Tuesday, 1 May 2018

Safety evaluation of a new anxiolytic product containing botanicals souroubea spp. and platanus spp. In dogs(Article)

Canadian Journal of Veterinary ResearchVolume 82, Issue 1, January 2018, Article number 9, Pages 3-11 Masic, A.aEmail Author, Liu, R.b, Simkus, K.c, Wilson, J.c, Baker, J.d, Sanchez, P.e, Saleem, A.b, Harris, C.C.b, Durst, T.b, Arnason, J.T.b View Correspondence (jump link) aFaculty of Ecological Agriculture, Educons University, Sremska Kamenica, Serbia bFaculty of Science, University of Ottawa, Ottawa, ON, Canada cNovometrix Research, Moffat, ON, Canada View additional affiliations Abstract View references (30) Separation anxiety and noise aversion are common behavioral problems in dogs. They elicit fear responses such as cowering, seeking out the owner, and attempting to escape. This can result in property damage, injury to the dog, and disruption of the owner-pet bond, possibly leading to pet abandonment or euthanasia. A novel botanical anxiolytic product was evaluated for safety in dogs as the target animal species. Its intended use is for the treatment and prevention of anxiety and noise aversion in dogs. It contains a defined mixture of Souroubeaspp. vine and Platanus spp. bark, delivering the active principle, betulinic acid, at a recommended dose of 1 mg/kg body weight (BW). In the current target animal safety study, 16 healthy male beagle dogs were administered either a placebo or the newly formulated botanical tablets at 0.5×, 2.5×, or 5× the recommended dose (1 mg/kg BW) over 28 d. The dogs were monitored for occurrence of any systemic or local adverse events. In the investigation presented here, there were no clinically significant adverse effects following treatment, as determined by clinical observations, physical examinations, BW, hematology, clinical biochemistry, and urinalysis. Pharmacokinetic analysis demonstrated that the concentration of betulinic acid in serum was below 0.020 μg/mL in treated animals. Under the conditions of these studies, the formulated blend of S. sympetala and P. occidentalis, when administered up to 5× the intended dose for 28 consecutive d, showed no adverse effects on the health of dogs. © 2018, Canadian Veterinary Medical Association. All rights reserved. Indexed keywords EMTREE drug terms: anxiolytic agentbetulic acidmicrocrystalline celluloseplaceboplant extractPlatanus extractSouroubea extractunclassified drug EMTREE medical terms: acclimatizationamylase blood levelanimal experimentanimal modelanimal tissueanxietyArticleaspartate aminotransferase levelaversionbehavior changebiochemistrybody weightclinical evaluationcontrolled studycreatine kinase blood levelcreatinine blood leveldogdrug formulationdrug safetyerythrocytegamma glutamyl transferase blood levelglucose blood levelhematocrithematologyhigh performance liquid chromatographyinjuryleukocyte countleukocyte differential countmalemass spectrometrymean corpuscular hemoglobinmean corpuscular volumeneurologic examinationnoisenonhumanprotein blood levelSoxhlet extractionurinalysis Chemicals and CAS Registry Numbers: betulic acid, 472-15-1; microcrystalline cellulose, 39394-43-9, 51395-75-6 Funding details Funding number Funding sponsor Acronym Funding opportunities I2I Natural Sciences and Engineering Research Council of Canada NSERC See opportunities by NSERC Amorfix Life Sciences AMF Life Sciences Research Foundation LSRF Amorfix Life Sciences AMF Funding text #1 Funding was provided by the Natural Sciences and Engineering Research Council of Canada (I2I and CRD grant programs) and by Bioniche Life Sciences (Belleville, Ontario, Canada). The target animal safety study was conducted by Kingfisher International, a contract research facility in Stouffville, Ontario. It was supervised by Dr. Jonathan Hare and reported by Ms. Jennifer Caldwell. Funding text #2 Financial support was provided by Bioniche Life Sciences to Novometrix Research and to Paul Dick and Associates for their work. Since the corporate reorganization of Bioniche Life Sciences, leading to the sale of veterinary technologies, the product has been licensed to Souroubea Botanicals and several of the authors are principals in the new company (Arnason, Baker, Durst, Sanchez). Dr. Masic was employed by Bioniche Life Sciences at the time of study execution. ISSN: 08309000 CODEN: CJVRE Source Type: Journal Original language: English Document Type: Article Publisher: Canadian Veterinary Medical Association References (30) View in search results format All 1 Sherman, B.L., Mills, D.S. 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