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7 protocols using opadry

1

Development and Characterization of Nifedipine Pellets

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Nifedipine was manufactured by Asmidhi Labs (India). Microcrystalline cellulose (MCC) 101, the main diluent in pellet manufacture, was obtained from Mingtai Chemical (Taoyuan Hsien, Taiwan). Lactose, used as a diluent, and polyvinylpyrrolidone (PVP-K30), used as a binder, were manufactured by Valdequímica Produtos Químicos Ltda (Brazil). Croscarmellose sodium manufactured by Amishi Drugs and Chemicals (Ahmedabad, Gujarat, India) was used as a disintegrant. Polyethylene glycol (PEG4000), used as a plasticizer and a lubricant, was manufactured by Valdequímica Produtos Químicos Ltda (Brazil). Methocel was manufactured by Colorcon (UK); it was used as a binder and was also added in a 1% w/w aqueous solution as the granulation liquid. Silicon dioxide was used as an adsorbent; it was manufactured by Longyan Shenghe Trading (German). The polymers used to coat the pellets were Opadry and Opadry II, which were manufactured by Colorcon (Dartford, Kent, UK). Opadry contains mostly hydroxypropyl methylcellulose, while Opadry II contains mostly polyvinyl alcohol.
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2

Reagent Procurement for Pharmaceutical Research

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Sodium bicarbonate (≥99.9%) was purchased from Ottogi Corp. (Anyang, Republic of Korea). Hydroxypropyl methylcellulose (Vivapharm Hypromellose 2910), triethyl citrate (≥99.0%), and magnesium stearate were obtained from Whawon Pharm. Co., Ltd. (Hwaseong, Republic of Korea), TCI Co., Ltd. (Tokyo, Japan), and Faci Asia Pacific Pte Ltd. (Singapore), respectively. Opadry (04K19229) and Acryl-Eze (93018509) were donated by Colorcon Inc. (Harleysville, PA, USA). All solutions were prepared with high-performance liquid chromatography (HPLC)-grade water purified with Arium Mini Plus (Sartorius, Goettingen, Germany) and cellulose nitrate membrane filters (47 mm, 0.2 μm, Whatman, Maidstone, UK). All other reagents were of analytical grade or better.
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3

Amoxicillin Trihydrate Formulation and Characterization

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Amoxicillin tryhydrate was supplied by the United Laboratories Co., Ltd (ZhuHai, China). The working standard of amoxicillin trihydrate (85.8% purity) and ampicillin trihydrate (Internal standard, IS) (Fig 1) were obtained from National institutes for food and drug control (Beijing, China). Eudragit L30 D-55 was received as a gift sample from Rohm Pharmaceutical Co., Ltd (Shanghai, China). HPMCAS was given by ShinEtsu Chemical Co., Ltd. (Tokyo, Japan). Microcrystalline cellulose (MCC, Avicel® PH 101, PH 102, PH 301) were from Asahi Kasei Corporation in Japan. Triethyl citrate (TEC) was given by AnHui BBCA Pharmaceutical Co., Ltd (AnHui, China). Polyplasdone (PVPP, Ashalnd, USA) was given from Industrial Polychemical Service Corporation (NewJersey, USA). Sodium hydroxide (GR grade), sodium lauryl sulfate (GR grade), sodium dihydrogen phosphate (GR grade) and phosphoric acid (GR grade) and glacial acetic acid (GR grade) were purchased from Sinopharm Chemical Reagent Co., Ltd (Shanghai, China). Methanol (HPLC grade) and acetonitrile (HPLC grade) were purchased from Merck Pvt. Ltd. (Shanghai, China). Polyoxyl 35 castor oil was purchased from BASF (Germany). Hydroxypropyl methyl cellulose (HPMC E5) and Opadry® were purchased from Colorcon (Shanghai, China).
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4

Formulation and Film Coating of Amoxicillin Tablets

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The pulseⅠ, Ⅱ, Ⅲ and other excipients were compressed by different compression forces (8KN, 13KN, 18KN) using a single-punch tableting machine (Riva Mini Press MⅡ, Riva, Germany) with a punch of 22 mm diameter by Box–Behnken design in Table 2. Avicel MCC PH 102 and colloidal silicon dioxide was selected as the glidant in the tablet compression procedure. Then, pulse Ⅰ, pulse Ⅱ, pulse Ⅲ, PVPP, magnesium stearate, Avicel MCC PH 102 and colloidal silicon dioxide were mixed and pressed to make the tablets with suitable compression force.
The tablets were prepared by film-coating of Opadry® (Colorcon). The coating suspension was prepared by adding Opadry® powder to the purified water with 500 rpm stirring for at least 45 min. The amoxicillin containing tablets were coated using the Opadry® suspension by a coating pan (BY300, Shanghai precision instruments Co., Ltd, Shanghai, China). The conditions were given as follows: the temperature was 35 ~ 40°C, the spray rate was 3 ~ 6 mL/min, the atomization pressure was 1.5 bar and weightening ratio of film coating was 3%. The film-coated tablets were saved in sealed pockets and closed containers.
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5

Formulation Development of LOS-K and HCTZ

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LOS-K and HCTZ were provided by Zhejiang Tianyu Pharmaceutical Co., Ltd. (Taizhou, China). Microcrystalline cellulose (MCC PH102) was provided by Asahi Kasei Pharmaceutical Co., Ltd. (Tokyo, Japan). Lactose monohydrate (SuperTab®14SD) was sourced from Dfe Pharma India Pvt.ltd. (Tamil Nadu, India). Pre-gelatinized starch (Starch 1500 ®) and Opadry® were provided by Colorcon.
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6

Dutasteride Solubility Enhancement with Cyclodextrins

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Dutasteride was purchased from Cipla Ltd (Mumbai, India). α-Cyclodextrin (α-CD), β-cyclodextrin (β-CD), γ-cyclodextrin (γ-CD) and hydroxypropyl-β-cyclodextrin (HP-β-CD) were obtained from Wacker Chemie AG (München, Germany). Polyvinylpyrrolidone K30 (PVP) (BASF, Germany), d-α-tocopheryl polyethylene glycol 1000 succinate (TPGS) (Isochem, France), stearoyl polyoxylglycerides (Gelucire 50/13) (Gattefosse, France), polyethyleneglycol (PEG400) (Yakuri Pure Chem, Japan) and polyethyleneoxide-polypropylene oxide copolymer (Poloxamer 407) (BASF, Germany) were used as solubilizers. Lactose (SuperTab 11SD) (DFE pharma, Japan), microcrystalline cellulose (Avicel PH102) (FMC, USA), crospovidone (Polyplasone XL) (Ashland, Netherland), magnesium stearate (Faci, Italy), Opadry® (Colorcon, Singapore) and ethylcellulose (Ethocel 10) (Colorcon, Korea) were used as excipients for the tablets. Avodart® soft capsules (GlaxoSmithKline, United Kingdom) were purchased from a local pharmacy.
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7

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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