Peri-and postnatal developmental toxicity of salcaprozate sodium (SNAC) in sprague-dawley rats

International Journal of Toxicology

Volumn 28, Issue 4, 2009, Pages 266-277

  Riley, M Gary I ^a   York, Raymond G ^b  

^a Emisphere Technologies   (United States)

^b RG York and Associates   (United States)

Author keywords

CAS RN 203787 91 1; Developmental toxicity; Rat; Salcaprozate sodium; SNAC

Indexed keywords

OCTANOIC ACID; SALCAPROZATE SODIUM; UNCLASSIFIED DRUG;

ADOLESCENT; ANIMAL TISSUE; ARTICLE; BIRTH; BODY WEIGHT; BREAST MILK; CESAREAN SECTION; FEMALE; FERTILITY; FETUS; LACTATION; MALE; MATERNAL BEHAVIOR; MATING; NEWBORN; NONHUMAN; ORGAN WEIGHT; POSTNATAL DEVELOPMENT; PREGNANCY; PRENATAL DEVELOPMENT; RAT; SALIVATION; SEXUAL MATURITY; SPRAGUE DAWLEY RAT; STILLBIRTH; WEIGHT GAIN;

ANIMALS; BODY WEIGHT; CAPRYLATES; FEMALE; FETAL DEATH; LITTER SIZE; MALE; ORGAN SIZE; PREGNANCY; RATS; RATS, SPRAGUE-DAWLEY; TERATOGENS;

RATTUS;

EID: 73149089116     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581809337736     Document Type: Article

References (23)

1. Baughman RA, Kapoor SC, Agarwal RK, Kisicki J, Catella-Lawson F, Fitzgerald GA. Oral delivery of anticoagulant doses of heparin: a randomized, double-blind, controlled study in humans. Circulation. 1998;98: 1610-1615.
2. Abbas R, Osgood G, Rivera-Schaub T, Kisicki JC, Baughman RA. A clinical drug-interaction study to evaluate the effect of antacid pretreatment on the absorption of heparin and its delivery agent, SNAC, following oral administration in healthy subjects. Pharm Sci. 2001;3(3): ISSN 1522.
3. Abbas R, Agarwal R, Rivera-Schaub T, Leone-Bay A, Chaudhary K, Baughman RA. Evaluation of the effect of three different oral heparin/SNAC formulations on pharmacokinetics (PK) of heparin following oral administration in healthy subjects. Pharm Sci. 2002;4(4):R621.
4. Berkowitz SD, Marder VJ, Kosutic G, Baughman RA. Oral heparin administration with a novel drug delivery agent (SNAC) in healthy volunteers and patients undergoing elective total hip arthroplasty. J Thromb Haemost. 2003;1:1914-1919.
5. Kidron M, Dinh S, Menachem Y, et al. A novel per-oral insulin formulation: proof of concept study in nondiabetic subjects. Diabetes Med. 2004;21:354-357.
6. Mousa SA, Zhang F, Aljada A, et al. Pharmacokinetics and pharmacodynamics of oral heparin solid dosage form in healthy human subjects. J Clin Pharmacol. 2007;47:1508-1520.
7. Leone-Bay A, Leipold H, Agarwal R, Rivera T, Baughman RA. The evolution of an oral heparin dosing solution. Drugs Future. 1997;22:885-891.
8. York RG. Oral (gavage) developmental and perinatal/ postnatal reproduction toxicity study of SNAC/heparin and SNAC in rats, including a postnatal behavioral/functional evaluation. Argus Research Protocol 805-1004, 1999. [EMISTOX98005].
9. ICH Harmonized Tripartite Guideline: Detection of Toxicity to Reproduction for Medicinal Products. Geneva, Switzerland: International Conference on Harmonization; 1994.
10. US Food and Drug Administration (FDA). Guideline on Detection of Toxicity to Reproduction for Medicinal Products. Silver Spring, MD: FDA; 1994.
11. Institute of Laboratory Animal Resources. Guide for the Care and Use of Laboratory Animals. Washington, DC: Institute of Laboratory Animal Resources; 1996.
12. Schneider K, Olsmanns J, Van Gelder R, Gebel T. Suitability of the limit dose in evaluating reproductive toxicity of substances and preparations. Int J Toxicol. 2007;26:183-195.
13. Salewski E. Faerbermethode zum Makroskopischen Nachweis von Implantations Stellen am Uterus der Ratte. Naunyn-Schmeidebergs Arch Pharmakol Exp Pathol. 1964;247:367.
14. Snedecor GW, Cochran WG. Statistical Methods. 6th ed. Ames: Iowa State University Press; 1967.
15. Sokol RR, Rohlf FJ. Biometry. San Francisco, CA: Freeman; 1969.
16. Dunnett CW. A multiple comparison procedure for comparing several treatments with a control. J Am Stat Assoc. 1955;50:1096-1121.
17. Siegel S. Nonparametric Statistics for the Behavioral Sciences. New York, NY: McGraw-Hill; 1956.
18. Dunn OJ. Multiple comparisons using rank sums. Technometrics. 1964;6:241-252.
19. Pasqualini JR, Kind FA, Sumida C. The binding of hormones in maternal and fetal biological fluids. In: Pasqualini JR, ed. Hormones and the Fetus. New York, NY: Pergamon; 1985:1-50.
20. Zimmermann SA, Clavenger WR, Brimhall BB, Bradshaw WS. Diethylstilbestrol induced perinatal lethality in the rat: II. Perturbation of parturition. Biol Reprod. 1991;44:583-589.
21. Prasad AS. Zinc deficiency in women, infants and children. J Am Coll Nutr. 1996;15:113-120.
22. Bedwal S, Bahuguna A. Zinc, copper and selenium in reproduction. Cell Mol Life Sci. 1994;50:626-640.
23. Evans HM, Lepkovsky S, Murphy EA. Vital need of the body for certain unsaturated fatty acids. J Biol Chem. 1934;106:431-440.