Melt compounding was adopted for producing the following blends: PCL/PEG and PCL/Starch. Each polymer was dried for 2 h under vacuum at a temperature of 30 °C before any characterization and processing. Polymers were mixed by a counter-rotating twin-screw micro-compounder (HAAKE MiniLab II Micro Compounder, by Thermo Scientific, Waltham, MA, USA) with an integrated backflow channel. The materials were mixed at 65 °C and 30 rpm, with a backflow time of 5 min. The blends were used to obtain films via compression molding, adopting a molding press (Model C, Fred S. Carver Inc., Menomonee Falls, WI, USA), following the procedure: (a) pre-heating at 120 °C for 5 min, (b) compression-molding at 15 MPa for 2 min, and (c) cooling in air.
Haake minilab 2 micro compounder
Manufactured by Thermo Fisher Scientific
Sourced in Germany, United States
The Haake MiniLab II Micro Compounder is a laboratory-scale twin-screw extruder designed for compounding and processing small amounts of thermoplastic materials. It features a compact and modular design, allowing for the analysis of material properties and the development of new formulations.
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10 protocols using haake minilab 2 micro compounder
1
Melt Compounding of PCL/PEG and PCL/Starch Blends
2
Polylactide-Hydroxyapatite Composite for 3D Printing
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Polylactide (PLA) with molecular weight 110 kg/mol (Ingeo 4032D, Natureworks LLC, MN 55345, USA) and 15 wt% hydroxyapatite (HAp) powder (nominal size 90 ± 10 nm, JSC Polystom, Moscow, Russia) were mixed by a screw extruder HAAKE MiniLab II Micro Compounder (Thermo Fisher Scientific, Waltham, USA). Screw speed and dwell time were optimised to ensure the uniform mixing and reduce the defects formed during the extrusion. Filaments of PLA-HAp composite were obtained with the diameter of ∼1.6 mm for the 3D printing. CubePro Trio (3D Systems, Rock Hill, USA) was used to produce a sheet of 3D printed PLA-based composite with a nozzle diameter of 350 μm at 210 °C. Detailed preparation route was described in a previous publication [20] . Samples were cut from the sheet with a thickness of 500 μm. The cross-sectional dimensions of samples and grip-to-grip length were measured before the mechanical or thermo-mechanical tests for converting the load and displacement into stress and strain.
3
Melt Extruded Itraconazole Formulation
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Preparation and Characterization of Niclosamide Amorphous Solid Dispersion
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The polymer Kollindon® VA64 (PVP–VA) and d -α-tocopheryl polyethylene glycol succinate (TPGS) were obtained from BASF, Germany. Niclosamide anhydrate was purchased from Shenzhen Nexconn Pharmatechs LTD (Shenzhen, China). In the preparation of niclosamide ASD, a PVP–VA–niclosamide–TPGS blend in a 60:35:5 ratio was ground using a mortar and pestle until the mixture was homogeneous. Then, the mixture was processed using a HAAKE MiniLab II Micro Compounder (Thermo Electron Corporation, Waltham, MA, USA) set at 150 rpm and 180 °C. Thereafter, the extrudate was milled using a Tube Mill Control (IKA, Staufen, Germany) and sieved to the range 45–125 µm. The solid-state characterization of the material was performed using powder X-ray diffraction (XRD) and differential scanning calorimetry (DSC). XRD studies were conducted using a Rigaku MiniFlex 600 II (Rigaku Americas, The Woodlands, TX, USA). The 2-theta angle was set at 5–40° (0.05° step, 2°/min, 40 kV, 15 mA). DSC was performed using a Model Q20 differential scanning calorimeter (TA Instruments, New Castle, DE, USA), increasing the temperature from 35 °C to 240 °C with a ramp temperature of 10 °C/min and a nitrogen purge of 50 mL/min.
5
Itraconazole-Loaded Amorphous Solid Dispersions
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ASDs were prepared by hot melt extrusion equipped with a conical co-rotating (5/14 mm diameter) twin screw HAAKE MiniLab II Microcompounder (Thermo Electron GmbH, Karlsruhe, Germany). All the formulations were prepared at a fixed drug loading (20%, w/w) with various ratios of HPMC AS to surfactant (Table 1 ). Briefly, the physical mixtures prepared by homogenously mixing ITZ and carriers were manually fed into the melt extruder, and the extrusion temperature and screw speed were adjusted to 170 °C and 100 rpm, respectively. The obtained hot melt extrudates were collected and cooled in ambient conditions, milled using a coffee grinder, and passed through a 100-mesh sieve for further analysis.
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Preparation of Niclosamide Amorphous Solid Dispersion
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The polymer Kollindon® VA64 (PVP-VA) D-ɑ-tocopheryl polyethylene glycol succinate (TPGS) was obtained from BASF, Germany. Niclosamide anhydrate was purchased from Shenzhen Nexconn Pharmatechs LTD (China). In the preparation of niclosamide ASD, a PVP-VA-niclosamide-TPGS blend in a 60:35:5 ratio was ground using a mortar and pestle until the mixture was homogeneous. Then, the mixture was processed using a HAAKE MiniLab II Micro Compounder (Thermo Electron Corporation, USA) set at 150 rpm and 180 °C. Thereafter, the extrudate was milled using a Tube Mill Control (IKA, Germany) and sieved to the range 45-125 µm.
