Controlled efficacy study of the bioequivalence of strongid® C and generic pyrantel tartrate in horses

• Published in: Veterinary parasitology Vol. 60; no. 1; pp. 83 - 102
• Main Authors: Valdez, R.A., DiPietro, J.A., Paul, A.J., Lock, T.F., Hungerford, L.L., Todd, K.S.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.11.1995
• Subjects: Animal Husbandry; Animals; ANTHELMINTHIQUE; ANTHELMINTICS; Anthelmintics - pharmacokinetics; Anthelmintics - therapeutic use; ANTIHELMINTICOS; Antiparasitic Agents - pharmacokinetics; Antiparasitic Agents - therapeutic use; CABALLOS; CHEVAL; Digestive System - parasitology; Digestive System - pathology; Horse; Horse Diseases; HORSES; NEMATODA; Organ Specificity; Parasite Egg Count; Parasites - classification; Parasites - isolation & purification; Parasitic Diseases - drug therapy; Parasitic Diseases - pathology; Parasitic Diseases, Animal; PIRANTEL; PYRANTEL; Pyrantel tartrate; Pyrantel Tartrate - pharmacokinetics; Pyrantel Tartrate - therapeutic use; Therapeutic Equivalency; Pyrantel tartrate; Horse
• ISSN: 0304-4017; 1873-2550
• DOI: 10.1016/0304-4017(94)00766-6

The bioequivalence of Strongid® C and generic pyrantel tartrate was determined in a controlled study using 30 horses with naturally acquired endoparasitic infections. Three horses were randomly allocated to each of ten replicates based on quantitative nematode and ascarid egg counts and fecal larvae culture results. Horses within each replicate were randomly assigned to one of three treatment groups. Horses in Treatment Group 1 received only oats; horses in Treatment Group 2 received generic pyrantel tartrate pellets (2.65 mg pyrantel tartrate kg −1) mixed with oats; horses in Treatment Group 3 were fed Strongid® C pellets (2.65 mg pyrantel tartrate kg −1) mixed with oats. Horses were treated daily for a 30 day continuous treatment period. At the termination of the study the horses were necropsied and endoparasites recovered, identified, and enumerated. In all instances, no significant difference ( P>0.05) in mean numbers of parasites recovered existed between horses treated with generic pyrantel tartrate and Strongid® C. Numbers of gastrointestinal parasites recovered from horses treated with generic pyrantel tartrate or Strongid® C were shown to be significantly different ( P<0.05) from numbers of gastrointestinal parasites recovered from non-treated controls for the large strongyles ( Strongylus vulgaris, S. edentatus, and Triodontophorus spp.), small strongyles ( Cyathostomum spp., Cylicocyclus spp., and Cylicostephanus spp.) and fourth-stage Parascaris equorum. Numbers of adult P. equorum recovered from horses treated with Strongid® C were also significantly different ( P<0.05) from those from non-treated controls. Numbers of adult P. equorum recovered from horses treated with generic pyrantel tartrate were not significantly different ( P = 0.0761) from those from non-treated controls. The determination of bioequivalence was based upon the 95% confidence interval of the difference between the mean number of parasites recovered from horses treated with generic pyrantel tartrate and the mean number of parasites recovered from horses treated with Strongid® C. For all instances in which the numbers of parasites recovered from horses treated with either Strongid® C or generic pyrantel tartrate were significantly different from the numbers of parasites recovered from non-treated controls, bioequivalence was demonstrated.