Opadry enteric

Gelatin (porcine, type A) was generously provided by Medana Pharma (Sieradz, Poland), Aquacoat CPD^® (FMC Biopolymer, Philadelphia, PA, USA), a 30% aqueous pseudolatex dispersion of cellulose acetate phthalate (CAP) and cellulose acetate propionate (CAP 482-0.5), cellulose acetate butyrate (CAB 381-0.5) (Eastman Chemical, Kingsport, TN, USA), hypromellose phthalate (HPMCP(HP-55), hypromellose acetate succinate (HPMCAS) (Aqoat AS-MF and AS-HF, Shin-Etsu, Tokyo, Japan) were gifts from IMCD Polska (Warsaw, Poland). Eudragit L30 D-55, Eudragit L100, and Acryl Eze II (Evonik, Essen, Germany) were obtained from Evonik. Opadry Enteric (Colorcon, Budapest, Hungary) was provided by Colorcon. Aquarius Control ENA (Ashland, Covington, KY, USA) was received from Ashland. Glycerol (99.5%) was purchased from Chempur (Piekary Śląskie, Poland), polyethylene glycol (PEG-400), sorbitol, ί-carrageenan, gellan, and xanthan were purchased from Sigma Aldrich (Saint Louis, MO, USA). The compositions of certain complex products are specified further in Table 1.

The enteric-coated tablets were prepared by first admixing 66.63% niclosamide ASD granules, 13.1% microcrystalline cellulose (Ceolus^® PH-102, Asahi Kasei Chemical Corporation, Tokyo, Japan), 8.8% croscarmellose sodium (Kiccolate^TM, Nichirin Chemical Industries, LTD., Dojima, Japan), 0.28% magnesium stearate (Spectrum Chemical, New Brunswick, NJ, USA), and 11.1% sodium chloride (Fisher Chemical, Ottawa, ON, Canada). The blend was filled into a hopper placed on a Stoke F4 Press. The tablet cores were produced using a 10 mm round standard cup tooling and with a target final tablet core weight of 428 mg. Then, the tablet cores were added to a Vector LDCS-Hi Coater (Vector Corporation, Marion, IA, USA). Opadry II Clear (Colorcon, West Point, PA, USA) dispersion in either water or 20:80 water/ethanol mixture was used for seal coating to a target weight gain of 3%. Then, the sub-coated tablets were enteric coated with either a completely water-based coating (Acryl-EZE^® 93 A, Colorcon, West Point, PA, USA) or a mixture of water and ethanol-based coating (Opadry^® Enteric, Colorcon, West Point, PA, USA) to a target 10% weight gain.