Preparation, physicochemical characterization, dissolution and formulation studies of telmisartan cyclodextrin inclusion complexes

Asian Journal of Pharmaceutics

Volumn 4, Issue 1, 2010, Pages 52-59

  Kane, Rajesh N ^a   Kuchekar, Bhanudas ^b  

^a Sinhgad Institute of Pharmaceutical Sciences   (India)

^b MAEER S MAHARASHTRA INSTITUTE OF PHARMACY   (India)

Author keywords

cyclodextrin; dissolution studies; hydroxypropyl cyclodextrin; inclusion complexes; telmisartan

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; CYCLODEXTRIN; TELMISARTAN;

ANALYTIC METHOD; AQUEOUS SOLUTION; ARTICLE; COMPLEX FORMATION; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; IN VITRO STUDY; INFRARED SPECTROSCOPY; PHYSICAL CHEMISTRY; X RAY POWDER DIFFRACTION;

EID: 77953820281     PISSN: 09738398     EISSN: 1998409X     Source Type: Journal    
DOI: 10.4103/0973-8398.63983     Document Type: Article

References (22)

1. Karlberg BE, Lins LE, Hermansson K. Efficacy and safety of telmisartan: A selective AT1 receptor antagonist, compared with enalapril in elderly patients with primary hypertension: TEES Study Group. J Hypertens 1999;17:293-302.
2. Ries UJ, Mihm G, Narr B, Hasselbach KM, Wittneben H, Entzeroth M, et al. 6-Substituted benzimidazoles as new nonpeptide angiotensin II receptor - antagonists: Synthesis, biological activity, and structure- activity relationships. J Med Chem 1993;36:4040-4051
3. Mallion JM, Siche JP, Lacourcière Y. ABPM comparison of the antihypertensive profiles of the selective angiotensin II receptor antagonists telmisartan and losartan in patients with mild to moderate hypertension. J Hum Hypertens 1999;13:657-664
4. Benson SC, Pershadsingh HA, Ho CI, Chittiboyina A, Desai P, Pravenec M, et al. Identification of telmisartan as a unique angiotensin II receptor antagonist with selective PPARgamma-modulating activity. Hypertension 2004;43:993-1002.
5. Product Information: Micardis® HCT, telmisartan and hydrochlorothiazide. Boehringer Ingelheim, Ridgefield, Connecticut. (PI revised 11/2000) reviewed 1/2001.
6. Proudfoot S. Factors affecting bioavailability: Factors influencing drug absorption from the gastrointestinal tract. In: Aulton ME, editor. Pharmaceutics, the science of dosage form design. UK: Churchill Livingstone London; 1991. p. 135-173
7. Cappello B, Clelia DM, Iervolino M, A. Improvement of solubility and stability of valsartan by hydroxypropyl-\boldbeta-cyclodextrin. J Incl Phenom Macro Chem 2006;54:289-294
8. Patel R, Patel M. Solid-state characterization and dissolution properties of lovastatin hydroxypropyl-cyclodextrin inclusion complex. Pharm Tech 2007; February 2:72-81.
9. Becket G, Schep LJ, Tan MY. Improvement of the in vitro dissolution of praziquantel by complexation with alpha, beta and gamma cyclodextrin. Int J Pharm 1999;179:65-71.
10. Higuchi T, Connors K. Phase solubility techniques. Adv Anal Chem Instru 1965;4:17-123.
11. Moore JW, Flanner H. Mathematical comparison of dissolution profiles. Pharm Tech 1996;20:64-74.
12. US food and drug administration, guidance for industry SUPAC-MR: Modified release solid oral dosage forms scale-up and postapproval changes: Chemistry, manufacturing, and controls; In vitro dissolution testing and in vivo bioequivalence documentation. Rockville, MD: FDA; 1997.
13. Human medicines evaluation unit, European agency for the Evaluation of Medicinal Products (EMEA), Notes for guidance on quality of modified-release products: A oral dosage forms; B transdermal dosage forms, Section 1 (Quality). London, UK: EMEA; 1999.
14. Reppas C, Nicolaides E. Analysis of drug dissolution data. In: Dressman JB, Lennerna's H, editors. Oral drug absorption prediction and assessment. New York: Marcel Decker; 2000. p. 229-254
15. Vueba ML, Batista de Carvalho LA, Veiga F, Sousa JJ, Pina ME. Influence of cellulose ether polymers on ketoprofen release from hydrophilic matrix tablets. Eur J Pharm Biopharm 2004;58:1-59.
16. Costa FO, Sousa JJ, Formosinho SJ. Comparison of dissolution profiles of Ibuprofen pellets. J Control Release 2003;89:199-212.
17. Rinaki E, Dokoumetzidis A, Macheras P. The mean dissolution time depends on the dose/solubility ratio. Pharm Res 2003;20:406-408
18. Loftsson T, Magnusdottir AM, Masson JF, Sigurjonsdottir. Self-association and cyclodextrin solubilization of drugs. J Pharm Sci 2002;91:2307-2316
19. Loftsson T, Hreinsdottir D, Masson M. The complexation efficiency. J Incl Phenom 2007;57:545-552
20. Bonini M, Rossi S, Karlsson G, Almgren M, Nostro LO, Baglioni P. Self-assembly of -cyclodextrin in water: Part 1, Cryo-TEM and dynamic and static light scattering. Langmuir 2006;22:1478-1484
21. Harry P, Hopkins JR, Alexander CJ. Transfer gibbs free energies from H2O to CH3OH for a series of substituted phenyltropylium ions, malachite green, and crystal violet. J Solution Chem 1976;5:249-255
22. Corrigan OI, Stanley T. Mechanism of drug dissolution rate enhancement from -cyclodextrin-drug systems. J Pharm Pharmacol 1982;34:621-626