Tafluprost is a prostaglandin F2α analog used in the treatment of open-angle glaucoma and ocular hypertension. It reduces intraocular pressure (IOP) by increasing uveoscleral outflow of aqueous humor. Tafluprost is notable for being available in a preservative-free ophthalmic formulation, making it suitable for patients with sensitivity to preservatives like benzalkonium chloride.
It is administered as an eye drop, typically once daily in the evening.
Indications include:
∙ Open-angle glaucoma
∙ Ocular hypertension (especially in patients intolerant to preservatives)
Due to its complex esterified structure and sensitivity to hydrolysis and oxidation, tafluprost is prone to various impurities during synthesis, formulation, and storage. Impurity control is critical due to its low-dose ophthalmic application, as per ICH Q3A/B, USP, and EP guidelines.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Photostability and forced degradation testing – for formulation robustness
Tafluprost is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension, especially those who are sensitive to preservatives.
It is a prostaglandin analog that increases uveoscleral outflow, thereby reducing intraocular pressure.
Tafluprost is comparable in efficacy to other agents like latanoprost but is often preferred for patients who require a preservative-free formulation.
Tafluprost is sensitive to light, heat, and moisture. It should be stored in the original container, protected from light, and refrigerated before opening. After opening, it is typically stable at room temperature for a defined period.