Bibliography
- DAVIS SS, ILLUM L: Drug delivery systems for challenging molecules. Int. .1. Pharm. (1998) 176(0:1–8.
- SMOLENSKY MH: Chronobiology and chronotherapeutics. Applications to cardiovascular medicine. Am. J. Hypertens. (1996) 9 (4II) :11s–21s.
- LEMMER B: The clinical relevance of chronopharmacology in therapeutics. Pharmacol Res. (1996) 33(2):107–115.
- •The rationale behind a novel chronopharmaceutical approach in the management of disease is outlined in this paper.
- SMOLENSKY MH, REINBERG AE, MARTIN RJ, HAUS E: Clinical chronobiology and chronotherapeutics with application to asthma. Chronobiol Int. (1999) 16(5):539–563.
- •This paper outlines the rationale behind a novel chronopharmaceutical approach in the management of bronchial asthma.
- CHIEN YW: Controlled- and modulated-release drug-delivery systems. In: Encyclopedia of Pharmaceutical Technology. J S JC Boylan (Eds), Marcel Dekker, New York, NY, USA (1990):281–313.
- YOUAN BBC: Chronopharmaceutics: gimmick or clinically relevant approach to drug delivery?' Control. Release (2004) 98(3)337–353.
- •This article highlights the benefits of pharmacological chronotherapy and presents an array of relevant formulation approaches.
- LEMMER B: Chronopharmacokinetics: implications for drug treatment. J. Pharm. Pharmacol (1999) 51(8):887–890.
- •This paper discusses the impact of circadian rhythms on pharmacokinetics and, consequently, on the outcome of drug therapies.
- LEMMER B: Circadian rhythms and drug delivery. J. Control. Release (1991) 16(1-2):63–74.
- ••This author, particularly as far as the abovepaper is concerned, is considered as a pioneer of chronotherapy.
- HRUSHESKY WJ: Timing is everything. Sciences. (1994) 34(4):32–37.
- ••This paper is considered as a milestone inthe field of chronotherapy.
- LEMMER B: Chronopharmacological aspects for the prevention of acute coronary syndromes. Eur. Heart J. (1998) 19(C):50–58.
- •This paper outlines the rationale behind a novel chronopharmaceutical approach in the management of ischaemic heart disease.
- BUSSEMER T, OTTO I, BODMEIER R: Pulsatile drug-delivery systems. Crit. Rev Ther. Drug Carrier Syst. (2001) 18(5):433–458.
- •This is a comprehensive, clearly exposed review on pulsatile delivery systems dated 2001.
- GOTHOSKAR AV, JOSHI AM, JOSHI NH: Pulsatile drug delivery systems: a review. Drug Del. Technol. (2004) 4(5).
- STUBBE BG, SMEDT SC, DEMEESTER J: 'Programmed polymeric devices' for pulsed drug delivery. Pharm. Res. (2004) 21(10):1732–1740.
- SIEGEL RA, PITT CG: A strategy for oscillatory drug release. General scheme and simplified theory. J. Control. Release (1995) 33(1):173–188.
- MORMONT M- LEVI F: Chronomodulation of cancer chemotherapy: achievements and perspectives. Drug Del. Syst. Sci. (2001) 1(2):48–51.
- ERIGUCHI M, LEVI F, HISA T et al: Chronotherapy for cancer. Biomed. Pharmacother. (2003) 57\(Suppl. 1):92s–95s.
- VYAS SP, SOOD A, VENUGOPALAN P, MYSORE N: Circadian rhythm and drug delivery design. Pharmazie (1997) 52(10:815–820.
- PRISANT LM: Hypertension and chronotherapy: shifting the treatment paradigm. Am. I Hypertens. (2001) 14(910:277s–279s.
- PRISANT LM, ELLIOTT WJ: Drug delivery systems for treatment of systemic hypertension. Clin. Pharmacokiriet. (2003) 42(10:931–940.
- GAZZANIGA A, GIORDANO F, SANGALLI ME, ZEMA L: Oral colon-specific drug delivery: design strategies. S.TP Pharma Prat. (1994) 4(5):336–343.
- LEOPOLD CS: Coated dosage forms for colon-specific drug delivery. Pharm. Technol Today (1999) 2(5):197–204.
