Development and evaluation of orally disintegrating tablets (ODTs) containing Ibuprofen granules prepared by hot melt extrusion

Colloids and Surfaces B: Biointerfaces

Volumn 86, Issue 2, 2011, Pages 275-284

  Gryczke, Andreas ^b   Schminke, Silke ^b   Maniruzzaman, Mohammed ^a   Beck, Julien ^c   Douroumis, Dennis ^a  

^a UNIVERSITY OF GREENWICH   (United Kingdom)

^b Evonik Rohm GmbH   (Germany)

^c UNIVERSITÉ DE ROUEN   (France)

Author keywords

Hot melt extrusion; Orally disintegrating tablets Eudragit EPO; Taste masking

Indexed keywords

COMPACTION FORCES; CROSSLINKED; DIRECT COMPRESSION; DISSOLUTION PROFILES; EUDRAGIT; HOT MELT; HOT-MELT EXTRUSION; HUMAN VOLUNTEERS; MATRIX; METHACRYLATE COPOLYMERS; ORALLY DISINTEGRATING TABLETS EUDRAGIT EPO; POLY VINYL PYRROLIDONE; SENSORY EVALUATION; SOLID DISPERSION; SUPERDISINTEGRANTS; TASTE MASKING;

COMPACTION; DISSOLUTION; EXTRUSION; GRANULATION; MELT SPINNING; SODIUM;

DRUG PRODUCTS;

COPOLYMER; CROSCARMELLOSE SODIUM; EUDRAGIT; IBUPROFEN; METHACRYLIC ACID; POVIDONE;

ADULT; ARTICLE; BITTER TASTE; CONTROLLED STUDY; CROSS LINKING; DRUG DELIVERY SYSTEM; DRUG GRANULE; DRUG RELEASE; DRUG SOLUBILITY; EVALUATION RESEARCH; FEMALE; HEAT TREATMENT; HOT MELT EXTRUSION; HUMAN; HUMAN EXPERIMENT; MALE; MASKING; MELTING POINT; NORMAL HUMAN; PHARMACOLOGICAL PROCEDURES; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; TABLET COMPRESSION; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TABLET FRIABILITY; TABLET HARDNESS; TABLET MANUFACTURE; TABLET POROSITY;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; CARBOXYMETHYLCELLULOSE SODIUM; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG COMPOUNDING; FEMALE; HARDNESS; HOT TEMPERATURE; HUMANS; IBUPROFEN; MALE; POLYMETHACRYLIC ACIDS; POVIDONE; PRESSURE; SOLUBILITY; TABLETS; TASTE; X-RAY DIFFRACTION;

EID: 79957644800     PISSN: 09277765     EISSN: 18734367     Source Type: Journal    
DOI: 10.1016/j.colsurfb.2011.04.007     Document Type: Article

References (33)

