Telmisartan Tablets Repackaged into Dose Administration Aids: Physicochemical Stability under Tropical Conditions

Area of Science:

• Pharmaceutical Science
• Drug Stability
• Medication Adherence

Background:

• Dose administration aids (DAAs) improve medication adherence for chronic disease patients.
• Telmisartan, a common hypertension medication, is available in various brands in Australia.
• Manufacturer guidelines advise keeping telmisartan tablets in blister packs until use.

Purpose of the Study:

• To evaluate the stability of different telmisartan tablet brands when repackaged into DAAs.
• To identify telmisartan brands suitable for repackaging into DAAs for improved patient adherence.
• To assess the impact of excipients on the stability of repackaged telmisartan.

Main Methods:

• Multiple telmisartan brands were repackaged into DAAs and stored at 30°C/75% RH for 28 days.
• Visual inspection and physical testing were used for initial screening.
• A selected brand underwent further physicochemical and photostability testing per pharmacopoeial standards.

Main Results:

• Mizart® telmisartan tablets remained stable after repackaging and storage under simulated tropical conditions (30°C/75% RH for 28 days).
• Several other telmisartan brands exhibited physical instability, rendering them unsuitable for repackaging.
• Excipient composition significantly influenced the stability of repackaged telmisartan tablets.

Conclusions:

• While general repackaging of telmisartan into DAAs is not recommended, Mizart® presents a stable option.
• Pharmacists can consider Mizart® for patients requiring DAAs, ensuring medication integrity.
• This study underscores the importance of evaluating both the active pharmaceutical ingredient and excipients for repackaging suitability.