Oral delivery system for two-pulse colonic release of protein drugs and protease inhibitor/absorption enhancer compounds

Journal of Pharmaceutical Sciences

Volumn 100, Issue 8, 2011, Pages 3251-3259

  Del Curto, Maria Dorly ^a   Maroni, Alessandra ^a   Palugan, Luca ^a   Zema, Lucia ^a   Gazzaniga, Andrea ^a   Sangalli, Maria Edvige ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

Coating; Colonic drug delivery; Formulation; In vitro release; Insulin; Oral drug delivery; Peptide delivery; Pulsatile release

Indexed keywords

CAMOSTAT MESILATE; GLYCOCHOLATE SODIUM; HYDROXYPROPYLMETHYLCELLULOSE; INSULIN; METHYLCELLULOSE; PENETRATION ENHANCING AGENT; PROTEINASE INHIBITOR;

ARTICLE; COLON; DRUG ABSORPTION; DRUG COATING; DRUG DELIVERY SYSTEM; DRUG RELEASE; IMMEDIATE RELEASE DRUG FORMULATION; PROTEIN STABILITY; PULSATILE DRUG RELEASE; TABLET DISINTEGRATION; TABLET FORMULATION; TABLET FRIABILITY; TABLET THICKNESS;

EID: 79958793843     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22560     Document Type: Article

References (20)

1. Sinha VR, Singh A, Kumar RV, Singh S, Kumria R, Bhinge JR. 2007. Oral colon-specific drug delivery of protein and peptide drugs. Crit Rev Ther Drug Carrier Syst 24:63-92.
2. Beauchesne PR, Chung NSC, Wasan KM. 2007. Cyclosporine A: A review of current oral and intravenous delivery systems. Drug Dev Ind Pharm 33:211-220.
3. Bernkop-Schnurch A. 1998. The use of inhibitory agents to overcome the enzymatic barrier to perorally administered therapeutic peptides and proteins. J Control Release 52:1-16.
4. Bourgeois S, Harvey R, Fattal E. 2005. Polymer colon drug delivery systems and their application to peptides, proteins, and nucleic acids. Am J Drug Deliv 3:171-204.
5. Rubinstein A, Tirosh B, Baluom M, Nassar T, David A, Radai R, Gliko-Kabir I, Friedman M. 1997. The rationale for peptide drug delivery to the colon and the potential of polymeric carriers as effective tools. J Control Release 46:59-73.
6. Luessen HL, Verhoef JC, Borchard G, Lehr CM, De Boer AG, Junginger HE. 1995. Mucoadhesive polymers in peroral peptide drug delivery. II. Carbomer and polycarbophil are potent inhibitors of the intestinal proteolytic enzyme trypsin. Pharm Res 12:1293-1298.
7. Dorkoosh FA, Verhoef JC, Borchard G, Rafiee-Tehrani M, Junginger HE. 2001. Development and characterization of a novel peroral peptide drug delivery system. J Control Release 71:307-318.
8. Dorkoosh FA, Verhoef JC, Verheijden JHM, Rafiee-Tehrani M, Borchard G, Junginger HE. 2002. Peroral absorption of octreotide in pigs formulated in delivery systems on the basis of superporous hydrogel polymers. Pharm Res 19:1532-1536.
9. Maroni A, Del Curto MD, Serratoni M, Zema L, Foppoli A, Gazzaniga A, Sangalli ME. 2009. Feasibility, stability and release performance of a time-dependent insulin delivery system intended for oral colon release. Eur J Pharm Biopharm 72:246-251.
10. Sangalli ME, Maroni A, Zema L, Busetti C, Giordano F, Gazzaniga A. 2001. In vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery. J Control Release 73:103-110.
11. Gazzaniga A, Sangalli ME, Giordano F. 1994. Oral Chronotopic® drug delivery systems: Achievement of time and/or site specificity. Eur J Pharm Biopharm 40:246-250.
12. Davis SS. 1985. The design and evaluation of controlled release systems for the gastro-intestinal tract. J Control Release 2:27-38.
13. Del Curto MD, Maroni A, Foppoli A, Zema L, Gazzaniga A, Sangalli ME. 2009. Preparation and evaluation of an oral delivery system for time-dependent colon release of insulin and selected protease inhibitor and absorption enhancer compounds. J Pharm Sci 98:4661-4669.
14. Sangalli ME, Del Curto MD, Gazzaniga A, Maroni A, Palugan L, Spreafico M, Zema L. 2010. System for the colon delivery of drugs subject to enzyme degradation and/or poorly absorbed in the gastrointestinal tract. Patent WO2010/007515.
15. Gazzaniga A, Busetti C, Moro L, Sangalli ME, Giordano F. 1995. Time dependent oral delivery systems for colon targeting. STP Pharma Sci 5:83-88.
16. Conte U, Colombo P, La Manna A, Gazzaniga A, Sangalli ME, Giunchedi P. 1989. A new ibuprofen pulsed release oral dosage form. Drug Dev Ind Pharm 15:2583-2596.
17. Paciotti M, Perinati L, Gori F, Rampazzo P. 1983. High-performance liquid chromatographic determination of bile acids involved in the synthesis of ursodeoxycholic acid. J Chromatogr 270:402-406.
18. Sangalli ME, Maroni A, Zema L, Cerea M, Gazzaniga A. 2009. The Chronotopic™ technology. In Chronopharmaceutics; Youan B-BC, Ed. New Jersey: John Wiley & Sons, pp 146-163.
19. Yamamoto A, Taniguchi T, Rikyuu K, Tsuji T, Fujita T, Murakami M, Muranishi S. 1994. Effects of various protease inhibitors on the intestinal absorption and degradation of insulin in rats. Pharm Res 11:1496-1500.
20. Fetih G, Habib F, Okada N, Fujita T, Attia M, Yamamoto A. 2005. Nitric oxide donors can enhance the intestinal transport and absorption of insulin and [Asu1, 7]-eel calcitonin in rats. J Control Release 106:287-297.