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Prosolv easytab sp

Manufactured by JRS Pharma
Sourced in Germany

PROSOLV® EASYtab SP is a functional excipient designed to aid in the production of solid oral dosage forms, such as tablets and capsules. It is a co-processed material composed of microcrystalline cellulose and silicon dioxide. The core function of PROSOLV® EASYtab SP is to improve the flow and compaction properties of active pharmaceutical ingredients and other formulation components during the manufacturing process.

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3 protocols using prosolv easytab sp

1

Direct Compression Tablet Preparation

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Example 4

Preparation of Tablets by Direct Compression.

5.0 g Masitinib mesylate from M and 11.2 g PROSOLV® EASYtab SP Ready to use tableting mixture (a ready-to-use excipient composite of microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and sodium stearyl fumarate having a bulk density of 0.30-0.42 g/ml obtainable from JRS Pharma, Rosenberg (Germany)), 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 as shown in FIG. 4.

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2

Formulation and Evaluation of Papaverine Tablets

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Papaverine hydrochloride (PAP) was the product of Farm-Impex Sp. J., Poland. Polyvinylpyrrolidone K 10 (PVP 10), microcrystalline cellulose (Avicel PH 101, Avicel PH 102), α-lactose (lactose), crospovidone CL (Kollidon CL), magnesium stearate (MS), and mannitol were produced by Sigma-Aldrich Chemmie Gmbh, Germany. Croscarmellose sodium (AcDiSol) was the product of BioPolymer, Belgium and gelatinized starch (CPharmGel) was the product of CargillBenelux BV, Netherlands. The manufactured mixture called Prosolv EasyTab SP (Prosolv) containing microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, and sodium stearyl fumarate was produced by JRS Pharma Gmbh & CO KG, Germany. The manufactured mixture called Prosolv SMCC 90 containing microcrystalline cellulose and colloidal silicon dioxide (CMSi), and manufactured by JRS Pharma Gmbh & CO KG, Germany, was also used. All other reagents and solvents were of analytical grade, distilled water was freshly distilled.
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3

Pharmacological Evaluation of CDCA and Pravastatin

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CDCA 250 mg tablets (Chenodal; lot #004949) were kindly supplied by Travere Therapeutics (San Diego, CA). Pravastatin 80 mg tablets were obtained from Accord Healthcare (Durham, NC). Metformin 500 mg tablets were obtained from Granules Pharmaceuticals (Chantilly, VA). Placebo tablets were manufactured at the University of Maryland Good Manufacturing Practice facility using PROSOLV EASYtab SP (JRS PHARMA, Weissenborn, Germany). The FGF19 human enzyme‐linked immunosorbent assay (ELISA) kit was obtained from Invitrogen (Waltham, MA). Liquid‐chromatography tandem mass spectrometry (LC–MS/MS) grade solvents were purchased from Fisher Scientific (Pittsburgh, PA). Pravastatin was obtained from United States Pharmacopeia (Rockville, MD). Pravastatin‐d3 was obtained from Toronto Research Chemicals (North York, ON, Canada). Bile acid standards and stable isotope labeled Bile acid standards were purchased from Sigma Aldrich (St. Louis, MO), Toronto Research Chemicals (North York, ON, Canada), Steraloids (Newport, RI), Cambridge Isotope Laboratories (Tewksbury, MA), or CDN Isotopes (Pointe‐Claire, QC, Canada). ISOLUTE PLD+ phospholipid depletion columns were purchased from Biotage (Uppsala, Sweden).
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