A new pressure-controlled colon delivery capsule for chronotherapeutic treatment of nocturnal asthma

References

• Alvarez-Fuentes J, Fernández-Arévalo M, González-Rodríguez ML, Cirri M, Mura P. (2004). Development of enteric-coated timed-release matrix tablets for colon targeting. J Drug Target, 12, 607–612.
   PubMed Web of Science ®Google Scholar
• Barakat NS. (2006). Etodolac-liquid-filled dispersion into hard gelatin capsules: an approach to improve dissolution and stability of etodolac formulation. Drug Dev Ind Pharm, 32, 865–876.
   PubMed Web of Science ®Google Scholar
• Bi-Botti CY. (2004). Chronopharmaceutics: Gimmick or clinically relevant approach to drug delivery. J Control Release, 98, 337–353.
   PubMed Web of Science ®Google Scholar
• Bjorn L. (1996). The clinical relevance of chronopharmacology in therapeutics. Pharmacol Res, 33, 107–115.
   PubMed Web of Science ®Google Scholar
• Calhoum WJ. (2002). Nocturnal asthma. Chest, 123, 399S–405S.
   Web of Science ®Google Scholar
• Chan WA, Boswell CD, Zhang Z. (2001). Comparison of the release profiles of a water soluble drug carried by Eudragit-coated capsules in different in-vitro dissolution liquids. Powder Technol, 119, 26–32.
   Web of Science ®Google Scholar
• Chen X, Jun Shou Z, Yun MO. (2005). Calcium pectinate capsule for colon specific drug delivery. Drug Dev Ind Pharm 31, 127–134.
   PubMed Web of Science ®Google Scholar
• Cheng G, An F, Zou MJ, Sun J, Hao XH, He YX. (2004). Time- and pH-dependent colon-specific drug delivery for orally administered diclofenac sodium and 5-aminosalicylic acid. World J Gastroenterol, 10, 1769–1774.
   PubMed Web of Science ®Google Scholar
• Coudert B, Focan C, Donato di Paola E, Lévi F; EORTC Chronotherapy Group. (2002). It’s time for chronotherapy! Eur J Cancer, 38 Suppl 4, S50–S53.
   PubMedGoogle Scholar
• D’Alonzo GE, Smolensky MH, Feldman S, Gianotti LA, Emerson MB, Staudinger H, Steinijans VW. (1990). Twenty-four hour lung function in adult patients with asthma. Chronoptimized theophylline therapy once-daily dosing in the evening versus conventional twice-daily dosing. Am Rev Respir Dis, 142, 84–90.
   PubMed Web of Science ®Google Scholar
• de Oliveira HP, Albuquerque JJ Jr, Nogueiras C, Rieumont J. (2009). Physical chemistry behavior of enteric polymer in drug release systems. Int J Pharm, 366, 185–189.
   PubMed Web of Science ®Google Scholar
• Digenis GA, Sandefer E. (1991). Gamma scintigraphy and neutron activation techniques in the in vivo assessment of orally administered dosage forms. Crit Rev Ther Drug Carrier Syst, 7, 309–345.
   PubMed Web of Science ®Google Scholar
• DiLuccio RC, Hussain MA, Coffin-Beach D, Torosian G, Shefter E, Hurwitz AR. (1994). Sustained-release oral delivery of theophylline by use of polyvinyl alcohol and polyvinyl alcohol-methyl acrylate polymers. J Pharm Sci, 83, 104–106.
   PubMed Web of Science ®Google Scholar
• El Massik MA, Abdallah OY, Galal S, Daabis NA. (2003). Semisolid matrix filled capsules: an approach to improve dissolution stability of phenytoin sodium formulation. Drug Dev Ind Pharm, 29, 531–543.
   PubMed Web of Science ®Google Scholar
• Ghimire M, McInnes FJ, Watson DG, Mullen AB, Stevens HN. (2007). In-vitro/in-vivo correlation of pulsatile drug release from press-coated tablet formulations: a pharmacoscintigraphic study in the beagle dog. Eur J Pharm Biopharm, 67, 515–523.
   PubMed Web of Science ®Google Scholar
• Gibaldi M, Perrier D. (1982). Pharmacokinetics. Dekker, New York.
   Google Scholar
• Gupta VK, Beckert TE, Price JC. (2001). A novel pH- and time-based multi-unit potential colonic drug delivery system. I. Development. Int J Pharm, 213, 83–91.
   PubMed Web of Science ®Google Scholar
• Hu Z, Mawatari S, Shibata N, Takada K, Yoshikawa H, Arakawa A, Yosida Y. (2000a). Application of a biomagnetic measurement system (BMS) to the evaluation of gastrointestinal transit of intestinal pressure-controlled colon delivery capsules (PCDCs) in human subjects. Pharm Res, 17, 160–167.
