Use of Extrusion-Spheronization to Develop: Controlled-Release Dosage Forms for Diltiazem Hydrochloride

Pharmaceutical Technology

Volumn 28, Issue 4, 2004, Pages 62-85

  Sood, Anurag ^a   Ashokraj, Yasvanth ^b   Panchagnula, Ramesh ^b  

^a RANBAXY RESEARCH LABORATORIES   (India)

^b NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS; EXTRUSION; SOLUBILITY; WATER;

CONTROLLED RELEASE; SPHERONIZATION;

DRUG DOSAGE;

DILTIAZEM; ETHYL CELLULOSE; EUDRAGIT; EXCIPIENT; GLYCEROL PALMITOSTEARATE; GLYCEROL STEARATE; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; POLYMER; POVIDONE;

CONTROLLED RELEASE FORMULATION; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STABILITY; HYDROPHOBICITY; MELTING POINT; PELLET EXTRUSION; REVIEW; SCANNING ELECTRON MICROSCOPY; TEMPERATURE;

EID: 1842452082     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (37)

1. P. DeHaan and C.F. Lerk, "Oral Controlled Release Dosage Forms: A Review," Pharm. Weekbl. Sci. Ed. 6, 57-67 (1984).
2. V.H.K. Li and V.H.L. Lee, "Influence of Drug Properties and Routes of Drug Administration on the Design of Sustained and Controlled Release Systems," in Controlled Drug Delivery: Fundamentals and Applications, J.R Robinson and V.H.L. Lee, Eds. (Marcel Dekker, Inc., New York, NY 1987), pp. 3-94.
3. J.R. Cardinal, "Matrix Systems," in Medical Applications of Controlled Release: Classes of Systems, R.S. Langer and D.L. Wise, Eds. (CRC Press, Boca Raton, FL, 1984), pp. 41-67.
4. D.A. Reynolds, "A New Technique for the Production of Spherical Particles," Mfg. Chem. Aerosol News, 41, 40-43 (1970).
5. J.W. Conine and H.R. Hadley, "Preparation of Small Solid Pharmaceutical Spheres," Drug Cosmet. Ind. 106, 38-41(1970).
6. C. Tapia, G. Buckton, and J.M. Newton, "Factors Influencing the Mechanism of Release from Sustained Release Matrix Pellets produced by Extrusion/Spheronization," Int. J. Pharm. 92 (2), 211-218 (1993).
7. S.R. Goskonda, G.A. Hileman, and S.M. Upadrashta, "Controlled Release Pellets by Extrusion-Spheronization," Int. J. Pharm. 111 (1), 89-97 (1994).
8. D. Blanque et al., "Some Factors Influencing the Formation and In Vitro Drug Release from Matrix Pellets Prepared by Extrusion/Spheronization," Int. J. Pharm. 119 (2), 203-211 (1995).
9. S.H. Neau, M.Y. Chow, and M.J. Durrani, "Fabrication and Characterization of Extruded and Spheronized Beads Containing Carbopol 974P, NF Resin," Int. J. Pharm. 131 (1), 47-55 (1996).
10. A. Sood and R. Panchagnula, "Drug Release Evaluation of Diltiazem CR Preparations," Int. J. Pharm. 175 (1), 95-107 (1998).
11. W.A. Ritschel,"Biopharmaceutic and Pharmacokinetic Aspects in the Design of Controlled Release Peroral Drug Delivery Systems," Drug Dev. Ind. Pharm. 15 (6,7), 1073-1103 (1989).
12. R. Gandhi, C.L. Kaul, and R. Panchagnula, "Extrusion and Spheronisation in the Development of Oral Controlled Release Dosage Forms, " Pharm. Sci. Technol. Today, 2 (4), 160-170 (1999).
13. P. Kleinebudde, "The Crystallite-Gel Model for Microcrystalline Cellulose in Wet Granulation, Extrusion, and Spheronization," Pharm. Res. 14 (6), 804-809 (1997).
14. J.W. Moore and H.H. Flanner, "Mathematical Comparison of Dissolution Profiles," Pharm. Technol. 20 (6), 64-74 (1996).
15. K.A. Khan and C.T. Rhodes, "Effect of Compression Pressure on the Dissolution Efficiency of Some Direct Compression Systems," Pharm. Acta. Helv. 47, 594-607 (1972).
16. K.A. Khan, "The Concept of Dissolution Efficiency," J. Pharm. Pharmacol, 27, 48-49 (1975).
