Formulation and Characterization of a Compacted Multiparticulate System for Modified Release of Water-Soluble Drugs—Part II Theophylline and Cimetidine

REFERENCES

• A. M. Agrawal, R. V. Manek, W. M. Kolling, and S. H. Neau. (2003). Studies on the interaction of water with ethylcellulose: Effect of polymer particle size. AAPS Pharm. Sci. 4 (4): 1–11
   PubMedGoogle Scholar
• H. Alkhatib, and A. Sakr. (2003). Optimization of methacrylic acid ester copolymers blends as controlled release coatings using response surface method. Pharm. Dev. Tech. 8 (1):87–96.
   PubMed Web of Science ®Google Scholar
• J. Alvarez-Fuentes, M. Fernandez-Arevalo, M. L. Gonzalez-Rodriguez, M. Cirri, and P. Mura. (2004). Development of enteric-coated timed-release matrix tablets for colon targeting. J. Drug. Target. 12 (9–10):607–612.
   PubMed Web of Science ®Google Scholar
• M. E. Aulton, A. M. Dyer, and K. A. Khan. (1994). The strength and compaction of millispheres. Drug Dev. Ind. Pharm. 20 (20):3069–3104.
   Web of Science ®Google Scholar
• P. M. G. Bavin, A. Post, and J. E. Zarembo. (1984). Cimetidine. K. Florey. Analytical profiles of drug substances. New York: Academic Press, 127–182.
   Google Scholar
• H. Bechgaard, and G. H. Nielsen. (1978). Controlled-release multiple-units and single-unit doses. Drug Dev. Ind. Pharm. 4:53–67.
   Web of Science ®Google Scholar
• R. Bodmeier, and O. Paeratakul. (1994). Mechanical properties of dry and wet cellulosic and acrylic films prepared from aqueous colloidal polymer dispersions used in the coating of solid dosage forms. Pharm. Res. 11 (6):882–888.
   PubMed Web of Science ®Google Scholar
• D. Brooke. (1975). Sieve cuts as monodisperse powders in dissolution studies. J. Pharm. Sci. 64:1409–1412.
   PubMed Web of Science ®Google Scholar
• G. Buckton, D. Ganderton, and R. Shah. (1988). In vitro dissolution of some commercially available sustained-release theophylline preparations. Int. J. Pharm. 42:35–39.
   Google Scholar
• T. Bussemer, N. A. Peppas, and R. Bodmeier. (2003). Time-dependent mechanical properties of polymeric coatings used in rupturable pulsatile release dosage forms. Drug Dev. Ind. Pharm. 29 (6):623–630.
   PubMed Web of Science ®Google Scholar
• S. L. Cantor, S. W. Hoag, and L. L. Augsburger. (2008). Formulation and characterization of a compacted multiparticulate system for modified release of water-soluble drugs –Part 1 Acetaminophen. Drug Dev. Ind. Pharm. accepted for publication. DOI: 10.1080/03639040802360502
   Web of Science ®Google Scholar
• J. T. Cartensen, J. L. Wright, K. Blessel, and J. Sheridan. (July, 1978). USP dissolution III. Semilogarithmic dissolution patterns in tablets in rotating basket assemblies. J. Pharm. Sci. 67:982–984.
   PubMed Web of Science ®Google Scholar
• M. Celik, and L. Maganti. (1994). Formulation and compaction of microspheres. Drug Dev. Ind. Pharm. 20:3151–3173.
   Web of Science ®Google Scholar
• R. K. Chang, and E. M. Rudnic. (1991). The effect of various polymeric coating systems on the dissolution and tableting properties of potassium chloride microcapsules. Int. J. Pharm. 70:261–270.
   Google Scholar
• J. Chatchawalsaisin, R. Podczeck, and J. M. Newton. (2005). The preparation by extrusion/spheronization and the properties of beads containing drugs, microcrystalline cellulose and glyceryl monostearate. Eur. J. Pharm. Sci. 24:35–48.
   PubMed Web of Science ®Google Scholar
• J. L. Cohen. (1975). Theophylline. K. Florey. Analytical profiles of drug substances. New York: Academic Press, 467–493.
   Google Scholar
• P. Costa, and J. M. S. Lobo. (2001). Modeling and comparison of dissolution profiles. Eur. J. Pharm. Sci 13:123–133.
   PubMed Web of Science ®Google Scholar
• A. Dashevsky, K. Kolter, and R. Bodmeier. (2004). Compression of beads coated with various aqueous polymer dispersions. Int. J. Pharm. 279:19–26.
   PubMed Web of Science ®Google Scholar
• A. Debunne, C. Vervaet, D. Mangelings, and J. P. Remon. (2004). Compaction of enteric-coated beads: Influence of formulation and process parameters on tablet properties and in vivo evaluation. Eur. J. Pharm. Sci. 22:305–314.
   PubMed Web of Science ®Google Scholar
• N. K. Ebube, A. H. Hikal, C. M. Wyandt, D. C. Beer, L. G. Miller, and A. B. Jones. (1997). Sustained release of Acetaminophen matrix tablets: Influence of polymer ratio, polymer loading, and co-active on drug release. Pharm. Dev. Tech. 2 (2):161–170.
