Case study: Oral form with accelerated bioavailability of paracetamol and aspirin
A Pharmaceutical company wants to develop and manufacture an oral form with accelerated bioavailability containing paracetamol (300 mg) and aspirin (200 mg).
Taking into account the physicochemical characteristics of these active ingredients, propose and justify a formulation, a choice of excipients, a method of manufacture, and control procedures for this drug.
• To increase the challenge and make your dosage form more interesting you will aim for a secondary objective which is to deliver the API without the need to take water, such formulations are called fast dissolving dosage forms (FDDFs) also known as the novel drug delivery system.
- Fast dissolving tablets (FDTs), also known as oral disintegrating tablets (ODT)
- Fast dissolving films (FDFs), also known as oral strip technology (OST)
- Fast dissolving granules (FDGs), also known as oral dissolving granules (ODG)
• Make a comparison between FDDF (ODT and ODG) and Effervescent tablets, then explain why ODG is the best dosage form for your case.
You will take care, in particular, to identify the characters and the physicochemical properties critical in the course of these operations.
Your entire study will be constantly guided by a concern for quality and must therefore take into account the requirements of Quality Assurance based on the application of Standards, Good Laboratory Practices and Good Manufacturing Practices.