Application of near-infrared spectroscopy to optimize dissolution profiles of tablets according to the granulation mechanism

References

• Faure A, York P, Rowe RC. Process control and scale-up of pharmaceutical wet granulation processes: a review. Eur J Pharm Biopharm. 2001;52:269–277.
   PubMed Web of Science ®Google Scholar
• Briens L, Logan R. The effect of the chopper on granules from wet high-shear granulation using a PMA-1 Granulator. AAPS PharmSciTech. 2011;12:1358–1365.
   PubMed Web of Science ®Google Scholar
• Pandey P, Badawy S. A quality by design approach to scale-up of high-shear wet granulation process. Drug Dev Ind Pharm. 2016;42:175–189.
   PubMed Web of Science ®Google Scholar
• Badawy SF, Narang AS, LaMarche K, et al. Mechanistic basis for the effects of process parameters on quality attributes in high shear wet granulation. Int J Pharm. 2012;439:324–333.
   PubMed Web of Science ®Google Scholar
• Tao J, Pandey P, Bindra DS, et al. Evaluating scale-up rules of a high-shear wet granulation process. J Pharm Sci. 2015;104:2323–2333.
   PubMed Web of Science ®Google Scholar
• Pandey P, Tao J, Chaudhury A, et al. Combined experimental and modeling approach to study the effects of high-shear wet granulation process parameters on granule characteristics. Pharm Dev Technol. 2013;18:210–224.
   PubMed Web of Science ®Google Scholar
• Badawy SF, Menning MM, Gorko MA, et al. Effect of process parameters on compressibility of granulation manufactured in a high-shear mixer. Int J Pharm. 2000;198:51–61.
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research. 2004. Guidance for industry, PAT-a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma-tion/Guidances/ucm070305.pdf
   Google Scholar
• De Beer T, Burggraeve A, Fonteyne M, et al. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. Int J Pharm. 2011;417:32–47.
   PubMed Web of Science ®Google Scholar
• Reich G. Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications. Adv Drug Deliv Rev. 2005;57:1109–1143.
   PubMed Web of Science ®Google Scholar
• Li W, Bashai-Woldu A, Ballard J, et al. Applications of NIR in early stage formulation development. Part I. Semi-quantitative blend uniformity and content uniformity analyses by reflectance NIR without calibration models. Int J Pharm. 2007;340:97–103.
   PubMedGoogle Scholar
• Li W, BagnoL l, Berman M, et al. Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis. Int J Pharm. 2009;380:49–54.
   PubMed Web of Science ®Google Scholar
• Miwa A, Yajima T, Itai S. Prediction of suitable amount of water addition for wet granulation. Int J Pharm. 2000;195:81–92.
   PubMed Web of Science ®Google Scholar
• Miwa A, Yajima T, Ikuta H, et al. Prediction of suitable amounts of water in fluidized bed granulation of pharmaceutical formulations using corresponding values of components. Int J Pharm. 2008;352:202–208.
   PubMedGoogle Scholar
• Miwa A, Makado K. A method for predicting the amount of water required for wet granulation using NIR. Int J Pharm. 2009;376:41–45.
   PubMedGoogle Scholar
• Vemavarapu C, Surapaneni M, et al. Role of drug substance material properties in the processibility and performance of a wet granulated product. Int J Pharm. 2009;374:96–105.
   PubMed Web of Science ®Google Scholar
• Rowe RC. Characterization of wet powder masses using a mixer torque rheometer. 4. Effect of blade orientation. Int J Pharm. 1996;133:133–138.
   Web of Science ®Google Scholar
• Shah RB, Tawakkul MA, Khan MA. Process analytical technology: chemometric analysis of Raman and near infra-red spectroscopic data for predicting physical properties of extended release matrix tablets. J Pharm Sci. 2007;96:1356–1365.
   PubMed Web of Science ®Google Scholar
• Chitu TM, Oulahna D, Hemati M. Rheology, granule growth and granule strength: application to the wet granulation of lactose-MCC mixtures. Powder Technol. 2011;208:441–453.
   Web of Science ®Google Scholar
• Leuenberger H. New trends in the production of pharmaceutical granules: the classical batch concept and the problem of scale-up. Eur J Pharm Biopharm. 2001;52:279–288.
