Croscarmellose sodium

OLZ was a gift from Rampex Labs Pvt. Ltd. (Telangana, India). SAC (Sigma-Aldrich, Steinheim, Germany) was used as the co-former and dichloromethane (Biochem Chemopharma, Cosne sur Loire, France) as the solvent for the preparation of OLZ-CAM. Liquid nitrogen (Air Liquide, Lisbon, Portugal) was used to prepare amorphous OLZ. Tablets were manufactured from blends of OLZ and SAC, dibasic calcium phosphate anhydrous (DI-CAFOS^® A60, a gift from Budenheim, Budenheim, Germany), microcrystalline cellulose (Avicel PH-101, FMC Corp., Cork, Ireland), polyvinylpyrrolidone (K25, BASF, Ludwigshafen, Germany) and croscarmellose sodium (JRS Pharma, Rosenberg, Germany). Demineralized water (Destillo 2, Herco, Freiberg am Neckar, Germany), sodium hydroxide (Eka, Marietta, GA, USA), and potassium phosphate monobasic (Carlo Erba Reagents, Val de Reuil, France) were used to prepare the phosphate buffer (pH 8.0) for the dissolution studies. Marketed tablets of OLZ (15 mg, Generis Farmacêutica, S.A., Amadora, Portugal) were used as controls in the dissolution studies. A desiccator containing magnesium nitrate (53% RH, ThermoFisher GmbH, Kandel, Germany) was used to store amorphous OLZ and OLZ-CAM.

Amlodipine besylate was supplied by Daewon Pharmaceutical Co., Ltd. (Seoul, Korea). Silicified microcrystalline cellulose (Prosolv SMCC^® 90) and croscarmellose sodium (CCM-Na) were purchased from JRS PHARMA GmbH & Co. KG (Rosenberg, Germany). Polyvinylpyrrolidone (PVP K25) was purchased from BASF AG (Ludwigshafen, Germany). Magnesium stearate (St-Mg) was purchased from Sigma-Aldrich Co. (St. Louis, MO, USA). All other reagents were of analytical or HPLC grade and were used as received.

All materials used were supplied in pharmaceutical or food-grade quality. The hard gelatin capsules (size 00; length 23.3 mm; diameter 8.2 mm) were purchased from Wepa (Hillscheid, Germany). Polyvinyl alcohol (PVA 18-88) was provided by Merck (Darmstadt, Germany). The glycerol needed as a plasticizer for film production was obtained from Caelo (Hilden, Germany). Demineralized water was used as a solvent. Food-grade polylactic acid filament from Formfutura (Nijmegen, the Netherlands) was being used for the production of the drinking cup and applicators. 3D printing of the drinking cup and applicators has been described previously [8 (link)]. Hibiscus tea was purchased from Spinnrad (Bad Segeberg, Germany) as a contrasting agent for MRI. A food-grade polyester string used (hereinafter referred to as “retainer”) was purchased from Westmark (Lennestadt-Elspe, Germany). Calcium dihydrogen phosphate and croscarmellose sodium were supplied by JRS Pharma (Rosenberg, Germany), magnesium stearate by Sigma Aldrich Chemie (Taufkirchen, Germany) and iron oxide by Caelo.