Formulation development and in-vitro/in-vivo correlation for a novel sterculia gum-based oral colon-targeted drug delivery system of azathioprine

References

• Jain A, Gupta Y, Jain SK. (2007). Perspectives of biodegradable natural polysaccharides for site-specific drug delivery to the colon. J Pharm Pharm Sci, 10:86–128.
   PubMed Web of Science ®Google Scholar
• Pantel N, Patel J, Gandhi T, Shah S. (2008) Novel pharmaceutical approach for colon-specific drug delivery: an overview. J Pharm Res, 1:2–10.
   Google Scholar
• Kwonho K, Kaur K. (2009). Studies of chitosan/organic acid/Eudragit® RS/RL-coated system for colonic delivery. Int J Pharm, 366:140–148.
   PubMed Web of Science ®Google Scholar
• Fan LF, He W, Chang YZ, Xiang B, Du Q, Wang F, Qin M, Cao DY. (2009). Studies of chitosan/Kollicoat SR 30D film-coated tablets for colonic drug delivery. Int J Pharm, 375:8–15.
   PubMed Web of Science ®Google Scholar
• Chivate AA, Poddar SS, Abdul S, Savant G. (2008). Evaluation of Sterculia foetida gum as controlled release excipient. AAPS PharmSciTech, 9:197–204.
   PubMed Web of Science ®Google Scholar
• Lankalapalli S, Kolapalli RM. (2012). Biopharmaceutical evaluation of diclofenac sodium controlled release tablets prepared from gum karaya-chitosan polyelectrolyte complexes. Drug Dev Ind Pharm, 38:815–824.
   PubMed Web of Science ®Google Scholar
• Waterman KC, MacDonald BC, Roy MC. (2009). Extrudable core system: Development of a single-layer osmotic controlled-release tablet. J Control Release, 134, 201–206.
   PubMed Web of Science ®Google Scholar
• Lu EX, Jiang ZQ, Zhang QZ, Jiang XG. (2003). A water-insoluble drug monolithic osmotic tablet system utilizing gum arabic as an osmotic, suspending and expanding agent. J Control Release, 92:375–382.
   PubMed Web of Science ®Google Scholar
• Lehmann KOR. Aqueous polymeric coatings for pharmaceutical dosage forms. Marcel Dekker, New York, 1997, 1–76.
   Google Scholar
• Singh BN, Kim KH. (2007). Characterization and relevance of physicochemical interactions among components of a novel multiparticulate formulation for colonic delivery. Int J Pharm, 341:143–151.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Bonnie H, Goldlust B, Goldberg AH. (2001). Targeted delivery of azathioprine (AZA) to the ileum and colon for the treatment of Crohn’s disease (CD): Scintigraphic and pharmacokinetic (PK) evaluation of a novel azathioprine delayed-release (AZA-DR) formulation. Gastroenterology, 120, 625–629.
   Web of Science ®Google Scholar
• Katsuma M, Watanabe S, Kawai H, Takemura S, Masuda Y, Fukui M. (2002). Studies on lactulose formulations for colon-specific drug delivery. Int J Pharm, 249:33–43.
   PubMed Web of Science ®Google Scholar
• Zhang H, Neau SH. (2002). In vitro degradation of chitosan by bacterial enzymes from rat cecal and colonic contents. Biomaterials, 23:2761–2766.
   PubMed Web of Science ®Google Scholar
• Jaleh V, Naser T, Fatemeh K. (2006). Use of hydrophilic natural gums in formulation of sustained-release matrix tablets of tramadol hydrochloride. AAPS Pharm Sci Tech, 7, E1–E7.
   PubMed Web of Science ®Google Scholar
• Schilling SU, Bruce CD, Shah NH, Malick AW, McGinity JW. (2008). Citric acid monohydrate as a release-modifying agent in melt extruded matrix tablets. Int J Pharm, 361:158–168.
   PubMed Web of Science ®Google Scholar
• Pandey P, Turton R, James E. (2006) Scale-up of a pan-coating process. AAPS Pharm Sci Tech, 7:E1–E8.
   PubMedGoogle Scholar
• Liu H, Yang XG, Nie SF, Wei LL, Zhou LL, Liu H et al. (2007). Chitosan-based controlled porosity osmotic pump for colon-specific delivery system: screening of formulation variables and in vitro investigation. Int J Pharm, 332:115–124.