   PubMed Web of Science ®Google Scholar
• Hu Z, Mawatari S, Shimokawa T, Kimura G, Yoshikawa Y, Shibata N, Takada K. (2000b). Colon delivery efficiencies of intestinal pressure-controlled colon delivery capsules prepared by a coating machine in human subjects. J Pharm Pharmacol, 52, 1187–1193.
   PubMed Web of Science ®Google Scholar
• Hu Z, Shimokawa T, Ohno T, Kimura G, Mawatari SS, Kamitsuna M, Yoshikawa Y, Masuda S, Takada K. (1999). Characterization of norfloxacine release from tablet coated with a new pH-sensitive polymer, P-4135F. J Drug Target, 7, 223–232.
   PubMed Web of Science ®Google Scholar
• Huyghebaert N, Vermeire A, Remon JP. (2005). In vitro evaluation of coating polymers for enteric coating and human ileal targeting. Int J Pharm, 298, 26–37.
   PubMed Web of Science ®Google Scholar
• Kamba M, Seta Y, Kusai A, Ikeda M, Nishimura K. (2000). A unique dosage form to evaluate the mechanical destructive force in the gastrointestinal tract. Int J Pharm, 208, 61–70.
   PubMed Web of Science ®Google Scholar
• Kamba M, Seta Y, Kusai A, Nishimura K. (2001). Evaluation of the mechanical destructive force in the stomach of dog. Int J Pharm, 228, 209–217.
   PubMed Web of Science ®Google Scholar
• Kamba M, Seta Y, Kusai A, Nishimura K. (2002). Comparison of the mechanical destructive force in the small intestine of dog and human. Int J Pharm, 237: 139–149.
   PubMedGoogle Scholar
• Kinget R, Kalala W, Vervoort L, van den Mooter G. (1998). Colonic drug targeting. J Drug Target, 6, 129–149.
   PubMed Web of Science ®Google Scholar
• Krögel I, Bodmeier R. (1998). Pulsatile drug release from an insoluble capsule body controlled by an erodible plug. Pharm Res, 15, 474–481.
   PubMed Web of Science ®Google Scholar
• Lemmer B. (1991). Circadian rhythms and drug delivery. J Control Release, 16, 63–74.
   Web of Science ®Google Scholar
• Libo Y, James SC, Joseph AF. (2002). Colon specific drug delivery: new approaches and in vitro/in vivo evaluation review. Int J Pharm, 235, 1–15.
   PubMedGoogle Scholar
• Mastiholimath VS, Dandagi PM, Jain SS, Gadad AP, Kulkarni AR. (2007). Time and pH dependent colon specific, pulsatile delivery of theophylline for nocturnal asthma. Int J Pharm, 328, 49–56.
   PubMed Web of Science ®Google Scholar
• Muraoka M, Hu Z, Shimokawa T, Sekino S, Kurogoshi R, Kuboi Y, Yoshikawa Y, Takada K. (1998). Evaluation of intestinal pressure-controlled colon delivery capsule containing caffeine as a model drug in human volunteers. J Control Release, 52, 119–129.
   PubMed Web of Science ®Google Scholar
• Niwa K, Takaya T, Morimoto T, Takada K. (1995). Preparation and evaluation of a time-controlled release capsule made of ethylcellulose for colon delivery of drugs. J Drug Target, 3, 83–89.
   PubMed Web of Science ®Google Scholar
• Oosegi T, Onishi H, Machida Y. (2008). Novel preparation of enteric-coated chitosan-prednisolone conjugate microspheres and in vitro evaluation of their potential as a colonic delivery system. Eur J Pharm Biopharm, 68, 260–266.
   PubMed Web of Science ®Google Scholar
• Raffin RP, Colomé LM, Guterres SS, Pohlmann AR. (2007). Enteric controlled-release pantoprazole-loaded microparticles prepared by using Eudragit S100 and poly(epsilon-caprolactone) blend. Pharm Dev Technol, 12, 463–471.
   PubMed Web of Science ®Google Scholar
• Rao S, Ritschel WA. (1995). Colonic drug delivery of small peptides. STP Pharma Sciences, 5, 19–29.
   Google Scholar
• Ritschel WA. (1991). Targeting in the gastrointestinal tract: new approaches. Methods Find Exp Clin Pharmacol, 13, 313–336.
   PubMed Web of Science ®Google Scholar
• Rogge MC, Solomon WR, Sedman AJ, Welling PG, Toothaker RD, Wagner JG.(1988). The theophylline-enoxacin interaction: I. Effect of enoxacin dose size on theophylline disposition. Clin Pharmacol Ther, 44, 579–587.
