Two microcrystalline cellulose grades Avicel® PH 200 (FMC BioPolymer, Philadelphia, PA, USA) and Pharmacel® 102 (DFE Pharma, Nörten-Hardenberg, Germany) were studied in depth. Henceforth, the powders shall be referred to by the abbreviations MCC-A and MCC-P. A certain proportion of the MCC particles, particularly the larger particle sizes, are rounded agglomerates. Taking this into account, and due to the simplicity of this approach in simulation, spherical shapes are used in DEM simulations. The powder characteristics particle size distribution (PSD) and true density, are given in Table 1 and are available in the literature [41 (link)].
Avicel ph 200
Manufactured by FMC Biopolymer
Sourced in United States
Avicel® PH 200 is a microcrystalline cellulose product manufactured by FMC Biopolymer. It is a fine, white, odorless, and tasteless powder. Avicel® PH 200 is primarily used as a binder, disintegrant, and diluent in pharmaceutical and nutraceutical formulations.
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Lab products found in correlation
Avicel ph105, by FMC Biopolymer (1 mentions)
D mannitol, by Merck Group (1 mentions)
Magnesium stearate, by Merck Group (1 mentions)
Emcompress an, by JRS Pharma (1 mentions)
Avicel ph102, by FMC Biopolymer (1 mentions)
Pectin from apple, by Merck Group (1 mentions)
Acetonitrile, by Merck Group (1 mentions)
Chitosan oligosaccharide lactate, by Merck Group (1 mentions)
Sodium phosphate monobasic, by Merck Group (1 mentions)
Sodium phosphate dibasic, by Merck Group (1 mentions)
7 protocols using avicel ph 200
1
Microcrystalline Cellulose Powder Characterization
2
Phase 1 Pharmacokinetic Studies of CK-107
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Three double‐blind, randomized, placebo‐controlled phase 1 studies were conducted (CY 5011, CY 5012, and CY 5013). Active doses for all studies consisted of a spray‐dried dispersion of CK‐107 prepared as a suspension in Ora‐Sweet flavored syrup vehicle (Paddock Laboratories, Minneapolis, MN), and placebo consisted of Avicel PH‐200 and Avicel PH‐105 (microcrystalline cellulose; FMC BioPolymer, Philadelphia, PA) suspended in Ora‐Sweet flavored syrup. Safety assessments included adverse events (AE), laboratory results, vital signs, electrocardiogram (ECG) findings, and neurological and physical examinations. Participants were judged by the investigator to be in good health from history, physical and laboratory examination, and ECG results. Participants who had had a clinically significant illness within 4 weeks of screening were excluded.
3
Microcrystalline Cellulose Catalyst Evaluation
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Microcrystalline cellulose (Avicel PH200, FMC Biopolymer) was utilized to investigate the performance of different solid catalysts.
4
Excipient Comparison for Tablet Formulation
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Four different excipient grades are used for tableting: Avicel® PH 200 (FMC BioPolymer, Philadelphia, Pa, USA) (MCC-A), Pharmacel® 102 (DFE Pharma, Nörten-Hardenberg, Germany) (MCC-P), Tablettose® 100 (Meggle Pharm, Wasserburg am Inn, Germany) (LAC), and DI-CAFOS® D160 (Budenheim, Budenheim, Germany) (CAPH). The first two constitute two grades of microcrystalline cellulose with a different particle size distribution: Tablettose® 100 is a lactose monohydrate, whereas the main component of DI-CAFOS® D160 is dicalcium phosphate dihydrate.
5
Formulation Development of Pharmaceutical Excipients
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D-mannitol, magnesium stearate and sodium chloride salt (NaCl) were purchased from Sigma-Aldrich (Pool, UK), while microcrystalline cellulose (MCC) (Avicel PH-200) was obtained from FMC BioPolymer Europe (Brussels, Belgium). Crospovidone (CrosPVP, Polyplasdone® XL-10) was obtained from Ashland (Wilmington, USA). All the ingredients were of pharmaceutical grade.
