ABSTRACT:
The objective of this study was to compare the physical parameters of uncoated Telmisartan tablets in strip, blister and alu-alu packages under prescribed storage conditions by the manufacturer. The strip, blister and alu-alu packaging of same drug of same formulation (uncoated tablets of three different brands) were procured randomly from the pharmacy outlets. These tablets were evaluated for their physical parameters like appearance, hardness, weight variation, disintegration time and friability. After comparing the results obtained, it was observed that the tablets in alu-alu packaging material had failed with respect to physical parameters like the hardness and friability as compared to those tablets packed in blister and strip. The physical tests were performed again after 3 months to validate the study and it was observed that, tablets packed in alu-alu still failed both the tests. So we can conclude that the formulation development and production aspects of the dosage form have to be kept in mind along with the quality of primary packaging material. Hence physical stability of a formulation not only depends on the primary packaging material selected, but also on the good developmental process and standards/controls during production in line with current Good Manufacturing Practices followed during manufacturing. To reconfirm our findings, the study was also performed on one more brand of similar dosage form containing the same medicament with the same packaging (alu-alu) wherein it passed all these tests. Finally it can be concluded that, the use of a high quality primary packaging material alone would not be enough to protect the dosage form if the formulation development doesn’t meet the required standards during manufacturing activity.