Floating tablet of trimetazidine dihydrochloride: An approach for extended release with zero-order kinetics

AAPS PharmSciTech

Volumn 11, Issue 3, 2010, Pages 1058-1067

  Abdelbary, Ahmed ^a   El Gazayerly, Omaima N ^a   El Gendy, Nashwa A ^b,c   Ali, Adel A ^b  

^a CAIRO UNIVERSITY   (Egypt)

^b Beni Suef University   (Egypt)

^c UNIVERSITY OF KANSAS   (United States)

Author keywords

effervescent; extended release; floating tablets; oral drug delivery; trimetazidine dihydrochloride

Indexed keywords

CARBOMER; GUAR GUM; POLYCARBOPHIL; POLYMER; TRIMETAZIDINE; UNCLASSIFIED DRUG; VASTREL;

ADULT; ARTICLE; CONTROLLED RELEASE FORMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COATING; DRUG SCREENING; DRUG SOLUBILITY; DRUG STABILITY; EXPIRATION DATE; HUMAN; HYDROPHILICITY; IN VITRO STUDY; IN VIVO STUDY; MALE; NORMAL HUMAN; PRIORITY JOURNAL; SINGLE DRUG DOSE; TABLET FORMULATION; TABLET FRIABILITY; TABLET HARDNESS; THERMOSTABILITY; WEIGHT;

ADMINISTRATION, ORAL; ADULT; BIOLOGICAL AVAILABILITY; DELAYED-ACTION PREPARATIONS; DIFFUSION; HUMANS; KINETICS; MALE; METABOLIC CLEARANCE RATE; ORGAN SPECIFICITY; TABLETS; TISSUE DISTRIBUTION; TRIMETAZIDINE; VASODILATOR AGENTS;

EID: 78649907843     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9468-y     Document Type: Article

References (35)

