A Multi-mechanistic Drug Release Approach in a Bead Dosage Form and In Vivo Predictions

Pharmaceutical Development and Technology

Volumn 8, Issue 4, 2003, Pages 419-430

  Liu, Ying ^a   Schwartz, Joseph B ^b,c   Schnaare, Roger L ^b   Sugita, Edwin T ^b  

^a West Pharmaceutical Services Inc   (United States)

^b UNIVERSITY OF THE SCIENCES   (United States)

^c Department of Pharmaceutics ^*  (United States)

Author keywords

Combined multi mechanism oral dosage form; Controlled release beads; Enteric coated beads; Immediate release beads; In vivo (dog); Prediction

Indexed keywords

THEOPHYLLINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BIOAVAILABILITY; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DOG; DRUG ABSORPTION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG RELEASE; ENTERIC COATED TABLET; MATHEMATICAL MODEL; NONHUMAN; PREDICTION; PRIORITY JOURNAL; STOMACH PH;

ADMINISTRATION, ORAL; ALGORITHMS; ANIMALS; BIOLOGICAL AVAILABILITY; CAPSULES; CHEMISTRY, PHARMACEUTICAL; DOGS; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; DRUG STABILITY; FORECASTING; GELATIN; MALE; MODELS, ANIMAL; SOLUTIONS; TABLETS; THEOPHYLLINE; TIME FACTORS;

EID: 0142126251     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-120024695     Document Type: Article

References (34)