17. V. Pillay and R. Fassihi, "Evaluation and Comparison of Dissolution Data Derived from Different Modified Release Dosage Forms: An Alternative Method," J. Controlled Release 55 (1), 45-55 (1998).
18. P.V. Parab, C.K. Oh, and W.A. Ritschel, "Sustained Release from Precirolä (Glycerol Palmitostearate) Matrix: Effect of Mannitol and Hydroxypropyl Methylcellulose on the Release of Theophylline," Drug Dev. Ind. Pharm. 12 (8, 9), 1309-1327 (1986).
19. M. Gibaldi and D. Perrier, in Pharmacokinetics (Marcel Dekker, Inc., New York, NY, 1982), pp. 182.
20. J.P. Skelly and W.H. Barr, "Regulatory Assessment," in Controlled Drug Delivery: Fundamentals and Applications, J.R. Robinson and V.H. L Lee, Eds. (Marcel Dekker, Inc., New York, NY, 1987), pp. 293-334.
21. J. Urquhart,"How Much Compliance Is Enough?" Pharm. Res. 13 (1), 10-11 (1996).
22. L.Z. Benet, S. Oie, and J.B. Schwartz, "Design and Optimization of Dosage Regimens: Pharmacokinetic Data," in Goodman and Gilman's The Pharmacological Basis of Therapeutics, J.G. Hardman and L.E. Limbird, Eds. (McGraw-Hill, New York, NY 1996), pp. 1707-1792.
23. W.A. Ritschel and G.L. Kearns, "Pharmacokinetic Parameters of Important Drugs," in Handbook of Basic Pharmacokinetics (American Pharmaceutical Association, Washington, DC, 1999), pp. 479-503.
24. K.V.R. Rao and K.P. Devi, "Swelling Controlled-Release Systems: Recent Developments and Applications," Int. J. Pharm. 48 (1-3), 1-13 (1988).
25. K.E. Uhrich et al., "Polymeric Systems for Controlled Drug Release," Chem. Rev. 99 (11), 3181-3198 (1999).
26. A.R. Rajabi-Siahboomi et al., "Imaging the Internal Structure of the Gel Layer in Hydrophilic Matrix Systems by NMR Microscopy," J. Pharm. Pharmacol. 44 (supp), 1062 (1992).
27. P. Colombo, "Swelling-Controlled Release in Hydrogel Matrices for Oral Route," Adv. Drug Del. Rev. 11 (1-2), 37-57 (1993).
28. R. Chatlapalli and B.D. Rohera, "Physical Characterization of HPMC and HEC and Investigation of Their Use as Pelletization Aids," Int. J. Pharm. 161 (2), 179-193 (1998).
29. E.S. Ghali, G.H. Klinger, and J.B. Schwartz, "Thermal Treatment of Beads with Wax for Controlled Release," Drug Dev. Ind. Pharm. 15 (9), 1311-1328 (1989).
30. K.K. Peh and K.H. Yuen, "Development and In Vitro Evaluation of a Novel Multiparticulate Matrix Controlled Release Formulation of Theophylline," Drug Dev. Ind. Pharm. 21 (13), 1545-1555 (1995).
31. Y. Miyagawa et al., "Controlled-Release of Diclofenac Sodium from Wax Matrix Granule," Int. J. Pharm. 138 (2), 215-224 (1996).
32. B. Johansson et al., "Compression Behaviour and Compactability of Microcrystalline Cellulose Pellets in Relationship to Their Pore Structure and Mechanical Properties," Int. J. Pharm. 117 (1), 57-73 (1995).
33. B. Johansson and G. Alderborn, "Degree of Pellet Deformation during Compaction and Its Relationship to the Tensile Strength of Tablets Formed of Microcrystalline Cellulose Pellets," Int. J. Pharm. 132 (1, 2), 207-220 (1996).
34. N.A. Peppas, "Analysis of Fickian and non-Fickian Drug Release From Polymers," Pharm. Acta. Helv. 60, 110-111 (1985).
35. A. Sood and R. Panchagnula, "Role of Dissolution Studies in Controlled Release Drug Delivery Systems," S.T.P. Pharm. Sci. 9, 157-168 (1999).
36. F. Langenbucher, "Linearization of Dissolution Rate Curves by the Weibull Distribution," 1. Pharm. Pharmacol. 24, 979-981 (1972).
37. F. Theeuwes and W. Bayne, "Dosage Form Index: An Objective Criterion for Evaluation and Controlled-Release Drug Delivery Systems," J. Pharm. Sci. 66 (10), 1388-1392 (1977).