References
- Levy G. Effect of dissolution rate on absorption, metabolism, and pharmacological activity of drugs. J Mond Pharm. 1967;3:237–254.
- Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution as a prognostic tool for oral drug absorption: Immediate release dosage forms. Pharm Res. 1988;15:11–22.
- Guidance for industry. Conduct of bioavailability and bioequivalence studies—Part A: Oral dosage formulations for systemic effects. Health Canada, 1992.
- “USP General Chapter <1088> - In-vitro and in-vivo evaluation of dosage forms”, 2004. United States Pharmacopeia and National Formulary, United States Pharmacopeial Convention, Inc., 29th edition:2513–2518.
- Rohrs BR. Dissolution method development for poorly water soluble compounds. Dissolution technologies. 2001;8:1–5.
- Gibaldi M, Feldman S. Establishment of sink conditions in dissolution rate experiments. J Pharm Sci. 1967;56:1238–1242.
- USP General Chapter <711> Dissolution of solid oral dosage forms. 2004. United States Pharmacopeia and National Formulary, United States Pharmacopeial Convention, Inc., 29th edition, 2004.
- Grundy JS, Anderson KE, Rogers JA, Foster RT. Studies on dissolution testing of the Nifedipine gastrointestinal therapeutic system. I. Description of two-phase in-vitro dissolution test. J of Controlled Release. 1997;48:1–8.
- Pillay V, Fassihi R. A new method for dissolution studies of lipid-filled capsules employing Nifedipine as a model drug. Pharm Res. 1999;16(2):333–337.
- Chaudhary RS, Gangwal SS, Gupta VK, Shah YN, Jindal KC, Khanna AS. Dissolution system for nifedipine sustained release formulations. Drug Dev Ind Pharm. 1994;20(7):1267–1274.
- Qureshi SA, Caille G, Brien R, Piccirilli G, Yu V, Mcgilveray IJ. Application of flow-through dissolution method for the evaluation of oral formulations of Nifedipine. Drug Dev Ind Pharm. 1994;20(11):1869–1882.
- Bak A, Gore A, Yanez E et al. The co-crystal approach to improve the exposure of an insoluble compound—AMG 517 sorbic acid co-crystal characterization and pharmacokinetics. J Pharm Sci. 2008;23:1–15.
- Doherty EM, Bannon AW, Bo Y et al. Novel vanilloid receptor-1 antagonists: Structure-activity relationships in the ‘‘A-region’’ and the selection of a clinical candidate, AMG 517. J Med Chem. 2007;50:3515–3527.
- Yanez E, Daurio D, Buntich S, Bak A. Physicochemical, solid-state, and pharmacokinetic properties of AMG 517 free base. 2005. Unpublished work.
- Electronic orange book, Approved drug products with therapeutic equivalence evaluations (http://www.fda.gov/cder/ob/).
- Almarsson ö,Zaworotko MJ. Crystal engineering of the composition of pharmaceutical phases. Do pharmaceutical co-crystals represent a new path to improved medicines? Chem Commun. 2004;17:1889–1896.
- Wagner JG, Nelson E. Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug. J Pharm Sci. 1964;53:1392–1403.
- Dissolution tests to predict bioavailability of drugs, 5th International Workshop on Physical Characterization of Pharmaceutical Solids, June 24, 2004, Sandra Klein, Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt.
- Stead JA, Freeman M, John EG, Ward GT, Whiting B. Ibuprofen tablets: Dissolution and bioavailability studies. Int J Pharm. 1983;14:59–72.
- Dressman, JB, 1995; Physiological aspects of the design of dissolution tests. Capsugel seminar, USA.
- Yunzhe S, Yang R, Zhou W and Xing T. Nimodipine semi-solid capsules containing solid dispersion for improving dissolution. Int J Pharm. 2008;359:144–149.
- Cardot JM, Beyssac E, and Alric M. In vitro–in vivo correlation: Importance of dissolution in IVIVC. Dissolution Technologies. 2007;2:15–19.
- Stanton MK and Bak A. Physicochemical properties of pharmaceutical co-crystals: A case study of ten AMG 517 co-crystals. Cryst. Growth Des. 2008;8:3856–3862.
- Krowczynski L. Pharmazie. 1978;33:241–247.
- Gibaldi M, Feldman S. Establishment of sink conditions in dissolution rate determinations. J Pharm Sci. 1967;56:1238–1242.
- Grundy JS, Anderson KE, Rogers JA, Fosterb TF. Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. I. Description of a two-phase in vitro dissolution test. J Controlled Release. 1997;48:9–17.
- Phillips JG, Chen Y, Wakeling IN. A flow-through dissolution approach to in vivo/in vitro correlation of adinazolam release from sustained release formulations. Drug Dev Ind Pharm. 1989;15:2177–2195.
- Porges E, Schade B, Ropte W. Automated flow-through method to determine the dissolution rate of slightly soluble substances. Pharm Ind. 1985;47:77–86.
- Sunesen VH, Pedersen BL, Kristensen HG, Mullertz A. In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur J Pharm Sci. 2005;24:305–313.