A2849C: Republic Pharmaceuticals is Planning to Develop a Generic Version of a Branded Medicine: Pharmaceutical Technology Assignment, RP, Singapore

Written Assignment

The context of the written assignment should discuss, explore, and analyze the following topics.

Republic Pharmaceuticals is planning to develop a generic version of a branded medicine Drug A coated tablet, upon expiration of the patent filed by the innovator company of Drug A. Listed below (Table 1) are some physicochemical properties of Drug A.

1. As a formulation scientist in Republic Pharmaceuticals, you are tasked to propose a suitable granulation method for Drug A powder to convert it to compressed tablets weigh 800mg each.

You may discuss the following aspects in this section

• Research and discuss the various granulation technologies available for manufacturing tablets
• Justify your choice of granulation method for Drug A
• Discuss the critical process steps involved in the chosen method
• Discuss how the process parameters of the chosen method may affect the quality of the granules produced.

2. Propose a suitable tablet coating method to use after Drug A powder is converted to compressed tablets.

You may discuss the following aspects in this section

• Research and discuss the various tablet coating technologies available
• Justify your choice of coating method for Drug A tablets
• Discuss the critical process steps involved in the chosen method
• Discuss how the process parameters of the chosen method may affect quality of Drug A coated tablets.

3. From the list of excipients provided in Annex A, select the excipients to formulate Drug A coated tablets based on the granulation and coating methods you have Justify your choice of excipients used in the formulation. (10 marks)

4. After Drug A Tablets are formulated and compressed by the formulation team, various quality control (QC) tests were performed on a trial batch of Drug A Tablets. You are tasked to compare the QC test results for the trial batch of Drug A tablets with USP standards and determine the quality of the tested Drug A Tablets.

The quality control test results and the corresponding USP limits are given

You may discuss the following aspects in this section

• Describe the steps taken to perform the various quality control tests (Table 2) on the trial batch of Drug A tablets indicating the materials and equipment used for each test.
• Review and analyze the various quality control tests done on the trial batch of Drug A tablets and comment on whether they meet the USP specifications.
• Suggest possible ways to increase the quality of the Drug A tablets if they don’t meet the USP specifications.
• Discuss the critical techniques or steps for various quality control tests that you think may affect accuracy in the test results.