See the DrugPatentWatch profile for tigecycline
Excipients, often referred to as "inactive ingredients," play a crucial role in pharmaceutical formulations, including antibiotics like tigecycline. They contribute to the drug's stability, solubility, and overall effectiveness. However, changes in excipients can potentially impact tigecycline's potency.
Tigecycline, a broad-spectrum antibiotic, is used to treat various bacterial infections. Its formulation often includes excipients such as mannitol, sodium citrate, and hydrochloric acid [1]. These ingredients help maintain the drug's stability and solubility, ensuring it can be effectively administered and absorbed by the body.
Changes in excipients can affect tigecycline's potency in several ways. For instance, a different excipient may alter the drug's solubility or stability, affecting its absorption rate and, consequently, its potency. Moreover, certain excipients may interact with the active ingredient, tigecycline, reducing its effectiveness [2].
However, it's important to note that changes in excipients are typically subject to rigorous testing and regulatory approval. The U.S. Food and Drug Administration (FDA) requires that any changes to a drug's formulation, including excipients, undergo thorough testing to ensure safety and efficacy [3].
In conclusion, while changes in excipients can potentially affect tigecycline's potency, these changes are carefully regulated and tested to minimize any negative impact on the drug's effectiveness.
Sources:
[1] "Tigecycline." MedlinePlus, U.S. National Library of Medicine, medlineplus.gov/druginfo/meds/a607045.html.
[2] "Excipients." World Health Organization, who.int/medicines/areas/quality_safety/quality_assurance/excipients/en/.
[3] "Changes to Approved NDAs and ANDAs." U.S. Food and Drug Administration, www.fda.gov/drugs/development-approval-process-drugs/changes-approved-ndas-and-andas.