scholarly journals Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Kensaku Matsunami ◽  
Fabian Sternal ◽  
Keita Yaginuma ◽  
Shuichi Tanabe ◽  
Hiroshi Nakagawa ◽  
...  
Keyword(s):  
Drug Product ◽  
Economic Assessment ◽  
Process Synthesis ◽  
Product Manufacturing

Process Model for Enhancing Yield in Sterile Drug Product Manufacturing

2017 ◽  
Vol 12 (3) ◽  
pp. 194-205 ◽  
Author(s):  
Keisho Yabuta ◽  
Masahiko Hirao ◽  
Hirokazu Sugiyama
Keyword(s):  
Process Model ◽  
Drug Product ◽  
Product Manufacturing

Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

2015 ◽  
Vol 104 (4) ◽  
pp. 1440-1450 ◽  
Author(s):  
Verena Saller ◽  
Julia Matilainen ◽  
Ulla Grauschopf ◽  
Karoline Bechtold-Peters ◽  
Hanns-Christian Mahler ◽  
...  
Keyword(s):  
Drug Product ◽  
Peristaltic Pump ◽  
Product Manufacturing

scholarly journals Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing

2018 ◽  
Vol 57 (30) ◽  
pp. 9798-9809 ◽  
Author(s):  
Kensaku Matsunami ◽  
Takuya Miyano ◽  
Hiroaki Arai ◽  
Hiroshi Nakagawa ◽  
Masahiko Hirao ◽  
...  
Keyword(s):  
Decision Support ◽  
Drug Product ◽  
Product Manufacturing ◽  
Decision Support Method

scholarly journals HPLC Method for Determination of Aspirin, Rosuvastatin, Ezetimibe and Clopidogrel in Combination Drug Products

2019 ◽  
Vol 31 (10) ◽  
pp. 2275-2283 ◽  
Author(s):  
Suresh Kumar Palacharla ◽  
G.V. Krishna Mohan
Keyword(s):  
Method Validation ◽  
Flow Rate ◽  
Mobile Phase ◽  
Drug Product ◽  
Hplc Method ◽  
Combination Drug ◽  
Injection Volume ◽  
Drug Products ◽  
Product Manufacturing

A single HPLC method for the determination of four active ingredients viz. aspirin, rosuvastatin, ezetimibe and clopidogrel in less run time is developed. HPLC method was developed and validated. X-terra C18 100 × 4.6 mm, 3.5 μ HPLC column, KH2PO4 buffer (mobile phase A) and acetonitrile (mobile phase B) were used. 20 μ injection volume, 1.0 mL/min flow rate, 230 nm and ambient column oven temperature were applied for separation. Gradient program: at 0 min mobile phase-B 13 %, at 4 min 13 %, at 8 min 44 %, 14 min 57 %, 17 min 57 %, 20 min 13 % and 25 min 13 %. Method validation was performed as per ICH guidance with precision, linearity, specificity, accuracy, ruggedness and robustness. Validation results were satisfactory and this method can be applied for regular drug product manufacturing

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