1. J Hirtz 1985 The gastrointestinal absorption of drugs in man: a review of current concepts and methods of investigation Br J Clin Pharmacol 19 77S 83S 1:CAS:528:DyaL2MXltFGns74%3D 3890912
2. S Arora J Ali A Ahuja RK Khar S Baboota 2005 Floating drug delivery systems: a review AAPS PharmSciTech 6 3 E372 E390 10.1208/pt060347 16353995 (Pubitemid 41631780)
3. J Kerc J Opara 2007 A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation Int J Pharm 335 1-2 106 113 1:CAS:528:DC%2BD2sXjs1Cns7o%3D 10.1016/j.ijpharm.2006.11.007 17141985 (Pubitemid 46482868)
4. Lenaerts VM, Gurny R. Gastrointestinal tract-physiological variables affecting the performance of oral sustained release dosage forms. In: Lenaerts V, Gurny R, editors. Bioadhesive drug delivery systems. Boca Raton: CRC; 1990.
5. G Ponchel J Irache 1998 Specific and non-specific bioadhesive particulate systems for oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 2-3 191 219 1:CAS:528:DyaK1cXnsFWlt78%3D 10.1016/S0169-409X(98)00040-4 10837678 (Pubitemid 28535112)
6. AA Deshpande NH Shah CT Rhodes W Malick 1997 Development of a novel controlled-release system for gastric retention Pharm Res 14 6 815 819 1:CAS:528:DyaK2sXkt1yitLY%3D 10.1023/A:1012171010492 9210203 (Pubitemid 27281680)
7. SS Davis AF Stockwell MJ Taylor JG Hardy DR Whalley CG Wilson, et al. 1986 The effect of density on the gastric emptying of single- and multiple-unit dosage forms Pharm Res 3 4 208 213 10.1023/A:1016334629169 (Pubitemid 17195371)
8. Rednick AB, Tucker SJ. Sustained release bolus for animal husbandry. US Patent 3,507,952; 1970.
9. Mamajek RC, Moyer ES. Drug dispensing device and method. US Patent 4,207,890; 1980.
10. Urguhart J, Theeuwes F (1994) Drug delivery system comprising a reservoir containing a plurality of tiny pills. US Patent 4,434,153
11. JA Fix R Cargill K Engle 1993 Controlled gastric emptying. III. Gastric residence time of a nondisintegrating geometric shape in human volunteers Pharm Res 10 7 1087 1089 1:STN:280:DyaK3szptFarug%3D%3D 10.1023/A:1018939512213 8378252 (Pubitemid 23211437)
12. F Kedzierewicz P Thouvenot J Lemut A Etienne M Hoffman P Maincent 1999 Evaluation of peroral silicone dosage forms in humans by gamma-scintigraphy J Control Release 58 2 195 205 1:CAS:528:DyaK1MXhsVent7k%3D 10.1016/S0168-3659(98) 00154-0 10053192 (Pubitemid 29112890)
13. R Groning C Cloer M Georgarakis RS Muller 2007 Compressed collagen sponges as gastroretentive dosage forms: in vitro and in vivo studies Eur J Pharm Sci 30 1 1 6 10.1016/j.ejps.2006.08.003 17101267 (Pubitemid 44908920)
14. R Groning C Cloer RS Muller 2006 Development and in vitro evaluation of expandable gastroretentive dosage forms based on compressed collagen sponges Pharmazie 61 7 608 612 1:STN:280:DC%2BD28vmsFOjsg%3D%3D 16889068
15. R Groning G Heun 1984 Oral dosage forms with controlled gastrointestinal transit Drug Dev Ind Pharm 10 527 539 10.3109/03639048409041405
16. R Groning G Heun 1989 Dosage forms with controlled gastrointestinal passage studies on the absorption of nitrofurantoin Int J Pharm 56 111 116 10.1016/0378-5173(89)90003-3 (Pubitemid 19283754)
17. KJ McClellan GL Plosker 1999 Trimetazidine. A review of its use in stable angina pectoris and other coronary conditions Drugs 58 1 143 157 1:CAS:528:DyaK1MXltFOju7k%3D 10.2165/00003495-199958010-00016 10439934 (Pubitemid 29373894)
18. Moffat AC, Jackson JV, Widdop B. Thin layer chromatography. In: Moffat AC, editor. Clarke's isolation and identification of drugs. 2nd ed. London: The Pharmaceutical Press; 1986. p. 1676.
19. Sievert B, Siewert M. Dissolution test for extended release products. In: Dressman JB, Lennernäs H, editors. Oral drug absorption: prediction and assessment. New York: Marcel Dekker; 2000. p. 183-95.
20. Z Rahman M Ali R Khar 2006 Design and evaluation of bilayer floating tablets of captopril Acta Pharm 56 1 49 57 1:CAS:528:DC%2BD28XhvFyhsL4%3D 16613734
21. Banker GS, Anderson NR. Tablets. In: Lachman L, Liberman HA, Kanig JL, editors. The theory and practice of industrial pharmacy. 3rd ed. Philadelphia: Lea and Febiger; 1986. p. 293-345.
22. C Narendra MS Srinath G Babu 2006 Optimization of bilayer floating tablet containing metoprolol tartrate as a model drug for gastric retention AAPS PharmSciTech 7 2 E34 1:STN:280:DC%2BD28zotVSgtw%3D%3D 10.1208/pt070234 16796352
23. N Rouge ET Cole E Doelker P Buri 1998 Buoyancy and drug release patterns of floating minitablets containing piretanide and atenolol as model drugs Pharm Dev Technol 3 1 73 84 1:CAS:528:DyaK1cXhvFSisb4%3D 10.3109/10837459809028481 9532602
24. SO Thoppil PD Amin 2001 Trimetazidine: stability indicating RPLC assay method J Pharm Biomed Anal 25 2 191 195 1:CAS:528:DC%2BD3MXit1Sjs7k%3D 10.1016/S0731-7085(00)00483-0 11275427 (Pubitemid 32244227)
25. SO Thoppil RM Cardoza PD Amin 2001 Stability indicating HPTLC determination of trimetazidine as bulk drug and in pharmaceutical formulations J Pharm Biomed Anal 25 1 15 20 1:CAS:528:DC%2BD3MXitF2qu7Y%3D 10.1016/S0731-7085(00)00440-4 11274854 (Pubitemid 32234395)
26. G Anderson M Scott 1991 Determination of product shelf life and activation energy for five drugs of abuse Clin Chem 37 3 398 402 1:CAS:528:DyaK3MXhslWiu7w%3D 2004447
27. A Oliva JB Fariña M Llabrés 1996 Influence of temperature and shaking on stability of insulin preparations: degradation kinetics Int J Pharm 143 2 163 170 1:CAS:528:DyaK28XmvFeju7Y%3D 10.1016/S0378-5173(96)04700-X (Pubitemid 26425821)
28. JG Slater HA Stone BT Palermo RN Duvall 1979 Reliability of Arrhenius equation in predicting vitamin A stability in multivitamin tablets J Pharm Sci 68 1 49 52 1:CAS:528:DyaE1MXpt1entA%3D%3D 10.1002/jps.2600680117 758465
29. N Rouge E Allemann M Gex-Fabry L Balant ET Cole P Buri, et al. 1998 Comparative pharmacokinetic study of a floating multiple-unit capsule, a high-density multiple-unit capsule and an immediate-release tablet containing 25 mg atenolol Pharm Acta Helv 73 2 81 87 1:CAS:528:DyaK1cXktFKht7o%3D 10.1016/S0031-6865(97)00050-2 9700936 (Pubitemid 28327969)
30. The British pharmacopoeia. London: The Pharmaceutical Press; 1998. p. 242.
31. The Pharmacopoeia of the United States of America 27, The National Formulary 22, Asian Edition. Rockville, MD: Pharmacopoeial Convention, Inc.; 2004. p. 454-8.
32. Bakan JA. Capsule part III, Microencapsulation. In: Lachmann L, Lieberman HA, Kanig JL, editors. The theory and practice of industrial pharmacy. 3rd ed. Philadelphia: Lea and Febiger; 1986. p. 412-29.
33. U Dopeshwarkar J Zata 1993 Evaluation of xanthan gum in the preparation of sustained release matrix tablets Drug Dev Ind Pharm 19 9 999 1017 10.3109/03639049309062997
34. A Steingoetter D Weishaupt P Kunz K Mader H Lengsfeld M Thumshirn, et al. 2003 Magnetic resonance imaging for the in vivo evaluation of gastric-retentive tablets Pharm Res 20 12 2001 2007 1:CAS:528:DC%2BD3sXpvVShsbY%3D 10.1023/B:PHAM.0000008049.40370.5a 14725366 (Pubitemid 38005532)
35. YS Krishnaiah RS Karthikeyan P Bhaskar V Satyanarayana 2002 Bioavailability studies on guar gum-based three-layer matrix tablets of trimetazidine dihydrochloride in human volunteers J Control Release 83 2 231 239 1:CAS:528:DC%2BD38XntlymtLo%3D 10.1016/S0168-3659(02)00215-8 12363449 (Pubitemid 35279468)