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Review of Continuous Process for Modafinil
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Review of Continuous Process for Modafinil
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Sep 17, 2009 -
Girish MALHOTRA, PE. President. EPCOT INTERNATIONAL. 29150
Bryce Road
. Pepper Pike, OH 44124. â(216)-292-0626. (216)-591-0932.
9/17/09
REVIEW OF CONTINUOUS PROCESS FOR MODAFINIL
Profitability through Simplicity
EPCOT International
BATCH CONTINUOUS
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
BATCH vs. CONTINUOUS
Profitability through Simplicity
EPCOT International
QBD FEASIBLE ONLY IF :
WE “DO NOT” HAVE COMPLETE COMMAND OF THE CHEMISTRY AND THE PROCESS.
CHALLENGE. CAN BE DONE. Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
1
9/17/09
ELEMENTS OF QBD • PHYSICAL PROPERTIES • REACTION MECHANISM • CHEMISTRY THEY ARE AN ALLY AND FACILITATOR. Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
UNDERSTAND AND MANIPULATE
Profitability through Simplicity
EPCOT International
PHYSICAL PROPERTIES:
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
2
9/17/09
APPLICATION OF MY DO’S FOR MODAFINIL PROCESS QUALITY PRODUCT FIRST TIME AND ALWAYS.
BETTER BATCH OR A CONTINUOUS PROCESS Profitability through Simplicity
EPCOT International
“CHEMISTRY-CENTRIC” TRADITIONS
USP 6,875,893 & 7,057,069 7,244,865 AND OTHER PATENTS
Profitability through Simplicity
EPCOT International
BENZHYDROL + THIOUREA+ HBr S-BENZHYDRYLTHIOURONIUM BROMIDE + H2O
SOLVENT BASED PROCESSES. BENZHYLDRYTHIOL + KBr + UREA + CHLOROACETAMIDE + ALKALI
NEED TO LOOK AT ALTERNATES.
2-(BENZHYDRYLTHIOL) ACETAMIDE + KCl 2-(BENZHYLDRYLSULFINYL) ACETAMIDE [MODAFINIL]
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
STEP # 1: Benzhydrol + HBr Bromodiphenyl methane + H2O + Thiourea S-benzhydrylthiouronium bromide + H2O
Profitability through Simplicity
EPCOT International
3
9/17/09
STEP # 1 REACTION MECHANISM SECOND POSSIBLE MECHANISM
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
# 1 MECHANISM (1) MORE LIKELY BASED ON PHYSICAL PROPERTIES AND REACTION MECHANISM, THERE ARE OPPORTUNITIES TO MANIPULATE REACTANTS AND THE PROCESS.
Profitability through Simplicity
EPCOT International
CHEMICAL
PHYSICAL STATE
MP°C
BENZHYDROL
SOLID
69
THIOUREA
SOLID
181
HBr
LIQUID
KOH/K2CO3
LIQUID/SOLID
CHLOROACETAMIDE
SOLID
ACETIC ACID
LIQUID
H2O2
LIQUID
SOLUBILITY
WATER WATER
118
Profitability through Simplicity
WATER
EPCOT International
BENZHYDROL FEED: CHEMICAL
PHYSICAL STATE MP°C LIQUID
• PATENTS SUGGEST USE AS A SOLUTION.
SOLID
• BASED ON MY EXPERIENCE:
SOLID SOLID
110
SOLID
164
PROPERTIES SUGGEST: BENZHYDROL MELT AS A POSSIBILITY.
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
4
9/17/09
RATIONALE FOR USE OF MELT
RATIONALE FOR USE OF MELT
HIGH PRODUCTIVITY & YIELD
HIGH PRODUCTIVITY & YIELD
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
MODAFINIL STOICHIOMETRY
STEPS 2 TO 4
EXAMPLE: Theoretical
Suggested
BENZHYDROL
1.0
1.0
THIOUREA
1.0
1.2
HBr
1.0
1.2
KOH
1.0
1.2
CHLOROACETAMIDE
1.0
2.88
ACETIC ACID
1.0
3.2
H2O2
1.0
2.0
Profitability through Simplicity
CAN BE RATIONALIZED SIMILARLY AND SIMPLIFIED. A SOLVENT WITH LOW WATER SOLUBILITY AND AZEOTROPE, CAN FACILITATE THE PROCESS AND COULD BE USED.
EPCOT International
Profitability through Simplicity
EPCOT International
Profitability through Simplicity
EPCOT International
COMMERCIAL CONTINUOUS PROCESS Benzhydrol, HBr & Thiourea Storage tanks Chloroacetamide And Alkali storage tanks
Rx
Rx Purification & Crystallization
Acetic acid Hydrogen peroxide Storage tanks
Profitability through Simplicity
Rx
Rx
EPCOT International
5
9/17/09
QBD ELEMENTS DELIVER: SMOOTH, SAFE, CONTROLLED AND A COMPLAINT PROCESS.
THANK YOU VERY MUCH.
Girish MALHOTRA, PE President EPCOT INTERNATIONAL 29150 Bryce Road Pepper Pike, OH 44124 (216)-292-0626 (216)-591-0932 Website:
QBA Profitability through Simplicity
Blog:
QBD EPCOT International
Profitability through Simplicity
EPCOT International
6
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