Development of hot-melt extrusion as a novel technique for the ...

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6. M.F. Al-Omran, S.A. Al-Suwayeh, A.M. El-Helw, S.I. Saleh. Taste masking ofdiclofenac sodium using microencapsulation. J Microencapsul. 19 (2002) 45-52.7. P.P. Shah, R.C. Mashru, Y.M. Rane, A. Thakkar. Design and optimization ofmefloquine hydrochloride microparticles for bitter taste masking. AAPSPharmSciTech. 9 (2008) 377-89.8. S.S. Behzadi, T. Toegel, H. Viernstein. Innovations in coating technology. Recent PatDrug Deliv Formul. 2 (2008) 209-30.9. T. Hamashita, M. Matsuzaki, T. Ono, M. Ono, Y. Tsunenari, T. Aketo, S. Watano.Granulation of core particles suitable for film coating by agitation fluidized bed II. Aproposal of a rapid dissolution test for evaluation of bitter taste of ibuprofen. ChemPharm Bull, (Tokyo). 56 (2008) 883-7.10. J.P. Benoit, H. Rolland, C. Thies, V. Vande Velde. Method of coating particles andcoated spherical particles. US Patent: 6,087,003 (2000)11. H. Mazen, P. York. Particle formation methods and their products. US Patent:7,115,280 (2006)12. A. Forster, J. Hempenstall, T. Rades. Characterization of glass solutions of poorlywater-soluble drugs produced by melts extrusion with hydrophilic amorphouspolymers. J Pharm Pharmacol, 53 (2001) 303–315.13. M. Kinoshita, K. Baba, A. Nagayasu, K. Yamabe, T. Shimooka, Y. Takeichi et al.Iimprovement of solubility and oral bioavailability of a poorly water-soluble drug,TAS-301, by its melt-adsorption on a porous calcium silicate. J Pharm Sci, 91 (2002)362–370.14. J. Breitenbach, M. Magerlein. Melt extruded molecular dispersions. In I. Ghebre-Sellassie & C. Martin (Eds.), Pharmaceutical Extrusion Technology, New York:Marcel Dekker Inc. 2003.15. I. Ozgüney, D. Shuwisitkul, R. Bodmeier. Development and characterization ofextended release Kollidon SR mini-matrices prepared by hot-melt extrusion. Eur. JPharm. Biopharm. 73 (2009) 140-5.16. E. Verhoeven, C. Vervaet, J.P. Remon. Xanthan gum to tailor drug release ofsustained-release ethylcellulose mini-matrices prepared via hot-melt extrusion: invitro and in vivo evaluation. Eur J Pharm Biopharm. 63 (2006) 320-3.17. C. De Brabander, C. Vervaet, J.P. Remon. Development and evaluation of sustainedrelease mini-matrices prepared via hot melt extrusion. J Cont Rel. 89 (2002) 235-47.61 | P a g e
18. Verhoeven, T.R.M. De Beer, E. Schacht, G. Van den Mooter, J.P. Remon, C. Vervaet.Influence of polyethylene glycol/polyethylene oxide on the release characteristics ofsustained-release ethylcellulose mini-matrices produced by hot-melt extrusion: invitro and in vivo evaluations. Eur J Pharm Biopharm. 72 (2009) 463-470.19. Innovative formulations from Melt Extrusionhttp://eudragit.evonik.com/product/eudragit/en/downloads/eudragitbrochures/pages/default.aspx.20. A. Fini, G. Fazio, G. Feroci. Solubility and solubilisation properties of non-steroidalanti-inflammatory drugs. Int J Pharm.126 (1995) 95–102.21. N.A. Peppas, P.A. Buri. Surface, interfacial and molecular aspects of polymerbioadhesion on soft tissues J Control Rel. 2 (1985) 257–75.22. J.T. Fell, J.M. Newton. Determination of tablet strength by diametral – compressiontest. J Pharm Sci, 59 (1970) 688 – 91.23. C.K. Tye, C.C. Sun, G.E. Amidon. Evaluation of the effects of tableting speed on therelationships between compaction pressure, tablet tensile strength, and tablet solidfraction. J Pharm Sci. 94 (2005) 465-67.24. G. Abdelbary, C. Eouani, P. Prinderre, J. Joachim, J.P. Reynier, P. Piccerelle.Determination of the in vitro disintegration profile of rapidly disintegrating tabletsand correlation with oral disintegration. Int J Pharm. 292 (2005) 29–41.25. S. Khan, P. Kataria, P. Nakhat, Y.P. Pramod. Taste Masking of OndansetronHydrochloride by Polymer Carrier System and Formulation of Rapid-DisintegratingTablets. AAPS PharmSciTech. 8 (2007) E1 – E7.26. H. Goel, N. Vora, V. Rana. A Novel Approach to Optimize and Formulate FastDisintegrating Tablets for Nausea and Vomiting. AAPS PharmSciTech. 