Background: The process of transforming a single formulation into capsule form
requires the mixing of two drugs through grinding/smoothing. There is a possibility
of microbial contamination during the formulation process, especially during the
grinding stage. Therefore, it is necessary to conduct tests on the physical
organoleptic stability, weight uniformity, and dissolution time, as well as microbial
contamination to determine the capsule's stability within its recommended usage
period. Method: Compounded prescription capsules were tested using the total
plate count and mold and yeast count methods. Organoleptic testing was conducted
for 30 days. Weight uniformity testing was performed using an analytical balance,
while dissolution time was measured using a disintegration tester. Results: The
stability test showed that the compounded capsules remained organoleptically
stable during 30 days of storage. The dissolution time results were below the
maximum limit for capsule disintegration, which is ≤ 30 minutes for all
prescriptions. The weight uniformity results for all prescriptions did not exceed
7.5% for a single capsule and 15% for two capsules. Most of the microbial
contamination results met the requirements, not exceeding the maximum limit of
2000 CFU/ml for bacteria and 200 CFU/ml. Conclusion: The compounded capsule
formulation remained stable during 30 days of closed storage, as indicated by
unchanged organoleptic properties, dissolution time, microbial contamination, and
weight uniformity meeting the requirements.