   PubMedGoogle Scholar
• A. Fan, S. Pallerla, G. Carlson, D. Ladipo, J. Dukich, R. Capella, and S. Leung. (2005). Effect of particle size distribution and flow property of powder blend on tablet weight variation. Am. Pharm. Rev. 8 (2):73–78.
   Google Scholar
• Guidance for Industry. (1995). Immediate release solid oral dosage forms—Scale-up and post-approval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, in vivo, bioequivalence documentation. Rockville, MD: CDER-FDA.. Retrieved September 6, 2008, from http://www.fda.gov/cder/guidance/cmc5.pdf.
   Google Scholar
• Guidance for Industry. (2000). Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Retrieved May 25, 2008, from http://www.fda.gov/cder/guidance/index.htm.
   Google Scholar
• Y. S. Habib, L. L. Augsburger, and R. F. Shangraw. (2002). Production of inert cushioning beads: Effect of excipients on the physicomechanical properties of freeze-dried beads containing microcrystalline cellulose produced by extrusion–spheronization. Int. J. Pharm. 233 (1):67–83.
   PubMedGoogle Scholar
• T. Hayshi, H. Kanbe, M. Okada, M. Suzuki, Y. Ikeda, Y. Onuki, T. Kaneko, and T. Sonobe. (2005). Formulation study and drug release mechanism of a new theophylline sustained-release preparation. Int. J. Pharm. 304:91–101.
   PubMedGoogle Scholar
• P. W. Heng, J. S. Hao, L. W. Chan, and S. H. Chew. (2004). Influences of osmotic agents in diffusion layer on drug release from multilayer coated beads. Drug Dev. Ind. Pharm. 30 (2):213–220.
   PubMed Web of Science ®Google Scholar
• Y. Huang, K. H. Khanvilkar, A. D. Moore, and M. Hilliard-Lott. (2003). Effects of manufacturing process variables on in vitro dissolution characteristics of extended-release tablets formulated with hydroxypropyl methylcellulose. Drug Dev. Ind. Pharm. 29 (1):79–88.
   PubMed Web of Science ®Google Scholar
• N. Iloanusi, and J. B. Schwartz. (1998). The effect of wax on compaction of microcrystalline cellulose beads made by extrusion and spheronization. Drug Dev. Ind. Pharm. 24:37–44.
   PubMed Web of Science ®Google Scholar
• B. J. Lee, S. G. Ryu, and J. H. Cui. (1999). Controlled release of dual drug-loaded hydroxypropyl methylcellulose matrix tablet using drug-containing polymeric coatings. Int. J. Pharm. 188:71–80.
   PubMed Web of Science ®Google Scholar
• K. Lehmann. (2001). Practical course in film coating of pharmaceutical dosage forms with EUDRAGIT. DarmstadtGermany: Rohm GmbH & Co.
   Google Scholar
• A. E. K. Lundqvist, F. Podczeck, and J. M. Newton. (1997). Influence of disintegrant type and proportion on the properties of tablets produced from mixtures of beads. Int. J. Pharm. 147:95–107.
   Web of Science ®Google Scholar
• A. E. K. Lundqvist, F. Podczeck, and J. M. Newton. (1998). Compaction of, and drug release from, coated drug beads mixed with other beads. Eur. J. Pharm. Biopharm. 46:369–379.
   PubMed Web of Science ®Google Scholar
• H. A. Merchant, H. M. Shoaib, J. Tazeen, and R. I. Yousuf. (2006). Once-daily tablet formulation and in vitro release evaluation of Cefpodoxime using hydroxypropyl methylcellulose: A technical note. AAPS Pharm. Sci. Tech. 7 (3): E1–E6
   PubMed Web of Science ®Google Scholar
• D. L. Mount, and J. B. Schwartz. (1996). Formulation and compaction of nonfracturing deformable coated beads. Drug Dev. Ind. Pharm. 22:609–621.
   Web of Science ®Google Scholar
• F. Nicklasson, and G. Alderborn. (1999a). Modulation of the tableting behaviour of microcrystalline cellulose beads by the incorporation of polyethylene glycol. Eur. J. Pharm. Sci. 9:57–65.
   PubMed Web of Science ®Google Scholar
• F. Nicklasson, B. Johansson, and G. Alderborn. (1999b). Occurrence of fragmentation during compression of beads prepared from a 4 to 1 mixture of dicalcium phosphate dehydrate and microcrystalline cellulose. Eur. J. Pharm. Sci. 7:221–229.
   PubMed Web of Science ®Google Scholar
• G. F. Palmieri, and P. Wehrle. (1997). Evaluation of ethylcellulose-coated beads optimized using the approach of Taguchi. Drug Dev. Ind. Pharm. 23 (11):1069–1077.
   Web of Science ®Google Scholar
• N. A. Peppas, and J. J. Sahlin. (1989). A simple equation for the description of solute release. III. Coupling of diffusion and relaxation. Int. J. Pharm. 57:169–172.
