Abstract:
Background: Ensuring the stability of pharmaceutical repackaged products is critical, especially
in medications, that have the potential degradation against light and oxygen, like chlorpromazine
(CPZ). This study may contribute to preserving the stability of repacked CPZ tablets throughout
the intended period by evaluating commonly used repackaging materials in Sri Lanka.
Objective: To evaluate the impact of different repackaging materials on the stability of
chlorpromazine hydrochloride tablets over a one-month period
Methods: Randomly selected baseline sample (BLS) tablets from an unopened container were
subjected to test the weight variation, hardness, friability, disintegration, dissolution, and assay
according to British Pharmacopeia (BP) 2022 at the point of collection. Then eight out of ten
samples from the remaining tablets were repacked pairwise with an amber-colored glass bottle
(B2, C2), Low-Density Polyethylene (LDPE) bag (B3, C3), paper bag (B4, C4), and Dose
Administration Aid (DAA) (B5, C5). The other two samples were stored in the original container
(B1, C1) to use as control samples (CS). All samples were stored for 30 days below 30℃. After 15
days (B series) and 30 days (C series), the same tests were performed. Results were analyzed by
independent sample t-test using SPSS version 25.0.
Results: All the samples complied with the BP, except the hardness test for B4 and C4. B1 and C1
have not shown any significant difference compared to the BLS. B3 and C3 gave significantly
different results for the tests carried out except for the hardness test compared to the BLS. B5
showed a significant difference in the dissolution test (p=0.043) and C5 in the disintegration
(p<0.001) and dissolution tests (p<0.001) compared to the BLS. B2 did not show significant
differences for the tests compared to the BLS or CS. C2 exhibited a significant difference in the
dissolution test (p=0.001) when compared to the BLS and also in both the dissolution test
(p=0.010) and assay (p=0.017) when compared to the CS.
Conclusion: Repackaging materials have a discernible impact on the stability of CPZ. However,
when stored at temperatures below 30°C for 30 days, they can retain and release the active
ingredient within the acceptable range.
