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Microcrystalline cellulose

Manufactured by JRS Pharma
Sourced in Germany, New Zealand

Microcrystalline cellulose is a purified, partially depolymerized cellulose prepared by treating alpha-cellulose, obtained as a pulp from fibrous plant material, with mineral acids. It is a fine, white, odorless, tasteless, crystalline powder composed of porous particles. Microcrystalline cellulose is used as a diluent and disintegrant in pharmaceutical formulations.

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3 protocols using microcrystalline cellulose

1

Formulation and Evaluation of Champix Tablets

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VRC and VRC-T were kindly supplied by Korea Institute of Science and Technology (Seoul, Korea). VRC-S was purchased from Hanseo Chem (Pyeongtaek-si, Korea). Microcrystalline cellulose (MCC) and croscarmellose sodium were purchased from JRS Pharma (Weissenbern, Germany). Anhydrous dibasic calcium phosphate was purchased from Innophos (Chicago, IL, USA). Colloidal silicon dioxide was purchased from Evonik (Rheinfelden, Germany). Magnesium stearate was purchased from FACI (Jurong Island, Singapore). All other excipients used in the manufacture of tablets were of standard pharmaceutical grade and all other reagents used were of analytical grade. Commercially available Champix tablets (Lot No 00003058; Pfizer) were used as the reference product.
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2

Formulation and Characterization of Micronized Abiraterone Acetate

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Micronized abiraterone acetate was purchased from Sterling (Cramlington, UK). Polyvinylpyrrolidone was obtained from Ashland (Covington, KY, USA). Soluplus® was purchased from BASF (Ludwigshafen, Germany). SIF powder was purchased from biorelevant.com, Switzerland. FaSSIF V2 biorelevant medium was prepared according to the manufacturer’s instructions. Lactose monohydrate was purchased from Meggle (Wasserburg am Inn, Germany), sodium deoxycholate was purchased for New Zealand Pharma (Palmerston North, New Zealand), microcrystalline cellulose was purchased from JRS Pharma (Rosenburg, Germany) and crospovidone was purchased from BASF (Florham Park, NJ, USA). All other chemicals were purchased from Sigma (St. Louis, MO, USA).
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3

Formulation and Production of Coated Tablets

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MSZ (Erregiere), microcrystalline cellulose (JRS Pharma), partially pregelatinized maize starch (Colorcon), povidone (BASF), magnesium stearate (Mosselman), lactose monohydrate (Meggle), croscarmellose sodium (FMC BioPolymer), colloidal silicon dioxide (Evonik), talc (Luzenac), calcium carbonate (Shangai Nuoceng Pharmaceuticals). All the components were of pharmaceutical grade and complied with the relevant monographs of the European Pharmacopoeia, 9th edition [10]. Coating system: Opadry clear (Colorcon), Triethylcitrate (Colorcon), Acryl-Eze (Colorcon). Also purified water (Ph. Eur., 2016) was used in the process.
Process steps and equipment -laboratory batches weighing -balance (Mettler Toledo), wet granulation -fluid bed granulator (Bosch), manual blending, tableting -eccentric press (Riva).
Process steps and equipment -pilot batches weighing -balances and scales (Mettler Toledo), wet granulation -fluid bed granulator (Bosch), blendingblender (Servolift), tableting -rotary tableting press (Fette 102i), oblong punch 18.2/7.7 mm, coatingcoating equipment (O'Hara Technologies).
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