Example: Ciprofloxacin - DRAFT

Disclaimer

This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.

Introduction

Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic that is used to treat a wide range of bacterial infections. The Novartis drug Ciloxan is available as a 0.3% w/w* ciprofloxacin ointment (3 mg ciprofloxacin base in 1g of ointment). As ciprofloxacin is insoluble in water, it is dissolved in dilute hydrochloric acid giving rise to ciprofloxacin hydrochloride monohydrate. In this example, Ciprofloxacin is the reference substance for ciprofloxacin hydrochloride.

NOTE: In the context of this product, the hydrate of ciprofloxacin is not modeled into the ontology. It can be another substance that could be used as a reference. However, it might need to be modeled in the case of another product that does not use the monohydrate derivative.

*3 mg = 0.003g, thus 0,003g of ciprofloxacin in 1g of ointment is equivalent to a 0.3% w/w ciprofloxacin ointment

**Number of moles = amount of substance (g)/ molecular weight (g/mol) = 0.003g/331g/mol = 9.06 x 10(-6) moles

***As 1 molecule of ciprofloxacin hydrochloride monohydrate gives rise to 1 molecule of ciprofloxacin hydrochloride which give rise to 1 molecule of ciprofloxacin, the moles of substance for ciprofloxacin hydrochloride and ciprofloxacin hydrochloride monohydrate are the same as for ciprofloxacin