- DAVIS SS: The design and evaluation of controlled release systems for the gastro-intestinal tract. J. Control. Release (1985) 2:27–38.
- ••This paper is considered as the cue for the time-dependent formulation approach to colon delivery (i.e., for the exploitation of pulsatile delivery systems to achieve colonic release of drugs).
- RUBINSTEIN A, TIROSH B, BALUOM M et al.: The rationale for peptide drug delivery to the colon and the potential of polymeric carriers as effective tools. Control. Release (1997) 46(1-2):59–73.
- BODMEIER R: Tableting of coated pellets. Eur. Pharm. Biopharm. (1997) 43(1):1–8.
- BUSSEMER T, DASHEVSKY A, BODMEIER R: A pulsatile drug delivery system based on rupturable coated hard gelatin capsules." Control. Release (2003) 93(3):331–339.
- •This paper describes the preparation and in vitro performances of rupturable systems based on hard-gelatin capsules. The interest in the above article is further increased by the considerable experience of the authors in the field.
- DASHEVSKY A, BUSSEMER T, MOHAMAD A, BODMEIER R: Process and formulation variables affecting the performance of a rupturable capsule-based drug delivery system with pulsatile drug release. Drug Dev.Pharm. (2004)30(2):171–179.
- BUSSEMER T, BODMEIER R: Formulation parameters affecting the performance of coated gelatin capsules with pulsatile release profiles. Int. I Pharm. (2003) 267(1-2):59–68.
- •This paper describes the preparation and in vitro performances of rupturable systems based on soft-gelatin capsules.
- SUNGTHONGJEEN S, PUTTIPIPATKHACHORN S, PAERATAKUL 0, DASHEVSKY A, BODMEIER R: Development of pulsatile release tablets with swelling and rupturable layers. J. Control. Release (2004) 95(2):147–159.
- BUSSEMER T, PEPPAS NA, BODMEIER R: Time-dependent mechanical properties of polymeric coatings used in rupturable pulsatile release dosage forms. Drug Dev. Ind. Pharm. (2003) 29(6):623–630.
- BUSSEMER T, PEPPAS NA, BODMEIER R: Evaluation of the swelling, hydration and rupturing properties of the swelling layer of a rupturable pulsatile drug delivery system. Eur. I Pharm. Biopharm. (2003) 56(2):261–270.
- MORITA R, HONDA R, TAKAHASHI Y: Development of oral controlled release preparations, a PVA swelling controlled release system (SCRS) I. Design of SCRS and its release controlling factor. J. Control. Release (2000) 63(3):297–304.
- FAN TY, WET SL, YAN WW, CHEN DB, LI J: An investigation of pulsatile release tablets with ethylcellulose and Eudragit® L as film coating materials and cross-linked polyvinylpyrrolidone in the core tablets. Control. Release (2001) 77(3):245–251.
- ISHINO R, YOSHINO H, HIRAKAWA Y, NODA K: Design and preparation of pulsatile release tablet as a new oral drug delivery system. Chem. Pharm. Bull. (1992) 40(10:3036–3041.
- ISHINO R, YOSHINO H, HIRAKAWA Y, NODA K: Absorption of diltiazem in beagle dog from pulsatile release tablet. Chem. Pharm. Bull. (1992) 40(11):3094–3096.
- ZHANG Y, ZHANG Z, WU F: A novel pulsed-release system based on swelling and osmotic pumping mechanism../. Control. Release (2003) 89(1):47–55.
- LIN S- LIN K- LI M-J: Micronized ethylcellulose used for designing a directly compressed time-controlled disintegration tablet. J. Control. Release (2001) 70(3):321–328.
- LIN K- LIN S- LI M-J: Compression forces and amount of outer coating layer affecting the time-controlled disintegration of the compression-coated tablets prepared by direct compression with micronized ethylcellulose. Pharm. Sci. (2001) 90(12):2005–2009.
- LIN S- LIN K- LI M-J: Influence of excipients, drugs, and osmotic agent in the inner core on the time-controlled disintegration of compression-coated ethylcellulose tablets. J. Pharm. Sci. (2002) 91(9):2040–2046.
- LIN S- LI M- LIN K-H: Hydrophilic excipients modulate the time lag of time-controlled disintegrating press-coated tablets. AAPS PharmSciTech. (2004) 5(4):1–5.
