Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet

AAPS PharmSciTech

Volumn 11, Issue 3, 2010, Pages 1026-1037

  Aboelwafa, Ahmed A ^a   Basalious, Emad B ^a  

^a CAIRO UNIVERSITY   (Egypt)

Author keywords

controlled release; factorial design; optimization; pharmacokinetic; three layer tablet; venlafaxine

Indexed keywords

GLYCEROL BEHENATE; VENLAFAXINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED RELEASE FORMULATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSAGE FORM COMPARISON; HUMAN; HYDROPHILICITY; IN VIVO STUDY; MALE; NORMAL HUMAN; PRIORITY JOURNAL; PROCESS OPTIMIZATION; SINGLE DRUG DOSE; SUSTAINED RELEASE FORMULATION; TABLET FORMULATION; TABLET PROPERTY;

ADULT; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CROSS-OVER STUDIES; CYCLOHEXANOLS; DELAYED-ACTION PREPARATIONS; HUMANS; MALE; METABOLIC CLEARANCE RATE; TABLETS;

EID: 78649904090     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9467-z     Document Type: Article

References (27)

1. RA de Oliveira GM Cunha KD Borges GS de Bruin EA dos Santos-Filho GS Viana, et al. 2004 The effect of venlafaxine on behaviour, body weight and striatal monoamine levels on sleep-deprived female rats Pharmacol Biochem Behav 79 499 506 10.1016/j.pbb.2004.09.001 15582021 (Pubitemid 39576167)
2. MC Gohel CD Soni SA Nagori KG Sarvaiya 2008 Modulation of venlafaxine hydrochloride release from press coated tablet Indian J Pharm Sci 70 292 7 1:STN:280:DC%2BC3c%2FgtlGksQ%3D%3D 10.4103/0250-474X.42974 20046735
3. MC Gohel SH Bariya 2009 Fabrication of triple-layer matrix tablets of venlafaxine hydrochloride using xanthan gum AAPS PharmSciTech 10 624 30 1:CAS:528:DC%2BC3cXovFantLk%3D 10.1208/s12249-009-9244-z 19444618
4. SN Makhija PR Vavia 2002 Once daily sustained release tablets of venlafaxine, a novel antidepressant Eur J Pharm Biopharm 54 9 15 1:CAS:528:DC%2BD38XkslKisb4%3D 10.1016/S0939-6411(02)00049-8 12084497 (Pubitemid 34663851)
5. S Abdul SS Poddar 2004 A flexible technology for modified release of drugs: multi layered tablets J Control Release 97 393 405 1:CAS:528: DC%2BD2cXkvF2itro%3D 15212872
6. N Chidambaram W Porter K Flood Y Qiu 1998 Formulation and characterization of new layered diffusional matrices for zero-order sustained release J Control Release 52 149 58 1:CAS:528:DyaK1cXhtlarsr0%3D 10.1016/S0168-3659(97)00207-1 9685945 (Pubitemid 28123182)
7. M Efentakis C Peponaki 2008 Formulation study and evaluation of matrix and three-layer tablet sustained drug delivery systems based on Carbopols with isosorbite mononitrate AAPS PharmSciTech 9 917 23 1:CAS:528:DC%2BC3cXovVKgtLg%3D 10.1208/s12249-008-9084-2 18686040
8. TM Systems) J Control Release 26 39 47 1:CAS:528:DyaK3sXmtleqtrs%3D 10.1016/0168-3659(93)90207-L (Pubitemid 23204077)
9. The United States Pharmacopeia 30/The National Formulary 25. Rockville: USP Convention; 2006.
10. JG Wagner 1969 Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules J Pharm Sci 58 1253 7 1:CAS:528:DyaF1MXlt1yltLc%3D 10.1002/jps.2600581021 5349114
11. T Higuchi 1961 Rate of release of medicaments from ointment bases containing drugs in suspension J Pharm Sci 50 874 5 1:CAS:528: DyaF38Xhtlahsg%3D%3D 10.1002/jps.2600501018 13907269
12. T Higuchi 1963 Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices J Pharm Sci 52 1145 9 1:CAS:528:DyaF2cXlt1Whsg%3D%3D 10.1002/jps.2600521210 14088963
13. RW Korsemeyer R Gurnya E Doelkera P Buria NA Peppas 1983 Mechanisms of solute release from porous hydrophilic polymers Int J Pharm 15 25 35 10.1016/0378-5173(83)90064-9 (Pubitemid 13092121)