   Web of Science ®Google Scholar
• J. F. Pinto, F. Podczeck, and J. M. Newton. (1997). Investigations of tablets prepared from beads produced by extrusion and spheronization. Part I: The application of canonical analysis to correlate the properties of the tablets to the factors studied in combination with principal component analysis to select the most relevant factors. Int. J. Pharm. 147:79–93.
   Web of Science ®Google Scholar
• A. M. Railkar, and J. B. Schwartz. (2001). Use of a moist granulation technique (MGT) to develop controlled-release dosage forms of Acetaminophen. Drug Dev. Ind. Pharm. 27 (4):337–343.
   PubMed Web of Science ®Google Scholar
• H. Rey, K. G. Wagner, P. Wehrle, and P. C. Schmidt. (2000). Development of matrix-based theophylline sustained-release microtablets. Drug Dev. Ind. Pharm. 26 (1):21–26.
   PubMed Web of Science ®Google Scholar
• P. L. Ritger, and N. A. Peppas. (1987). A simple equation for description of solute release I. Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or discs. J. Control Reease. 5:23–36.
   Google Scholar
• M. Salako, F. Podczeck, and J. M. Newton. (1998). Investigations into the deformability and tensile strength of beads. Int. J. Pharm. 168:49–57.
   Web of Science ®Google Scholar
• N. M. Sanghavi, P. R. Kamath, and D. S. Amin. (1990). Sustained release tablets of theophylline. Drug Dev. Ind. Pharm. 16 (11):1843–1848.
   Web of Science ®Google Scholar
• V. P. Shah, Y. Tsong, P. Sathe, and J.-P. Liu. (1998). In vitro dissolution profile comparison—Statistics and analysis of the similarity factor, f2. Pharm. Res. 15 (6):889–896.
   PubMed Web of Science ®Google Scholar
• A. Sood, and R. Panchagnula. (1998). Drug release evaluation of diltiazem CR preparations. Int. J. Pharm. 175:95–107.
   Web of Science ®Google Scholar
• S. Sumathi, and A. R. Ray. (2002). Release behavior of drugs from tamarind seed polysaccharide tablets. J. Pharm. Pharmaceut. Sci. 5 (1):12–18.
   PubMed Web of Science ®Google Scholar
• S. B. Tiwari, T. M. Murthy, M. R. Pai, P. R. Mehta, and P. B. Chowdary. (2003). Controlled release formulation of tramadol hydrochloride using hydrophilic and hydrophobic matrix system. AAPS Pharm. Sci. Tech. 4 (3):1–6.
   Google Scholar
• J. J. Torrado, and L. L. Augsburger. (1994). Effect of different excipients on the tableting of coated particles. Int. J. Pharm. 106:149–155.
   Web of Science ®Google Scholar
• G. J. Vergote, F. Kiekens, C. Vervaet, and J. P. Remon. (2002). Wax beads as cushioning agents during the compression of coated diltiazem beads. Eur. J. Pharm. Sci. 17:145–151.
   PubMed Web of Science ®Google Scholar
• C. Vervaet, L. Baert, and J. P. Remon. (1995). Extrusion-spheronization: A literature review. Int. J. Pharm. 116:131–146.
   Web of Science ®Google Scholar
• M. K. Vuppala, D. M. Parikh, and H. R. Bhagat. (1997). Application of powder-layering technology and film coating for manufacture of sustained-release beads using a rotary fluid bed processor. Drug Dev. Ind. Pharm. 23 (7):687–694.
   Web of Science ®Google Scholar
• C. Wang, G. Zhang, N. H. Shah, M. H. Infeld, A. W. Malick, and J. W. McGinity. (1997). Influence of plasticizers on the mechanical properties of beads containing Eudragit RS-30D. Int. J. Pharm. 152:153–163.
   Web of Science ®Google Scholar
• G. Zhang, K. B. Schwartz, and R. L. Schnaare. (1991a). Bead coating I. Change in release kinetics (and mechanism) due to coating levels. Pharm. Res. 8 (3):331–335.
   PubMed Web of Science ®Google Scholar
• G. Zhang, K. B. Schwartz, and R. L. Schnaare. (1991b). Bead coating II. Effect of spheronization technique on drug release from coated spheres. Drug Dev. Ind. Pharm. 17 (6):817–830.
   Web of Science ®Google Scholar
• F. Zhou, C. Vervaet, and J. P. Remon. (1996). Matrix beads based on the combinations of waxes, starches and maltodextrins. Int. J. Pharm. 133 (1–2):155–160.
   Google Scholar
• F. Zhou, C. Vervaet, M. Schelkens, R. Lefebvre, and J. P. Remon. (1998). Bioavailability of ibuprofen from matrix beads based on the combination of waxes and starch derivatives. Int. J. Pharm. 168:79–84.
   Web of Science ®Google Scholar
• Y. C. Zhu, K. A. Mehta, and J. W. McGinity. (2006). Influence of plasticizer level on the drug release from sustained release film coated and hot-melt extruded dosage forms. Pharm. Dev. Tech. 11 (3):285–294.
   PubMed Web of Science ®Google Scholar