- LIN S- LIN K- LI M-J: Formulation design of double-layer in the outer shell of dry-coated tablet to modulate lag time and time-controlled dissolution function: studies on micronized ethylcellulose for dosage form design (VII). AAPS J. (2004) 6(3):17.
- KROGEL I, BODMEIER R: Floating or pulsatile drug delivery systems based oncoated effervescent cores. Int. J. Pharm. (1999) 187(2):175–184.
- •This paper describes the preparation of a particular rupturable system, in which effervescent excipients have been exploited as the agents responsible for the core expansion finally resulting in the time-dependent disruption of the outer film.
- UEDA S, HATA T, ASAKURA S et al: Development of a novel drug release system, time-controlled explosion system (TES). I. Concept and design. I Drug. Target. (1994) 2(1):35–44.
- •This paper introduces the TES, which is the first example of multiple-unit delivery system for pulsatile release. TES is based on a highly swellable polymer as the expansion agent responsible for disruption of the ethylcellulose film.
- UEDA S, YAMAGUCHI H, KOTANI M et al: Development of a novel drug release system, time-controlled explosion system (TES). II. Design of multiparticulate TES and in vitro drug release properties. Chem. Pharm. Bull. (1994) 42(2):359–363.
- UEDA S, IBUKI R, KIMURA S et al: Development of a novel drug release system, time-controlled explosion system (TES). III. Relation between lag time and membrane thickness. Chem. Pharm. Bull. (1994) 42(2):364–367.
- HATA T, SHIMAZAKI Y, KAGAYAMA A, TAMURA S, UEDA S: Development of a novel drug release system, time-controlled explosion system (TES). V. Animal pharmacodynamic study and human bioavailability study. Int. J. Pharm. (1994) 110(0:1–7.
- KOK PJA, VONK P, HOEKZEMA MA, KOSSEN NWF: Development of particulate pulse-release formulations and their mathematical description. Powder 7echnol. (2001) 119(0:33–44.
- SCHULTZ P, KLEINEBUDDE P: A new multiparticulate delayed release system. Part I: dissolution properties and release mechanism../. Control. Release (1997) 47(2):181–189.
- •These authors describe the preparation and in vitro performances of a multiparticulate delivery system in pellets for pulsatile release, in which osmotic agents are exploited to induce mechanical disruption of the outer release-controlling film.
- SCHULTZ P, THO I, KLEINEBUDDE P: A new multiparticulate delayed release system. Part II: coating formulation and properties of free films. I Control. Release (1997) 47(2):191–199.
- MATSUO M, NAKAMURA C, ARIMORI K, NAKANO M: Evaluation of hydroxyethylcellulose as a hydrophilic swellable material for delayed-release tablets. Chem. Pharm. Bull. (1995) 43(2):311–314.
- MATSUO M, ARIMORI K, NAKAMURA C, NAKANO M: Delayed-release tablets using hydroxyethylcellulose as a gel-forming matrix. Int. J. Pharm. (1996) 138(2):225–235.
- FUKUI E, UEMURA K, KOBAYASHI M: Studies on applicability of press-coated tablets using hydroxypropylcellulose (HP C) in the outer shell for timed-release preparations. ./. Control. Release (2000) 68(2):215–223.
- MAFFIONE G, IAMARTINO P, GAZZANIGA A: High-viscosity HPMC as a film-coating agent. 10th Pharmaceutical Technology Conference. Bologna, Italy (1991) 3:66.
- •This work describes the first experiments reported in the literature on spray-coating based on high-viscosity HPMC aimed at the attainment of swellable/erodible delayed-release systems.
- GAZZANIGA A, IAMARTINO P, MAFFIONE G, SANGALLI ME: Oral delayed-release system for colonic specific delivery. 6th International Conference on Pharmaceutical Technology. Paris, France (1992) V:305.
- MAFFIONE G, IAMARTINO P, GUGLIELMINI G, GAZZANIGA A: High-viscosity HPMC as a film-coating agent. Drug Dev. Ind. Pharm. (1993) 19(16):2043–2053.
