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Research Article

The impact of chirality on the development of robust and stable tablet formulation of (S-) amlodipine besylate

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Pages 930-941 | Received 15 Jul 2013, Accepted 27 Aug 2013, Published online: 07 Oct 2013

References

  • Hutt AJ, Valentova J. The chiral switch: the development of single enantiomer drugs from racemates. Acta facultatis pharmaceuticae Universitatis Comenianae 2003;50:7–23
  • Shaikh SA, Shaikh SS, Thota RS, et al. Formulation and development of s-(-)-Amlodipine besylate tablets to improve the dissolution profile. AJP 2007;1:124–128
  • Tucker GT. Chiral switches. Lancet 2000;355:1085–1087
  • Shimazawa R, Nagai N, Toyoshima S, Okuda H. Present state of new chiral drug development and review in Japan. J. Health Sci 2008;54:23–29
  • Zaliunas R, Brazdzionyte J, Zabiela V, Jurkevicius R. Effects of amlodipine and lacidipine on heart rate variability in hypertensive patients with stable angina pectoris and isolated left ventricular diastolic dysfunction. Int J Cardiol 2005;101:347–353
  • Harekrishna R, Kirti RP, Sisir N, et al. Design of fast dissolving amlodipine besylate tablet formulateons. Asian J Pharm 2012;6:51–59
  • Ansari RA, Pager KP, Vavia PR. Development and validation of HPLC method for the determination of S (-) amlodipine besylate and its related substances in the tablet formulation by using chiral separation. Asian J Biomed Pharm Sci 2012;2:60–64
  • Kang SW, Lee KR. Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized open-label, two-period, comparative, crossover study. Clin Ther 2006;28:1837–1847
  • Thacker HP. S-amlodipine-the 2007 clinical review. J Ind Med Assoc 2007;105:180–182, 184, 186
  • Okeke C. <1175> Preformulation guidelines. Pharmacopoeal Forum 2000;26:1672–1683
  • ICH Harmonized Tripartite Guideline. Stability testing of new drug substances and products Q1 A (R2); 2003
  • Chen Y, Li Y. A new model for predicting moisture uptake by packaged solid pharmaceuticals. Int J Pharm 2003;255:217–225
  • Gharpure MM, Bhawal BM, Ranade PV, et al. Process for producing enantiomer of amlodipine in high optical purity. WO2006/043148 A1; 2006
  • Rollinger JM, Burger A. Physico-chemical characterization of hydrated and anhydrous crystal forms of amlodipine besylate. J Therm Anal Calorim 2002;68:361–372
  • Koradia V, Fontelonga de Lemos AF, Alleso M, et al. Phase transformations of amlodipine besylate solid forms. J Pharm Sci 2011;100:2896–2910
  • Kontny MJ, Koppenol S, Graham ET. Use of sorption-desorption moisture transfer model to assess the utility of desiccant in a solid product. Int J Pharm 1992;84:261–271
  • Hadžidedić S. Chirality of amlodipine besylate: the influence on designing and development of a stable and efficient formulation [PhD thesis]. University of Tuzla, Bosnia and Herzegovina; 2011
  • Hadžidedić S, Uzunovic A, Pilipovic S, Kocova El-Arini S. Use of forced degradation studies on S(-)-amlodipine besylate to generate information on the degradation products. Book of Abstracts, 8th Central European Symposium on Pharmaceutical and 4th International Graz Congress for Pharmaceutical Engineering; 2010 September 16–18; Graz, Austria, Sci. Pharm. 2010, 78699, PPAT10
  • Bharata SS, Bharata BS, Bajaj NA. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients – a comprehensive review. J Excipients Food Chem 2010;1:3–26
  • Abdo A, Al-Omaei MM, Badwan AA, Jaber AM. Amlodipine besylate excipients interactions in solid dosage forms. Pharm Dev Technol 2004;9:15–24
  • Directive 75/318 EEC. Investigation of chiral active substances; 1994. pp. 381–391
  • Vukmanovic K. Enantioselektivna analiza 1,4-dihidropiridinskih lijekova kiralnom tekucinskom kromatografijom [PhD dissertation]. Croatia: University of Zagreb; 2007. pp. 23–50

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