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Ludipress

Manufactured by BASF
Sourced in Germany

Ludipress is a direct tabletting excipient developed by BASF. It is a co-processed excipient composed of lactose monohydrate, polyvinylpyrrolidone, and crospovidone. Ludipress is designed to provide direct compression properties for the formulation of solid oral dosage forms.

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5 protocols using ludipress

1

Development of Co-Processed Excipients

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α-lactose monohydrate (LMH, Sigma Aldrich, St. Louis, MO, USA), polyethylene glycol 4000 (PEG 4000, Sigma Aldrich, St. Louis, MO, USA), poloxamer 188 (P188, Kolliphor® P188, BASF, Ludwigshafen, Germany), glyceryl palmitostearate (GPS, Precirol® ATO 5, Gattefossé, Saint-Priest, France), croscarmellose sodium (Primellose®, DFE Pharma, Goch, Germany), calcium dihydrogen phosphate dihydrate (Emcompress®, JRS Pharma, Rosenberg, Germany) have been used for the preparation of co-processed excipients. Commercially available co-processed excipient Ludipress® (BASF, Ludwigshafen, Germany) has been used for comparison with the prepared co-processed mixtures.
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2

Masitinib Mesylate Tablet Formulation

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Example 5

Preparation of Tablets by Direct Compression.

5.0 g Masitinib mesylate form M, 10.0 g Ludipress® ready to use tableting mixture (a low hygroscopicity/high flowability mixture of lactose monohydrate, povidine [Kollidon 30®] and crospovidone [Kollidon CL®] obtainable from BASF) and 0.2 g magnesiumstearate were sieved (0.8 mm sieve) and mixed for 5 min by using a Turbula mixer.

Tablets were compressed by using a Korsch XP1 tablet press and analyzed by XRPD. No conversion to crystal form I was detectable as evident from the lack of a peak at 11.2° 2-Theta.

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3

Formulation Development and Characterization of FUR

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FUR was provided as a gift sample from UNIPHARMA pharmaceutical industries (AMRI, Aurangabad, India). Tween 80 was obtained from Riedel-De häen (Seelze-Hannover, Germany). Cremophor EL and Cremophor RH40 were a gift sample from Dar Al Dawa' pharmaceutical Co. Ltd (Amman, Jordan). Castor oil, Oleic acid, Glycerol, Propylene glycol (PG) and Polyethylene glycol 400 (PEG 400) were purchased from Panreac Co. Ltd (Barcelona, Spain). Sesame oil, Sunflower oil, and Soybean oil were purchased from the local market. Avicel PH101 was obtained from FMC Co. Ltd (Philadelphia, USA). Aerosil 200 was from Evonik industries (Rheinfelden, Germany). Ludipress was purchased from BASF (Ludwigshafen, Germany).
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4

Formulation Development and Evaluation

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Fst and Mrb were purchased from Lupin Pharmaceuticals (Nagpur, India). Erythritol and magnesium stearate were purchased from Daejung Chemicals and Metals (Siheung, South Korea). Ludipress and Kolliphor P188 were purchased from BASF (Ludwigshafen, Germany). Hydroxypropyl methylcellulose (HPMC) 4,000 cP (metolose 90 SH-4000 SR) and HPMC 100,000 cP (metolose 90 SH-100000 SR) were obtained from Shin-Etsu Chemical (Tokyo, Japan). Xanthan gum (Xantural 180) was purchased from CP Kelco(Atlanta, GA, USA). Polyethylene oxide (PEO; Polyox WSR 301 LEO NF) was bought from Colorcon Asia Pacific (Singapore). Glyceryl behenate (Compritol 888 ATO) was provided by Gattefossé (Saint-Priest, France). Talc and ferric (III) oxide red were purchased from Samchun Chemical (Pyeongtaek, South Korea). Hydroxypropyl cellulose (HPC; Klucel JF Pharm) was obtained from Ashland (Covington, KY, USA). Low-substituted HPC (L-HPC) LH22 type was provided by Huzhou Zhanwang Tianming Pharmaceutical (Zhejiang, China). Potassium phosphate and sodium hydroxide were purchased from Sigma-Aldrich. HPLC-grade solvents were used for analysis.
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5

Effervescent Clotrimazole Tablets for Topical Use

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Clotrimazole (Beijing Double Crane Pharmaceutical Co. Ltd-China) as dug substance; sodium hydrogen carbonate, anhydrous sodium carbonate and citric acid form Chimopar (Romania) as effervescent mixture; sodium laurylsulphate from Loba Feinchemie (Austria) as foaming agent; Ludipress from BASF (Germany) as direct compression filler; low viscosity Methocel E15-LV-EP, from Colorcon LTD (U.K) as direct compression binder; fumed silica form Evonik (Germany) and magnesium stearate from Union Derivan (Spain) as flowing agents.
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