Abstract:
Background/Objectives: Factors including storage condition and mode of transport can be challenged to
the quality of medicines. In Sri Lankan public hospitals due to not having air-conditioned stores
medicines that should be stored under 25°C are exposing to high temperatures. This study aimed to
investigate the impact of storage conditions of amoxicillin capsules and famotidine tablets in Sri Lankan
public hospitals towards their stability.
Methods: Samples of amoxicillin BP 250mg capsules and famotidine USP 20mg tablets were collected
from six public hospitals in Matara District. Identical stability samples were obtained from manufacturer
as standards which were stored at temperature 30°C+ /-2, relative humidity 75% in the manufacturer's
facility. According to BP/USP specifications samples were subjected to quality assurance tests including
weight variation, disintegration, dissolution and assay. Friability and hardness tests were performed only
for famotidine tablets. All the tests were conducted twice.
Results: Two hospitals had air-conditioned drug stores. All the samples and standards had a 100%
compliance with BP/ USP specifications. There was no significant difference between hospital and
stability samples for each assay and disintegration results (independent t test, p<0.05). Two hospitals
showed significant difference in dissolution test results compared to stability samples but according to
mean difference ( MD) between hospital and stability sample, hospital sample had better dissolution
profile compared to stability sample (p=0.010, MD= 4.344, p=0.003, MD=3.594).
Conclusions: The results of this study indicate that quality of amoxicillin and famotidine medicines in
the hospitals in Matara District were in line with the BP/USP specifications despite of resource limited
storage condition specifically absence of air-conditioning in the tropical warm weather.
