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31 protocols using avicel ph 101

1

Functionalization of Microcrystalline Cellulose

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All chemicals were used as received from commercial suppliers without further purification. The microcrystalline cellulose (MCC), named Avicel PH-101®, was provided by FMC BioPolymer (Sandvika, Norway). The average particle size of Avicel PH-101® was about 50 µm. The silane coupling agent (3–mercaptopropyl)trimethoxysilane (MRPS) was purchased from Sigma-Aldrich (95%, Steinheim, Germany). All reactions with alkoxysilane were carried out in deionized water. Triethylamine (TEA) was obtained from Merck (99%, Darmstadt, Germany). Methyl ethyl ketone, acetone, and ethanol were of technical grade.
All reactions were carried out under nitrogen atmosphere and magnetic stirring in a 100 mL reaction flask equipped with a reflux condenser.
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2

Verapamil-Based Controlled-Release Formulations

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Verapamil hydrochloride (HCl, Safic Alcan, Puteaux, France); microcrystalline cellulose (MCC, Avicel PH 101, FMC BioPolymer, Brussels, Belgium); lactose monohydrate (Lactochem fine powder, DFE Pharma, Goch, Germany); Kollicoat SR 30D (a 30% aqueous dispersion of polyvinyl acetate, also containing small amounts of poly(vinyl pyrrolidone) and sodium lauryl sulfate) and Kollicoat IR (polyvinyl alcohol-polyethylene glycol graft copolymer) (BASF, Ludwigshafen, Germany); two analogues of fluorescein: Anionic Oregon Green 488 dextran (10,000 MW, Invitrogen, Carlsbad, CA, USA) and anionic 2′,7′-bis-(2-carboxyethyle)-5-(and-6)-carboxyfluorescein (BCECF) dextran (10,000 MW, Invitrogen). Sodium acetate, acetic acid glacial, potassium dihydrogen phosphate, hydrochloric acid and sodium hydroxide (pellets, Fisher Scientific, Illkirch, France).
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3

MCC Functionalization with Glutaraldehyde

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Microcrystalline cellulose (MCC) powder was supplied by FMC BioPolymer (Avicel-PH101). Sulfuric acid (H2SO4) Reagent Grade (95–97%) was procured from VWR Chemicals-USA. Ethanol and the 25 wt.% glutaraldehyde aqueous solution were purchased from Sigma Aldrich-USA. All chemicals were used as received without further modifications.
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4

Formulation and Characterization of Paracetamol-Zinc Sulfate Tablets

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Paracetamol and zinc sulfate, pharmaceutical grades (Fagron, Newcastle, UK), microcrystalline cellulose (Avicel® PH101, FMC Biopolymer, Girvan, UK), crospovidone (Polyplasdone® XL, FMC Biopolymer, Girvan, UK), sodium stearyl fumarate (FMC Biopolymer, Girvan, UK), lactose (SuperTab 14SD), sodium starch glycollate (Explotab CLV, Mendell GmbH, Volklingen, Germany); sodium croscarmellose (Ac-Di-Sol, FMC Biopolymer, Girvan, UK; mannitol, (Pearlitol® 200SD Roquette, UK), magnesium stearate, technical grade (Sigma Aldrich, Dorset, UK); Buxton® bottled water, Buxton, UK; Aptamil® 1 first milk, ready-to-feed (Nutricia, Trowbridge, UK).
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5

Copovidone-based Pharmaceutical Formulations

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Two types of copovidone grades PS630 and PS630U were supplied by Ashland, Inc. (Lexington, KY, USA). QF was obtained from RIA International LLC (East Hanover, NJ, USA). Avicel PH® 101 (microcrystalline cellulose) and Ac-Di-Sol® (croscarmellose sodium) were gift samples from FMC Biopolymer (Walnut Street, PA, USA); magnesium stearate and Aerosil® 200 (colloidal silica) were purchased from Alfa Aesar (Ward Hill, MA, USA). All other chemicals used were of analytical reagent grade.
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6

Preparation of Nicotine-MCC Premix

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Example 3

Preparation of Nicotine MCC Premix

A nicotine-MCC premix is made by adding first adding free nicotine to propylene glycol (PG) to obtain a 20% solution of nicotine in propylene glycol. Then, 50 grams of the nicotine-propylene glycol solution is added to 50 gram of microcrystalline cellulose provided as Avicel PH 101 from FMC Biopolymer. The nicotine-propylene glycol solution and the microcrystalline cellulose are then mixed in a Kitchenaid mixer operated at about 30 RPM for about 30 minutes at room temperature. Finally, the obtained mixture of the nicotine-propylene glycol solution and the microcrystalline cellulose is equilibrated for about 60 minutes in a sealed container.

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7

Controlled Release Formulation Development

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l-Carnitine Base (Kaiyuan Hengtai Chemical Co. Ltd., China); Croscarmellose sodium “Ac-Di-Sol” and microcrystalline cellulose “Avicel PH 101 and Avicel PH 112” (FMC biopolymer, Ireland); Magnesium stearate (Peter Greven, Malaysia); Polyvinylpyrrolidone K30 “Povidone K30” (Fluka, USA); Colloidal silicon dioxide “Aerosil 200” (Evonik Degussa, Germany); Aqualon ® Ethylcellulose N 100 (Ashland, USA); Ethocel ® Standard 20 Premium (Dow Chemicals, USA); Span 80 (Sorbitan monooleate) (Loba Chemie, India); Acetonitrile HPLC grade (Merck, Germany); Potassium dihydrogen phosphate, Phosphoric acid, Liquid Paraffin, Acetone and Hexane (El-Nasr Chemicals Co., Egypt).
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8

Microcrystalline Cellulose Surface Modification

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Microcrystalline cellulose (MCC) powder was supplied by FMC BioPolymer (Avicel-PH101, Philadelphia, PA, USA), 95% Sulfuric acid (H2SO4) Reagent Grade was procured from VWR Chemicals (Randor, PA, USA), 25 wt.% glutaraldehyde aqueous solution was purchased from Sigma-Aldrich (St. Louis, MO, USA).
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9

Rapidly Disintegrating Tablet Formulation

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Mefenamic acid (SIGMA, St. Louis, MO, USA) and acetylsalicylic acid (ASA) (Lot: W004649, Glatt GmbH, Binzen, Germany) were selected as a model compound to prepare rapidly disintegrating tablets. d-mannitol (Pearlitol 25C, Roquette, Lestrem, France) and microcrystalline cellulose (Avicel PH-101, FMC bioPolymer, Philadelphia, PA, USA) were used as diluents, and croscarmellose sodium (Ac-Di-Sol, FMC bioPolymer, Philadelphia, PA, USA) was used as a disintegrant. Hydroxypropyl cellulose (HPC SL, NIPPON SODA, Tokyo, Japan) was a binder, and magnesium stearate (Peter Greven GmbH & Co, Bad Münstereifel, Germany) as a lubricant was also selected. Polycaprolactone (1639, Abifor, Zurich, Switzerland) was used for the inert 2nd layer of the triple-layer tablet. Cetyltrimethylammonium bromide (CTAB) (Merck, Kenilworth, NJ, USA) was used as a surfactant for dissolution tests.
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10

Direct Compression ODT Formulation

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The ready to use co-processed excipient designed for ODT direct compression, i.e. F-MELT® type C (Fuji Chemical Industry, Japan) was kindly provided by Harke Pharma GmbH. Kollidon CL (BASF, Germany) was used as a superdisintegrant, microcrystalline cellulose – Avicel PH-101 (FMC Biopolymer) as a filler, and magnesium stearate (POCh, Poland) as a lubricant.
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