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4 protocols using vivapur 12

1

Oxycodone Extended-Release Formulation

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The following materials were purchased from various companies and used as received: oxycodone hydrochloride (Macfarlan Smith, Edinburgh, Scotland); hydroxypropyl methylcellulose (HPMC; Metolose 90SH-100,000SR, 60SH-10,000SR, and 90SH-4,000SR; Shin-Etsu Chemical, Tokyo, Japan); hydroxypropyl cellulose (HPC; Klucel™-HF, Ashland, Covington, KY, USA); lactose monohydrate (FlowLac® 100; Molkerei MEGGLE Wasserburg GmbH & Co. KG, Wasserburg, Germany); microcrystalline cellulose (Vivapur 12®; JRS Pharma, Rosenberg, Germany); and fumed silica (Aerosil® R972; Evonik, Essen, Germany). All other chemicals used were of high-performance liquid chromatography (HPLC) or reagent grade.
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2

Excipient Evaluation for DAP-CA Cocrystal

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DAP-CA cocrystal (99.9% purity) was obtained from Sun Pharm. Industries, Ltd. (Mumbai, India). Anhydrous lactose (Supertab 21AN) was obtained from DFE Pharma (Goch, Germany). Lactose monohydrate (Tablettose) was obtained from Meggle Pharma (Wasserburg, Germany). Microcrystalline cellulose (Avicel PH-101) was purchased from FMC biopolymer (Philadelphia, PA, USA). Microcrystalline cellulose (Vivapur 12) was obtained from JRS Pharma (Rosenberg, Germany). Mannitol (Pearlitol 100 SD) was obtained from ROQUETTE Pharma (Lestrem, France), crospovidone (Polyplasdone XL) was provided by Ashland (DA, USA), colloidal silicon dioxide (Aerosil 200 pharma) was purchased from Evonik (Essen, Germany), and magnesium stearate was purchased from FACI (Genova, Italy). Opadry was purchased from Colorcon (Stoughton, WI, USA). DAP amorphous (99.9% purity) and DAP-PH (99.9% purity) were provided by Dr. Reddy (Hyderabad, India), and Forxiga® 10 mg, a control agent, was provided by AstraZeneca Korea (Seoul, Korea).
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3

Formulation of Rosuvastatin Calcium Tablets

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Rosuvastatin calcium (Insud Pharma) (Fig 1), lactose monohydrate (Guinama), microcrystalline cellulose (Vivapur 12®, JRS Pharma GmbH& CO.KG), dibasic calcium phosphate (Emcompress®, Fagron), crospovidone (PVPP, Sigma-Aldrich) and magnesium stearate (Guinama).
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4

Pregabalin Formulation and Evaluation

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Pregabalin was purchased from MSN Pharmachem (India). PEO (Polyox WSR 303) was purchased from Dow Chemical. Microcrystalline cellulose (MCC, Vivapur® 12) was purchased from JRS Pharma (Germany), povidone (Kollidon® 90F) from BASF (Germany), L-tartaric acid from Caviro (Italy), and D-mannitol from Roquette. All other excipients used were of pharmaceutical grade. All reagents used in the analyses were of analytical grade. An IR formulation (Lyrica Capsules, Pfizer) was used as a reference drug for pharmacokinetic studies.
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