Dissolution of solid lipid extrudates in biorelevant media

International Journal of Pharmaceutics

Volumn 422, Issue 1-2, 2012, Pages 116-124

  Witzleb, R ^a   Mullertz A ^b   Kanikanti, V R ^c   Hamann, H J ^c   Kleinebudde, P ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c BAYER PHARMA AG   (Germany)

Author keywords

Biorelevant medium; Dissolution; In vitro lipolysis; Pancreatic lipase; Praziquantel; Solid lipid extrudates

Indexed keywords

BILE SALT; CALCIUM CHLORIDE; CETYL PALMITATE; GLYCEROL STEARATE; GLYCERYL DIBEHENATE; HYDROCHLORIC ACID; MALEIC ACID; PARAFFIN; PHOSPHOLIPID; PHOSPHOLIPID DERIVATIVE; POLYSORBATE; PRAZIQUANTEL; SODIUM CHLORIDE; SODIUM HYDROXIDE; TRIACYLGLYCEROL LIPASE; TRIPALMITIN; UNCLASSIFIED DRUG;

ARTICLE; CONTROLLED STUDY; CULTURE MEDIUM; DISSOLUTION; DRUG RELEASE; DRUG STABILITY; ENZYME DEGRADATION; LIPOLYSIS; PRIORITY JOURNAL; SOLUBILIZATION; STORAGE TEMPERATURE; THERMAL ANALYSIS;

ANTHELMINTICS; BILE ACIDS AND SALTS; CHEMISTRY, PHARMACEUTICAL; DRUG STORAGE; GLYCERIDES; HUMIDITY; HYDROCHLORIC ACID; HYDROGEN-ION CONCENTRATION; INTESTINAL SECRETIONS; KINETICS; LIPASE; LIPIDS; LIPOLYSIS; PALMITATES; PARAFFIN; PHOSPHOLIPIDS; POLYSORBATES; PRAZIQUANTEL; SOLUBILITY; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; TIME FACTORS; TRIGLYCERIDES;

EID: 84655169627     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.10.037     Document Type: Article

References (41)