- GAZZANIGA A, IAMARTINO P, MAFFIONE G et al.: Rivestimento rigonfiabile idrofilo per il rilascio ritardato di farmaci (delayed-release systems). Boll. Chim. Farm. (1993) 132(2):66–69.
- GAZZANIGA A, IAMARTINO P, MAFFIONE G, SANGALLI ME: Sistema orale a cessione ritardata per il rilascio al colon. Boll. Chim. Farm. (1993) 132 (3):78–80.
- GAZZANIGA A, SANGALLI ME, GIORDANO F: Oral Chronotopic® drug delivery systems: achievement of time and/ or site specificity. Eur. j Pharm. Biopharm. (1994) 40(4):246–250.
- GAZZANIGA A, IAMARTINO P, MAFFIONE G, SANGALLI ME: Oral delayed-release system for colonic specific delivery. Int. J. Pharm. (1994) 108(1):77–83.
- GAZZANIGA A, BUSETTI C, MORO L, SANGALLI ME, GIORDANO F: Time-dependent oral delivery systems for colon targeting. S. ER Pharma Sri. (1995) 5(1):83–88.
- •In this paper, the feasibility of HPMC-based aqueous spray-coating procedures is explored for the first time in the preparation of swellable/erodible pulsatile release systems.
- SANGALLI ME, MARONI A, ZEMA L et al.: Li vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery. J. Control. Release (2001) 73(1):103–110.
- •This paper points out the benefits, in terms of both process feasibility and in vitro/ in vivo performances, provided by low-viscosity HPMC employed as an aqueous spray-coating agent for the preparation of swellable/erodible pulsatile release systems.
- SANGALLI ME, MARONI A, FOPPOLI A et al.: Different HPMC viscosity grades as coating agents for an oral time and/or site-controlled delivery system: a study on process parameters and in vitro performances. Eur. I Pharm. Sri. (2004) 22(5):469–476.
- MARONI A, SANGALLI ME, CEREA M et al.: Low viscosity HPMC coating of soft and hard gelatin capsules for delayed and colonic release: preliminary investigations on process parameters and in vitro release performances. Proceedings of the 26th International Symposium on Controlled Release of Bioactive Materials. Boston, MA, USA (1999) 6320.
- •This work explores the preparation and in vitro performances of swellable/erodible pulsatile release systems obtained from soft- and hard-gelatin capsules.
- MARONI A, CEREA M, GERVASUTTI C et al.: LI vitro and in vivo evaluation of HPMC-coated hard gelatin capsules for oral time-controlled release. AAPS PharmSci. (2001) 3(3):T3120.
- •This work focuses on the in vitro/in vivo performances of swellable/erodible pulsatile release systems based on hard-gelatin capsule cores.
- PIRULLI V, CEREA M, MARONI A et al: HPMC-coating of tablets in tangential-spray rotary fluid bed for the achievement of an oral time and/or site-controlled delivery system. Proceedings of the 31st International Symposium on Controlled Release of Bioactive Materials. HI USA (2004).
- •An alternative technique, such as tangential spray-coating in rotary fluid bed, is explored for the application of swellable/erodible release-delaying coats onto solid dosage forms
- CEREA M, SERRATONI M, PALUGAN L et al: Powder-layering technique for the preparation of the HPMC-based retarding coating of an oral system for pulsatile and/or colon-specific release. AAPS Pharm. Sci. (2003) 5(4):W5135.
- •This work discusses the application of another alternative technique (i.e., powder layering) for the application of swellable/ erodible release-delaying coats onto solid dosage forms.
- SANGALLI ME, MARONI A, CEREA M et al.: Pharmacoscintigraphic investigation into the performances of a 5-ASA-containing oral system for colon targeting. Proceedings of the International Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology. Nuremberg, Germany (2004):815.
- CONTE U, MAGGI L, GIUNCHEDI P, MANNA A: New oral system for timing-release of drugs. Boll. Chim. Farm. (1992) 131(5):199–204.
- CONTE U, MAGGI L, TORRE ML, GIUNCHEDI P, MANNA A: Press-coated tablets for time-programmed release of drugs. Biomaterials (1993) 14(13):1017–1023.
- HALSAS M, ERVASTI P, VESKI P, JORJENSON H, MARVOLA M: Biopharmaceutical evaluation of time-controlled press-coated tablets containing polymers to adjust drug release. Eur. J. Drug Metab. Pharmacokinet. (1998) 23(2):190–196.
