A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

References

• Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413–420
   PubMed Web of Science ®Google Scholar
• Kawabata Y, Wada K, Nakatani M, et al. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int J Pharm 2011;420:1–10
   PubMed Web of Science ®Google Scholar
• Sacks LV, Shamsuddin HH, Yasinskaya YI, et al. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000–2012. JAMA 2014;311:378–384
   PubMed Web of Science ®Google Scholar
• Bellamy LJ, Nordon A, Littlejohn D. Effects of particle size and cohesive properties on mixing studied by non-contact NIR. Int J Pharm 2008;361:87–91
   Google Scholar
• Olusanmi D, Jayawickrama D, Bu D, et al. A control strategy for bioavailability enhancement by size reduction: effect of micronization conditions on the bulk, surface and blending characteristics of an active pharmaceutical ingredient. Powder Technol 2014;258:222–233
   Google Scholar
• Kim S, Wei C, Kiang S. Crystallization process development of an active pharmaceutical ingredient and particle engineering via the use of ultrasonics and temperature cycling. Org Process Res Dev 2003;7:997–1001
   Web of Science ®Google Scholar
• Waknis V, Chu E, Schlam R, et al. Molecular basis of crystal morphology-dependent adhesion behavior of mefenamic acid during tableting. Pharm Res 2014;31:160–172
   Google Scholar
• Carstensen JT, Chan PC. Relation between particle size and repose angles of powders. Powder Technol 1976;15:129–131
   Web of Science ®Google Scholar
• Lam KK, Newton JM. Influence of particle size on the adhesion behaviour of powders, after application of an initial press-on force. Powder Technol 1992;73:117–125
   Web of Science ®Google Scholar
• Iacocca RG, Burcham CL, Hilden LR. Particle engineering: a strategy for establishing drug substance physical property specifications during small molecule development. J Pharm Sci 2010;99:51–75
   PubMed Web of Science ®Google Scholar
• Wildfong PLD, Morris KR, Anderson CA, Short SM. Demonstration of a shear-based solid-state phase transformation in a small molecular organic system: chlorpropamide. J Pharm Sci 2007;96:1100–1113
   PubMed Web of Science ®Google Scholar
• Schmidt AG, Wartewig S, Picker KM. Potential of carrageenans to protect drugs from polymorphic transformation. Eur J Pharm Biopharm 2003;56:101–110
   PubMed Web of Science ®Google Scholar
• Morris KR, Griesser UJ, Eckhardt CJ, Stowell JG. Theoretical approaches to physical transformations of active pharmaceutical ingredients during manufacturing processes. Adv Drug Deliv Rev 2001;48:91–114
   PubMed Web of Science ®Google Scholar
• Descamps M, Willart JF, Dudognon E, Caron V. Transformation of pharmaceutical compounds upon milling and comilling: the role of Tg. J Pharm Sci 2007;96:1398–1407
   PubMed Web of Science ®Google Scholar
• Leane MM, Sinclair W, Qian F, et al. Formulation and process design for a solid dosage form containing a spray-dried amorphous dispersion of ibipinabant. Pharm Dev Technol 2013;18:359–366
   PubMed Web of Science ®Google Scholar
• Airaksinen S, Karjalainen M, Kivikero N, et al. Excipient selection can significantly affect solid-state phase transformation in formula wet granulation. AAPS PharmSciTech 2005;6:311–322
   PubMedGoogle Scholar
• Leuenberger H. The application of percolation theory in powder technology. Adv Powder Technol 1999;10:323–352
   Web of Science ®Google Scholar
• Stepan AF, Walker DP, Bauman J, et al. Structural alert/reactive metabolite concept as applied in medicinal chemistry to mitigate the risk of idiosyncratic drug toxicity: a perspective based on the critical examination of trends in the top 200 drugs marketed in the United States. Chem Res Toxicol 2011;24:1345–1410
   PubMed Web of Science ®Google Scholar
• Tan SB, Newton JM. Powder flowability as an indication of capsule filling performance. Int J Pharm 1990;61:145–155
   Web of Science ®Google Scholar
• Danjo K, Kinoshita K, Kitagawa K, et al. Effect of particle shape on the compaction and flow properties of powders. Chem Pharm Bull 1989;37:3070–3073
   Web of Science ®Google Scholar
• Leane MM, Gamble JF, Brown J, et al. Imaging dehydration kinetics of a channel hydrate form of the HIV-1 attachment inhibitor prodrug BMS-663068. J Pharm Sci 2013;102:4375–4383
   Google Scholar
