scire J, Jacobs B. (1988). Effect of particle size and microstructure properties on encapsulated orange oil. Flavor encapsul, 370:87–102.
  • Sheu T, Rosenberg M. (1995). Microencapsulation by spray drying ethyl caprylate in whey protein and carbohydrate wall systems. J Food Sci, 60:98–103.
  • Shohin IE, Ramenskaya GV, Vasilenko GF, Malashenko EA. (2010). In vitro dissolution kinetics of amlodipine tablets marketed in Russia under biowaiver conditions. Dissolut Technol, 17:20–22.
  • Pokharkar VB, Mandpe LP, Padamwar MN, Ambike AA, Mahadik KR, Paradkar A. (2006). Development, characterization and stabilization of amorphous form of a low Tg drug. Powder Technol, 167:20–25.

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