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Research Article

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine

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Pages 889-903 | Received 15 Jan 2016, Accepted 05 May 2016, Published online: 27 Jun 2016

References

  • Guideline IHT. Pharmaceutical development Q8 (R2). Rockville (MD): U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2009.
  • Lionberger RA, Lee SL, Lee L, et al. Quality by design: concepts for ANDAs. AAPS J 2008;10:268–276.
  • Lawrence XY. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008;25:781–791.
  • Mandenius CF, Graumann K, Schultz TW, et al. Quality-by-design for biotechnology-related pharmaceuticals. Biotechnol J 2009;4:600–609.
  • Verma S, Lan Y, Gokhale R, Burgess DJ. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm 2009;377:185–198.
  • Beg S, Sandhu PS, Batra RS, et al. QbD-based systematic development of novel optimized solid self-nanoemulsifying drug delivery systems (SNEDDS) of lovastatin with enhanced biopharmaceutical performance. Drug Deliv 2015;22:765–784.
  • Wu H, Tawakkul M, White M, Khan MA. Quality-by-design (QbD): an integrated multivariate approach for the component quantification in powder blends. Int J Pharm 2009;372:39–48.
  • Fisher RA. The design of experiments. Oliver and Boyd, Edinburgh. 1935.
  • Anderson MJ, Whitcomb PJ. Design of experiments. Kirk–Othmer Encyclopedia of Chemical Technology, John Wiley & Sons, Inc.; 2010.
  • Pabari RM, Ramtoola Z. Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets. Int J Pharm 2012;430:18–25.
  • Goel H, Vora N, Rana V. A novel approach to optimize and formulate fast disintegrating tablets for nausea and vomiting. AAPS PharmSciTech 2008;9:774–781.
  • Shoukri RA, Ahmed IS, Shamma RN. In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets. Eur J Pharm Biopharm 2009;73:162–171.
  • Pfister WR, Ghosh TK. Orally disintegrating tablets: products, technologies and development issues. Pharm Technol. 2005;29:136–150.
  • Patil HG, Tiwari RV, Repka MA, Singh KK. Formulation and development of orodispersible sustained release tablet of domperidone. Drug Dev Ind Pharm 2016;42:906–1015.
  • Fu Y, Yang S, Jeong SH, et al. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004;21:433–476
  • McLaughlin R, Banbury S, Crowley K. Orally disintegrating tablets: the effect of recent FDA guidance on ODT technologies and applications. Pharm Technol. 2009.
  • Van Arnum P. Advancing ODT technology. Pharm Technol. 2007.
  • Montgomery W, Treuer T, Karagianis J, et al. Orally disintegrating olanzapine review: effectiveness, patient preference, adherence, and other properties. J Patient Prefer Adherence 2012;6:109.
  • Perissutti B, Rubessa F, Moneghini M, Voinovich D. Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique. Int J Pharm 2003;256:53–63.
  • Manyikana M, Choonara YE, Tomar LK, et al. A review of formulation techniques that impact the disintegration and mechanical properties of oradispersible drug delivery technologies. Pharm Dev Technol 2016;21:354–366.
  • Vogt FG, Kord AS. Development of quality-by-design analytical methods. J Pharm Sci 2011;100:797–812.
  • Guidance for Industry: Q9 Quality Risk Management. Rockville (MD): U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2006.
  • Charoo NA, Shamsher AA, Zidan AS, Rahman Z. Quality by design approach for formulation development: a case study of dispersible tablets. Int J Pharm 2012;423:167–178.
  • Jeong SH, Takaishi Y, Fu Y, Park K. Material properties for making fast dissolving tablets by a compression method. J Mater Chem 2008;18:3527–3535.
  • Gohel M, Patel M, Amin A, et al. Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique. AAPs PharmSciTech 2004;5:10–15.
  • YAPAR EA. Orally disintegrating tablets: an overview. J Appl Pharm Sci 2014;4:118–125.
  • Zidan AS, Aljaeid BM, Mokhtar M, Shehata TM. Taste-masked orodispersible tablets of cyclosporine self-nanoemulsion lyophilized with dry silica. Pharm Dev Technol 2015;20:652–661.
  • Mittapalli PK, Suresh B, Hussaini S, et al. Comparative in vitro study of six carbamazepine products. AAPS PharmSciTech 2008;9:357–365.
  • Nokhodchi A, Maghsoodi M, Hassan-Zadeh D, Barzegar-Jalali M. Preparation of agglomerated crystals for improving flowability and compactibility of poorly flowable and compactible drugs and excipients. Powder Technol 2007;175:73–81.
  • Juppo AM, Yliruusi J. Effect of amount of granulation liquid on total pore volume and pore size distribution of lactose, glucose and mannitol granules. Eur J Pharm Biopharm 1994;40:299–309.
  • Mizumoto T, Masuda Y, Yamamoto T, et al. Formulation design of a novel fast-disintegrating tablet. Int J Pharm 2005;306:83–90.
  • Koizumi K-i, Watanabe Y, Morita K, et al. New method of preparing high-porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material. Int J Pharm 1997;152:127–131.
  • Shah RB, Tawakkul MA, Khan MA. Comparative evaluation of flow for pharmaceutical powders and granules. Aaps Pharmscitech 2008;9:250–258.
  • Tye CK, Sun CC, Amidon GE. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction. J Pharm Sci 2005;94:465–472.