• Abdullah EC, Geldart D. The use of bulk density measurements as flowability indicators. Powder Technol 1999;102:151–165
   Web of Science ®Google Scholar
• Rohrs BR, Amidon GE, Meury RH, et al. Particle size limits to meet USP content uniformity criteria for tablets and capsules. J Pharm Sci 2006;95:1049–1059
   PubMed Web of Science ®Google Scholar
• Yalkowsky SH, Bolton S. Particle size and content uniformity. Pharm Res 1990;7:962–966
   PubMed Web of Science ®Google Scholar
• Thiel WJ, Nguyen LT. Fluidized bed granulation of an ordered powder mixture. J Pharm Pharmacol 1982;34:692–699
   PubMed Web of Science ®Google Scholar
• Pitt KG, Heasley MG. Determination of the tensile strength of elongated tablets. Powder Technol 2013;238:169–175
   Web of Science ®Google Scholar
• Hancock BC, Colvin JT, Mullarney MP, Zinchuk AV. The relative densities of pharmaceutical powders, blends, dry granulations and immediate-release tablets. Pharm Technol 2003;April:64–80
   Google Scholar
• Makino T. Advances in tabletting technology. Pharm Tech Japan 2009;25:1625–1632
   Google Scholar
• Roberts RJ, Rowe RC. The compaction of pharmaceutical and other model materials – a pragmatic approach. Chem Eng Sci 1987;42:903–911
   Web of Science ®Google Scholar
• Wang JJ, Li T, Bateman SD, et al. Modeling of adhesion in tablet compression – I. Atomic force microscopy and molecular simulation. J Pharm Sci 2003;92:798–814
   PubMed Web of Science ®Google Scholar
• Mullarney MP, Macdonald BC, Hutchins A. Assessing tablet-sticking propensity: weighing accumulated powder on a removable punch tip. Pharm Technol Eur 2012;36:57–62
   Google Scholar
• Roberts M, Ford JL, MacLeod GS, et al. Effects of surface roughness and chrome plating of punch tips on the sticking tendencies of model ibuprofen formulations. J Pharm Pharmacol 2003;55:1223–1228
   PubMed Web of Science ®Google Scholar
• McDermott TS, Farrenkopf J, Hlinak A, et al. A material sparing method for quantitatively measuring tablet sticking. Powder Technol 2011;212:240–252
   Web of Science ®Google Scholar
• McCormick D. Evolutions in direct compression. Pharm Technol 2005;29:52–62
   Google Scholar
• Dalziel G, Nauka E, Zhang F, et al. Assessment of granulation technologies for an API with poor physical properties. Drug Dev Ind Pharm 2013;39:985–995
   PubMed Web of Science ®Google Scholar
• Vasanthavada M, Wang Y, Haefele T, et al. Application of melt granulation technology using twin-screw extruder in development of high-dose modified-release tablet formulation. J Pharm Sci 2011;100:1923–1934
   PubMed Web of Science ®Google Scholar
• Lakshman JP, Kowalski J, Vasanthavada M, et al. Application of melt granulation technology to enhance tabletting properties of poorly compactible high-dose drugs. J Pharm Sci 2011;100:1553–1565
   PubMed Web of Science ®Google Scholar
• Desai DS, Rao V, Guo H, et al. An active film-coating approach to enhance chemical stability of a potent drug molecule. Pharm Dev Technol 2012;17:227–235
   PubMed Web of Science ®Google Scholar
• Desai D, Li D, Harianawala A, et al. Solubilization of entecavir by povidone to overcome content uniformity challenges for low-dose tablet formulations. Pharm Dev Technol 2013;18:1305–1313
   PubMed Web of Science ®Google Scholar
• Richardson M, Wilson M. Liquid Dispensing Technology (LDT) – Summary Presentation. Available from: http://www.ddfevent.com/pdf/MartinRichardson&MarkWilson.pdf: G.S.K.; 2013 [last accessed 10 Apr 2014]
   Google Scholar
• Timmins P, Brown J. Formulation technology enables the delivery of HIV medicines. Eur Ind Phar J 2013;19:12–17
   Google Scholar
• Cole ET, Cadé D, Benameur H. Challenges and opportunities in the encapsulation of liquid and semi-solid formulations into capsules for oral administration. Adv Drug Deliv Rev 2008;60:747–756
   PubMed Web of Science ®Google Scholar
• Merck Research Laboratories. Merck Index, 12th ed. Whitehouse Station (NJ): Merck Research Laboratories; 1996
   Google Scholar
• Wells JI. Pharmaceutical preformulation: the physicochemical properties of drug substances. Chichester: Ellis Horwood Limited; 1988
   Google Scholar
• United States Pharmacopeia and National Formulary. USP 36-NF 31. Rockville (MD): United States Pharmacopeia Convention; 2013. p 1174 Powder Flow
   Google Scholar
• Jenike A. Storage and flow of solids. Utah: University of Utah; 1964
   Google Scholar