1. Liu, Y.; Schwartz, J.B.; Schnaare, R.L. A multi-mechanistic drug release approach in a bead dosage form and in vitro predictions. Pharmaceutical Development and Technology 2003, 8 (2), 163-173.
2. Chang, S.; Robinson, J.R. Sustained drug release from tablets and particles. In Pharmaceutical Dosage Forms: Tablets; Lieberman, H.A., Lachman, L., Schwartz, J.B., Eds.; Marcel Dekker, Inc.: New York, 1989; Vol. 3, 243.
3. Blythe, R.H. The formulation and evaluation of sustained release products. Drug Standards 1958, 26(1), 1-7.
4. Swintosky, J.V. Design of oral sustained-action dosage forms. Drug Cosmet. Ind. 1960, 87 (4), 464.
5. Gupta, P.K.; Robinson, J.R. Oral controlled-release delivery. In Treatise on Controlled Drug Delivery; Kydonieus, A., Ed.; Marcel Dekker, Inc.: New York, 1992; 255 pp.
6. Bialer, M.; Kaplan, S.A.; Yacobi, A. Animal models in the primary screening of controlled release formulations. In Oral Sustained Release Formulations: Design and Evaluation, 1st Ed.; Yacobi, A., Halperin-Walega, E., Eds.; Peagamon Press: New York, 1988; 183-193.
7. Ogata, H.; Aoyagi, N.; Kaniwa, N.; Shibazaki, T.; Ejima, A.; Takagishi, Y.; Ogura, T.; Tomita, K.; Inoue, S.; Zaizen, M. Bioavailability of metronidazole from sugar-coated tablets in humans. II. Evaluation of beagle dogs as an animal model. Int. J. Pharm. 1985, 23, 289-298.
8. Lui, C.Y.; Amidon, G.L.; Berardi, R.R.; Fleisher, D. Comparison of gastrointestinal pH in dogs and humans: implications on the use of the beagle dog as a model for oral absorption in humans. J. Pharm. Sci. 1986, 75 (3), 271-274.
9. Hussein, Z.; Bialer, M.; Friedman, M.; Raz, I. Comparative pharmacokinetic evaluation of sustained-release theophylline formulations in dogs and humans. Int. J. Pharm. 1987, 37, 97-102.
10. Cook, C.S.; Hauswald, C.L.; Grahn, A.Y.; Kowalski, K.; Karim, A.; Koch, R.; Schoenhard, G.L.; Oppermann, J.A. Suitability of the dog as an animal model for evaluating theophylline absorption and food effects from different formulations. Int. J. Pharm. 1990, 60, 125-132.
11. Tse, F.L.S.; Szeto, D.W. Theophylline bioavailability in the dog. J. Pharm. Sci. 1982, 71 (11), 1301-1303.
12. Glynn-Barnhart, A.; Hill, M.; Szefler, S.J. Sustained release theophylline preparations practical recommendations for prescribing and therapeutic drug monitoring. Drugs 1988, 35, 711-726.
13. Yu, Z.; Schwartz, J.B.; Sugita, E.T. Theophylline controlled-release formulations: in vivo-in vitro correlations. Biopharm. Drug Dispos. 1996, 17, 259-272.
14. Liaw, J.; Rubinstein, A.; Robinson, J.R. Bioavailability study of theo-dur tablets in the fasted cannulated dog. Int. J. Pharm. 1990, 59, 105-114.
15. Ishibashi, T.; Hatano, H.; Kobayashi, M.; Mizobe, M.; Yoshino, H. In vivo drug release behavior in dogs from a new colon-targeted delivery system. J. Control. Release 1999, 57, 45-53.
16. Cox, D.R. Planning of Experiments; John Wiley & Sons, Inc.: New York, 1992; 269-278.
17. McKiernan, B.C.; Neff-Davis, C.A.; Koritz, G.D.; Davis, L.E.; Pheris, D.R. Pharmacokinetic studies of theophylline in dogs. J. Vet. Pharmacol. Ther. 1981, 4, 103-110.
18. Wagner, J.G. Pharmacokinetics for the Pharmaceutical Scientist; Technomic Publishing Company, Inc.: Lancaster, PA, 1993.
19. Gibaldi, M. Biopharmaceutics and Clinical Pharmacokinetics, 4th Ed.; Lea & Febiger: Malvern, PA, 1991.
20. Bourne, D.W.A. Mathematical Modeling of Pharmacokinetic Data; Technomic Publishing Company, Inc.: Lancaster, PA, 1995.
21. FDA. Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, 1997.
22. Wagner, J.G. Unusual pharmacokinetics. In Pharmacokinetics - A Modern View; Benet, L.Z., Levy, G., Ferraiolo, B.L., Eds.; Plenum Press: New York, 1984; 173-188.
23. Hussein, Z.; Friedman, M. Release and absorption characteristics of novel theophylline sustained-release formulations: in vitro-in vivo correlation. Pharm. Res. 1990, 7 (11), 1167-1171.
24. Kiriyama, A.; Sugahara, M.; Yoshikawa, Y.; Kiso, Y.; Takada, K. The bioavailability of oral dosage forms of a new HIV-1 protease inhibitor, KNI-272, in beagle dogs. Biopharm. Drug Dispos. 1996, 17, 125-134.
25. Yamada, K.; Furuya, A.; Akimoto, M.; Maki, T.; Suwa, T.; Ogata, H. Evaluation of gastrointestinal transit controlled-beagle dog as a suitable animal model for bioavailability testing of sustained-release acetaminophen dosage form. Int. J. Pharm. 1995, 119, 1-10.
26. Munday, D.L.; Fassihi, A.R.; Villiers, C.D. Bioavailability study of a theophylline oral controlled release capsule containing film coated mini-tablets in beagle dogs. Int. J. Pharm. 1991, 69, 123-127.
27. Dressman, J.; Yamada, K. Animal models for oral drug absorption. In Pharmaceutical Bioequivalence; Welling, P.G., Tse, F.L.S., Dighe, S., Eds.; Marcel Dekker, Inc.: New York, 1991; 235-266.
28. Woolson, R.F. Statistical Methods for the Analysis of Biomedical Data; Wiley: New York, 1987.
29. Levy, G.; Hollister, L.E. Dissolution rate limited absorption in man. J. Pharm. Sci. 1965, 54 (8), 1121-1125.
30. Chien, Y.W. Novel Drug Delivery Systems-Fundamentals, Developmental Concepts, Biomedical Assessments; Marcel Dekker, Inc.: New York, 1982.
31. Liu, Y.; Schwartz, J.B.; Schnaare, R.L.; Sugita, E.T. A multi-mechanistic drug release approach in a bead dosage form and in vitro/in vivo correlation. Submitted Manuscript in Pharmaceutical Development and Technology.
32. Shoemaker, D.P.; Garland, C.W.; Niblep, J.W. The Experiments in Physical Chemistry, 6th Ed.; WCB/McGraw-Hill: New York, 1996; 55-61.
33. Davis, S.S. The design and evaluation of controlled release systems for the gastrointestinal tract. J. Control. Release 1985, 2, 27-38.
34. Rubinstein, A.; Li, V.H.K.; Gruber, P.; Robinson, J.R. Gastrointestinal-physiological variables affecting the performance of oral sustained release dosage forms. In Oral Sustained Release Formulations: Design and Evaluation, 1st Ed.; Yacobi, A., Halperin-Walega, E., Eds.; Peagamon Press: New York, 1988; 183-193.