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Pharmaceutical API Process Development and Design
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Abstract
API process development involves selection, preliminary design and scale-up of the equipment used to carry out the recipe for producing the desired form of the drug substance. This course will cover selected topics in API process development. Operations studied include batch reaction, evaporation, crystallization and filtration. The material is organized into two parallel tracks. One track introduces the basic concepts, equipment types and modes of operation for common API unit operations. The other track incorporates a set of applications demonstrating the use of simulation models and tools in solving design problems.
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| Lecture Number/Topic | Online Lecture | Video | Lecture Notes | Supplemental Material | Suggested Exercises |
|---|---|---|---|---|---|
| Introduction to API Process Simulation | Notes (ppt) | ExampleFitUA.doc ExampleFedBatch.doc |
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| This module describes model building methods and tools that can be used to simulate unit operations in pharmaceutical API processes. The use of simulation tools is introduced through simulations of... |
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| Batch Distillaton Basics | Notes (ppt) | ||||
| This module introduces topics related to batch distillation:
Vapor-liquid equilibrium.
Single stage distillation.
Column configuration and operating policies.
Simulation and design of... |
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| Applications: Solvent Switching | Notes (ppt) | ExampleSolventSwitch.doc |
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| This module presents an application of a simulation model in API process development and design. The application involves the use of a simulation model to compare feed profiles for solvent... |
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| Solid-Liquid Separations | Notes (ppt) | ||||
| This module covers topics related to solid-liquid separations:
Flow in packed beds.
Cake filtration.
Centrifuges.
Deliquoring and washing. |
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| Introduction to solid dosage processing | Notes (ppt) | ||||
| This module provides an introduction to solid dosage processing. It highlights the importance of particle properties and their potential impact on the quality attributes of the dosage form. Unit... |
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