A2849C The context of the written assignment should discuss, explore and analyse the following topics: Pharmaceutical Formulation and Processing Report, RP, Singapore

Written Assignment

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

Strait Pharmaceuticals is planning to develop coated tablet of a Herbal powder (Figure 1). This Herbal powder was extracted from flowers of a local plant and had just been proven to exhibit analgesic and anti-inflammatory activity.

Listed below (Table 1) are some physicochemical properties of the Herbal powder.

Table 1.

1. The company decided to use the wet granulation method to transform the Herbal powder (Figure 1) into granules to produce compressed tablets. As a formulation scientist in Strait Pharmaceuticals, you are tasked to identify a suitable wet granulation method to deliver the dose of 100mg Herbal powder per 500mg tablet.

You may discuss the following aspects in this section

• Research and briefly discuss the granulation technologies you have learnt for manufacturing tablets (Fluid bed granulation, Extrusion – Spheronisation and High shear granulation)  
• Justify your choice of granulation method for the Herbal powder based on its physicochemical properties given.
• Discuss the critical process steps involved in the chosen method.
• Discuss the effect of three(3) process parameters of the chosen method on the quality of the granules produced.
• Discuss how the quality of the granules produced by different methods can be characterised and compared.

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

You may discuss the following aspects in this section

• Research and briefly discuss three tablet coating technologies available.
• Justify your choice of coating method for the Herbal powder tablet
• Discuss the critical process steps involved in the chosen method.
• Discuss the effect of three (3) process parameters of the chosen method on the quality of coated tablets.

3. From the list of excipients provided in Annex A, select the excipients to formulate coated tablets of Herbal powder based on the granulation and coating methods you have chosen. Justify your choice of excipients used in the formulation.
4. After Herbal powder tablets are formulated and compressed by the formulation team, various quality control (QC) tests were performed on a trial batch of Herbal powder tablets. You are tasked to compare the QC test results for trial batch of Herbal powder tablets with USP standards and determine the quality of the tested Herbal powder tablets.
   

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