1. R. Bergauer, O. Lutz, and P. Speiser Wirkstoff-Freigabe aus Fettpellets Pharm. Ind. 39 1977 1274 1278
2. S. Chakraborty, D. Shukla, B. Mishra, and S. Singh Lipid - an emerging platform for oral delivery of drugs with poor bioavailability Eur. J. Pharm. Biopharm. 73 2009 1 15
3. J.Ø. Christensen, K. Schultz, B. Mollgaard, H.G. Kristensen, and A. Müllertz Solubilisation of poorly water-soluble drugs during in vitro lipolysis of medium- and long-chain triacylglycerols Eur. J. Pharm. Sci. 23 2004 287 296 (Pubitemid 39369884)
4. R.J. Deckelbaum, J.A. Hamilton, A. Moser, G. Bengtsson-Olivecrona, E. Butbul, Y.A. Carpentier, A. Gutman, and T. Olivecrona Medium-chain versus long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for the mechanisms of lipase action Biochemistry 29 1990 1136 1142 (Pubitemid 20053833)
5. J.K. Embleton, and C.W. Pouton Structure and function of gastro-intestinal lipases Adv. Drug Deliv. Rev. 25 1997 15 32 (Pubitemid 27107788)
6. W. Fang, H. Mayama, and K. Tsujii Spontaneous formation of fractal structures on triglyceride surfaces with reference to their super water-repellent properties J. Phys. Chem. B 111 2007 564 571
7. E. Galia, E. Nicolaides, D. Hörter, R. Löbenberg, C. Reppas, and J.B. Dressman Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs Pharm. Res. 15 1998 698 705 (Pubitemid 28275645)
8. J.W. Hagemann Thermal behaviour and polymorphism of acylglycerides K. Sato, N. Garti, Crystallization and Polymorphism of Fats and Fatty Acids 1988 Marcel Dekker New York 9 95
9. J. Hamdani, A.J. Moës, and K. Amighi Development and evaluation of prolonged release pellets obtained by the melt pelletization process Int. J. Pharm. 245 2002 167 177 (Pubitemid 35299902)
10. A.J. Humberstone, C.J.H. Porter, and W.N. Charman A physicochemical basis for the effect of food on the absolute oral bioavailability of halofantrine J. Pharm. Sci. 85 1996 525 529 (Pubitemid 26150986)
11. A.J. Humberstone, and W.N. Charman Lipid-based vehicles for the oral delivery of poorly water soluble drugs Adv. Drug Deliv. Rev. 25 1997 103 128
12. E. Jantratid, N. Janssen, C. Reppas, and J.B. Dressman Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update Pharm. Res. 25 2008 1663 1676
13. P. Kahela, E. Laine, and M. Anttila A comparison of the bioavailability of paracetamol from a fatty and a hydrous suppository base and the effect of storage on the absorption in man Drug Dev. Ind. Pharm. 13 1987 213 224 (Pubitemid 17042405)
14. J. Kanto Plasma concentrations of diazepam and its metabolites after peroral, intramuscular and rectal administration Int. J. Clin. Pharmacol. Biopharm. 12 1975 427 432
15. N. Khan, and D.Q.M. Craig Role of blooming in determining the storage stability of lipid-based dosage forms J. Pharm. Sci. 93 2004 2962 2971 (Pubitemid 39657800)
16. J. Krause, M. Thommes, and J. Breitkreutz Immediate release pellets with lipid binders obtained by solvent-free cold extrusion Eur. J. Pharm. Biopharm. 71 2009 138 144
17. H. Ljusberg-Wahren, F.S. Nielsen, M. Brogrd, E. Troedsson, and A. Müllertz Enzymatic characterization of lipid-based drug delivery systems Int. J. Pharm. 298 2005 328 332 (Pubitemid 40910737)
18. M.E. Lowe Structure and function of pancreatic lipase and colipase Annu. Rev. Nutr. 17 1997 141 158 (Pubitemid 27328796)
19. M. Marques Dissolution media simulating fasted and fed states Dissolution Technol. 5 2004 16
20. K.J. MacGregor, J.K. Embleton, J.E. Lacy, E.A. Perry, L.J. Solomon, H. Seager, and C.W. Pouton Influence of lipolysis on drug absorption from the gastro-intestinal tract Adv. Drug Deliv. Rev. 25 1997 33 46 (Pubitemid 27107789)
21. A. Michalk, V.R. Kanikanti, H.J. Hamann, and P. Kleinebudde Controlled release of active as a consequence of the die diameter in solid lipid extrusion J. Control. Release 132 2008 35 41
22. J.W. Moore, and H.H. Flanner Mathematical comparison of dissolution profiles Pharm. Technol. 6 1996 64 74 (Pubitemid 126450495)
23. N. Morley, and A. Kuksis Positional specificity of lipoprotein lipase J. Biol. Chem. 247 1972 6389 6393
24. T. O'Hara, A. Dunne, J. Butler, and J. Devane A review of methods used to compare dissolution profile data PSTT 1 1998 214 223 (Pubitemid 28387122)
25. C. Olbrich, O. Kayser, and R.H. Müller Lipase degradation of Dynasan 114 and 116 solid lipid nanoparticles (SLN) - effect of surfactants, storage time and crystallinity Int. J. Pharm. 237 2002 119 128 (Pubitemid 34310485)
26. J.S. Patton, and M.C. Carey Watching fat digestion Science 204 1979 145 148
27. C.J.H. Porter, and W.N. Charman In vitro assessment of oral lipid based formulations Adv. Drug Deliv. Rev. 50 2001 S127 S147
28. C. Reitz Extrudierte Fettmatrizes mit retardierter Wirkstofffreigabe 2007 Cuvillier Verlag Göttingen
29. C. Reitz, and P. Kleinebudde Solid lipid extrusion of sustained release dosage forms Eur. J. Pharm. Biopharm. 67 2007 440 448 (Pubitemid 47211916)
30. K. Sato Crystallization of fats and fatty acids K. Sato, N. Garti, Crystallization and Polymorphism of Fats and Fatty Acids 1988 Marcel Dekker New York 227 263
31. K. Sato Crystallization behaviour of fats and lipids - a review Chem. Eng. Sci. 56 2001 2255 2265 (Pubitemid 33763447)
32. S. Schulze, and G. Winter Lipid extrudates as novel sustained release systems for pharmaceutical proteins J. Control. Release 134 2009 177 185
33. V.P. Shah, J.J. Konecny, R.L. Everett, B. McCullough, A.C. Noorizadeh, and J.P. Skelly In vitro dissolution profile of water-insoluble drug dosage forms in the presence Pharm. Res. 6 1989 612 618 (Pubitemid 19214427)
34. D.M. Small A classification of biologic lipids based upon their interaction in aqueous systems J. Am. Oil Chem. Soc. 45 1968 108 119
35. H. Suzuki, H. Onishi, Y. Takahashi, M. Iwata, and Y. Machida Development of oral acetaminophen chewable tablets with inhibited bitter taste Int. J. Pharm. 251 2003 123 132 (Pubitemid 36071467)
36. L.J. Thomsen, T. Schæfer, and H.G. Kristensen Prolonged release matrix pellets prepared by melt pelletization. II. Hydrophobic substances as meltable binders Drug Dev. Ind. Pharm. 20 1994 1179 1197 (Pubitemid 24136492)
37. L.S.C. Wan, and P.F.S. Lee CMC of polysorbates J. Pharm. Sci. 63 1974 136 137
38. M. Windbergs, C.J. Strachan, and P. Kleinebudde Understanding the solid-state behaviour of triglyceride solid lipid extrudates and its influence on dissolution Eur. J. Pharm. Biopharm. 71 2009 80 87
39. R. Witzleb, V.R. Kanikanti, H.J. Hamann, and P. Kleinebudde Solid lipid extrusion with small die diameters - electrostatic charging, taste masking and continuous production Eur. J. Pharm. Biopharm. 77 2011 170 177
40. R. Witzleb, V.R. Kanikanti, H.J. Hamann, and P. Kleinebudde Influence of needle-shaped drug particles on the solid lipid extrusion process Powder Technol. 207 2011 407 413
41. N.H. Zangenberg, A. Müllertz, H.G. Kristensen, and L. Hovgaard A dynamic in vitro lipolysis model. I. Controlling the rate of lipolysis by continuous addition of calcium Eur. J. Pharm. Sci. 14 2001 115 122 (Pubitemid 32737533)