6
Direct Compression Tableting Excipient Evaluation
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The selected materials are pharmaceutical grade excipients with moderate flow properties, which can be used in the direct compression tableting process. The following commercial grade materials were tested: Emcompress AN (dicalcium phosphate anhydrous; DCPA) obtained from JRS Pharma (Mnf. Chicago Heights, IL, USA, B.N. 124741), Avicel PH 102 and Avicel PH 200 obtained from FMC BioPolymer (Cork, Ireland, B.N. 71250C and M1247C, respectively; MCC102, MCC200), SuperTab 14SD (spray-dried lactose; SDL) obtained from DMV-Fonterra Excipients GmbH (Nörten-Hardenberg, Germany, B.N. 10671590).
Powder bulk properties are presented in Table 1. Powder mass flow rate was determined by funnel method. 20 Powder volume flow rate was then calculated from mass flow rate and powder bulk density. Angle of repose was measured on a Pharma Test PTG-2 instrument: 100 8 (link) and true densities, 21 particle-size distribution D(0.1), D(0.5) D(0.9), 8 (link) funnel measured mass and volume flow rates and angle of repose for tested materials, which include dicalcium phosphate anhydrous (DCPA), microcrystalline cellulose PH102 and PH200 (MCC102 and MCC200), and spray-dried lactose (SDL).
Powder bulk properties are presented in Table 1. Powder mass flow rate was determined by funnel method. 20 Powder volume flow rate was then calculated from mass flow rate and powder bulk density. Angle of repose was measured on a Pharma Test PTG-2 instrument: 100 8 (link) and true densities, 21 particle-size distribution D(0.1), D(0.5) D(0.9), 8 (link) funnel measured mass and volume flow rates and angle of repose for tested materials, which include dicalcium phosphate anhydrous (DCPA), microcrystalline cellulose PH102 and PH200 (MCC102 and MCC200), and spray-dried lactose (SDL).
7
Mucoadhesive NFC and ANFC Films
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1.5% NFC hydrogel (processed from birch pulp, UPM-Kymmene Corporation, Finland) and 2.7 % ANFC hydrogel (UPM-Kymmene Corporation, Finland) with carboxyl groups at 1.03 mmol/g of fibers were used as film forming polymers. Chitosan oligosaccharide lactate (Sigma-Aldrich, USA), mucin from bovine submaxillary gland (EMD Millipore, USA) and pectin from apple (Sigma-Aldrich, China) were used as mucoadhesive polymers in NFC and ANFC films. Microcrystalline cellulose (MCC, Avicel PH200, FMC BioPolymer, Ireland) and mucin from porcine stomach (Type-II) (Sigma-Adrich, USA) were used for the preparation of 600 mg mucin/MCC discs in 4:1 mass ratio (wt/wt) respectively. Mucin from bovine submaxillary glands (Type-I) was prepared as a 1 % solution (Sigma-Aldrich, USA) for the hydration of mucin discs prior to adhesion testing with TA.XT plus.
Metronidazole (Sigma-Aldrich, China) was used as a model drug compound in mucoadhesive film formulations. Analytical grades sodium phosphate dibasic (Sigma-Aldrich, Germany) and sodium phosphate monobasic (Sigma-Aldrich, Germany) were used in the preparation of 50 mM pH 6.8 phosphate buffer. Acetonitrile (Sigma-Aldrich, Germany) was of analytical grade.
Metronidazole (Sigma-Aldrich, China) was used as a model drug compound in mucoadhesive film formulations. Analytical grades sodium phosphate dibasic (Sigma-Aldrich, Germany) and sodium phosphate monobasic (Sigma-Aldrich, Germany) were used in the preparation of 50 mM pH 6.8 phosphate buffer. Acetonitrile (Sigma-Aldrich, Germany) was of analytical grade.
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