Formulation development of oral controlled release tablets of hydralazine: Optimization of drug release and bioadhesive characteristics

Acta Pharmaceutica

Volumn 59, Issue 1, 2009, Pages 1-13

  Singh, Bhupinder ^a   Pahuja, Sonia ^a   Kapil, Rishi ^a   Ahuja, Naveen ^a  

^a PANJAB UNIVERSITY   (India)

Author keywords

Bioadhesive; Experimental design; Gastrointestinal therapeutic system; Hydralazine; Hydrophilic matrices; Response surface methodology

Indexed keywords

CARBOMER; CARBOPOL 971P; HYDRALAZINE; HYDROXYPROPYLMETHYLCELLULOSE; UNCLASSIFIED DRUG;

ANIMAL TISSUE; ARTICLE; CONTROLLED RELEASE FORMULATION; MUCOADHESION; NONHUMAN; RESPONSE SURFACE METHOD; STOMACH MUCOSA; SWINE; TABLET FORMULATION;

EID: 62949193568     PISSN: 13300075     EISSN: None     Source Type: Journal    
DOI: 10.2478/v10007-009-0005-z     Document Type: Article

References (26)

1. Y. W. Chien, Rate-control drug delivery systems: Controlled release vs. sustained release, Med. Prog. Technol. 15 (1989) 21-46.
2. Y. Song, Y. Wang, R. Thakur, V. M. Meidan and B. Michniak, Mucosal drug delivery: membranes, methodologies, and applications, Crit. Rev. Ther. Drug Carrier Syst. 21 (2004) 195-256; DOI:10.1615/ CritRevTherDrugCarrierSyst.v21.i3.20.
3. B. Singh, S. K. Chakkal and N. Ahuja, Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology, AAPS PharmSciTech 7 (2006) E1-E10; DOI: 10.1208/pt070103.
4. th ed. (Ed. J. G. Hardman and L. E. Limbird), Mc Graw Hill Medical Publishing Division, New York 2001, pp. 871-900.
5. K. Wulff, K. Lenz, A. R. Krogsgaard and B. Holst, Hydralazine in arterial hypertension. Randomized, double-blind comparison between conventional and slow-release preparations, Ugeskr. Laeger. 142 (1980) 1862-1865.
6. T. Talseth, P. Fauchald and J. F. Pape, Hydralazine slow-release: Observations on serum profile and clinical efficacy in man, Curr. Ther. Res. Clin. Exp. 21 (1977) 157-168.
7. J. Adir, S. M. Janda, C. L. Curry, R. E. Taylor, C. D. Poku and K. S. Rotenberg, Comparative efficacy and safety of immediate-release and controlled-release hydralazine in black hypertensive patients, Clin. Ther. 9 (1987) 640-650.
8. J. H. Silas, L. E. Ramsay and S. Freestone, Hydralazine once daily in hypertension, Br. Med. J. 284 (1982) 1602-1624.
9. B. Singh, R. Kumar and N. Ahuja, Optimizing drug delivery systems using systematic »design of experiments«. Part I: fundamental aspects, Crit. Rev. Ther. Drug Carrier Syst. 22 (2005) 27-105; DOI: 10.1615/CritRevTherDrugCarrierSyst.v22.i1.20.
10. United States Pharmacopoeia 27, National Formulary 22, USP Convention, Rockville 2004.
11. B. Singh and S. Singh, A compreshensive computer program for study of drug release kinetics from compressed matrices, Indian J. Pharm. Sci. 60 (1998) 313-316.
12. B. Singh, T. Kaur and S. Singh, Correction of raw dissolution data for loss of drug during sampling, Indian J. Pharm. Sci. 59 (1997) 196-199.
13. R. W. Korsemeyer, R. Gurny, E. Doelker, P. Buri and N. Peppas, Mechanisms of solute release from porous hydrophilic polymers, Int. J. Pharm. 15 (1983) 23-35.
14. B. Singh and N. Ahuja, Development of controlled-release buccoadhesive hydrophilic matrices of diltiazem hydrochloride: optimization of bioadhesion, dissolution, and diffusion parameters, Drug Dev. Ind. Pharm. 28 (2002) 431-442; DOI: 10.1081/DDC-120003004.
15. V. V. Yamsani, R. Gannu, C. Kolli, M. E. Rao and M. R. Yamsani, Development and in vitro evaluation of buccoadhesive carvedilol tablets, Acta Pharm. 57 (2007) 185-197; DOI: 10.2478/v10007-007-0015-7.
16. A. O. Nur and J. S. Zhang, Captopril floating and/or bioadhesive tablets: design and release kinetics, Drug Dev. Ind. Pharm. 26 (2000) 965-969; DOI: 10.1081/DDC-100101323.
17. B. Singh, M. Dahiya, V. Saharan and N. Ahuja, Optimizing drug delivery systems using systematic »design of experiments«. Part II: retrospect and prospects, Crit. Rev. Ther. Drug Carrier Syst. 22 (2005) 215-294; DOI: 10.1615/CritRevTherDrugCarrierSyst.v22.i3.10.
18. J. B. Schwartz and R. E. Connor, Optimization Techniques in Pharmaceutical Formulation and Processing, in Modern Pharmaceutics (Eds. G. S. Banker and C. T. Rhodes), Marcel Dekker, New York 1996, pp. 727-752.
19. B. Singh, R. K. Gupta and N. Ahuja, Computer-assisted optimization of pharmaceutical formulations and processes, in Pharmaceutical Product Development (Ed. N. K. Jain), CBS Publishers, New Delhi 2006, pp. 273-318.
20. M. J. Vazquaz, B. Perez Macros, J. L. Gomez-Amoza and N. A. Peppas, Influence of technological variables on release of drugs from hydrophilic matrices, Drug Dev. Ind. Pharm. 18 (1992) 1355-1375.
21. USFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, U.S. Department of Health and Human Services, Food and Drug Administration: Center for Drug Evaluation and Research (CDER) (1997), Rockwille 1997.
22. S. Chopra, G. V. Patil and S. K. Motwani, Release modulating hydrophilic matrix systems of losartan potassium: Optimization of formulation using statistical experimental design, Eur. J. Pharm. Biopharm. 66 (2007) 73-82; DOI: 10.1016/j.ejpb.2006.09.001.
23. B. Perez-Marcos, J. L. Ford, D. J. Armstrong, P. N. Elliott, C. Rostron and J. E. Hogan, Influence of pH on the release of propranolol hydrochloride from matrices containing hydroxypropylmethylcellulose K4M and carbopol 974, J. Pharm. Sci. 85 (1996) 330-334; DOI: 10.1021/js950359z.
24. A. Nokhodchi, J. L. Ford and M. H. Rubinstein, Studies on the interaction between water and (hydroxypropyl)methylcellulose, J. Pharm. Sci. 86 (1997) 608-615; DOI: 10.1021/js960279a.
25. G. Ponchel, F. Touchard, D. Duchene and N. A. Peppas, Bioadhesive analysis of controlled release systems. I. Fracture and interpenetration analysis in poly(acrylic acid) containing systems, J. Control. Rel. 5 (1987) 129-141; DOI: 10.1016/0168-3659(87)90004-6.
26. F. Madson, K. Eberth and J. D. Smart, A rheological assessment of the nature of interactions between mucoadhesive polymers and a homogenised mucus gel, Biomaterials 19 (1998) 1083-1092.