Development and in vivo evaluation of extended release dextromethorphan tablets Part 1


Bharaj S., Takka S., Kelm G., Sakr A.

PHARMAZEUTISCHE INDUSTRIE, vol.68, no.1, pp.116-119, 2006 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 68 Issue: 1
  • Publication Date: 2006
  • Journal Name: PHARMAZEUTISCHE INDUSTRIE
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.116-119
  • Gazi University Affiliated: Yes

Abstract

The objective of this study was to develop extended release (ER) tablets of dextromethorphan hydrobromide (DMHBr, CAS 6700-34-1). A comparison with a marketed ER product in vivo was made. In vitro drug release data were obtained and the three formulations were found to be similar upon application of the FDA f2 similarity factor. A randomized crossover study was performed in healthy adult male beagle dogs for the in vivo evaluation. The three treatments, 1.) a hydroxypropyl methylcellulose and methacrylic acid copolymer combination ER matrix tablet, 2.) a polyvinylacetate/povidone copolymer ER matrix tablet and 3.) a marketed German ER capsule product (Tuss Hustenstitler retardkapseln) each containing 60 mg DMHBr were given once a day while an immediate release (IR) gelatin capsule containing 30 mg DMHBr was given twice a day.