Critical assessment of pharmaceutical processess - A rationale for changing the synthetic route

被引：175

作者：

Butters, Mike

Catterick, David

Craig, Andrew

Curzons, Alan

Dale, David

Gillmore, Adam

Green, Stuart P.

Marziano, Ivan

Sherlock, Jon-Paul

White, Wesley

机构：

[1] AstraZeneca, Proc R&D, Bristol BS10 7ZE, Avon, England

[2] GlaxoSmithKline, Synth Chem, Tonbridge TN11 9AN, Kent, England

[3] Pfizer, Chem R&D, PGR&D, Sandwich CT13 9NJ, Kent, England

来源：

CHEMICAL REVIEWS | 2006年 / 106卷 / 07期

关键词：

D O I：

10.1021/cr050982w

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

An overview is given of the most common types of issues in a pharmaceutical process. The review provides a uniform set of criteria (SELECT- safety, environmental, legal, economics, control, and throughput), which represent the different drivers for changing a synthetic route. Each criterion is illustrated by reference to examples that have been selected to highlight important features of each issue and to illustrate the positive benefits associated with a new route.

引用

收藏

页码：3002 / 3027

页数：26

相关论文

共 82 条

[1] Development of an efficient and stereoselective manufacturing route to idoxifene [J].

Ace, KW ;

Armitage, MA ;

Bellingham, RK ;

Blackler, PD ;

Ennis, DS ;

Hussain, N ;

Lathbury, DC ;

Morgan, DO ;

O'Connor, N ;

Oakes, GH ;

Passey, SC ;

Powling, LC .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2001, 5 (05) :479-490

[2] Development of a manufacturing route to 1-hydroxy-4-(3-pyridyl)butan-2-one using heck methodology [J].

Ainge, D ;

Vaz, LM .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2002, 6 (06) :811-813

[3]

AMENDE DJ, 2003, ORG PROCESS RES DEV, V7, P1029

[4] The development of a manufacturing route for the GPIIb/IIIs receptor antagonist SB-214857-A.: Part 1:: Synthesis of the key intermediate 2,3,4,5-tetrahydro-4-methyl-3-oxo-1H-1,4-benzodiazepine-2-acetic acid methyl ester, SB-235349 [J].

Andrews, IP ;

Atkins, RJ ;

Breen, GF ;

Carey, JS ;

Forth, MA ;

Morgan, DO ;

Shamji, A ;

Share, AC ;

Smith, SAC ;

Walsgrove, TC ;

Wells, AS .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2003, 7 (05) :655-662

[5]

[Anonymous], 1999, PROCESS CHEM PHARM I

[6] Asymmetric synthesis of an MMP-3 inhibitor incorporating a 2-alkyl succinate motif [J].

Ashcroft, CP ;

Challenger, S ;

Derrick, AM ;

Storey, R ;

Thomson, NM .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2003, 7 (03) :362-368

[7] The development of a manufacturing route for the GPIIb/IIIs receptor antagonist SB-214857-A. Part 2: Conversion of the key intermediate SB-235349 to SB-214857-A [J].

Atkins, RJ ;

Banks, A ;

Bellingham, RK ;

Breen, GF ;

Carey, JS ;

Etridge, SK ;

Hayes, JF ;

Hussain, N ;

Morgan, DO ;

Oxley, P ;

Passey, SC ;

Walsgrove, TC ;

Wells, AS .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2003, 7 (05) :663-675

[8] Application of oxathiazolidine-S-oxide chemistry to the large-scale single-step synthesis of an O-arylethanolamine [J].

Barker, AC ;

Boardman, KA ;

Broady, SD ;

Moss, WO ;

Patel, B ;

Senior, MW ;

Warren, KEH .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 1999, 3 (04) :253-255

[9]

BARTON J, 1997, CHEM REACIONS HAZARD

[10] The discovery and process development of a commercial route to the water soluble prodrug, fosfluconazole [J].

Bentley, A ;

Butters, M ;

Green, SP ;

Learmonth, WJ ;

Macrae, JA ;

Morland, MC ;

O'Connor, G ;

Skuse, J .

ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2002, 6 (02) :109-112

← 1 2 3 4 5 6 7 8 9 →