7
Fabrication of PVOH-Based Mini-Tablets
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Pure PVOH, mixtures of PVOH/HCT and mixtures of PVOH/sorbitol were processed using a co-rotating, fully intermeshing twin screw extruder (Prism Eurolab 16, Thermo Fisher, Germany), operating at a screw speed of 100 rpm and processing temperatures of 130-180°C. The extruder was equipped with a gravimetric feeder, two Archimedes screws with 3 mixing zones and a cylindrical die of 3 mm. Afterwards, the extrudates were either manually cut using surgical blades into mini-tablets of 2 mm length or quench-cooled in liquid nitrogen, cryomilled and sieved through a 300 micron sieve.
Mixtures of cryomilled PVOH/sorbitol extrudate (<300µm) and CEL were processed using a co-rotating twin screw extruder (Haake MiniLab II Micro Compounder, Thermo Electron, Karlsruhe, Germany), operating at a screw speed of 60 rpm and a processing temperature of 140°C. The extruder was equipped with a pneumatic feeder, two Archimedes screws and a 2 mm cylindrical die. The extrudates were quench-cooled in liquid nitrogen, cryomilled and sieved through a 300-micron sieve.
Mixtures of cryomilled PVOH/sorbitol extrudate (<300µm) and CEL were processed using a co-rotating twin screw extruder (Haake MiniLab II Micro Compounder, Thermo Electron, Karlsruhe, Germany), operating at a screw speed of 60 rpm and a processing temperature of 140°C. The extruder was equipped with a pneumatic feeder, two Archimedes screws and a 2 mm cylindrical die. The extrudates were quench-cooled in liquid nitrogen, cryomilled and sieved through a 300-micron sieve.
8
HME Formulation of TPU-Metformin Matrices
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Hot melt extrusion (HME) was performed on a mixture of TPUs and metformin hydrochloride (60% drug load, w/w, in all cases). Physical mixtures were extruded using a co-rotating twinscrew extruder (Haake MiniLab II Micro Compounder, Thermo Electron, Karlsruhe, Germany), operating at a screw speed of 100rpm. Extrusion temperature was set at 100°C for formulations containing TG2000. For formulations based on (a mixture of) Tecoflex TM EG72D, Tecophilic TM SP60D60 and Tecophilic TM SP93A100, the extrusion temperature was set at 160°C. After HME, the extrudates were immediately processed into mini-matrices (3.5mm height; 3mm diameter) via manual cutting (using a surgical blade).
9
Polymer-Drug Solubility Optimization
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Physical mixtures of each polymer and CEL were made with mortar and pestle, and afterwards extruded on a co-rotating twin-screw extruder (Haake MiniLab II Micro Compounder, Thermo Electron, Karlsruhe, Germany) at a screw speed of 70 rpm and different processing temperatures (130 °C for EPO-mixtures; 150 °C for SOL-mixtures and 160 °C for VA 64-mixtures). Modulated differential scanning calorimetry (MDSC) was used for solid state characterization of the resulting extrudates and detecting the maximal solubilising capacity of each polymer for the drug.
10
Extrusion of Felodipine FDM Filaments
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Placebo and 10% w/w felodipine FDM filaments consisting of three sets of excipient mixtures (compositions are shown in Table 1) were prepared using a co-rotating twin-screw extruder (Haake MiniLab II Micro Compounder, Thermo Electron, Karlsruhe, Germany).
The formulations containing Eudragit EPO, Soluplus and PVA as the main matrix materials are labelled with the abbreviations of CME, CMS and CMV, respectively. All ingredients were accurately weighed and premixed using a mortar and pestle for 2 minutes. For each extrusion experiment, 7 g of the premixed blend was fed into the extruder and 3 g was kept for the characterization of the physical mixtures. The extrusion was performed at the specified extrusion temperature (Table 2) with 5 minutes retention time and 100 rpm screw speed. After decreasing the rotation speed of the screws to 25 rpm the extruded soft mass of the blends was flushed directly through a metal attachment with a circular die of a diameter 1.75 mm onto a conveyer belt to produce placebo and 10% w/w felodipine loaded filaments.
The formulations containing Eudragit EPO, Soluplus and PVA as the main matrix materials are labelled with the abbreviations of CME, CMS and CMV, respectively. All ingredients were accurately weighed and premixed using a mortar and pestle for 2 minutes. For each extrusion experiment, 7 g of the premixed blend was fed into the extruder and 3 g was kept for the characterization of the physical mixtures. The extrusion was performed at the specified extrusion temperature (Table 2) with 5 minutes retention time and 100 rpm screw speed. After decreasing the rotation speed of the screws to 25 rpm the extruded soft mass of the blends was flushed directly through a metal attachment with a circular die of a diameter 1.75 mm onto a conveyer belt to produce placebo and 10% w/w felodipine loaded filaments.
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