A monoclonal antibody (IgG 1 , MW ~145 kDa, pI 9.15, referred to as mAb1) and an enzyme (MW ~59 kDa, pI 7.16) were supplied by F. Hoffmann-La Roche/Genentech. The antibody was formulated at protein concentrations of 10 and 100 mg/mL with 240 mM sucrose in a 20 mM histidine hydrochloride buffer at pH 5.8. The 10 mg/mL and the 100 mg/mL formulation contained 0.004% (w/v) or 0.04% (w/v) polysorbate 20 (Croda, Snaith, UK). The enzyme was formulated at a protein concentration of 2.5 mg/mL with 500 mM arginine phosphate buffer at pH 7.3 and 0.01% (w/v) polysorbate 80 (Croda, Snaith, UK). All formulations were filtered with 0.22 µm polyethersulfone membrane filters (Corning, Corning, NY, USA) prior to filling to nominal fill volumes in vial configurations as summarized in Table 1. All vials were pharmaceutical Type 1 borosilicate glass tubing vials (Schott AG, Mainz, Germany). The 2 cc vials had 13 mm openings, while the 6 cc, 20 cc, and 50 cc vials had 20 mm openings. All vials were partially stoppered with lyophilization stoppers (Daikyo Seiko, Tochigi Prefecture, Japan). The vials were arranged in hexagonal packs in the lyophilizer.
Polysorbate 80
Manufactured by Croda
Sourced in United Kingdom
Polysorbate 80 is a non-ionic surfactant and emulsifier commonly used in laboratory settings. It has the ability to solubilize and disperse various substances in aqueous solutions.
Automatically generated - may contain errors
Lab products found in correlation
Polysorbate 20, by Croda (1 mentions)
Ascorbic acid, by Thermo Fisher Scientific (1 mentions)
Arium pro, by Sartorius (1 mentions)
Propylparaben, by Merck Group (1 mentions)
Methylparaben, by Merck Group (1 mentions)
Sorbitan oleate, by Croda (1 mentions)
Guava easycyte 8ht flow cytometer, by Merck Group (1 mentions)
Chx a dtpa, by Macrocyclics (1 mentions)
Df bz ncs, by Macrocyclics (1 mentions)
Es100, by Evonik (1 mentions)
Sodium stearyl fumarate ssf, by JRS Pharma (1 mentions)
D mannitol, by Roquette (1 mentions)
Rituximab, by Genentech (1 mentions)
Porcine liver esterase, by Merck Group (1 mentions)
5 5 dimethyl 1 pyrroline n oxide dmpo, by Dojindo Laboratories (1 mentions)
Tempol, by Merck Group (1 mentions)
Sucrose, by Avantor (1 mentions)
Glycine, by Avantor (1 mentions)
Citric acid monohydrate, by Avantor (1 mentions)
8 protocols using polysorbate 80
1
Monoclonal Antibody and Enzyme Formulation
2
Δ9THC Nanoformulation Development
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Δ9THC (3.2537 g) was added to a beaker. To this 0.625 g of 100% Ethanol (Lot no-007116 , Decon Lab, King of Prussia, PA) was added and sonicated until Δ9THC was dissolved. This was followed by the addition of 7.5 g of GTCC MBAL SG oil (Lot no- 42733, Crodamol, Plainsboro, NJ) and 2.7 g of polysorbate 80 (Lot no-1186606, Croda, Plainsboro, NJ). The mixture was sonicated until dissolved. This is the oil phase. In another beaker, 0.06 g of ascorbic acid (Lot no-181977 Fisher Chemicals, Waltham, MA) was dissolved in 18 g of Milli-Q water. This water was added to the oil phase while stirring using an electric stirrer for about 15 minutes to make it an emulsion. After this, the pH of this solution was set around 7 using a diluted sodium hydroxide solution. This emulsion was passed through the homogenizer (Make-Avestin, Emulsiflex C3) for 3 cycles at 10,000–15,000 psi. The particle size of this formulation was found to be an average of 150 nm. The concentration Δ9THC in the nanoformulation was 8% by weight. The cannabinoid metabolites 11-hydroxy-THC (THC-OH) and tetrahydrocannabinol carboxylic acid (Δ9THC-COOH) were purchased from Cayman Chemicals (Ann Arbor, MI).
3
Development of Carbamazepine-Sacha Inchi Oil Formulation
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CBZ and sacha inchi oil (SIO) were provided by Tecnoquimicas S.A Pharmaceutical Company (Cali, Valle del Cauca, Colombia) and Nutresacha SA (Santander de Quilichao, Cauca, Colombia), respectively. Sorbitan oleate (SpanTM 80, hydrophilic-lipophilic balance (HLB) = 4.3) and Polysorbate 80 (TweenTM 80, HLB = 15) were purchased from Croda (Snaith, UK). Methyl-paraben and propyl-paraben were acquired from Sigma-Aldrich (St. Louis, MO, USA). Water Type II (ultrapure water) was obtained via a Millipore Elix Essential purification system (Merck KGaA, Darmstadt, Germany), while the water employed for high-performance liquid chromatography (HPLC) was purified using a Sartorius Arium-Pro (Sartorius AG, Gotinga, Germany). All solvents were of analytical reagent grade.
