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5 protocols using kollidon va64 fine

1

Kollidon VA64 Powder Characterization

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Kollidon® VA64 (KVA64) and Kollidon® VA64 Fine (KVA64F) were generously donated by BASF (Ludwigshafen, Germany). Duraform® polyamide 12 (PA12) was provided by 3D Systems (Santa Clarita, CA, USA) and used as a reference powder. Paracetamol crystal (PAR) and paracetamol crystal fine (PAR F) were purchased from Sequens (Porcheville, France).
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2

Development of Irbesartan Solid Dispersion

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Irbesartan, a model active substance, was donated by Hemofarm (Vrsac, Serbia). Lactose monohydrate was purchased from CARLO ERBA (Milan, Italy). Vivapharm® E3, (hydroxypropylmethylcellulose, HPMC) was obtained from JRS Pharma (Rosenberg, Germany). Mannitol Parteck® M 200 and Candurin® Gold Sheen were obtained from Merck, Darmstadt, Germany. Kollidon® VA 64 Fine (vinylpyrrolidone-vinyl acetate copolymer) was supplied from BASF, Ludwigshafen, Germany. Crospovidone NF (Polyplasdone® XL-10) was obtained from Ashland (Wilmington, DE, USA) and AEROSIL® 200 (colloidal silicon dioxide) was provided by Evonik (Essen, Germany).
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3

Biphasic Dissolution of Amorphous Solid Dispersions

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The model APIs for this study were RTV (Desano Pharmaceuticals, China) and LPV (Arene Life Sciences, India). The polymers for the preparation of the ASDs were either Kollidon® VA 64 fine (PVPVA, BASF, Germany) or the three different grades of AQOAT® LMP, MMP and HMP (HPMCAS, Shin Etsu, Japan). The film-coated tablet Kaletra® 200/50 mg was chosen as reference product. Fasted State Simulated Gastric Fluid (FaSSGF) and Fasted State Simulated Intestinal Fluid (FaSSIF) used as biorelevant dissolution media were prepared using ready-to-use powder mixtures (Biorelevant.com, United Kingdom). For each experiment, the media were freshly prepared according to the supplier manual. Decanol (Sigma Aldrich Chemie GmbH, Germany) was utilized as organic phase in the biphasic dissolution setup. Ammonium acetate, methanol HPLC grade and hydrochloric acid (all VWR Chemicals, Germany) were used for the preparation of the mobile phase for HPLC analysis. Polylactide (PLA) (Bavaria Filaments, Germany) was used as material for the additional 3D printed paddle for the biphasic dissolution studies.
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4

Chlorthalidone-Caffeine Sustained-Release Formulation

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Chlorthalidone (99% purity) was obtained from Shaanxi Dideu Medichem Co. Ltd. (Shaanxi, China). Anhydrous Caffeine (98.5–100% purity) was obtained from Productos Químicos Monterrey (Monterrey, Mexico). Copovidone (Kollidon VA® 64 Fine) and polyvinylpyrrolidone (Kollidon® 90) were obtained from BASF Chemical Co. (Ludwigshafen, Germany). Methylcellulose (Methocel® A15), hydroxypropyl methylcellulose (Methocel® E5LV, Methocel® E15LV, and Methocel® E50LV) were kindly donated by Colorcon Inc. (West Point, PA, USA). Hydroxypropyl methylcellulose (HPMC 80–120 cPs), methylcellulose (Methocel® 60 HG), hydroxypropyl cellulose (HPC 80,000, and HPC 370,000), polyvinylpyrrolidone (Kollidon® 25), poloxamer (Kolliphor® P 188 and Kolliphor® P 407), monobasic potassium phosphate (99% purity), sodium hydroxide (97% purity), and HPLC-grade methanol were obtained from Sigma-Aldrich Co. (St. Louis, MO, USA). Hydrochloric acid, absolute ethanol, and dibasic sodium phosphate (99% purity) were obtained from J.T. Baker (Philipsburg, NJ, USA). All other chemicals and the solvents were analytical or reagent grade and used as received without further purification. Ultra-pure water obtained from a Classic UVF water purification system (ELGA LabWater Ltd., High Wycombe, Bucks, UK) was used in this study.
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5

Formulation and Characterization of Losartan Potassium Tablets

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Losartan potassium (Form I, Dr. Reddy’s Laboratories, Jinnaram Mandal, Telangana, India), silicified microcrystalline cellulose (PROSOLV® SMCC 50, JRS Pharma, Rosenberg, Germany), copovidone (Kollidon® VA 64 (Fine), BASF Pharma, Ludwigshafen, Germany), crospovidone (Kollidon® CL, BASF, Ludwigshafen, Germany), dicalciumphosphate anhydrous (DI-CAFOS® A 150, Chemische Fabrik Budenheim, Budenheim, Germany), lactose (Tablettose® 80, Flowlac® 100, MEGGLE, Wasserburg am Inn, Germany), isomalt (galenIQTM 721, BENEO-Palatinit, Mannheim, Germany), microcrystalline cellulose (VIVAPUR® 102, JRS Pharma, Rosenberg, Germany), Ludipress® (BASF Pharma, Ludwigshafen, Germany), magnesium stearate (Parteck® LUB MST, Merck, Darmstadt, Germany), sodium stearyl fumarate (PRUV®, JRS Pharma, Rosenberg, Germany), talc (Talkum® Pharma G, C.H. Erbslöh, Krefeld, Germany), HPMC (PHARMACOAT® 603, Shin-Etsu Chemical, Tokyo, Japan), macrogol (PEG 6000, BASF Pharma, Ludwigshafen, Germany), methanol (HPLC grade, VWR Chemicals, Radnor, PA, USA), acetonitrile (HPLC grade, Honeywell, Charlotte, NC, USA), phosphoric acid (Merck, Darmstadt, Germany), monobasic potassium phosphate (Fisher Scientific, Waltham, MA, USA), disodium hydrogen phosphate anhydrous (AppliChem, Darmstadt, Germany), and sodium hydroxide solution 1 N (Merck, Darmstadt, Germany) were used.
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