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Comparative pharmacokinetic evaluation of compressed suppositories of diclofenac sodium in humans.
Arzneimittelforschung. 1996 Feb; 46(2):175-7.A

Abstract

Diclofenac sodium (CAS 15307-79-6) suppositories were formulated using polyethylene glycol 4000 as the base by dispersing the drug in the molten base, congealing the mass, followed by pulverization, sieving and subsequent compression of the resultant granules. These suppositories were evaluated with respect to their pharmacokinetic behaviour in 12 healthy, male human volunteers. The results were compared with those obtained after oral administration of a commercial enteric coated tablet. Bioequivalence between rectal suppositories and commercial tablets was observed with respect to AUC0-infinity and Cmax. However, tmax differed significantly (p < 0.05) in case of rectal administration (0.625 +/- 0.065 h) compared to oral tablet (1.58 +/- 0.06 h). The relative rectal bioavailability was 107.19 +/- 3.2.

Authors+Show Affiliations

Pharmacology Division, Indian Institute of Chemical Technology, Hyderabad, India.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8720309

Citation

Ramakrishna, S, et al. "Comparative Pharmacokinetic Evaluation of Compressed Suppositories of Diclofenac Sodium in Humans." Arzneimittel-Forschung, vol. 46, no. 2, 1996, pp. 175-7.
Ramakrishna S, Fadnavis NW, Diwan PV. Comparative pharmacokinetic evaluation of compressed suppositories of diclofenac sodium in humans. Arzneimittelforschung. 1996;46(2):175-7.
Ramakrishna, S., Fadnavis, N. W., & Diwan, P. V. (1996). Comparative pharmacokinetic evaluation of compressed suppositories of diclofenac sodium in humans. Arzneimittel-Forschung, 46(2), 175-7.
Ramakrishna S, Fadnavis NW, Diwan PV. Comparative Pharmacokinetic Evaluation of Compressed Suppositories of Diclofenac Sodium in Humans. Arzneimittelforschung. 1996;46(2):175-7. PubMed PMID: 8720309.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative pharmacokinetic evaluation of compressed suppositories of diclofenac sodium in humans. AU - Ramakrishna,S, AU - Fadnavis,N W, AU - Diwan,P V, PY - 1996/2/1/pubmed PY - 1996/2/1/medline PY - 1996/2/1/entrez SP - 175 EP - 7 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 46 IS - 2 N2 - Diclofenac sodium (CAS 15307-79-6) suppositories were formulated using polyethylene glycol 4000 as the base by dispersing the drug in the molten base, congealing the mass, followed by pulverization, sieving and subsequent compression of the resultant granules. These suppositories were evaluated with respect to their pharmacokinetic behaviour in 12 healthy, male human volunteers. The results were compared with those obtained after oral administration of a commercial enteric coated tablet. Bioequivalence between rectal suppositories and commercial tablets was observed with respect to AUC0-infinity and Cmax. However, tmax differed significantly (p < 0.05) in case of rectal administration (0.625 +/- 0.065 h) compared to oral tablet (1.58 +/- 0.06 h). The relative rectal bioavailability was 107.19 +/- 3.2. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/8720309/Comparative_pharmacokinetic_evaluation_of_compressed_suppositories_of_diclofenac_sodium_in_humans_ DB - PRIME DP - Unbound Medicine ER -