Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro–in vivo investigations

References

• Lagece M, Gravelle L, Di Maso M, McClintock S. (2004). Developing a discriminating dissolution procedure for a dual active pharmaceutical product with unique solubility characteristics. Dissolution Technol, 11:13–17.
   Google Scholar
• He Z, Zhong D, Chen X, Liu X, Tang X, Zhao L. (2004). Development of a dissolution medium for nimodipine tablets based on bioavailability evaluation. Eur J Pharm Sci, 21:487–491.
   PubMed Web of Science ®Google Scholar
• Galia E, Nicolaides E, Hörter D, Löbenberg R, Reppas C, Dressman JB. (1998). Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm Res, 15:698–705.
   PubMed Web of Science ®Google Scholar
• Lue BM, Nielsen FS, Magnussen T, Schou HM, Kristensen K, Jacobsen LO et al. (2008). Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound. Eur J Pharm Biopharm, 69:648–657.
   PubMed Web of Science ®Google Scholar
• Dressman JB, Amidon GL, Reppas C, Shah VP. (1998). Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm Res, 15:11–22.
   PubMed Web of Science ®Google Scholar
• Wei H, Löbenberg R. (2006). Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur J Pharm Sci, 29:45–52.
   PubMed Web of Science ®Google Scholar
• Sunesen VH, Pedersen BL, Kristensen HG, Müllertz A. (2005). In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur J Pharm Sci, 24:305–313.
   PubMed Web of Science ®Google Scholar
• Jantratid E, Janssen N, Reppas C, Dressman JB. (2008). Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm Res, 25:1663–1676.
   PubMed Web of Science ®Google Scholar
• Zoeller T, Klein S. (2007). Simplified biorelevant media for screening dissolution performance of poorly soluble drugs. Dissolution Technol, 14:8–13.
   Web of Science ®Google Scholar
• Rane Y, Mashru R, Sankalia M, Sankalia J. (2007). Effect of hydrophilic swellable polymers on dissolution enhancement of carbamazepine solid dispersions studied using response surface methodology. AAPS PharmSciTech, 8: Article 27.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hundt HK, Aucamp AK, Müller FO. (1983). Pharmacokinetic aspects of carbamazepine and its two major metabolites in plasma during overdosage. Hum Toxicol, 2:607–614.
   PubMedGoogle Scholar
• Tsong Y, Thomas H, Sathe P, Shah VP. (1996). Statistical assessment of mean differences between two dissolution data sets. Drug Inf J, 30:1105–1112.
   Google Scholar
• Mittapalli PK, Suresh B, Hussaini SS, Rao YM, Apte S. (2008). Comparative in vitro study of six carbamazepine products. AAPS PharmSciTech, 9:357–365.
   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
• 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
• Jung H, Milán RC, Girard ME, León F, Montoya MA. (1997). Bioequivalence study of carbamazepine tablets: In vitro-in vivo correlation. Int J Pharm, 152:37–44.
   Web of Science ®Google Scholar
• Kovačević I, Parojčić J, Homsěk I, Tubić-Grozdanis M, Langguth P. (2009). Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Mol Pharm, 6:40–47.
   PubMed Web of Science ®Google Scholar
• US Pharmacopeia (USP) 34, US Pharmacopeial Convention, Roydan, Monograph: Carbamazepine tablet (2011).
   Google Scholar
• Chinese Pharmacopeia (ChP) 2010, Chinese Pharmacopeial Covention, Monograph: carbamazepine tablets (2010).
   Google Scholar
• Shah VP, Konecny JJ, Everett RL, McCullough B, Noorizadeh AC, Skelly JP. (1989). In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Pharm Res, 6:612–618.
   PubMed Web of Science ®Google Scholar
• Lee H, Park SA, Sah H. (2005). Surfactant effects upon dissolution patterns of carbamazepine immediate release tablet. Arch Pharm Res, 28:120–126.
   PubMed Web of Science ®Google Scholar
• Kollipara S, Bende G, Movva S, Saha R. (2010). Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel. Drug Dev Ind Pharm, 36:1377–1387.
