Advertisement

Pharmacy World and Science

, Volume 22, Issue 2, pp 67–71 | Cite as

Oral bioavailability of phenobarbital: a comparison of a solution in myvacet 9‐08, a suspension, and a tablet

  • Jan Peter Yska
  • Guus W.G. Essink
  • Adriaan A. van Sorge
  • Frank H. Bosch
  • Gert Lankhaar
Article

Abstract

Purpose: A three‐way crossover study with seven healthy male volunteers was conducted to determine the relative bioavailability of phenobarbital after single dose administration of 100 mg of phenobarbital as oral solution in Myvacet 9‐08, and as a suspension, compared with a 100 mg phenobarbital tablet. Materials and methods: At 4‐week intervals each subject received the solution in Myvacet 9‐08, the suspension and the tablet in randomized order. Blood samples were collected for 48 h after each dose for analysis of phenobarbital. From the individual serum concentration‐versus‐time curves Cmaxand Tmax were determined and AUC0‐48 was calculated. Results: All three oral dosage forms of phenobarbital are bioequivalent. No significant diffences in Tmaxwere observed. Conclusion: The oral solution in Myvacet 9‐08, and the suspension of phenobarbital proved to be bioequivalent to a tablet.

Bioequivalence Myvacet 9‐08 Oral bioavailability Phenobarbital Suspension. 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Constantinides PP. Lipid microemulsions for improving drug dissolution and oral absorption: physical and biopharmaceutical aspects. Pharm. Res. 1995;12: 1561-72.Google Scholar
  2. 2.
    Shah NH, Carvajal MT, Patel CI, Infeld MH, Malick AW. Selfemulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs. Int. J. Pharm. 1994;106: 15-23.Google Scholar
  3. 3.
    Acetic and fatty acid esters of glycerol. In: Toxicological evaluation of some food additives. FAO Nutrition meetings report series No. 53A, Rome, 1974:210-3.Google Scholar
  4. 4.
    Mono-and di-acetylated monoglycerides. In: The United States Pharmacopeia, USP 23 / The National Formulary, NF 18. Rockville MD: The United States Pharmacopeial Convention Inc, 1994:2269-70.Google Scholar
  5. 5.
    Wilensky AJ, Friel PN, Levy RH, Comfort CP, Kaluzny SP. Kinetics of phenobarbital in normal subjects and epileptic patients. Eur. J. Clin. Pharmacol. 1982;23: 87-92.Google Scholar
  6. 6.
    Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of onfidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 1992;30, Supp No 1: 51-8.Google Scholar
  7. 7.
    In vivo bioequivalence guidances. In: The United States Pharmacopeia, USP 23 / The national Formulary, NF 18. Rockville MD: The United States Pharmacopeial Convention Inc, 1994:1929-32.Google Scholar
  8. 8.
    SAS Institute Inc. SAS/STAT User's guide version 6, fourth edition, volume 2. Cary, NC: SAS Institute Inc., 1989.Google Scholar
  9. 9.
    Hollander M, Wolfe DA. In: Nonparametric statistical methods. New York: John Wiley & Sons, 1973:26-66.Google Scholar
  10. 10.
    Nelson E, Powell JR, Conrad K, Likes K, Byers J, Baker S, et al. Phenobarbital pharmacokinetics and bioavailability in adults. J. Clin. Pharmacol. 1982;22: 141-8.Google Scholar
  11. 11.
    Leucuta SE, Popa Lidia, Ariesan M, Popa Letitia, Pop RD, Kory M, et al. Bioavailability of phenobarbital from different pharmaceutical dosage forms. Pharm. Acta Helv. 1977;52: 261-6.Google Scholar
  12. 12.
    Carey MC. Lipid digestion and absorption, Ann. Rev. Physiol. 1983;45: 651-77.Google Scholar

Copyright information

© Kluwer Academic Publishers 2000

Authors and Affiliations

  • Jan Peter Yska
    • 1
  • Guus W.G. Essink
    • 1
  • Adriaan A. van Sorge
    • 1
  • Frank H. Bosch
    • 2
  • Gert Lankhaar
    • 3
  1. 1.Department of Clinical PharmacyRijnstate HospitalArnhemThe Netherlands
  2. 2.Department of Internal MedicineRijnstate HospitalArnhemThe Netherlands
  3. 3.Pharma Bio‐Research International B.V.ZuidlarenThe Netherlands

Personalised recommendations