REVIEW JURNAL: EVALUASI UJI STABILITAS SEDIAAN CAIR ORAL

Authors

  • Wima Triana Universitas Muhammadiyah Banjarmasin, Barito Kuala, Kalimantan Selatan
  • Alfia Mujahra Universitas Muhammadiyah Banjarmasin, Barito Kuala, Kalimantan Selatan
  • Nor Latifah Universitas Muhammadiyah Banjarmasin, Barito Kuala, Kalimantan Selatan

Keywords:

Sediaan Cair Oral, Uji Stabilitas, Evaluasi Sediaan Cair, Quality by Design (QbD), Eksipien Farmasi

Abstract

Sediaan cair oral banyak digunakan dalam praktik farmasi karena kemudahan pemberian dan penerimaannya, terutama pada populasi pediatrik dan geriatri. Namun, kestabilan fisik, kimia, dan mikrobiologis sediaan ini sangat rentan terganggu oleh kondisi penyimpanan dan formulasi yang tidak optimal. Kajian ini bertujuan untuk mengevaluasi secara sistematis uji stabilitas sediaan cair oral berdasarkan studi literatur terkini dalam rentang 2018–2024. Metode yang digunakan adalah kajian pustaka terhadap jurnal ilmiah, pedoman ICH, serta laporan WHO dan BPOM. Hasil kajian menunjukkan bahwa penggunaan eksipien yang tepat, pemilihan kemasan pelindung seperti botol kaca amber, serta penerapan metode uji stabilitas jangka panjang dan dipercepat sangat menentukan mutu dan umur simpan sediaan. Selain itu, pemantauan parameter seperti viskositas, pH, potensi zat aktif, dan kontaminasi mikrobiologis merupakan langkah penting untuk menjamin kualitas produk. Penelitian ini menekankan pentingnya pendekatan Quality by Design (QbD) dan validasi metode analitik sebagai dasar pengembangan formulasi yang aman dan stabil. Kesimpulannya, strategi stabilisasi berbasis bukti sangat krusial dalam memastikan efektivitas dan keamanan sediaan cair oral di berbagai kondisi penyimpanan.

References

Attebäck, M., Hedin, B., and Mattsson, S. “Formulation Optimization of Extemporaneous Oral Liquids Containing Naloxone and Propranolol for Pediatric Use.” Scientia Pharmaceutica 90, no. 1 (2022): 15.

Belayneh, A., and Tessema, A. G. “A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations.” Pediatric Health, Medicine and Therapeutics 12 (2021): 93–105.

Boscolo, O., Perra, F., Salvo, L., Buontempo, F., and Lucangioli, S. “Formulation and Stability Study of Omeprazole Oral Liquid Suspension for Pediatric Patients.” Hospital Pharmacy 55, no. 4 (2020): 1–8.

Carpentier, T., Maillard, E., Royer, M., and Marçon, F. “Antimicrobial Preservation Efficacy of Liquid Glucose and Maltitol Syrups with and without 0.1% Sorbic Acid.” Pharmaceutical Technology in Hospital Pharmacy 6, no. 1 (2021): 3–9.

Carpentier, T., Maillard, E., Royer, M., and Marçon, F. “Interactions Between Sorbic Acid, Cosolvents, and pH in Antimicrobial Efficacy of Oral Liquids.” Journal of Pharmaceutical Sciences 108, no. 5 (2019): 1739–1747.

Duralliu, A., Matejtschuk, P., Stickings, P., Hassall, L., Tierney, R., and Williams, D. R. “The Influence of Moisture Content and Temperature on the Long-Term Storage Stability of Freeze-Dried High Concentration Immunoglobulin G (IgG).” Pharmaceutics 12, no. 4 (2020).

Foley, L., et al. “Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension.” Molecules 26, no. 2 (2021): 301.

International Conference on Harmonisation (ICH). Stability Testing of New Drug Substances and Products Q1A(R2): ICH Harmonised Tripartite Guideline. Geneva: ICH, 2003.

Jîtcă, C. M., Jîtcă, G., Ősz, B. E., Pușcaș, A., and Imre, S. “Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review.” Pharmaceutics 15, no. 1 (2023): 235.

Lingertat-Walsh, K., Law, S., and Walker, S. E. “Stability of Extemporaneously Compounded Domperidone 5 mg/mL Suspension in Oral Mix in Plastic and Glass Bottles and Plastic Syringes.” Canadian Journal of Hospital Pharmacy 71, no. 3 (2018).

Makkad, S., Sheikh, M., Shende, S., and Jirvankar, P. “Pharmaceutical Excipients: Functions, Selection Criteria, and Emerging Trends.” International Journal of Pharmaceutical Investigation 15, no. 2 (2025): 361–376.

Mansourian, M., Dijkers, E., Silva, C. C. V., and Polonini, H. C. “Compatibility of Commonly Used Active Pharmaceutical Ingredients in a Ready-to-Use Oral Suspending Vehicle.” Pharmaceutics 15, no. 10 (2023).

Murtaza, G., Ahmed Khan, M., Zeb-Un-Nisa, M., and Shafiq, S. “A Review on the Microbial Contamination in the Non-Sterile Pharmaceutical Products.” Pharmaceutical Science and Technology 5, no. 2 (2021): 68.

RSC Pharmaceutics. “Particle-Based Investigation of Excipient Stability under Stress Conditions.” Journal of Pharmaceutical Sciences and Drug Discovery, 2025.

Rouaz, F. A., El Khirat, S., Cherrah, Y., and Alaoui, T. “Potentially Harmful Excipients in Oral Liquid Forms Used in Neonatology and Pediatrics Units.” Pharmaceutics 15, no. 3 (2023): 716.

Santovena, A., Ortega, G., and Zubiaur, M. “Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use.” Pharmaceutics 14, no. 10 (2022): 2117.

Sutriyo, and Nisa, Z. M. “Preparation and Physicochemical Stability of Liquid Oral Dosage Forms Free of Potentially Harmful Excipient Designed for Pediatric Patients.” International Journal of Applied Pharmaceutics 10, no. 5 (2018): 152–157.

Vázquez-Blanco, S., González-Freire, L., Dávila-Pousa, M. C., and Crespo-Diz, C. “pH Determination as a Quality Standard for the Elaboration of Oral Liquid Compounding Formula.” Farmacia Hospitalaria 42, no. 6 (2018): 221–227.

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Published

19-07-2025

How to Cite

Wima Triana, Alfia Mujahra, & Nor Latifah. (2025). REVIEW JURNAL: EVALUASI UJI STABILITAS SEDIAAN CAIR ORAL. Jurnal Cakrawala Ilmiah, 4(11), 1605–1616. Retrieved from https://bajangjournal.com/index.php/JCI/article/view/10810

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