- HALSAS M, SIMELIUS R, KIVINIEMI A et al.: Effect of different combinations of hydroxypropylmethyl cellulose on bioavailability of ibuprofen from press-coated time-controlled tablets. S.TP Pharma Sci. (1998) 8(3):155–161.
- HALSAS M, PENTTINEN T, VESKI P, JORJENSON H, MARVOLA M: Time-controlled release pseudoephedrine tablets: bioavailability and in vitro I in vivo correlations. Pharmazie (2001) 56(9):718–723.
- CAO Q- CHOI H- KIM D- LEE B-J: Release behavior and photo-image of nifedipine tablet coated with high viscosity grade hydroxypropylmethylcellulose: effect of coating conditions. Lk. Pharm. (2004) 274(1-2):107–117.
- TAKEUCHI H, YASUJI T, YAMAMOTO H, KAWASHIMA Y: Spray-dried lactose composite particles containing an ion complex of alginate-chitosan for designing a dry-coated tablet having a time-controlled releasing function. Pharm. Res. (2000) 17(1):94–99.
- HARIHARAN M, GUPTA VK: ENCORE: A novel compression-coated tablet dosage form. Proceedings of the 28th International Symposium on Controlled Release of Bioactive Materials. San Diego, USA (2001): 6102.
- OZEKI Y, ANDO M, WATANABE A, DANJO K: Evaluation of novel one-step dry-coated tablets as a platform for delayed-release tablets. Control. Release (2004) 95(1):51–60.
- CONTE U, COLOMBO P, LA MANNA A et al.: A new ibuprofen pulsed release oral dosage form. Drug Dev. Ind. Pharm. (1989) 15(14-16):2583–2596.
- •This paper reports on the initial attempts to prepare swellable/erodible polymeric coatings by double-compression technique. In addition, the resulting system is the first example of multilayered tablet provided with a partial outer coating designed to afford single- or multiple-pulse delayed delivery of drugs.
- CONTE U, GIUNCHEDI P, MAGGI L et al: Ibuprofen delayed release dosage forms: a proposal for the preparation of an in vitro/in vivo pulsatile system. Eur. Pharm. Biopharm. (1992) 38(6):209–212.
- MAGGI L, CONTE U, BRUNT R: Delivery device for the release of the active ingredient in subsequent times. Proceedings of the 26th International Symposium on Controlled Release of Bioactive Materials. Boston, USA (1999): 5926.
- VANDELLI MA, LEO E, FORNI F, BERNABEI MT: In vitro evaluation of a potential colonic delivery system that releases drug after a controllable lag-time. Eur. I Pharm. Biopharm. (1996) 43(2):148–151.
- POZZI F, FURLANI P, GAZZANIGA A, DAVIS SS, WILDING IR: The Time Clock® system: a new oral dosage form for fast and complete release of drug after a predetermined lag time../. Control. Release (1994) 31(1):99–108.
- •This paper deals with the Time-Clock® technology, which envisages the unique utilisation of natural waxes and surfactant hydrophobic blends as the release-controlling material for the preparation of a single-unit pulsatile release system. Such a device has shown to correctly perform in vivo on humans as well.
- WILDING IR, DAVIS SS, POZZI F, FURLANI P, GAZZANIGA A: Enteric coated timed release systems for colonic targeting. Int. Pharm. (1994) 111(1):99–102.
- STEED KP, HOOPER G, MONTI N, BENEDETTI M, FORNASINI G, WILDING IR: The use of pharmacoscintigraphy to focus the development strategy for a novel 5-ASA colon targeting system (Time Clock®' system). J. Control. Release (1997) 49(2-3):115–122.
- KATSTRA WE, PALAZZOLO RD, ROWE CW et al.: Oral dosage forms fabricated by Three Dimensional Printing. .1 Control. Release (2000) 66(1):1–9.
- ROWE CW, KATSTRA WE, PALAZZOLO RD et al: Multimechanism oral dosage forms fabricated by three dimensional printing'. I Control. Release (2000) 66(1):11–17.
