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3 protocols using aquacoat cpd

1

Development of Enteric Polymer-Coated Gelatin Capsules

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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.
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2

Diclofenac Sodium Capsule Formulation

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Components of films and capsules: gelatin type B, bovine hide, 220 bloom (Sigma Aldrich, Saint Louis, MO, USA), glycerol 99.5% w/w (Chempur, Piekary Slaskie, Poland), Aquacoat® CPD (FMC Biopolymer, Philadelphia, PA, USA), aqueous dispersion of cellulose acetate phthalate (CAP), iota-carrageenan (Sigma Aldrich, Saint Louis, MO, USA), medium-chain triglycerides (MCT)—Miglyol 812 N (Caelo, Hilden, Germany), polyethylene glycol 400 (PEG 400)—Kollisolv PEG E400 (Sigma Aldrich, Saint Louis, MO, USA), cetearyl alcohol—TEGO Alkanol 1618 (Evonik, Essen, Germany). Diclofenac sodium was a gift from Polpharma Pharmaceutical Works (Starogard Gdanski, Poland).
Analysis: QCM-D: branched polyethyleneimine Mw 25,000 (Sigma Aldrich, Saint Louis, MO, USA), formaldehyde 37% (Sigma Aldrich, Saint Louis, MO, USA), ethanol 95% (Sigma Aldrich, Saint Louis, MO, USA). Disintegration and dissolution media (0.1 M HCl and phosphate buffer pH 6.8) were prepared according to the European Pharmacopeia 10th edition.
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3

Bovine Gelatin and Cellulose Acetate Phthalate Formulation

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Bovine gelatin (type B) from Italgelatine (Cuneo, Italy) was generously provided by Curtis Health Caps (Wysogotowo, Poland), and Aquacoat CPD® (FMC Biopolymer, Philadelphia, PA, USA), a 30% aqueous pseudolatex dispersion of cellulose acetate phthalate (CAP), was a gift from IMCD Polska (Warsaw, Poland). Glycerol (99.5%) was purchased from Glackonchemie (Merseburg, Germany), ί-carrageenan was purchased from Sigma Aldrich (Saint Louis, MO, USA), and tritium-labeled water was purchased from Amersham (Little Chalfont, UK). The liquid scintillation cocktail (Ultima Gold®) used in the permeability test was purchased from Perkin Elmer (Waltham, MA, USA).
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