Vivapur 102

Microcrystalline cellulose (MCC, Vivapur^® 102, JRS Pharma, Rosenberg, Germany) and anhydrous dicalcium phosphate (DCPA, Emcompress^® Anhydrous, JRS Pharma, Rosenberg, Germany) were used as model materials. Magnesium stearate (MgSt, Magnesia GmbH, Lüneburg, Germany) was used as a lubricant. The characteristic particle sizes of MCC and DCPA are in a comparable range with slightly lower particle sizes for MCC (Table 1). The solid, bulk and tapped density of DCPA is higher, almost double, than MCC.

Pancreatin (from porcine pancreas) EMPROVE^® ESSENTIAL USP was from Merck KGaA (Darmstadt, Germany). Anhydrous dibasic calcium phosphate, DCPA (DI-CAFOS^® A150), tribasic calcium phosphates, TCPs (TRI-CAFOS^® 500 and TRI-CAFOS^® 200-7) were produced by Chemische Fabrik Budenheim KG (Budenheim, Germany). Low-substituted hydroxypropyl cellulose, L-HPC (LH-11) was provided by ShinEtsu (Wiesbaden, Germany). Microcrystalline cellulose, MCC (VIVAPUR^® 102 was from JRS Pharma (Rosenberg, Germany), Magnesium stearate (Ligamed^® MF-2-V) was supplied by Peter Greven Fett-Chemi (Venlo, The Netherlands).

Damping results quoted in the Results and discussion section are from Ref.^{1 (link)}. They are for PA610 composites filled with: (i) cellulose nanocrystal (NVC 100; manufactured by CelluForce) which is specified to have dimensions from 2.3 to 103 nm, but form particles from 1 to 50 μm; (ii) 4 μm and (iii) 100 μm cellulose (VIVAPUR CS 4 FM, VIVAPUR 102; both manufactured by JRS Pharma). The matrix material is PA610 bio-based nylon resin (BASF).

The microcrystalline cellulose (MCC, Vivapur 102, JRS Pharma, Troisdorf, Germany) was selected as a plastically deformable material and lactose (FlowLac 100, Meggle, Wasserburg am Inn, Germany) as a more brittle material. Lactose was blended with magnesium stearate (Parteck LUB MST, Merck, Darmstadt, Germany) before tableting (Section 2.7). All materials were stored at 21 °C and 45% relative humidity under controlled conditions at least one week before use to allow for equilibration. All prepared ribbons, granules and tablets were also stored for at least one week under these controlled conditions prior to analysis.

Four different excipients were investigated. Microcrystalline cellulose (Vivapur 102, JRS Pharma, Germany), lactose (Tablettose® 80, Meggle, Germany), isomalt (galenIQ™721, BENEO-Palatinit, Germany) and Ludiflash®, a co-processed excipient based on d-Mannitol, crospovidone and a polymer dispersion of polyvinyl acetate (BASF, Germany). External lubrication was applied using magnesium stearate (Parteck® LUB MST, Merck, Germany) or sodium stearyl fumarate (PRUV®, JRS Pharma, Germany).

In this study, two pharmaceutical polymers, which are commonly used as carriers for the manufacturing of ASDs, vinylpyrrolidone vinylacetate copolymer (Kollidon VA64, BASF, Basel, Switzerland) and aminoalkyl methacrylate copolymer (Eudragit EPO, Evonik, Essen, Germany) were investigated in a formulation with fillers and disintegrants. Microcrystalline cellulose (MCC, Vivapur^®102, JRS Pharma, Rosenberg, Germany), a hydrophilic and water-insoluble excipient with plastic deformation behaviour, was used as filler [39 (link)]. Cross-linked sodium carboxymethyl cellulose (NaCMCXL, AcDiSol^®SD-711, FMC Europe NV, Brussels, Belgium) and polyvinyl polypyrrolidone (PVPP, Polyplasdone™ XL, Ashland, Schaffhausen, Switzerland) were employed as disintegrants. Rhodamine B (RhB, Merck, Darmstadt, Germany) was used as fluorescent dye. Aqueous dispersions of spherical polyethylene (PE) particles of four different particle size ranges (45–53 µm, 125–150 µm, 355–425 µm, 710–850 µm) containing an orange fluorescent dye (Cospheric LLC, Santa Barbara, CA, USA) were prepared with Polysorbate 80 (Tween^® 80, Merck, Darmstadt, Germany) as dispersant and used to verify the analytical method. The dispersion with the finest PE particles was additionally used as calibration suspension. Demineralised water at 22 ± 2 °C with a pH of 7 was used as test medium throughout the study.