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Tablets & Capsules April 2014 45 Gray TJ and Gangolli SD. Aspects of the testicular toxicity of phthalate esters. Environ Health Perspect. 1986 Mar; 65:229-235. Hodge HC (1944). The Chronic Tox iciy of Cellulose Acetate Phthalate in Rats and Dogs. Journal of Pharmacology and Experimental Therapeutics 80(3):250-255. Hodge HC, Forsyth HH, and Ramsey GH. (1944). Clinical Tests of Cellulose Acetate Phthalate as an Enteric Coating. Journal of Pharmacology and Experimental Therapeutics 80(3):241-249. International Pharmaceutical Excipients Council of the Americas (IPEC-Americas). Correspondence: Defining "Phthalates". Environmental Health Perspectives. 120(11), November 2012. Ito R and Toida S. (1972), Studies on the Teratogenicity of a New Enteric Coat ing Material, Hydroxypropyl methyl cel lu lose Phthalate (HPMCP) in Rats and Mice, J. Med. Soc. Toho, Japan, 19(5):453-461. Kato T et al. (1982), Measurements of Molecular Weight and Molecular Weight Distribution for Watwer-Soluble Cellulose Derivatives Used in the Film Coating of Tablets, Kobunshi Ronbunshu, 39(4):293- 298 (in Japanese). Kelley KE, Hernández-Díaz S, Chaplin EL, Hauser R, and Mitchell AA. Iden - tification of phthalates in medications and dietary supplement formulations in the United States and Canada. Environ Health Perspective. 2012 Mar; 120(3):379-84. Kitagawa H et al. (1970). Acute, Sub - acute Toxicities of Hydroxypropyl meth yl - cellulose phthalate, Pharma co metrics, 4(6):1017-1025. Kitagawa, H et al (1973). Chronic Toxicity of Hydroxypropylmethylcellulose Phthalate in Rats, Pharmacometrics, 7(5), 689-701. Kitgawa, H et al (1971). Absorption, Distribution and Excretion of Hydroxy pro - pyl methylcellulose Phthalate in the Rat, Pharmacometrics, 5(1):1-4. Kitagawa H et al (1974). Absorption, Distribution, Excretion and Metabolism of 1 4 C - H y d r o x y p r o p y l m e t h y l c e l l u l o s e Phthalate , Pharmacometrics, 8 (8):1123- 1132. Kotkoskie LA, Freeman C, and Palmieri MA. (1999). Subchronic Toxicity and Developmental Toxicity Studies in Rats With Aquateric Aqueous Enteric Coating. International Journal of Toxicology 18(2):109-116. Malm, CJ, Emerson J., and Hiatt, GD. (1951). Cellulose acetate phthalate as an enteric coating material. J. Am. Pharm. Assoc. Am. Pharm. Assoc. 40(10):520-525. Rowe RC, Sheskey PJ, Cook WG, and Fenton ME. Handbook of Pharmaceutical Excipients, 7th Edition: Pharmaceutical Press 2012. Saillenfait AM, Payan JP, Fabry JP, Beydon D, Langonne I, Gallissot F, and Sabate JP. Assessment of the developmental toxicity, metabolism, and placental transfer of Di-n- butyl phthalate administered to pregnant rats. Toxicol Sci. 1998 Oct; 45(2):212-24. Thomas JA, Curto KA, and Thomas MJ. MEHP/DEHP: gonadal toxicity and effects on rodent accessory sex organs. Environ Health Perspect. 1982 Nov; 45:85-8. United States Pharmacopeial Con - vention, USP (2011). USP35/ NF30, 2012: Williams DT and Blanchfield BJ. Retention, excretion and metabolism of phthalic acid administered orally to the rat, Bulletin of Environmental Contamination and Toxicology, (1974), 12 (1):109-112. Woodward Research Corp. (1974). HP- 50 and HP-55—Repeated Oral Administration of Each Test Material to Dogs for 53 Weeks—Final Report, Internal Document of Shin-Etsu Chemical. The authors are members of IPEC-Amer- icas' Working Group on Phthalate Excipients, 3138 N. 10th St., Suite 500, Arlington VA 22201. Tel. 571 814 3449. Website: www.ipecamericas.org. David Kossor is associate toxicologist at Eastman Chemical, Kingsport, TN. Chris DeMerlis is manager of regulatory affairs at Colorcon, Harleysville, PA. Sakae Obara is technical director of excipients at SE Tylose USA, a Shin- Etsu Chemical company, Totowa, NJ. April Hernandez is global regulatory affairs specialist at FMC, Philadelphia, PA. Chris Moreton is a partner at FinnBrit Consulting, Waltham, MA. Readers seeking more information about this topic should contact Kim Beals, executive director of IPEC-Americas. Tel. 571 814 3451. E-mail: kim.beals@ ipecamericas.org. The Proven Innovation Optimize tablet development and manufacture Benefits: • • • • • • ystalline Cellulose ocr Silicified Micr ystalline Cellulose rinsic flow ed lubricat w Enhanced lubrication efficiency ed lubricat d blending oduction yields pr oved content Impr p Enhanced lubrication efficiency ties oper oved blending pr oduction yields mity oved content unifor i-EOE_38-45_Masters 4/3/14 2:58 PM Page 45