1. Habibh W., Khankarik R., Hontz J. Fast-dissolve drug delivery system. Crit. Rev. Ther. Drug Carrier Syst. 2000, 17:61-72. 3.
2. Douroumis D. Practical approaches of taste masking technologies in oral solid forms. Expert Opin. Drug Deliv. 2007, 4:417-426.
3. Mahesh A., Shastri N., Sadanandam M. Development of taste masked fast disintegrating films of levocetirizine dihydrochloride for oral use. Curr. Drug Deliv. 2010, 7:21-27.
4. Dinge A., Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech 2008, 9:349-356.
5. Zydis fast dissolving technology (). http://www.catalent.com/documents/file/zydis_bro_v15b_Web_MedRES.pdf.
6. Al-Omran M.F., Al-Suwayeh S.A., El-Helw A.M., Saleh S.I. Taste masking of diclofenac sodium using microencapsulation. J. Microencapsul. 2002, 19:45-52.
7. Shah P.P., Mashru R.C., Rane Y.M., Thakkar A. Design and optimization of mefloquine hydrochloride microparticles for bitter taste masking. AAPS PharmSciTech 2008, 9:377-389.
8. Behzadi S.S., Toegel T., Viernstein H. Innovations in coating technology. Recent Pat. Drug Deliv. Formul. 2008, 2:209-230.
9. Hamashita T., Matsuzaki M., Ono T., Ono M., Tsunenari Y., Aketo T., Watano S. Granulation of core particles suitable for film coating by agitation fluidized bed. II. A proposal of a rapid dissolution test for evaluation of bitter taste of ibuprofen. Chem. Pharm. Bull. (Tokyo) 2008, 56:883-887.
10. J.P. Benoit, H. Rolland, C. Thies, V. Vande Velde, Method of coating particles and coated 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. Forster A., Hempenstall J., Rades T. Characterization of glass solutions of poorly water-soluble drugs produced by melt extrusion with hydrophilic amorphous polymers. J. Pharm. Pharmacol. 2001, 53:303-315.
13. Kinoshita M., Baba K., Nagayasu A., Yamabe K., Shimooka T., Takeichi Y., 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. 2002, 91:362-370.
14. Breitenbach J., Magerlein M. Melt extruded molecular dispersions. Pharmaceutical Extrusion Technology 2003, Marcel Dekker Inc., New York. I. Ghebre-Sellassie, C. Martin (Eds.).
15. Ozgüney I., Shuwisitkul D., Bodmeier R. Development and characterization of extended release Kollidon SR mini-matrices prepared by hot-melt extrusion. Eur. J. Pharm. Biopharm. 2009, 73:140-145.
16. Verhoeven E., Vervaet C., Remon J.P. Xanthan gum to tailor drug release of sustained-release ethylcellulose mini-matrices prepared via hot-melt extrusion: in vitro and in vivo evaluation. Eur. J. Pharm. Biopharm. 2006, 63:320-323.
17. De Brabander C., Vervaet C., Remon J.P. Development and evaluation of sustained release mini-matrices prepared via hot melt extrusion. J. Control. Release 2002, 89:235-247.
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 of sustained-release ethylcellulose mini-matrices produced by hot-melt extrusion: in vitro and in vivo evaluations. Eur. J. Pharm. Biopharm. 2009, 72:463-470.
19. Innovative formulations from Melt Extrusion, http://eudragit.evonik.com/product/eudragit/en/downloads/eudragitbrochures/pages/default.aspx.
20. Fini A., Fazio G., Feroci G. Solubility and solubilisation properties of non-steroidal anti-inflammatory drugs. Int. J. Pharm. 1995, 126:95-102.
21. Peppas N.A., Buri P.A. Surface, interfacial and molecular aspects of polymer bioadhesion on soft tissues. J. Control. Release 1985, 2:257-275.
22. Fell J.T., Newton J.M. Determination of tablet strength by diametral - compression test. J. Pharm. Sci. 1970, 59:688-691.
23. Tye C.K., Sun C.C., Amidon G.E. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction. J. Pharm. Sci. 2005, 94:465-467.
24. Abdelbary G., Eouani C., Prinderre P., Joachim J., Reynier J.P., Piccerelle P. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int. J. Pharm. 2005, 292:29-41.
25. Khan S., Kataria P., Nakhat P., Pramod Y.P. Taste masking of Ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets. AAPS PharmSciTech 2007, 8:E1-E7.
26. 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.
27. Qi S., Gryczke A., Belton P., Craig D.Q. Characterisation of solid dispersions of paracetamol and EUDRAGIT E prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis. Int. J. Pharm. 2008, 354:158-167.
28. De Brabander C., Van Den Mooter G., Vervaet C., Remon J.P. Characterization of ibuprofen as a nontraditional plasticizer of ethyl cellulose. J. Pharm. Sci. 2002, 91:1678-1685.
29. Wesseling M., Kuppler F., Bodmeier R. Tackiness of acrylic and cellulosic polymer films used in the coating of solid dosage forms. Eur. J. Pharm. Biopharm. 1999, 47:73-78.
30. Saerens L., Dierickx L., Lenain B., Vervaet C., Remon J.P., De Beer T. Raman spectroscopy for the in-line polymer-drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process. Eur. J. Pharm. Biopharm. 2011, 7:158-163.
31. Pharma Polymers, 51st International, EUDRAGIT® Workshop, March 14-16, Degussa AG, Business Line Pharma Polymers, Darmstadt, Germany, 2006.
32. Parrott E.L. Pharmaceutical Dosage Forms: Tablets 1990, vol. 2:201-243. Marcel Dekker, New York. 2nd ed.
33. Bi Y.X., Sunada H., Yonezawa Y., Danjo K. Evaluation of rapidly disintegrating tablets prepared by a direct compression method. Drug Dev. Ind. Pharm. 1999, 25:571-581.