- LI Y- ZHU J-B: Modulation of combined-release behaviors from a novel 'tablets-in-capsule system'. ./. Control. Release (2004) 95(3):381–389.
- KOK PJA, VONK P, KOSSEN NW: A particulate pulse-release system and mathematical description with the Maxwell-Stefan theory. J. Control. Release (2000) 66(2-3):293–306.
- KAO C- CHEN S- SHEU M-T: Lag time method to delay drug release to various sites in the gastrointestinal tract. J. Control. Release (1997) 44(2-3):263–270.
- NARISAWA S, NAGATA M, DANYOSHI C et al: An organic acid-induced sigmoidal release system for oral controlled-release preparations. Pharm. Res. (1994) 11(1):111–116.
- •In this paper, the SRS is introduced. This multiparticulate device relies on a peculiar working mechanism consisting in the permeability increase of an outer acrylic film brought about by its interaction with an organic acid contained in the inner layers.
- NARISAWA S, NAGATA M, ITO T et al: Drug release behavior in gastrointestinal tract of beagle dogs from multiple unit type rate-controlled or time-controlled release preparations coated with insoluble polymer-based film. J. Control. Release (1995) 33(2):253–260.
- •This paper describes the in vivo performances of SRS in beagle dogs.
- NARISAWA S, NAGATA M, HIRAKAWA Y, KOBAYASHI M, YOSHINO H: An organic acid-induced sigmoidal release system for oral controlled-release preparations. 2. Permeability enhancement of Eudragit® RS coating led by the physicochemical interactions with organic acid. ./. Pharm. Sci. (1996) 85(2):184–188.
- NARISAWA S, NAGATA M, HIRAKAWA Y, KOBAYASHI M, YOSHINO H: An organic acid-induced sigmoidal release system for oral controlled preparations. III. Elucidation of the anomalous drug release behaviour through osmotic pumping mechanism. Int. J. Pharm. (1997) 148(1):85–91.
- WILDING IR, DAVIS SS, BAKHSHAEE M et al: Gastrointestinal transit and systemic absorption of captopril from a pulsed-release formulation. Pharm. Res. (1992) 9(5):654–657.
- •In this article, the design and in vivo behaviour of PulsincapTm are dealt with. The system represents the first capsular delivery system for time-controlled release.
- BINNS JS, BAKHSHAEE M, MILLER CJ, STEVENS HN: Application of a pH independent PEG based hydrogel to afford pulsatile drug delivery. Proceedings of the 20th International Symposium on Controlled Release of Bioactive Materials. Washington, DC, USA (1993): 342.
- BINNS J, STEVENS HN, MCEWEN J et al.: The tolerability of multiple oral doses of PulsincapTm capsules in healthy volunteers. ./. Control. Release (1996) 38(2-3):151–158.
- •In this paper, the tolerability related to repeated administrations of placebo PulsincapTm is assessed on volunteers over a 28-day period.
- WILSON CG, BAKHSHAEE M, STEVENS HN et al.: Evaluation of a gastro-resistant pulsed release delivery system (PulsincapTm) in humans. Drug Del. (1997) 4(3):201–206.
- HEBDEN JM, WILSON CG, SPILLER RC et al: Regional differences in quinine absorption from the undisturbed human colon assessed using a timed release delivery system. Pharm. Res. (1999) 16(7):1087–1092.
- HEBDEN JM, GILCHRIST PJ, PERKINS AC, WILSON CG, SPILLER RC: Stool water content and colonic drug absorption: contrasting effects of lactulose and codeine. Pharm. Res. (1999) 16(8):1254–1259.
- STEVENS HNE, WILSON CG, WELLING PG et al: Evaluation of PulsincapTm to provide regional delivery of dofetilide to the human GI tract. Int. J. Pharm. (2002) 236(1-2):27–34.
- ROSS AC, MACRAE RJ, WALTHER M, STEVENS HNE: Chronopharmaceutical drug delivery from a pulsatile capsule device based on programmable erosion. ./. Pharm. Pharmacol (2000) 52(8):903–909.
- MCCONVILLE JT, ROSS AC, CHAMBERS AR et al: The effect of wet granulation on the erosion behaviour of an HPMC-lactose tablet, used as a rate-controlling component in a pulsatile drug delivery capsule formulation. Eur. Pharm. Biopharm. (2004) 57(3):541–549.