14. NA Peppas 1985 Analysis of Fickian and non-Fickian drug release from polymers Pharm Acta Helv 60 110 1 1:CAS:528:DyaL2MXktFWgtb8%3D 4011621
15. D Sinha Roy BD Rohera 2002 Comparative evaluation of rate of hydration and matrix erosion of HEC and HPC and study of drug release from their matrices Eur J Pharm Sci 16 193 9 1:CAS:528:DC%2BD38XlsVKrtLg%3D 10.1016/S0928-0987(02) 00103-3 12128174 (Pubitemid 34786454)
16. R Mandrioli L Mercolini R Cesta S Fanali M Amore MA Raggi 2007 Analysis of the second generation antidepressant venlafaxine and its main active metabolite O-desmethylvenlafaxine in human plasma by HPLC with spectrofluorimetric detection J Chromatogr B Analyt Technol Biomed Life Sci 856 88 94 1:CAS:528:DC%2BD2sXpvFKnsro%3D 10.1016/j.jchromb.2007.05.046 17581798 (Pubitemid 47307441)
17. V Mahaguna RL Talbert JI Peters S Adams TD Reynolds FY Lam, et al. 2003 Influence of hydroxypropylmethylcellulose polymer on in vitro and in vivo performance of controlled release tablets containing alprazolam Eur J Pharm Biopharm 56 461 8 1:CAS:528:DC%2BD3sXos12qu70%3D 10.1016/S0939-6411(03)00116-4 14602191 (Pubitemid 37351032)
18. LS Bernardi PR Oliveira FS Murakami MAS Silva SHM Borgmann SG Cardoso 2009 Characterization of venlafaxine hydrochloride and compatibility studies with pharmaceutical excipients J Therm Anal Cal 97 729 33 1:CAS:528: DC%2BD1MXhtlWns73M 10.1007/s10973-009-0282-2
19. T Phaechamud 2008 Variables influencing drug release from layered matrix system comprising hydroxypropylmethylcellulose AAPS PharmSciTech 9 668 74 1:CAS:528:DC%2BC3cXnslGjuro%3D 10.1208/s12249-008-9085-1 18500559
20. FQ Li JH Hu JX Deng H Su S Xu JY Liu 2006 In vitro controlled release of sodium ferulate from Compritol 888 ATO-based matrix tablets Int J Pharm 324 152 7 1:CAS:528:DC%2BD28XhtVOgu7%2FN 10.1016/j.ijpharm.2006.06.006 16837152 (Pubitemid 44528916)
21. J Liu F Zhang JW McGinity 2001 Properties of lipophilic matrix tablets containing phenylpropanolamine hydrochloride prepared by hot-melt extrusion Eur J Pharm Biopharm 52 181 90 1:CAS:528:DC%2BD3MXmtV2ktLY%3D 10.1016/S0939-6411(01) 00162-X 11522484 (Pubitemid 32755897)
22. Y Qiu N Chidambaram K Flood 1998 Design and evaluation of layered diffusional matrices for zero-order sustained-release J Control Release 51 123 30 1:CAS:528:DyaK1cXot12mtQ%3D%3D 10.1016/S0168-3659(97)00119-3 9685909 (Pubitemid 28252863)
23. J Singh AK Philip K Pathak 2008 Optimization studies on design and evaluation of orodispersible pediatric formulation of indomethacin AAPS PharmSciTech 9 60 6 1:CAS:528:DC%2BC3cXosFGnsbY%3D 10.1208/s12249-007-9018-4 18446462
24. GS Rekhi RV Nellore AS Hussain LG Tillman HJ Malinowski LL Augsburger 1999 Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets J Control Release 59 327 42 1:CAS:528:DyaK1MXjtVykurY%3D 10.1016/S0168-3659(99)00004-8 10332064 (Pubitemid 29238176)
25. AB Solanki JR Parikh RH Parikh 2007 Formulation and optimization of piroxicam proniosomes by 3-factor, 3-level Box-Behnken design AAPS PharmSciTech 8 E86 10.1208/pt0804086 18181547
26. MV Velasco JL Ford P Rowe AR Rajabi-Siahboomi 1999 Influence of drug:hydroxypropylmethylcellulose ratio, drug and polymer particle size and compression force on the release of diclofenac sodium from HPMC tablets J Control Release 57 75 85 1:CAS:528:DyaK1cXotVymtLk%3D 10.1016/S0168-3659(98) 00110-2 9863041 (Pubitemid 29005075)
27. FDA Center for Drug Evaluation and Research. Guidance for industry: dissolution testing of immediate release solid oral dosage form. Rockville: FDA; 1997.