Fabrication of modified release tablet formulation of metoprolol succinate using hydroxypropyl methylcellulose and xanthan gum

AAPS PharmSciTech

Volumn 10, Issue 1, 2009, Pages 62-68

  Gohel, Mukesh C ^a   Parikh, Rajesh K ^a   Nagori, Stavan A ^a   Jena, Dillip G ^a  

^a L M COLLEGE OF PHARMACY   (India)

Author keywords

Factorial design; Hydroxypropyl methylcellulose; Matrixtablet; Metoprolol; Modified release; Xanthan gum

Indexed keywords

HYDROXYPROPYLMETHYLCELLULOSE; METOPROLOL SUCCINATE; XANTHAN; BACTERIAL POLYSACCHARIDE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BUFFER; DRUG CARRIER; DRUG DERIVATIVE; METHYLCELLULOSE; METOPROLOL;

ARTICLE; CALCULATION; CONTROLLED STUDY; DRUG RELEASE; DRUG SOLUBILITY; GELATION; HYDRATION; HYDROPHILICITY; MATRIX TABLET; MOLECULAR WEIGHT; PH; PROCESS OPTIMIZATION; SLOW DRUG RELEASE; TABLET FORMULATION; TABLET PROPERTY; CHEMICAL MODEL; CHEMISTRY; COMPARATIVE STUDY; DELAYED RELEASE FORMULATION; GEL; KINETICS; METHODOLOGY; PHARMACEUTICS; SOLUBILITY; TABLET;

ADRENERGIC BETA-ANTAGONISTS; BUFFERS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; GELS; HYDROGEN-ION CONCENTRATION; KINETICS; METHYLCELLULOSE; METOPROLOL; MODELS, CHEMICAL; POLYSACCHARIDES, BACTERIAL; SOLUBILITY; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 67549147388     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-008-9174-1     Document Type: Article

References (50)

