José Homero De Souza Filho *

Autor invitado por SIIC

Influência da alimentação no perfil farmacocinético da venlafaxina

AVALIAÇÃO DA INFLUÊNCIA DA ALIMENTAÇÃO NA FARMACOCINÉTICA DA VENLAFAXINA

Conclui-se que os medicamentos atendem os critérios para serem considerados bioequivalente de acordo com as normas da ANVISA e FDA. Obtive-se aumento nos parâmetros farmacocinéticos (Cmáx e ASC) e redução dos eventos adversos quando os medicamentos foram administrados 30 minutos após a alimentação.

*José Homero De Souza Filho
describe para SIIC los aspectos relevantes de su trabajo
RELATIVE BIOAVAILABILITY OF TWO FORMULATIONS OF VENLAFAXINE EXTENDED-RELEASE 75-MG CAPSULES IN HEALTHY BRAZILIAN MALE VOLUNTEERS: A SINGLE-DOSE, RANDOMIZED-SEQUENCE, OPEN-LABEL, TWO-PERIOD CROSSOVER STUDY IN THE FASTING AND FED STATES
Institución principal de la investigación
*Núcleo de Desenvolvimento Farmacêutico e Cosméticos da Universidade Federal de Pernambuco - Nudfac/ufpe, Recife, Brasil
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Referencias bibliográficas
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.
1. Troy S, Dilea C, Leister P, et al. Pharmacokinetics of oncedaily venlafaxine extended release in healthy volunteers. Curr Ther Res 58:504-514, 1997.
2. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs 49:280-294, 1995.
3. Gonzalez Ruelas E, Diaz Martinez A, Martinez Ruiz R, for the Venlafaxine-Global Awareness Program Study Collaborative Group. An open assessment of the acceptability, efficacy and tolerance of venlafaxine in usual care settings. Curr Ther Res Clin Exp 58:609-630, 1997.
4. Preskorn S. Pharmacotherapeutic profile of venlafaxine. Eur Psychiatry 12(Suppl 4):285s-294s, 1997.
5. Gutierrez MA, Stimmel GL, Aiso JY. Venlafaxine: A 2003 update. Clin Ther 25:2138-2154, 2003.
6. Stahl SM, Entsuah R, Rudolph RL. Comparative efficacy between venlafaxine and SSRIs: A pooled analysis of patients with depression. Biol Psychiatry 52:1166-1174, 2002.
7. Deakin B, Dursun S. Optimizing antidepressant treatment: Efficacy and tolerability. Int Clin Psychopharmacol 17(Suppl 1):S13-S24, 2002.
8. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol 59:312, 1986.
9. Howell SR, Husbands GE, Scatina JA, Sisenwine SF. Metabolic disposition of 14C-venlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica 23:349-359, 1993.
10. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol 32:716-724, 1992.
11. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol 35:404-409, 1995.
12. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit 16:100-107, 1994.
13. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 1170. Evidence Guide for Relative Bioavailability/ Bioequivalence of Medicines [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2006.
14. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies: Study design, data analysis, and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf. Accessed October 3, 2008.
15. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 899. Guidelines for validation of analytical and bioanalytical methods [in Portuguese]. Brasília, Brasil:Diário Oficial da União; 2003.
16. Hirsch AF, ed. Good Laboratory Practice Regulations. New York, NY: Marcel Dekker; 1989.
17. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed October 3, 2008.
18. Ritschel WA, Kearns GL. Handbook of basic pharmacokinetics-Including clinical applications. 6th ed. Washington, DC:American Pharmacists Association, 2004.
19. Agência Nacional de Vigilância Sanitária-ANVISA. Resolution no. 898. Guidelines for planning and performing the statistical phase of relative bioavailability and bioequivalence studies [in Portuguese]. Brasília, Brasil: Diário Oficial da União; 2003.
20. Hsuan FC. Estimating treatment means in a mixed-effect ANOVA model for bioequivalence studies. Biometrics 49:703-713, 1993.
21. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657-680, 1987.
22. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd ed. New York, NY: Marcel Dekker, 2000.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat Theor Meth 12:2663-2692, 1983.
24. World Health Organization (WHO). Working document QAS/04.093/ Rev.4. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Draft revision. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.