9 (2008) 774– 781.27. S. Qi, A. Gryczke, P. Belton, D.Q. Craig. Characterisation of solid dispersions ofparacetamol and EUDRAGIT E prepared by hot-melt extrusion using thermal,microthermal and spectroscopic analysis. Int J Pharm. 354 (2008) 158-67.28. C. De Brabander, G. Van Den Mooter, C. Vervaet, J.P. Remon. Characterization ofibuprofen as a nontraditional plasticizer of ethyl cellulose. J Pharm Sci. 91 (2002)1678-85.29. M. Wesseling, F. Kuppler, R. Bodmeier. Tackiness of acrylic and cellulosic polymerfilms used in the coating of solid dosage forms. Eur J Pharm Biopharm. 47 (1999) 73-8.62 | P a g e
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DECLARATION“I certify that this w
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taste masking effect of the process
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CHAPTER 2: DISSOLUTION ENHANCEMENT
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3.2 Powder and ODT characterization
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3.7 In vitro drug release profiles
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3.1 Solubility parameters and extru
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polymers.7.2 DSC findings of all AP
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2.4b Diffractograms of FMT formulat
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4.3 Schematic representation of the
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55 exrudates (b) DPD/L100-55 PM (c)
Page 26 and 27:
8.5d A plot of the logarithm of HCS
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L100Eudragit L100L100-55 Eudragit L
Page 30 and 31:
Maniruzzaman M, Rai D, Boateng JS.
Page 32 and 33:
Maniruzzaman M, Boateng JS, Bonnefi
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CHAPTER 1: INTRODUCTION1.0 Backgrou
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Table 1.1: HME and other convention
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homogenize but also compress the ex
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properties of polymers and excipien
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particles‘ wettability [46] . A v
Page 44 and 45: Table 1.2: Different hot-melt extru
Page 46 and 47: 1.8 Aims and objectivesThe purpose
Page 48 and 49: 29. Zheng X, Yang R, Tang X and Zhe
Page 50 and 51: 56. International Conference on Har
Page 52 and 53: CHAPTER 2: DISSOLUTION ENHANCEMENT
Page 54 and 55: Fdid ,Vi F2pip , p( Ehi/ ViVi )i =
Page 56 and 57: used. Each sample was scanned from
Page 58 and 59: Furthermore, by means of thermodyna
Page 60 and 61: 3.2 Particle size morphology and pa
Page 62 and 63: Fig. 2.4a: Diffractograms of INM fo
Page 64 and 65: However, the DSC thermograms of the
Page 66 and 67: Fig. 2.5b: DSC thermograms of INM a
Page 68 and 69: Fig. 2.5e: DSC thermograms of FMT a
Page 70 and 71: Nevertheless, more than 80% FMT was
Page 72 and 73: 6. Caron V, Tajber L, Corrigan OI,
Page 74 and 75: CHAPTER 3: DEVELOPMENT AND EVALUATI
Page 76 and 77: 2.2 Hot-Melt extrusionHot-melt extr
Page 78 and 79: Committee of the University of Gree
Page 80 and 81: The PM of formulation II (40% IBU)
Page 82 and 83: Fig. 3.3: DSC thermograms of pure I
Page 84 and 85: As a general rule, the powder compr
Page 86 and 87: Fig. 3.4: Schematic diagram of ODT
Page 88 and 89: Fig. 3.5: Schematic diagram of ODTs
Page 90 and 91: Fig. 3.7: Schematic diagram of ODTs
Page 92 and 93: F2 0 0.5 0 1 0 1F6 0 0.5 0 1 0 2F7
Page 96 and 97: 30. L. Saerens, L. Dierickx, B. Len
Page 98 and 99: leading to significant variations w
Page 100 and 101: 2.6. In vitro drug release studiesI
Page 102 and 103: v2d 2p(4.1)Table 4.1: Calculated so
Page 104 and 105: The observed melting peaks are shif
Page 106 and 107: Fig. 4.2a: Powder XRPD patterns of
Page 108 and 109: Interestingly, no difference was ob
Page 110 and 111: 7 Astree sensors Taste masking effi
Page 112 and 113: The in vitro e-tongue evaluation wa
