CPE7004-B: A Pharmaceutical Company Has Synthesized 200 kg Of A Water-Insoluble: Food And Pharmaceutical Process Engineering Report, UOB, Ireland

A pharmaceutical company has synthesized 200 kg of a water-insoluble and thermolabile drug. Synthesis has been carried out in a 5000-liter reactor. Currently, the drug is present as a 25% w/v alcoholic solution. The company wishes to take the drug to the market in the form of an oral tablet. In order to achieve the desired solubility, the drug has to be present in the final tablet in its amorphous form.

You have been asked to prepare a project report for the review of the Technical Director. In this report, you should propose the unit operations and equipment which should be selected for the manufacturing process. It should include a process appreciation – a justification of your selection, with a discussion of comparative advantages and limitations of alternative process steps. Where possible, you should consider the effect of processing variables on material properties.

The unit operations you should include are:
Step-1: Suitable separation process to obtain a free-flowing crystalline powder of the thermolabile drug from the solution. The powder should have a narrow particle size distribution.

Step-2: Drying of the crystalline drug obtained in Step 1

Step-3: Technology to obtain a stabilized amorphous drug form

Step-5: Tabletting

You may also consider the equipment that can combine some of these steps.

Aims & Learning Outcomes

The aim of the coursework is to assess the ability of students to collate and apply information and perform basic process design based on concepts covered within the module.

The learning outcomes to be assessed from this coursework are:

1. The ability to specify the characteristics of unit operations and material properties

2. Demonstration of a critical understanding of different unit operations applied to the design of pharmaceutical manufacturing processes