1. M. C. Gohel, A. F. Amin, K. V. Patel, and M. K. Panchal. Studies in release behavior of diltiazem HCL from matrix tablets containing (hydroxypropyl) methyl cellulose and xanthan gum. Boll. Chim. Farmac. 141:21-28(2002).
2. J. Sujjaareevath, D. L. Munday, P. J. Cox, and K. A. Khan. Relationship between swelling, erosion and drug release from hydrophilic natural gum mini-matrix formulations. Eur. J. Pharm. Sci. 6:207-217 (1998).
3. A. G. Thombre. Palatable controlled-release formulation for companion animals. US patent US20050271708. February 4, 2005.
4. M. M. Talukdar, A. Michael, P. Rombaut, and R. Kinget. Comparative study on xanthan gum and hydroxypropyl methylcellulose as matrices for controlled-release drug delivery I. Compaction and in vitro drug release behavior. Int. J. Pharm. 129:233-241 (1996).
5. S. A. Altaf, K. Yu, J. Parasrampuria, and D. R. Friend. Guar gum-based sustained release diltiazem. Pharm. Res. 15:1196-1201 (1998).
6. L. Raimar, K. Jae Seung, and L. A. Gordon. Pharmacokinetics of an immediate release, a controlled release and a two pulse dosage form in dogs. Eur. J. Pharm. Biopharm. 60:17-23 (2000).
7. J. Wikstrand, B. Andersson, M. Kendall, H. Stanbrook, and M. Klibaner. Pharmacokinetic considerations of formulation: Extended-release metoprolol succinate in the treatment of heart failure. J. Cardiovascular Pharmacology. 41:151-157 (2003).
8. M. V. Shteinhart, inventor. Tablet with controlled release of metoprolol. Ukraine patent UA15351U. February 6, 2006.
9. B. Schluetermann, M. Kohlmeyer, inventors. Oral preparation with controlled release. PCT patent application WO2007073894 A3. July 5, 2007.
10. M. Sriwongjanva, S. Yuk, A. Nangia, inventors. Formulation and process for drug loaded cores. US patent US2005008701. July 13, 2005.
11. T. Gold, N. Shterman, inventors. Metoprolol succinate extended release tablets and methods for their preparation. European patent EP1842534. June 27, 2007.
12. E. Mendell, inventors. Controlled release metoprolol oral composition containing heteropolysaccharide and a method for the preparation thereof. US patent US5399362. April 25, 1995.
13. E. Mendell, A. R. Baichwal, T. W. Mccall, inventors. Once-a-day metoprolol oral dosage form. PCT patent application WO9528917. November 2, 1995.
14. A. R. Raochwal, J. N. Staniforth, inventors. Sustained release formulations for 24 hour release of metoprolol. US patent US5399358. March 3, 1995.
15. L. D. Dahlinder, M. O. Johansson, J. A. Sandberg, J. A. Sjoegren, U. E. Jonsson, inventors. Controlled release drug preparation. Canadian patent CA1293449. December 24, 1991.
16. G. A. Ragnarsson, K. M. Silfverstrand, J. A. Sjoegren, inventors. Pharmaceutical preparation with extended release of a dihydropyridine and a beta-adrenoreceptor antagonist and a process of preparation thereof. European patent EP0311582A1. April 12, 1988.
17. M. V. Shteinhart, inventors. Tablet with controlled release of metoprolol and method of its production. Ukraine patent UA80243. August 27, 2007.
18. E. Hoffman, inventors. Die folgenden Angabed sind den vom Anmelder eingereichten unterlagen entrnommen. German patent DE20220901U1. January 24, 2004.
19. G. B. Tianjin, inventors. Tartaric acid metoprolol sustained release capsules and its preparation method. Chinese patent CN1989954. July 4, 2007.
20. R. Thembalath, A. K. Bansal, S. Sengupta, N. Singh, inventors. Pharmaceutical compositions and process of production thereof. PCT patent application WO2004069234. February 3, 2004.
21. N. J. M. Sune, P. M. Vall, C. N. Alvarez, P. F. Gual, inventors. Extended release pharmaceutical formulation of metoprolol and process for its preparation. PCT patent application WO2008012346. January 31, 2008.
22. R. S. Raghuvanshi, P. Kharwade, P. M. Mandaogade, A. Rampal, inventors. A process for the preparation of controlled-release pharmaceutical composition of metoprolol. PCT patent application WO2005084636 A2. September 15, 2005.
23. I. Racz, S. Marton, inventors. Process for the production of stable liquid form of beta-blocker-containing medicaments with controlled release of the active constituent for oral administration. US patent US5484776. January 1, 1996.
24. N. Mulye, Inamdar Kavita. Sustained release tablet containing hydrocolloid and cellulose ether. US patent US6416786. July 9, 2002.
25. T. Darig, and R. Fassihi. Mechanistic evaluation of binary effects of magnesium stearate and talc as dissolution retardants at 85% drug loading in an experimental extended-release formulation. J. Pharm. Sci. 86:1092-1098 (1997).
26. G. S. Rekhi, R. V. Nellore, A. S. Hussain, L. G. Tillman, H. J. Mailnowski, and L. L. Augsburger. Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablet. J. Control. Release. 59:327-342 (1999).
27. S. Takka, O. H. Ocak, and F. Acarturk. Formulation and investigation of nicardipine HCl-alginate gel beads with factorial design-based studies. Eur. J. Pharm. Sci. 6:241-246 (1998).
28. J. W. Moore, and H. H. Flanner. Mathematical comparison of dissolution profiles. Pharm. Technol. 20:64-74 (1996).
29. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Dissolution Testing of Immediate Release Solid Dosage Forms, August 1997.
30. J. E. Polli, G. S. Rekhi, L. L. Augsburger, and V. P. Shah. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for Metoprolol tartrate tablets. J. Pharm. Sci. 86:690-700 (1997).
31. United States Pharmacopoeia, XXVI, NF XXI, The United States Pharmacopoeial Convention Inc., 2003 Asian Edition. pp. 1221.
32. M. Bamba, F. Puisievx, J. P. Marty, and J. T. Carstensen. Release mechanism in gel forming sustained release formulation. Int. J. Pharm. 2:307-315 (1979).
33. M. Gibaldi, and S. Feldman. Establishment of sink conditions in dissolution rate determinations: Theoretical considerations and application to nondisintegrating dosage forms. J. Pharm. Sci. 56:1238-1242 (1967).
34. R. Korsmeyer, R. Gurny, E. Doelker, P. Buri, and N. Peppas. Mechanisms of solute release from porous hydrophilic polymers. Int. J. Pharm. 15:25-35 (1983).
35. T. Higuchi. Rate of release of medicaments from ointment bases containing drugs in suspension. J. Pharm. Sci. 50:874-875 (1961).
36. T. Higuchi. Mechanism of sustained-action medication. J. Pharm. Sci. 52:1145-1149 (1963).
37. I. Higuchi. Analysis of data on the medicament release from ointments. J. Pharm. Sci. 51:802-804 (1962).
38. F. Langenbucher. Linearization of dissolution rate curve by Weibull distribution. J. Pharm. Pharmacol. 24:979-989 (1972).
39. 2 factorial design. Drug Dev. Ind. Pharm. 28:77-87 (2002).
40. D. Linder, and B. C. Lippold. Drug release from hydrocolloid embeddings with high or low susceptibility to hydrodynamic stress. Pharm. Res. 12:1781-1785 (1995).
41. 2 in comparison of dissolution profile. Dissolution Technologies 18-22 (2002).
42. 2. Pharm. Res. 15:889-896 (1998).
43. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Dissolution Testing of Immediate Release Solid Dosage Forms, August 1997.
44. J. Ford, M. Rubinstein, and J. Hogan. Propranolol hydrochloride and aminophylline release from matrix tablet containing hydroxypropyl methylcellulose. Int. J. Pharm. 24:339-350 (1985).
45. P. I. Lee, and N. A. Peppas. Prediction of polymer dissolution in swellable controlled-release systems. J. Control. Release. 6:207-215 (1987).
46. J. W. Skoug, M. V. Mikelsons, C. N. Vigneron, and N. L. Stemm. Qualitative evaluation of the mechanism of release of matrix sustained release dosage forms by measurement of polymer release. J. Control. Release. 27:227-245 (1993).
47. C. W. Vendruscolo, I. F. Andreazza, J. L. M. S. Ganter, C. Ferrero, and T. M. B. Bresolin. Xanthan and galactomannan (from M. scabrella) matrix tablets for oral controlled delivery of theophylline. Int. J. Pharm. 296:1-11 (2005).
48. L. Kirilmaz. Data mining exercises for controlled release dosage forms. Pharm. Tech. (Europe) 1 (2001).
49. X. Bodeam, and S. E. Leucuta. Optimization of hydrophilic matrix tablets using a D-optimal design. Int. J. Pharm. 153:247-255 (1997).
50. M. C. Bonferoni, S. Rossi, M. Tamayo, J. L. Pedraz, A. Dominguez-Gil, and C. Caramella. On the employment of λ-carrageenan in a matrix system II. λ-Carrageenan and hydroxypropyl methylcellulose mixtures. J. Control. Release. 30:175-182 (1994).