   PubMed Web of Science ®Google Scholar
• Omwancha W, Kouba C, Yelamanchili S, Neau SH. (2006) Colon-specific drug delivery using ethylcellulose and chitosan in the coat of compression-coated tablets. Drug Dev Ind Pharm, 37:945–953.
   Google Scholar
• Akhgari A, Sadeghi F, Garekani HA. (2006). Combination of time-dependent and pH-dependent polymethacrylates as a single coating formulation for colonic delivery of indomethacin pellets. Int J Pharm, 320:137–142.
   PubMed Web of Science ®Google Scholar
• Yang L. (2008). Biorelevant dissolution testing of colon-specific delivery systems activated by colonic microflora. J Control Release, 125:77–86.
   PubMed Web of Science ®Google Scholar
• Raghavan CV, Muthulingam C, Jenita JA, Ravi TK. (2002). An in vitro and in vivo investigation into the suitability of bacterially triggered delivery system for colon targeting. Chem Pharm Bull, 50:892–895.
   PubMed Web of Science ®Google Scholar
• Lai H, Zhu F, Yuan W, He N, Zhang Z, Zhang X, He Q. (2011). Development of multiple-unit colon-targeted drug delivery system by using alginate: in vitro and in vivo evaluation. Drug Dev Ind Pharm, 37:1347–1356.
   PubMed Web of Science ®Google Scholar
• Kramar A, Turk S, Vrecer F. (2003). Statistical optimisation of diclofenac sustained release pellets coated with polymethacrylic films. Int J Pharm, 256:43–52.
   PubMed Web of Science ®Google Scholar
• Fu HX, Li H, Zhang FZ, Zhao YZ, Wan CW, Chen MT, Jia XC, Yan L, Sun CC, Xu YY. (2012). Experiment on formulation and drug release behavior of porosity asymmetric membrane capsules in vitro. Drug Dev Ind Pharm, 38:670–678.
   PubMed Web of Science ®Google Scholar
• Kotagale N, Maniyar M, Somvanshi S, Umekar M, Patel CJ. (2010). Eudragit-S, Eudragit-L and cellulose acetate phthalate coated polysaccharide tablets for colonic targeted delivery of azathioprine. Pharm Dev Technol, 15:431–437.
   PubMed Web of Science ®Google Scholar
• Marucci M, Ragnarsson G, Nyman U, Axelsson A. (2008). Mechanistic model for drug release during the lag phase from pellets coated with a semi-permeable membrane. J Control Release, 127:31–40.
   PubMed Web of Science ®Google Scholar
• Costa P, Sousa Lobo JM. (2001). Modeling and comparison of dissolution profiles. Eur J Pharm Sci, 13:123–133.
   PubMed Web of Science ®Google Scholar
• Cartensen JT, Rhodes CT. Drug stability, principles and practices of pharmaceuticals. Informa Healthcare: New York, 2010, 358–365.
   Google Scholar
• Umrethia ML, Ghosh PK, Majithiya RJ, Murthy RSR. (2006). New RP-HPLC method for the estimation of 6-mercaptopurine in rat plasma and various tissue homogenates. J Liquid Chromat Related Techno, 29:55–67.
   Web of Science ®Google Scholar
• Tang J, Zhou S, Huang L, Huang Y, Zhang H. (1998). [Determination of azathiopurine and 6-mercaptopurine in serum by reversed-phase high performance liquid chromatography]. Se Pu, 16:513–515.
   PubMedGoogle Scholar
• Shao-Jun S, Zhong-Fang L, Hua-Ting C, Fan-Dian Z. (2006). Pharmacokinetics and bioequivalence evaluation of azathioprine in healthy Chinese volunteers. Asian J Pharmacodyn Pharmacokin, 6:331–336.
   Google Scholar
• Tamilvanan S, Venkatesh Babu R, Nappinai A, Sivaramakrishnan G. (2011). In vitro and in vivo evaluation of hydrophilic and hydrophobic polymers-based nicorandil-loaded peroral tablet compared with its once-daily commercial sustained-release tablet. Drug Dev Ind Pharm, 37:436–445.
   PubMed Web of Science ®Google Scholar