A Review Stability Studies of Tablet Dosage Forms and Their Influence on Physicochemical Characteristics: A Review

Authors

  • Weka Nabil Ubhayahita Sambarana Universitas Negeri Semarang
  • Aulya Elsa Safitri Universitas Negeri Semarang
  • Hasna Aulia Qisthi Universitas Negeri Semarang
  • Faradila Elsa Anggraeni Universitas Negeri Semarang
  • Juanita Mulia Mahbubah Universitas Negeri Semarang
  • Salzha Noor Fajrina Febrianti Universitas Negeri Semarang
  • Delta Happy Friantina Universitas Negeri Semarang
  • Sabrina Maharani Universitas Negeri Semarang

DOI:

https://doi.org/10.37287/ijghr.v8i2.1811

Keywords:

excipient compatibility, physicochemical stability, stability studies, tablet stability

Abstract

Tablet dosage forms generally exhibit better stability compared to liquid formulations; however, stability testing remains essential to evaluate both physical and chemical parameters. This study aimed to compare the stability of tablet formulations under various testing conditions in terms of their physicochemical properties. This study aimed to compare the stability of tablet formulations under various testing conditions in terms of their physical and chemical properties. This study employed a literature review approach. Scientific articles were retrieved from Scopus, ScienceDirect, PubMed, MDPI, Web of Science, and Google Scholar, as well as national databases such as GARUDA and SINTA-indexed journals database using the used keywords such as “tablet,” “formulation,” “optimization,” “stability evaluation,” and “stability studies.” The search covered publications from 2016 to 2026. A total of 2,201 articles were initially identified and then screened based on their relevance to the research topic. The main inclusion criterion was studies focusing on the stability of tablet dosage forms, particularly those evaluating both physical stability (such as hardness, friability, and disintegration time) and chemical stability (including active ingredient content and degradation). Based on these criteria, 8 relevant articles were selected and further analyzed to evaluate the physicochemical stability of tablet formulations. The findings indicate that several tablet formulations experienced deterioration in physical and chemical parameters, including changes in hardness, disintegration time, and decreased active ingredient content. These alterations were primarily associated with changes in excipient properties and interactions with environmental factors such as light exposure and moisture. Furthermore, inappropriate storage conditions contributed to the instability of the formulations. The stability of tablet dosage forms is therefore influenced by both formulation factors and storage conditions. The application of drug–excipient compatibility studies (DECS) and crystallo-co-agglomeration techniques during the formulation stage, along with proper control of temperature and humidity and the use of suitable packaging such as aluminium blisters and silica gel are crucial to maintaining tablet stability during storage.

References

Adullahi, A., Olowosulu, A., & Allagh, T. (2024). Quality Assesment and Stability Studies of Metronidazole Tablets Formulations Obtained via Crystallo Co-Agglomeration Technique. Fudma Journal of Sciences. https://doi.org/10.33003/fjs-2024-0803-2273.

Ahsan, S. F., Sheraz, M. A., Khan, M. F., Anwar, Z., Ahmed, S., & Ahmad, I. (2019). Formulation and stability studies of fast disintegrating tablets of amlodipine besylate. Indian J. Pharm. Educ. Res, 53(3), 480-493.

Bankhele, A. D., Gaikwad, D. A., & Oswal, R. (2022). Accelerated stability testing and evaluation of telmisartan brands: A comparative study. International Journal of Pharmaceutical Research and Applications, 7(4), 1010–1019.

Deshmukh, P.R., Gaikwad, V.L., & Tamane, P.K. (2019). Development of Stability-Indicating HPLC Methode and Accelerated Stability Studies for Osmotic and Pulsatile Tablet Formulatons of Clopidogrel Bisulfate. Journal of Pharmaceutical and Biomedical Analysis, 346–356.

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). (2025). ICH Q1 guideline on stability testing of drug substances and drug products: Step 2b draft version. Geneva: ICH

Maclean, N., Khadra, I., Mann, J., Williams, H., Abbott, A., Mead, H., & Markl, D. (2021). Investigating the role of excipients on the physical stability of directly compressed tablets. International journal of pharmaceutics: X, 4.

Mamgain, T., & Gahtori, A. (2022). Stability testing of new pharmaceutical drug products. Indo American Journal of Pharmaceutical Sciences, 9(2), 199–207.

Natarajan, R., Revathi, S., Sivanantham, K., & Sambathkumar, R. (2023). Formulation, Evaluation and Stability Studies of Paracetamol IR Tablets. 11(2), 159–175.

Othman, A. M., Alburyhi, M. M., & Al-Ahad, G. H. (2025). Formulation and Stability Studies Evaluation of the Selected Captopril Mouth Dissolving Tablet MDTs. World Journal of Pharmaceutical and Medical Research, 11(11): 275-284.

Tanujaya, D., & Riniwasih, L. (2019). Formulation and Physical Stability Test of Effervescent Tablets Containing Lactobacillus bulgaricus Probiotic Bacteria Using the Wet Method. Indonesia Natural Research Pharmaceutical Journal, 4(2), 101–112.

Yulianita, R., Sopyan, I., Gazzali, A. M., & Muchtaridi, M. (2021). A Novel Stability Study of Simvastatin Generic Tablet in Public Pharmacy Facilities of Purwakarta, Indonesia. Indonesian Journal of Pharmacy/Majalah Farmasi Indonesia, 32(4).

Downloads

Published

2026-04-14

How to Cite

Sambarana, W. N. U., Safitri, A. E., Qisthi, H. A., Anggraeni, F. E., Mahbubah, J. M., Febrianti, S. N. F., … Maharani, S. (2026). A Review Stability Studies of Tablet Dosage Forms and Their Influence on Physicochemical Characteristics: A Review. Indonesian Journal of Global Health Research, 8(2), 1131–1136. https://doi.org/10.37287/ijghr.v8i2.1811

Similar Articles

<< < 4 5 6 7 8 9 10 > >> 

You may also start an advanced similarity search for this article.