Effect of crospovidone and hydroxypropyl cellulose on carbamazepine in high-dose tablet formulation

References

• Lindenberg M, Kopp S, Dressman JB. (2004). Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm, 58:265–278.
   PubMed Web of Science ®Google Scholar
• Wang JT, Shiu GK, Ong-Chen T, Viswanathan CT, Skelly JP. (1993). Effects of humidity and temperature on in vitro dissolution of carbamazepine tablets. J Pharm Sci, 82:1002–1005.
   PubMed Web of Science ®Google Scholar
• Meyer MC, Straughn AB, Mhatre RM, Shah VP, Williams RL, Lesko LJ. (1998). The relative bioavailability and in vivo-in vitro correlations for four marketed carbamazepine tablets. Pharm Res, 15:1787–1791.
   PubMed Web of Science ®Google Scholar
• Meyer MC, Straughn AB, Jarvi EJ, Wood GC, Pelsor FR, Shah VP. (1992). The bioinequivalence of carbamazepine tablets with a history of clinical failures. Pharm Res, 9:1612–1616.
   PubMed Web of Science ®Google Scholar
• Davidson A. (1995). A multinational survey of the quantity of carbamazepine tablets. Drug Dev Ind Pharm, 21:2167–2186.
   Web of Science ®Google Scholar
• Jung H, Milan R, Girard M, Leon F, Montoya M. (1997). Bioequivalence study of carbamazepine tablets: in vitro/in vivo correlation. Int J Pharm, 152:37–44.
   Web of Science ®Google Scholar
• Lake OA, Olling M, Barends DM. (1999). In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers. Eur J Pharm Biopharm, 48:13–19.
   PubMed Web of Science ®Google Scholar
• Mittapalli PK, Suresh B, Hussaini SS, Rao YM, Apte S. (2008). Comparative in vitro study of six carbamazepine products. AAPS Pharm Sci Tech, 9:357–365.
   PubMed Web of Science ®Google Scholar
• Fleischman SG, Kuduva SS, McMahon JA, Moulton B, Walsh RDB, Rodriguez-Hornedo N, Zaworotko MJ. (2003). Crystal engineering of the composition of pharmaceutical phases: multiple-component crystalline solids involving carbamazepine. Crystal Growth and Design, 3:909–919.
   Web of Science ®Google Scholar
• Hickey MB, Peterson ML, Scoppettuolo LA, Morrisette SL, Vetter A, Guzmán H et al. (2007). Performance comparison of a co-crystal of carbamazepine with marketed product. Eur J Pharm Biopharm, 67:112–119.
   PubMed Web of Science ®Google Scholar
• Laine E, Tuominen V, Ilvessalo P, Kahela P. (1984). Formation of dihydrate from carbamazepine anhydrate in aqueous conditions. Int J Pharm, 20:307–314.
   Web of Science ®Google Scholar
• Kobayashi Y, Ito S, Itai S, Yamamoto K. (2000). Physicochemical properties and bioavailability of carbamazepine polymorphs and dihydrate. Int J Pharm, 193:137–146.
   PubMed Web of Science ®Google Scholar
• Sˇehić S, Betz G, Hadzidedic S, El-Arini SK, Leuenberger H. (2010). Investigation of intrinsic dissolution behavior of different carbamazepine samples. Int J Pharm, 386:77–90.
   PubMedGoogle Scholar
• Flicker F, Eberle VA, Betz G. (2011). Variability in commercial carbamazepine samples–impact on drug release. Int J Pharm, 410:99–106.
   PubMed Web of Science ®Google Scholar
• Gift AD, Luner PE, Luedeman L, Taylor LS. (2008). Influence of polymeric excipients on crystal hydrate formation kinetics in aqueous slurries. J Pharm Sci, 97:5198–5211.
   PubMed Web of Science ®Google Scholar
• Tian F, Sandler N, Gordon KC, McGoverin CM, Reay A, Strachan CJ et al. (2006). Visualizing the conversion of carbamazepine in aqueous suspension with and without the presence of excipients: a single crystal study using SEM and Raman microscopy. Eur J Pharm Biopharm, 64:326–335.