   PubMed Web of Science ®Google Scholar
• Rojanasthien N, Kovjiriyapan K, Manorot M, Pothirat C. (2001). Comparative steady-state bioavailability of sustained-release theophylline preparations: Theo-Dur, Uni-Dur and Xanthium. Asian Pac J Allergy Immunol, 19, 69–78.
   PubMed Web of Science ®Google Scholar
• Sarasija S, Stutie P. (2005). Chronotherapeutics: emerging role of biorhythms in optimizing drug therapy. Indian J Phrm Sci, 67, 135–140.
   Google Scholar
• Sawada T, Kondo H, Nakashima H, Sako K, Hayashi M. (2004). Time-release compression-coated core tablet containing nifedipine for chronopharmacotherapy. Int J Pharm, 280, 103–111.
   PubMed Web of Science ®Google Scholar
• Schellekens RC, Stellaard F, Mitrovic D, Stuurman FE, Kosterink JG, Frijlink HW. (2008). Pulsatile drug delivery to ileo-colonic segments by structured incorporation of disintegrants in pH-responsive polymer coatings. J Control Release, 132, 91–98.
   PubMed Web of Science ®Google Scholar
• Shah VP, Midha KK, Dighe S, McGilveray IL, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S. (1992). Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. J Pharm Sci, 81, 309–312.
   Web of Science ®Google Scholar
• Smolensky MH. (1996). Chronobiology and chronotherapeutics. Applications to cardiovascular medicine. Am J Hypertens, 9, 11S–21S.
   PubMed Web of Science ®Google Scholar
• Staib AH, Loew D, Harder S, Graul EH, Pfab R. (1986). Measurement of theophylline absorption from different regions of the gastro-intestinal tract using a remote controlled drug delivery device. Eur J Clin Pharmacol, 30, 691–697.
   PubMed Web of Science ®Google Scholar
• Takaya T, Ikeda C, Imagawa N, Niwa K, Takada K. (1995). Development of a colon delivery capsule and the pharmacological activity of recombinant human granulocyte colony-stimulating factor (rhG-CSF) in beagle dogs. J Pharm Pharmacol, 47, 474–478.
   PubMed Web of Science ®Google Scholar
• Tatsis G, Tsoukalas G, Haviaras A, Peristerakis A, Filaditaki V, Orfanidou D, Anagnostou E. (1996). Bioavailability of a new sustained-release anhydrous theophylline product. J Int Med Res, 24, 331–339.
   PubMed Web of Science ®Google Scholar
• Tulain U, Ur-Rahman N. (2008). Comparative bioavailability and in vitro in vivo correlation of two sustained release brands of theophylline: tablets and pellets. Pak J Pharm Sci, 21, 131–138.
   PubMed Web of Science ®Google Scholar
• Ueda S, Hata T, Asakura S, Yamaguchi H, Kotani M, Ueda Y. (1994). Development of a novel drug release system, time-controlled explosion system (TES). I. Concept and design. J Drug Target, 2, 35–44.
   PubMed Web of Science ®Google Scholar
• Vippagunta SR, Maul KA, Tallavajhala S, Grant DJ. (2002). Solid-state characterization of nifedipine solid dispersions. Int J Pharm, 236, 111–123.
   PubMed Web of Science ®Google Scholar
• Watts PJ, Illum L. (1997). Colonic drug delivery. Drug Dev Ind Pharm, 23, 893–913.
   Web of Science ®Google Scholar
• White WB, Black HR, Weber MA, Elliott WJ, Bryzinski B, Fakouhi TD. (1998). Comparison of effects of controlled onset extended release verapamil at bedtime and nifedipine gastrointestinal therapeutic system on arising on early morning blood pressure, heart rate, and the heart rate-blood pressure product. Am J Cardiol, 81, 424–431.
   PubMed Web of Science ®Google Scholar
• Wilding IR, Davis SS, O’Hagan DT. (1994). Targeting of drugs and vaccines to the gut. Pharmacol Ther, 62, 97–124.
   PubMed Web of Science ®Google Scholar
• Yassin AE, Alanazi FK, El-Badry M, Alsarra IA, Barakat NS, Alanazi FK. (2009). Preparation and characterization of spironolactone-loaded gelucire microparticles using spray-drying technique. Drug Dev Ind Pharm, 35, 297–304.
   PubMed Web of Science ®Google Scholar
• Yassin AE, Al-Suwayeh S, Aodah AH, Taha E. A new theophylline chronotherapeutic drug delivery system for the treatment of nocturnal asthma. J Pharm Pharmacol (Submitted).
   Google Scholar