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Research Article

Development and validation of a dissolution test for lodenafil carbonate based on in vivo data

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Pages 488-493 | Received 08 Oct 2012, Accepted 16 Jan 2013, Published online: 24 Apr 2013

References

  • Shah VP, Siewert M, Dressman J, et al. Dissolution/in vitro release testing of special dosage forms. Dissol Technol 2002:1–5
  • Wang Y, Armenante PM. A novel Off-Center Paddle Impeller (OPI) dissolution testing system for reproducible dissolution testing of solid dosage forms. J Pharm Sci 2012;10:746–60
  • O’Hara T, Hayes S, Davis J, et al. In vivo–in vitro correlation (IVIVC) modeling incorporating a convolution step. J Pharmacokinetics Pharmacodyn 2001;28:277–98
  • Bajerski L, Rossi RC, Dias CL, et al. Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets. AAPS PharmSciTech 2010;11:637–44
  • Induri M, Raju B, Prasad MR, Reddy KYP. Development and validation of a spectrophotometric method for quantification and dissolution studies of glimepiride in tablets. Eur J Chem 2012;9:993–8
  • FDA. Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Rockville (MD): Food and Drug Administration; 1997
  • Cardot JM, Davit BM. In vitro–in vivo correlations: tricks and traps. AAPS J 2012;14:491–9
  • Glina S, Toscano I, Gomatzky C, et al. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial. J Sex Med 2010;7:1928–36
  • Toque H, Teixeira CE, Lorenzetti R, et al. Pharmacological characterization of a novel phosphodiesterase type 5 (PDE5) inhibitor lodenafil carbonate on human and rabbit corpus cavernosum. Eur J Pharmacol 2008;591:189–95
  • McNamara ER, Donatucci CF. Newer phosphodiesterase inhibitors: comparison with established agents. Urol Clin N Am 2011;38:155–63
  • Codevilla CF, Castilhos TS, Fröehlich PE, Bergold AM. Development and validation of a UV-spectrophotometric method for the determination of lodenafil carbonate in tablets and comparison with the LC-method. J Pharm Res 2011;4:2368–70
  • Fortunato D. Dissolution method development for immediate release solid oral dosage forms “quick start guidelines for early phase development compounds”. Dissol Technol 2005:12–14
  • Wang Q, Ma D, Higgins JP. Analytical method selection for drug product dissolution testing. Dissol Technol 2006:6–13
  • Silva AC, Toffoletto O, Lucio AG, et al. Cardiovascular repercussion of lodenafil carbonate, a new PDE5 inhibitor, with and without alcohol consumption. Arq Bras Cardiol 2010;94:160–7
  • HELLEVA. Monografia Cristália. MONO-UVF-HEL 2008;1:1–21
  • United States Pharmacopoeia (USP) 34. Pharmacopoeial convention. Rockville, MD; 2011
  • Shargel L, Wu-Pong S, Yu ABC. Applied biopharmaceutics & pharmacokinetics. New York: McGraw-Hill; 2005
  • Validation of analytical procedures: text and methodology. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use; 2005; Geneva, Switzerland Q2 (R1)
  • Rowe RC, Sheskey PJ, Owen SC. Handbook of pharmaceutical excipients. Washington, DC: American Pharmacists Association; 2006
  • Costa PJC. Avaliação in vitro da lioequivalência de formulações farmacêuticas. Braz J Pharma Sci 2002;38:141–53
  • Rodrigues PO, Cardoso TM, Silva MAS, Mato JR. Caracterização termoanalítica e estudo do perfil de dissolução de comprimidos contendo metronidazol. Lat Am J Pharm 2008;27:528–34
  • Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol Pharm – Drug Res 2010;67:217–23
  • Rodrigues PO, Stulzer HK, Cruz AP, et al. Equivalência farmacêutica entre comprimidos de propranolol comercializados no mercado nacional. Infarma 2006;18:3–7
  • Scheshowitsch K, Pereira A, Cruz A, et al. Avaliação da qualidade e perfil de dissolução de cápsulas manipuladas de piroxicam. Lat Am J Pharm 2007;26:645–51
  • Sinha S, Ali M, Baboota S, et al. Solid dispersion as an approach for bioavailability enhancement of poorly, water-soluble drug ritonavir. AAPS PharmSciTech 2010;11:518–27
  • Rohrs BR. Dissolution method development for poorly soluble compounds. Dissol Technol 2001;8:1–5
  • Lee H, Park SA, Sah H. Surfactant effects upon dissolution patterns of carbamazepine immediate release tablet. Arch Pharm Res 2005;28:120–6
  • Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413–20

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