   PubMed Web of Science ®Google Scholar
• Kumar A, Gernaey KV, Beer TD, et al. Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – a critical review. Eur J Pharm Biopharm. 2013;85:814–832.
   PubMed Web of Science ®Google Scholar
• Iveson SM, Lister JD, Hapgood K, et al. Nucleation, growth and breakage phenomena in agitated wet granulation process: a review. Powder Technol. 2001;117:3–39.
   Web of Science ®Google Scholar
• Hancock BC, York P, Rowe RC. Assessment of substrate-binder interactions in model wet masses. 1: mixer torque rheometry. Int J Pharm. 1994;102:167–176.
   Web of Science ®Google Scholar
• Uemura T, Uramatsu S, Morizane M, et al. Usefulness of mixer torque rheometer for pharmaceutical design. Pharm Tech Japan. 2012;28:125–131.
   Google Scholar
• Simpson MB. Chapter 3, Near-infrared spectroscopy for process analytical chemistry: theory, technology and implementation. In: Bakeev KA, editor. Process analytical technology. UK: Blackwell Publishing Ltd; 2005. p. 39–90.
   Google Scholar
• Schwanninger M, Rodrigues JC, Fackler K. A review of band assignments in near infrared spectra of wood and wood components. J Near Infrared Spectrosc. 2011;19:287–308.
   Web of Science ®Google Scholar
• Hattori Y, Otsuka M. Time-resolved near-infrared spectroscopic study of the dissolution of crystalline lactose. Eur J Pharm Sci. 2012;47:884–889.
   PubMed Web of Science ®Google Scholar
• Hattori Y, Otsuka M. NIR spectroscopic study of the dissolution process in pharmaceutical tablets. Vib Spectrosc. 2011;57:275–281.
   Web of Science ®Google Scholar
• Buckton G, Yonemochi Y, Hammond J, et al. The use of near infra-red spectroscopy to detect changes in the form of amorphous and crystalline lactose. Int J Pharm. 1998;168:231–241.
   Web of Science ®Google Scholar
• Luukkonen P, Rantanen J, Mäkelä K, et al. Characterization of wet massing behavior of silicified microcrystalline cellulose and α-lactose monohydrate using near-infrared spectroscopy. Pharm Dev Technol. 2001;6:1–9.
   PubMed Web of Science ®Google Scholar
• Gombás Á, Antal I, Szabó-Révész P, et al. Quantitative determination of crystallinity of alpha-lactose monohydrate by near infrared spectroscopy (NIRS). Int J Pharm. 2003;256:25–32.
   PubMed Web of Science ®Google Scholar
• Fix I, Steffens J. Quantifying low amorphous or crystalline amounts of alpha-lactose-monohydrate using X-ray powder diffraction, near-infrared spectroscopy, and differential scanning calorimetry. Drug Dev Ind Pharm. 2004;30:513–523.
   PubMed Web of Science ®Google Scholar
• Smirani-Khayati N, Falk V, Bardin-Monnier N, et al. Binder liquid distribution during granulation process and its relationship to granule size distribution. Powder Technol. 2009;195:105–112.
   Web of Science ®Google Scholar
• Pearson JMK, Hounslow MJ, Instone T. Tracer studies of high-shear granulation: I. Experimental results. AIChE J. 2001;47:1978–1983.
   Web of Science ®Google Scholar
• Tan HS, Salman AD, Hounslow MJ. Kinetics of fluidized bed melt granulation III: tracer studies. Chem Eng Sci. 2005;60:3835–3845.
   Web of Science ®Google Scholar
• Bouwman AM, Henstra MJ, Westerman D, et al. The effect of the amount of binder liquid on the granulation mechanisms and structure of microcrystalline cellulose granules prepared by high shear granulation. Int J Pharm. 2005;290:129–136.
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research. 1997. Guidance for industry, Dissolution testing of immediate release dosage forms. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf
   Google Scholar
• Yaro Y, Xin H, Liu W, et al. In vitro–in vivo correlations for three different commercial immediate-release indapamide tablets. Drug Dev Ind Pharm. 2014;40:1670–1676.
   PubMed Web of Science ®Google Scholar
• Sherif I, Farag B, David BG, et al. A study on the effect of wet granulation on microcrystalline cellulose particle structure and performance. Pharm Res. 2006;23:634–640.
   PubMed Web of Science ®Google Scholar