  • Bi Y, Sunada H, Yonezawa Y, Danjo K. Evaluation of rapidly disintegrating tablets prepared by a direct compression method. Drug Dev Indus Pharm 1999;25:571–581.
  • Moradiya HG, Nokhodchi A, Bradley MS, et al. Increased dissolution rates of carbamazepine–gluconolactone binary blends processed by hot melt extrusion. Pharm Dev Technol 2016;21:445–452.
  • Aslan N. Application of response surface methodology and central composite rotatable design for modeling and optimization of a multi-gravity separator for chromite concentration. Powder Technol 2008;185:80–86.
  • Miao L, Ji G, Gao G, et al. Extraction of alumina powders from the oil shale ash by hydrometallurgical technology. Powder Technol 2011;207:343–347.
  • Aslan N, Cebeci Y. Application of Box–Behnken design and response surface methodology for modeling of some Turkish coals. Fuel 2007;86:90–97.
  • Sunada H, Bi Y. Preparation, evaluation and optimization of rapidly disintegrating tablets. Powder Technol 2002;122:188–198.
  • Sugimoto M, Matsubara K, Koida Y, Kobayashi M. The preparation of rapidly disintegrating tablets in the mouth. Pharm Dev Technol 2001;6:487–493.
  • Bezerra MA, Santelli RE, Oliveira EP, et al. Response surface methodology (RSM) as a tool for optimization in analytical chemistry. Talanta 2008;76:965–977.
  • Lepore J, Spavins J. PQLI design space. J Pharm Innov 2008;3:79–87.
  • Garcia T, Cook G, Nosal R. PQLI key topics-criticality, design space, and control strategy. J Pharm Innov 2008;3:60–68.
  • Abed KK, Hussein AA, Ghareeb MM, Abdulrasool AA. Formulation and optimization of orodispersible tablets of diazepam. AAPS PharmSciTech 2010;11:356–361.
  • Zhao N, Augsburger LL. Functionality comparison of 3 classes of superdisintegrants in promoting aspirin tablet disintegration and dissolution. AAPS Pharmscitech 2005;6:E634–E640.
  • Iveson SM, Litster JD, Hapgood K, Ennis BJ. Nucleation, growth and breakage phenomena in agitated wet granulation processes: a review. Powder Technol 2001;117:3–39.
  • Bolhuis G, Zuurman K, Te Wierik G. Improvement of dissolution of poorly soluble drugs by solid deposition on a super disintegrant. II. The choice of super disintegrants and effect of granulation. Eur J Pharm Sci 1997;5:63–69.
  • Ryshkewitch E. Compression strength of porous sintered alumina and zirconia. J Am Ceramic Soc 1953;36:65–68.
  • Dees PJ, Polderman J. Mercury porosimetry in pharmaceutical technology. Powder Technol 1981;29:187–197.
  • Juppo AM. Relationship between breaking force and pore structure of lactose, glucose and mannitol tablets. Int J Pharm 1996;127:95–102.
  • Kuentz M, Leuenberger H. A new model for the hardness of a compacted particle system, applied to tablets of pharmaceutical polymers. Powder Technol 2000;111:145–153.
  • Rahman Z, Siddiqui A, Khan MA. Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation. Eur J Pharm Biopharm 2013;85:1300–1309.
  • Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablets. Eur J Pharm Sci 2002;15:295–305.
  • Leuenberger H. The application of percolation theory in powder technology. Adv Powder Technol 1999;10:323–352.
  • Leuenberger H, Rohera B, Haas C. Percolation theory – a novel approach to solid dosage form design. Int J Pharm 1987;38:109–115.
  • Caramella C, Colombo P, Conte U, et al. A physical analysis of the phenomenon of tablet disintegration. Int J Pharm 1988;44:177–186.
  • Battu SK, Repka MA, Majumdar S, Rao YM. Formulation and evaluation of rapidly disintegrating fenoverine tablets: effect of superdisintegrants. Drug Dev Indus Pharm 2007;33:1225–1232.
  • Luginbühl R, Leuenberger H. Use of percolation theory to interpret water uptake, disintegration time and intrinsic dissolution rate of tablets consisting of binary mixtures. Pharm Acta Helv 1994;69:127–134.
  • Caramella C, Colombo P, Conte U, et al. The role of swelling in the disintegration process. Int J Pharm Technol Prod Manufacture 1984;5:1–5.
  • Riippi M, Antikainen O, Niskanen T, Yliruusi J. The effect of compression force on surface structure, crushing strength, friability and disintegration time of erythromycin acistrate tablets. Eur J Pharm Biopharm 1998;46:339–345.
  • Salmani JMM, Lv H, Asghar S, Zhou J. Amorphous solid dispersion with increased gastric solubility in tandem with oral disintegrating tablets: a successful approach to improve the bioavailability of atorvastatin. Pharm Dev Technol 2015;20:465–472.
  • Ferrari F, Bertoni M, Bonferoni CM, et al. Dissolution enhancement of an insoluble drug by physical mixture with a superdisintegrant: optimization with a simplex lattice design. Pharm Dev Technol 1996;1:159–164.
  • Manivannan R. Oral disintegrating tablets: a future compaction. Drug Invent Today 2009;1:61–65.
  • Scheubel E. Predictive in vitro dissolution tools: application during formulation development. Université d’Auvergne-Clermont-Ferrand I; 2010.
  • Ragonese R, Macka M, Hughes J, Petocz P. The use of the Box–Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation. J Pharm Biomed Anal 2002;27:995–1007.

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