ABSTRACT
Background: The procurement costs of medicines are lowered by bulk purchasing and repackaging in multi-dose wrappers during dispensing. Repacking involves the transfer of medicines from the manufacturers’ primary packs and packaging in other storage containers/materials. These packaging materials might not guarantee the same level of stability compared to the manufacturer's original package.
Objective: This study aimed to assess the chemical and physical stability of propranolol hydrochloride 40 mg tablets repacked in plastic multi-dose packages and amber-colored glass containers.
Method: A sample of 1000 tablets of propranolol hydrochloride 40 mg was obtained from a semi-government pharmacy with the same lot number. The physical and chemical stability of the propranolol tablets, repackaged in plastic multi-dose packages and amber-colored glass containers was evaluated after 30 days of storage at optimum storage conditions (pharmacy condition 20.0 0C – 26.2 0C; RH 57% - 64%) and extreme storage conditions (home conditions 27.3 0C – 46.5 0C; RH 50% - 79%). The changes in appearance, assay, disintegration, friability, and weight variation were examined following British Pharmacopeia 2020 specifications.
Results: All repackaged samples stored in both home and pharmacy conditions for 30 days confirmed chemical stability by assay test and physical stability by weight uniformity, friability, and disintegration tests. The propranolol tablet sample which was repackaged in multi-dose plastic packages and stored in simulated home conditions showed discoloration of tablet surfaces after 7 days of storage. In-home storage conditions, propranolol tablets in amber-colored glass containers possessed a high percentage of C16H21NO2. HCl content (99.11 ± 0.39%) than in plastic multi-dose packages (96.76 ± 0.51%).
Conclusion: Both storage conditions and repackaging material affect the stability of the propranolol tablets. Therefore, patients should be educated to store repackaged propranolol tablets in the proper storage conditions and to use proper alternative repackage forms such as amber-colored glass containers to store propranolol for a long time.
Keywords: Propranolol hydrochloride, medicine repackaging, medicine stability, storage conditions, tropical countries