   PubMed Web of Science ®Google Scholar
• El Gamal SS, Naggar VF, Allam AN. (2011). Optimization of acyclovir oral tablets based on gastroretention technology: factorial design analysis and physicochemical characterization studies. Drug Dev Ind Pharm, 37:855–867.
   PubMed Web of Science ®Google Scholar
• Chilukuri DM, Sunkara G, Young D. (2007). Pharmaceutical product development in vitro-in vivo correlation. 1st ed., Informa Healthcare, New York, pp. 95–101.
   Google Scholar
• Vertzoni M, Symillides M, Iliadis A, Nicolaides E, Reppas C. (2003). Comparison of simulated cumulative drug versus time data sets with indices. Eur J Pharm Biopharm, 56:421–428.
   PubMed Web of Science ®Google Scholar
• Vertzoni M, Fotaki N, Kostewicz E, Stippler E, Leuner C, Nicolaides E et al. (2004). Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects. J Pharm Pharmacol, 56:453–462.
   PubMed Web of Science ®Google Scholar
• Tomson T. (1987). Clinical pharmacokinetics of carbamazepine. Clin Pharmacokinet, 3:128–143.
   Google Scholar
• Veng-Pedersena P, Gobburu JVS, Meyerc MC, Straughn AB. (2000). Carbamazepine level-A in vivo-in vitro correlation (IVIVC): a scaled convolution based predictive approach. Biopharm Drug Dispos, 21:1–6.
   PubMed Web of Science ®Google Scholar
• O’Hara T, Hayes S, Davis J, Devane J, Smart T, Dunne A. (2008). In vivo-in vitro correlation (IVIVC) modeling incorporating a convolution step. J Pharmacokinet Pharmacodyn, 28:277–298.
   Google Scholar
• EL-Massik MA, Abdallash OY, Galal S, Daabis NA. (2006). Towards a universal dissolution medium for carbamazepine. Drug Dev Ind Pharm, 32:893–905.
   PubMed Web of Science ®Google Scholar
• Qiang D, Gunn JA, Schultz L, Li ZJ. (2010). Evaluation of the impact of sodium lauryl sulfate source variability on solid oral dosage form development. Drug Dev Ind Pharm, 36:1486–1496.
   PubMed Web of Science ®Google Scholar
• Singla N, Gupta GD, Kohli K, Singla AK. (2009). A discriminatory and biorelevant dissolution test method for simvastatin drug products. Dissolution Technol, 16:11–13.
   Web of Science ®Google Scholar
• Noory C, Tran N, Ouderkirk L, Shah V. (2000). Steps for development of a dissolution test for sparingly water-soluble drug products. Dissolution Technol, 7:16–21.
   Google Scholar
• Scheubel E, Adamy L, Hoffart V, Carsot JM. (2011). Selection of the most suitable dissolution method for an extended release formulation based on IVIVC level A obtained on cynomogus monkey. Drug Dev Ind Pharm, 36:1320–1329.
   Web of Science ®Google Scholar
• Yin LF, Huang SJ, Jiang SG, Zhao CJ, Pei ZQ, Zhang Q. (2011). In vitro and in vivo evaluation of levofloxacin sustained-release capsules. Drug Dev Ind Pharm, 37:33–40.
   PubMed Web of Science ®Google Scholar
• Levy G. (1964). Effect of dosage form on drug absorption a frequent variable in clinical pharmacology. Arch Int Pharmacodyn Ther, 152:59–68.
   PubMedGoogle Scholar
• Brockmeier D, Voegele D, von Hattingberg HM. (1983). In vitro–in vivo correlation, a time scaling problem? Basic techniques for testing equivalence. Arzneimittelforschung, 33:598–601.
   PubMed Web of Science ®Google Scholar
• Sirisuth N, Augsburger LL, Eddington ND. (2002). Development and validation of a non-linear IVIVC model for a diltiazem extended release formulation. Biopharm Drug Dispos, 23:1–8.
   PubMed Web of Science ®Google Scholar
• Brockmeier D, Dengler HJ, Voegele D. (1985). In vitro–in vivo correlation of dissolution, a time scaling problem? Transformation of in vitro results to the in vivo situation, using theophylline as a practical example. Eur J Clin Pharmacol, 28:291–300.
   PubMed Web of Science ®Google Scholar