4
EphA2 Expression and DS-8895a Conjugation
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EphA2 expression was assessed by staining 1 • 10 6 MDA-MB-231 cells with a 10 mg/mL dose of humanized DS-8895a, followed by phycoerythrin antihuman secondary antibody. Flow cytometric analysis was performed using Guava flow cytometry (Guava easyCyte 8HT flow cytometer, model 0500-4008; Guava Technologies).
Conjugation of Deferoxamine-p-SCN to DS-8895a for Radiolabeling DS-8895a was obtained from Daiichi Sankyo Co., Ltd., and was chelated either with the bifunctional metal ion chelator CHX-A$-DTPA (Macrocyclics Inc.) at a 5.0-fold molar excess or with deferoxaminep-SCN (Df-Bz-NCS; Macrocyclics Inc.) at a 3.0-fold molar excess. Two-milligram aliquots of the conjugates in 50 mM sodium acetate buffer (BDH/VWR Chemicals), pH 5.6, containing 5% w/v sorbitol (BDH/VWR Chemicals) and 0.01% w/v polysorbate 80 (Croda) were stored at 280°C until required.
Conjugation of Deferoxamine-p-SCN to DS-8895a for Radiolabeling DS-8895a was obtained from Daiichi Sankyo Co., Ltd., and was chelated either with the bifunctional metal ion chelator CHX-A$-DTPA (Macrocyclics Inc.) at a 5.0-fold molar excess or with deferoxaminep-SCN (Df-Bz-NCS; Macrocyclics Inc.) at a 3.0-fold molar excess. Two-milligram aliquots of the conjugates in 50 mM sodium acetate buffer (BDH/VWR Chemicals), pH 5.6, containing 5% w/v sorbitol (BDH/VWR Chemicals) and 0.01% w/v polysorbate 80 (Croda) were stored at 280°C until required.
5
Formulation and Evaluation of a Gastro-Resistant Drug Delivery System
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EMP was a gift from Lee Pharma Limited (Hyderabad, India). D-mannitol was provided by Roquette (Lesterem, Singapore). Low-substituted hydroxypropyl cellulose (L-HPC) and hypromellose (HPMC) 2910 were purchased from Shin-Etsu (Tokyo, Japan). Croscarmellose sodium (CMC-Na) was obtained from DuPont Nutrition (Newark, DE, USA). HPC L-type (HPC-L) was supplied by Nippon Soda Co., Ltd. (Tokyo, Japan). Sodium stearyl fumarate (SSF) was purchased from JRS Pharma (Polanco, Spain). Talc was purchased from Merck (Darmstadt, Germany). Triethyl citrate (TEC) was purchased from MORIMURA Bros., INC. (Tokyo, Japan). Glycerol monostearate (GMS) was obtained from Gattefosse (Saint-Priest, France). Polysorbate 80 was purchased from CRODA (Seraya, Singapore). Iron oxide red was obtained from VENATOR (Turin, Italy). ELD-55, ES-100, and EL-100 were obtained from Evonik Industries (Darmstadt, Germany). Hard capsules (HPMC) were obtained from SUHEUNG Co., Ltd. (Cheongju, Korea). A commercial product (Nexium® tablet; 40 mg) was purchased from AstraZeneca Korea Co. (Seoul, Korea). All other reagents were of reagent grade and used without further purification.
6
Polysorbate 80 Characterization and Validation
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polysorbate 80 NF was purchased from Spectrum Biochemical. Super refined polysorbate 80 with C18:1 fatty acid content ≥98% designated as “high oleic acid PS80 (PS80 HOA)” throughout this manuscript, was kindly provided by Croda Inc. rhG-CSF was purchased as filgrastim reference standard from USP and rituximab from Genentech, Inc. Porcine liver esterase was purchased from Sigma. Mouse phospholipase B-like 2 (PLBD2) was purchased from Biorbyt. All chemicals were purchased from Sigma unless otherwise specified.
7
Polysorbate 80 Characterization and EPR
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Different quality grades and batches of polysorbate 80 were purchased from Croda (International Plc. Snaith, UK): (i) high purity (HP), (ii) super-refined (SR), and (iii) all-oleate (AO) as well as from Nanjing Well (Nanjing, China): (iv) china grade (CG) (see Table S1). DMPO (5,5-Dimethyl-1-Pyrroline-N-Oxide) was purchased from Dojindo Molecular Technologies (Rockville, US), Tempol (4-Hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) in a solid crystalline form from Sigma-Aldrich Chemie GmbH (Taufkirchen, Germany). Glass capillaries (Blaubrand) and Critoseal for the EPR experiments were obtained from Brand GmbH & Co. KG (Wertheim, Germany).
8
Lyophilized IgG1 mAb Protein Formulation
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