New Therapeutic Approach for Delivering a Combination of Antibiotic IT Assignment Help

Assignment Task

Task
Based on preliminary in vitro cell data, your company has secured IP on a new therapeutic approach for delivering a combination of antibiotic (ciprofloxacin, CIP) and steroid (fluticasone FLU) to the nasal cavity for treating chronic rhinosinusitis (where patients have inflammation and associated infection). The target dose is 100/100 µg CIP/FLU per nostril twice daily. As a formulation expert, you have been asked to develop a formulation that can routinely deliver this dose from a 100 µl valve using a conventional nasal spray.
Task
In 1000 +/-10% words, using the Pharmacopeia (BP and/or USP), associated monographs and guidelines available;outline the key development steps that you would undertake to come up with a working nasal formulation (take into account the desired formulation (API and excipients), effect of physicochemical properties, required container closure system, manufacturing processes, stability considerations, nasal environment etc),outline the analytical procedures and testing methodology you would use/develop,outline the product/methodological specifications you would set (from Pharmacopoeia nasal spray preparations), and give an example of your proposed/suggested final formulation (e.g. what excipients are you using).

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