- SUTCH JCD, ROSS AC, KOCKENBERGER W et al: Investigating the coating-dependent release mechanism of a pulsatile capsule using NMR microscopy. J. Control. Release (2003) 92(3):341–347.
- KROGEL I, BODMEIER R: Pulsatile drug release from an insoluble capsule body controlled by an erodible plug. Pharm. Res. (1998) 15(3):474–481.
- KROGEL I, BODMEIER R: Evaluation of an enzyme-containing capsular shaped pulsatile drug delivery system. Pharm. Res. (1999) 16(9):1424–1429.
- GOHEL MC, SUMITRA GM: Modulation of active pharmaceutical material release from a novel 'tablet in capsule system' containing an effervescent blend. J. Control. Release (2002) 79(1-3):157–164.
- CRISON JR, SIERSMA PR, TAYLOR MD, ON GL: Programmable oral release technology, Port Systems®: a novel dosage form for time and site specific oral drug delivery. Proceedings of the 22nd International Symposium on Controlled Release of Bioactive Materials. Seattle, WA, USA (1995): 1126.
- •The design and in vivo behaviour of the PORT system are dealt with in this work. Compared with other capsular devices, this system is based on the time-dependent expulsion of a lipid plug following osmotically-induced water influx into the body.
- CRISON JR, SIERSMA PR, ON GL: A novel programmable oral release technology for delivering drugs: human feasibility testing using gamma scintigraphy. Proceedings of the 23rd International Symposium on Controlled Release of Bioactive Materials. Kyoto, Japan (1996): 128.
- •This paper also details the design and in vivo behaviour of the PORT system.
- LEE WW, O'MAHONY B, BAR-SHALOM D et al: Scintigraphic characterisation of a novel injection-moulded dosage form. Proceedings of the 27th International Symposium on Controlled Release of Bioactive Materials. Paris, France (2000) 8446.
- •In this paper, the Egalet® technology is proposed in its Burst-Egalet® configuration for pulsatile release. The system envisages an alternative design comprising a cylindrical impermeable outer shell, an inner drug core and two swellable release-controlling plugs sealing each open end.
- MAHONY B, KOBERLE M, WILSON CG et al: Scintigraphic assessment of a system (Egalet®) for pulsatile peptide delivery in marl. Proceedings of the 28th International Symposium on Controlled Release of Bioactive Materials. San Diego, CA, USA (2001): 6187.
- •This work also discusses the Egalet® technology proposition in its Burst-Egalet® configuration for pulsatile release.
- BAR-SHALOM D, SLOT L: An erosion-based approach to the delivery of substances poorly soluble in water. Proceedings of the 30th International Symposium on Controlled Release of Bioactive Materials. Glasgow, UK (2003): 43.
- SMITH DHG: Pharmacology of cardiovascular chronotherapeutic agents. Am. Hypertens. (2001) 14(911):296s-301s.
- GUPTA SK, ATKINSON L, THEEUWES F, WONG P, GILBERT PJ, LONGSTRETH J: Pharmacokinetics of verapamil from an osmotic system with delayed onset. Eur. j Pharm. Biopharm. (1996) 42(1):74–81.
- •This research points out that the release of verapamil hydrochloride from an osmotic once-daily COER-24 formulation can occur over a period of several hours after a 4–5 h delay, thus ideally meeting ischaemic heart disease chronotherapeutic needs. The interest in the above article is augmented by the fact that Covera-HS®, a well-known anti-hypertensive medicinal product available on the US market, is merely based on COER-24 technology.
- GLASSER SP: Circadian variations and chronotherapeutic implications for cardiovascular management: a focus on COER verapamil. Heart Dis. (1999) 1(4):226–232.
- WHITE WB, ANDERS RJ, MACINTYRE JM et al: Nocturnal dosing of a novel delivery system of verapamil for systemic hypertension. Am. I Cardiol (1995) 76(5):375–380.
- WHITE WB: A chronotherapeutic approach to the management of hypertension. Am. I Hypertens. (1996) 9(411):29s-33s.
Websites
- http://www.advancispharm.comi newsroomiviewnews.asp?newsId=91 Researchers give early insight into mechanism of action for Advancis' novel biological discovery (Press release).