Preparation and in vitro/in vivo evaluation of sustained-release metformin hydrochloride pellets

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 64, Issue 2, 2006, Pages 185-192

  Hu, Lian Dong ^a   Liu, Yang ^b   Tang, Xing ^c   Zhang, Qian ^c  

^a HEBEI UNIVERSITY   (China)

^b ZHENGZHOU UNIVERSITY   (China)

^c SHENYANG PHARMACEUTICAL UNIVERSITY   (China)

Author keywords

Centrifugal granulation; Eudragit L30D 55; Eudragit NE30D; Metformin hydrochloride; Sustained release pellets

Indexed keywords

METFORMIN;

ABSORPTION; ARTICLE; BIOAVAILABILITY; CORRELATION ANALYSIS; EVALUATION; SURFACE PROPERTY; SUSPENSION; SUSTAINED DRUG RELEASE;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; COATED MATERIALS, BIOCOMPATIBLE; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; HALF-LIFE; HUMANS; HYPOGLYCEMIC AGENTS; INTESTINES; MALE; METFORMIN; METHACRYLATES; POLYMERS; SOLUBILITY; TABLETS; TALC; TECHNOLOGY, PHARMACEUTICAL;

EID: 33747880054     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2006.04.004     Document Type: Article

References (29)

1. Hermann L.S., and Melander A. Biguanides: basic aspects and clinical use. In: Alberti K.G.M.M., DeFronzo R.A., Keen H., et al. (Eds). International Textbook of Diabetes Mellitus (1992), Wiley, New York 773-795
2. Tucker G.T., Casey C., and Phillips P.J. Metformin kinetics in healthy subjects and in patients with diabetes mellitus. Br. J. Clin. Pharmacol. 12 2 (1981) 235-246
3. Dunn C.J., and Peters D.H. Metformin: a review of its pharmacological properties and therapeutic use in noninsulin-dependent diabetes mellitus. Drugs 49 (1995) 721-749
4. Scheen A.J. Clinical pharmacokinetics of metformin. Clin. Pharmacokinet. 30 5 (1996) 359-371
5. Gajdos B. Rotary granulators - evaluation of process technology for pellet production using factorial design. Drugs Made Ger. 27 (1984) 30-36
6. Ghebre-Sellassie I., Gordon R., Fawzi M.B., and Nesbitt R.U. Evaluation of a high-speed pelletization process and equipment. Drug Dev. Ind. Pharm. 11 (1985) 1523-1541
7. M. Niskanen, Powder layering and coating in a centrifugal granulator: Effect of binder-solution concentration, powder particle size and coating amount on pellets properties, Doctor's Thesis, University of Helsinki, 2001, pp. 9-11.
8. Lehmann K. Chemistry and application properties of polymethacrylate coating systems. In: McGinity J.W. (Ed). Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. second ed. (1997), Marcel Dekker, New York, Basel, HongKong 101-176
9. Bodmeier R., and Paeratakul O. Evaluation of drugcontaining polymer films prepared from aqueous latexes. Pharm. Res. 6 (1989) 725-730
10. Watano S., Ando K., Miyanami K., Ii Y., and Sasatani S. Preparation of core particles for aqueous film coating using agitation fluidized bed. Chem. Pharm. Bull. 45 (1997) 2039-2042
11. Trojak A., Pisek R., Planinsek O., and Srcic S. Granulation of model drugs with different binders in the fluid bed granulator and prediction of optimum binder with spreading coefficient values. Farmacevtski. Vestnik. 50 (1999) 365-366
12. Niskanen T., Yliruusi J., Niskanen M., and Kontro O. Granulation of potassium chloride in instrumented fluidized bed granulator. part 1. Effect of flow rate. Acta Pharm. Fenn. 99 (1990) 13-22
13. Valenta C., and Biebel R. In vitro release study of transdermal delivery systems of progesterone. Drug Dev. Ind. Pharm. 24 (1998) 187-191
14. Deshpande A.A., Shah N.H., Rhodes C.T., and Malick W. Evaluation of film used in development of a novel controlled-release system for gastric retention. Int. J. Pharm. 159 (1997) 255-258
15. Lehmann K. Preparation and use of latex dispersions from redispersible anionic acrylic resins. Acta Pharm. Technol. 31 (1985) 96-106
16. Lehmann K., and Dreher D. Mixtures of aqueous polymethacrylate dispersions for drug coating. Drugs Made In Germany 31 (1988) 101-102
17. Amighi K., Timmermans J., Puigdevall J., Baltes E., and Moës A.J. Peroral sustained-release film-coated pellets as a means to overcome physicochemical and biological drug-related problems. I. In vitro development and evaluation. Drug Dev. Ind. Pharm. 24 (1998) 509-515
18. Amighi K., and Moës A.J. Evaluation of thermal and film forming properties of acrylic aqueous polymer blends: application to the formulation of sustained-release film-coated theophylline pellets. Drug Dev. Ind. Pharm. 21 (1995) 2355-2369
19. Dunn D.H. Metformin: a review of its pharmacological properties and therapeutic use in non-insulin-dependent diabetes mellitus. Drugs 49 (1995) 721-749
20. Pentikainen P.J. Bioavailability of metformin: comparison of solution, rapidly dissolving tablet, and three sustained release products. Int. J. Clin. Pharm. Ther. Toxicol. 24 (1986) 213-220
21. Marathe P.H., Wen Y., Norton J., Greene D.S., Barbhaiya T.F., and Wilding I.R. Effect of altered gastric emptying and gastrointestinal motility on metformin absorption. Br. J. Clin. Pharmacol. 50 (2000) 325-332
22. Evans D.F., Pye G., Bramley R., Clark A.G., Dyson T.J., and Hardcastle J.D. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut 29 (1988) 1035-1041
23. Watts P.J., and IIIum L. Colonic Drug Delivery. Drug Dev. Ind. Pharm. 23 (1997) 893-913
24. Devereux J.E., Newton J.M., and Short M.B. The influence of density on the gastrointestinal transit of pellets. J. Pharm. Pharmacol. 42 (1990) 500-501
25. Yuen K.H., Deshmukh A.A., Newton J.M., Short M., and Melchor R. Gastrointestinal transit and absorption of theophylline from a multiparticulate controlled release formulation. Int. J. Pharm. 97 (1993) 61-77
26. Clarke G.M., Newton J.M., and Short M.B. Comparative gastrointestinal transit of pellet systems of varying density. Int. J. Pharm. 114 (1995) 1-11
27. Podczeck F., Newton J.M., and Yuen K.H. The description of the gastrointestinal transit of pellets assessed by gamma scintigraphy using statistical moments. Pharm. Res. 12 (1995) 376-379
28. Sambol N.C., Chiang J., and O'Conner M. Pharmacokinetics and pharmacodynamics of metformin in healthy subjects and patients with noninsulin dependent diabetes mellitus. J. Clin. Pharmacol. 36 (1996) 1012-1021
29. Vidon N., Chaussade S., Noel M., Franchisseur C., Huchet B., and Bernier J.J. Metformin in the digestive tract. Diabetes Res. Clin. Pract. 4 (1988) 223-229