In vivo and in vitro evaluation of three controlled release principles of 6-N-cyclohexyl-2′-O-methyladenosine

Journal of Controlled Release

Volumn 97, Issue 1, 2004, Pages 79-90

  Royce, Alan ^a   Li, Shoufeng ^a   Weaver, Margaret ^b   Shah, Uday ^c  

^a NOVARTIS PHARMA AG   (Switzerland)

^b NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^c ABBOTT LABORATORIES   (United States)

Author keywords

Absorption; Biorelevant dissolution method; Controlled release; In vitro in vivo correlation; Matrix tablets; Membrane coated pellets; Osmotic pump; Zero order release

Indexed keywords

ABSORPTION; DRUG PRODUCTS; PERMSELECTIVE MEMBRANES; PH EFFECTS; PHARMACOKINETICS;

CONTROLLED RELEASE; DRUG DELIVERY; TABLETS;

AROMATIC COMPOUNDS;

6 N CYCLOHEXYL 2' O METHYLADENOSINE; NVR WAG994;

ARTICLE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CORRELATION ANALYSIS; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG METABOLISM; DRUG RELEASE; FRACTIONATION; HYDRODYNAMICS; IN VITRO STUDY; IN VIVO STUDY; LINEAR SYSTEM; MALE; MATRIX TABLET; NONHUMAN; NONLINEAR SYSTEM; OSMOTIC PUMP; PH; PRIORITY JOURNAL; TABLET FORMULATION;

ADENOSINE; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DOGS; DRUG EVALUATION, PRECLINICAL; MALE;

EID: 2442473964     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2004.02.016     Document Type: Article

References (18)

1. Robinson J.R., Lee V.H.L. Controlled drug delivery. Fundamentals and Applications. 1987;Marcel Dekker, New York
2. Sandber A., Abrahamsson B., Svenheden A., Olofsson B., Bergstrand R. Steady-state bioavailability and day-to-day variability of a multiple-unit (CR/ZOK) and a single-unit (OROS) delivery system of metoprolol after once-daily dosing. Pharm. Res. 10:1993;28-34
3. Green D.M. Tablets of coated aspirin microspherules - a new dosage form. J. New Drugs. 6:1966;294
4. Samuelov Y., Donbrow M., Friedman M. Sustained release of drugs from ethylcellulose-polyethylene glycol films and kinetics of drug release. J. Pharm. Sci. 68:1979;325-329
5. U.S. Department of Health and Human Services Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In vivo Correlation. 1979;Center for Drug Evaluation and Research (CDER), Rockville, MD
6. Sirisuth N., Eddington N.D. In vitro in vivo correlation definitions and regulatory guidance. Int. J. Generic Drugs. 2002
7. Papadimitriou E., Buckton G., Efentakis M., Choulis N. Swelling studies on mixtures of two hydrophilic excipients, S.T.P. Pharma. Sci. 3:1993;232-236
8. Ramakrishna N., Mishra B. Plasticizer effect and comparative evaluation of cellulose acetate and ethylcellulose-HPMC combination coatings as semipermeable membranes for oral osmotic pumps of naproxen sodium. Drug Devel. Ind. Pharm. 28:2002;403-412
9. Sadeghi F., Ford J.L., Rubinstein M.H., Rajabi-Siahboomi A.R. Study of drug release from pellets coated with surelease containing hydroxypropylmethylcellulose. Drug Devel. Ind. Pharm. 27:2001;419-430
10. Wesseling M., Bodmeier R. Influence of plasticization time, curing conditions, storage time, and core properties on the drug release from aquacoat coated pellets. Pharm. Dev. Technol. 6:2001;325-331
11. Frohoff-Hulsmann M.A., Lippold B.C., McGinity J.W. Aqueous ethyl cellulose dispersion containing plasticizers of different water solubility and hydroxypropyl methylcellulose as coating material for diffusion pellets: Part 2. Properties of sprayed films. Eur. J. Pharm. Biopharm. 48:1999;67-75
12. Reynolds T.D., Mitchell S.A., Balwinski K.M. Investigation of the effect of tablet surface area/volume on drug release from hydroxypropylmethylcellulose controlled-release matrix tablets. Drug Dev. Ind. Pharm. 28:2002;457-466
13. Using Methocel Cellulose ethers for controlled release of drugs in hydrophilic matrix systems. Dow Chemical Technical Literature. 2002;10-25 The Dow Chemical Company, Midlane, Michigan
14. Meddeb F., Brossard C., Devissaguet J.P. Influence of formulation on the release of furosemide from hydrophilic matrices of hydroxypropylmethylcellulose. STP Pharma. Pratiques. 2:1986;623-629
15. Ju R.T.C., Cooper A., Patel M.V. pH controlled release oral drug delivery: effect of bulk and internal pH. Pharm. Res. 11:1994;S297
16. Schug B.S., Brendel E., Wolf D., Wonnemann M., Blume H.H., et al. Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union. Eur. J. Pharm. Sci. 15:2002;279-285
17. Sorasuchart W., Wardrop J., Ayres J.W. Drug release from spray layered and coated drug-containing beads: effects of pH and comparison of different dissolution methods. Drug Dev. Ind. Pharm. 25:1999;1093-1098
18. Thoma K., Ziegler I. pH-independent release of fenoldopam from pellets with insoluble film coats. Eur. J. Pharm. Biopharm. 46:1998;105-113