Page 114 and 115: 3. K. Woertz, C. Tissen, P. Kleineb
Page 116 and 117: 25. B.C. Hancock, P. York, R.C. Row
Page 118 and 119: CHAPTER 5: AN IN VIVO AND IN VITRO
Page 120 and 121: (dispersion forces and polarization
Page 122 and 123: Table 5.1: Sample preparation for t
Page 124 and 125: Table 5.2: Solubility parameters ca
Page 126 and 127: Physical mixtures (PM) and extruded
Page 128 and 129: Fig. 5.2c: Thermograms of CTZ and V
Page 130 and 131: masking effect for active concentra
Page 132 and 133: Fig. 5.5b: Distance and discriminat
Page 134 and 135: Table 5.4: Mean standard deviation
Page 136 and 137: Fig. 5.6b: Release profiles of VRP
Page 138 and 139: 17. Woertz K,Tissen C, Kleinebudde
Page 140 and 141: scale or lower. XPS is more accurat
Page 142 and 143: patterns were identified after ener
Page 144 and 145:
3.3 Differential scanning calorimet
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Fig. 6.3a: Diffractograms of PRP fo
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good agreement with the anticipated
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Since L100 contained higher proport
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at ~533.01 eV is the combination of
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Finally, the XPS analysis confirmed
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Fig. 6.6b: 1 H NMR spectra of all P
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6) Bonferoni, M.C.; Rossi, S.; Ferr
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26) Vandencasteele, N.; Reniers, F.
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Gibbs free energy change before and
Page 164 and 165:
2.5 Hot-melt extrusion (HME) proces
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2.11 X-ray photoelectron spectrosco
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Table 7.2: DSC findings of all APIs
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3.4 In vivo and in vitro taste mask
Page 172 and 173:
Fig. 7.3c: Normalised DI (%) of all
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Table 7.4: Binding energy calculati
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PRP/ polymers extruded in compariso
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atom as NH + 4 . This observed N 1s
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8.0 ConclusionsThe presence of inte
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20. Davies MC, Wilding IR, Short RD
Page 184 and 185:
CHAPTER 8: SUSTAINED RELEASE HYDROC
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2.3 Preparation of formulation blen
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medium pH was maintained as 1.2 by
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Fig. 8.1: SEM images of [(a), (b)]
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Fig. 8.2b: DSC transitions of HCS/E
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in the range of 10-12 kP. However,
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ate and time on the basis of Eq. (8
Page 198 and 199:
Fig. 8.5c: A plot of the cubic root
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when n > 0.89. From the results of
Page 202 and 203:
14. Lam PL, Lee KKH,Wong RSM, Cheng
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Furthermore, HME has successfully b
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Supp. Fig. 2: XPS O 1s peaks for PR
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Supp. Fig. 4: O 1s BE peaks for L10
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8.2 s 6.2 s 3.8 s 1.8 s 200 msS
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12.2 s 9.0 s 6.2 s 3.8 s 1.8 s
Page 214 and 215:
Supplementary table 1: Solubility p
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N = 55000/ 219.2 = 250.912Density:
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(4) Eudragit L100, N = (125000/202
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