Determination of the transdermal bioavailability of a newly developed diclofenac sodium patch in comparison with a reference preparation

Arzneimittel-Forschung/Drug Research

Volumn 55, Issue 7, 2005, Pages 403-413

  Gschwend, Michael H ^a,c   Martin, Wolfgang ^a   Arnold, Peter ^a   Verdun, Marie Odile ^b   Cambon, Nathalie ^b   Frentzel, Adrian ^b   Scheiwe, Werner ^b  

^a Pharmakin GmbH   (Germany)

^b Mepha Ltd   (Switzerland)

^c Pharmakin GmbH   (Germany)

Author keywords

Anti inflammatory drug, non steroidal; CAS 15307 86 5; Diclofenac epolamine, plaster, topical administration, transdermal bioavailability; Diclofenac sodium, plaster, topical administration, transdermal bioavailability; Olfen patch

Indexed keywords

DICLOFENAC; DICLOFENAC DERIVATIVE; DICLOFENAC EPOLAMINE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BURNING SENSATION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG HALF LIFE; FEMALE; HEADACHE; HEMATOMA; HUMAN; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MULTIPLE DRUG DOSE; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STEADY STATE; TRANSDERMAL PATCH; VOLUNTEER; VOMITING;

EID: 22544441127     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296879     Document Type: Article

References (19)

1. Davies, N. M., Anderson, K. E., Clinical pharmacokinetics of diclofenac. Therapeutic insights and pitfalls. Clin. Pharmacokinet. 33, 184 (1997)
2. Todd, P. A., Sorkin, E. M., Diclofenac sodium. A re-appraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 35, 244 (1988)
3. Predel, H. G., Koll, R., Pabst, H. et al., Diclofenac patch for topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study. Br. J. Sports Med. 38, 318 (2004)
4. Radermacher, J., Jentsch, D., Scholl, M. A. et al., Diclofenac concentrations in synovial fluid and plasma after cutaneous administration in inflammatory and degenerative joint disease. Br. J. Clin. Pharmacol. 31, 537 (1991)
5. Pietschmann, H., Silberbauer, K. F., Ring, F. et al., Diclofenac and platelet aggregation. Wien. Med. Wochenschr. 24, 747 (1977)
6. Wilkens, R. F., Worldwide clinical safety experience with diclofenac. Semin. Arthritis Rheum. 15 (Suppl. 1), 105 (1985)
7. Fowler, P. D., Dawes, P. T., John, V. A. et al., Plasma and synovial fluid concentrations of diclofenac sodium and its hydroxylated metabolites during once-daily administration of a 100 mg slow-release formulation. Eur. J. Clin. Pharmacol. 31, 469 (1986)
8. Wiesenberg-Boettcher, I., Pfeilschifter, J., Schweizer, A. et al., Pharmacological properties of five diclofenac metabolites identified in human plasma. Agents Actions 34, 135 (1991)
9. Assandri, A., Canali, S., Giachetti, C., Local tolerability and pharmacokinetic profile of a new transdermal delivery system, diclofenac hydroxyethylpyrrolidine plaster. Drugs Exp. Clin. Res. 19, 89 (1993)
10. Riess, W., Schmid, K., Botta, L. et al., The percutaneous absorption of diclofenac. Arzneim.-Forsch./Drug Res. 36, 1092 (1986)
11. Sioufi, A., Pommier, F., Boschet, F. et al., Percutaneous absorption of diclofenac in healthy volunteers after single and repeated topical application of diclofenac Emulgel. Biopharm. Drug Dispos. 15, 441 (1994)
12. Heyneman, C. A., Lawless-Liday, C., Wall, G. C., Oral versus topical NSAIDs in rheumatic diseases: a comparison. Drugs 60, 555 (2000)
13. Gallacchi, G., Marcolongo, R., Pharmacokinetics of diclofenac hydroxyethylpyrrolidine (DHEP) plasters in patients with monolateral knee joint effusion. Drugs Exp. Clin. Res. 19, 95 (1993)
14. Gallacchi, G., Frentzel, A., Heidecker, J. L., Die topische Therapie stumpfer Weichteilverletzungen - Topical treatment of blunt impact injuries. Praxis 92, 967 (2003)
15. EMEA - ICH Topic E6: Note for Guidance on Good Clinical Practice, CPMP/ICH/135/95
16. Shah, V. P., Midha, K. K., Dighe, S. et al., Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies, J. Pharmac. Sci. 81, 309 (1992)
17. Schulz, H.-U., Steinijans, V. W., Striving for standards in bioequivalence assessment. A review. Int. J. Pharmacol. Ther. Toxicol. 29, 293 (1991)
18. Gardner, S., Bioavailability and bioequivalence requirements. Procedures for establishing a bioequivalence requirement. Fed. Reg. 42, 1624 (1977)
19. CPMP - Note for Guidance III/54/89-EN, Final December 1991 "Investigation of Bioavailability and Bioequivalence"; The European Agency for the Evaluation of Medicinal Product, London, UK