   PubMed Web of Science ®Google Scholar
• Otsuka M, Ohfusa T, Matsuda Y. (2000). Effect of binders on polymorphic transformation kinetics of carbamazepine in aqueous solution. Colloid Surface, 17:145–152.
   Web of Science ®Google Scholar
• Rodríguez-Hornedo N, Murphy D. (2004). Surfactant-facilitated crystallization of dihydrate carbamazepine during dissolution of anhydrous polymorph. J Pharm Sci, 93:449–460.
   PubMed Web of Science ®Google Scholar
• Katzhendler I, Azoury R, Friedman M. (1998). Crystalline properties of carbamazepine in sustained release hydrophilic matrix tablets based on hydroxypropyl methylcellulose. J Control Release, 54:69–85.
   PubMed Web of Science ®Google Scholar
• Katzhendler I, Azoury R, Friedman M. (2000). The effect of egg albumin on the crystalline properties of carbamazepine in sustained release hydrophilic matrix tablets and in aqueous solutions. J Control Release, 65:331–343.
   PubMed Web of Science ®Google Scholar
• Salameh AK, Taylor LS. (2006). Physical stability of crystal hydrates and their anhydrates in the presence of excipients. J Pharm Sci, 95:446–461.
   PubMed Web of Science ®Google Scholar
• Schulz M, Fussnegger B, Bodmeier R. (2010). Adsorption of carbamazepine onto crospovidone to prevent drug recrystallization. Int J Pharm, 391:169–176.
   PubMedGoogle Scholar
• Rowe RC, Sheskey PJ, Owen SC. (Eds.), 2006. Handbook of Pharmaceutical Excipients, Part 3, 5th Edn. Pharmaceutical Press.
   Google Scholar
• Machiste EO, Giunched P, Setti M, Conte U. (1995). Characterization of carbamazepine in systems containing a dissolution rate enhancer. Int J Pharm, 126:65–72.
   Google Scholar
• Kawashima Y, Takeuchi H, Hino T, Niwa T, Lin TL, Sekigawa F et al. (1993). Low-substituted hydroxypropylcellulose as a sustained-drug release matrix base or disintegrant depending on its particle size and loading in formulation. Pharm Res, 10:351–355.
   PubMed Web of Science ®Google Scholar
• Lefebvre C, Guyot-Hermann AM, Draguet-Brughmans M, Bouch R, Guyot JC. (1986). Polymorphic transitions of carbamazepine during grinding and compression. Drug Dev Ind Pharm, 12:1913–1927.
   Web of Science ®Google Scholar
• Nokhodchi A, Maghsoodi M, Hassan-Zadehb D, Barzegar-Jalali M. (2007). Preparation of agglomerated crystals for improving flowability and compactibility of poorly flowable and compactible drugs and excipients. Powder Technol, 175:73–81.
   Web of Science ®Google Scholar
• FDA. (1997). Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Center for drug evaluation and research, Rockville, MD August.
   Google Scholar
• Yuksel N, Kanik AE, Baykara T. (2000). Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm, 209:57–67.
   PubMed Web of Science ®Google Scholar
• Tian F, Zhang F, Sandler N, Gordon KC, McGoverin CM, Strachan CJ et al. (2007). Influence of sample characteristics on quantification of carbamazepine hydrate formation by X-ray powder diffraction and Raman spectroscopy. Eur J Pharm Biopharm, 66:466–474.
   PubMed Web of Science ®Google Scholar
• Savolainen M, Kogermann K, Heinz A, Aaltonen J, Peltonen L, Strachan C et al. (2009). Better understanding of dissolution behaviour of amorphous drugs by in situ solid-state analysis using Raman spectroscopy. Eur J Pharm Biopharm, 71:71–79.
   PubMed Web of Science ®Google Scholar
• Qu H, Louhi-Kultanen M, Kallas J. (2006). Solubility and stability of anhydrate/hydrate in solvent mixtures. Int J Pharm, 321:101–107.
   PubMedGoogle Scholar
• Li Y, Chow PS, Tan RBH, Black SN. (2008). Effect of water activity on the transformation between hydrate and anhydrate of carbamazepine. Org Process Res Dev, 12:264–270.
   Web of Science ®Google Scholar