PENGARUH KOMBINASI BAHAN PELICIN MAGNESIUM STEARAT DAN TALK DALAM PEMBUATAN TABLET GLIMEPIRID DENGAN TEKNIK PENCAMPURAN INTERAKTIF

DOI: https://doi.org/10.31596/cjp.v10i2.419

Ilham Kuncahyo(1*), Siti Aisiyah(2), Shabrina Nindya Hutami(3), RR Sri Wulandari(4)

(1) Universitas Setia Budi Surakarta
(2) Universitas Setia Budi Surakarta
(3) Universitas Setia Budi Surakarta
(4) Universitas Bhakti Husada Mulia Madiun
(*) Corresponding Author

Abstract


Homogeneity is one of the primary challenges in the formulation of tablets containing low-dose drugs such as glimepiride. The interactive mixing technique, in which the drug is adhered to a host carrier, has been developed as an innovative approach to address this issue. One of the essential excipients required in tablet manufacturing is a lubricant. The use of micronized lubricants, namely magnesium stearate and talc, plays a critical role in determining the outcome of the compression process of interactive mixture tablets. This study aimed to investigate the effect of magnesium stearate and talc as lubricants on the physical quality and dissolution behavior of glimepiride interactive mixture tablets. Five formulations were prepared using different proportions of magnesium stearate and talc: F1 (magnesium stearate : talc) = 1,25 : 0,75; F2 = 0,5 : 1,5; F3 = 0,25 : 1,25; F4 = 1,5 : 0,5; and F5 = 1 : 1. The host carrier was prepared by mixing Avicel PH 101 and lactose in a 1:1 ratio, followed by granulation using polyvinylpyrrolidone (PVP) as a binder. The lubricants were then blended with the host particles onto which glimepiride had been adhered, and the mixture was subsequently compressed using the direct compression method. The resulting tablets were evaluated for physical quality parameters, including friability, hardness, disintegration time, and dissolution. The data obtained from each formulation were statistically analyzed using SPSS version 12.0. The results demonstrated that all five formulations met the homogeneity requirements, with coefficient of variation (CV) values of less than 5%. The combination of magnesium stearate and talc significantly affected the physical quality and dissolution behavior of glimepiride interactive mixture tablets. Formula 4, which contained the highest proportion of magnesium stearate and the lowest proportion of talc compared to F1, F2, F3, and F5, produced tablets with greater hardness, reduced friability, prolonged disintegration time, and a slower dissolution rate.

Keywords


Campuran interaktif; Host; Magnesium stearat; Talk; Tablet glimepirid

Full Text:

PDF

Article Metrics

Abstract viewed : 0 times | PDF files downloaded : 0 times

References


Adithya, B. P., Vijayalakshmi, M., Krishna, U. V. R., & Reddy, K. N. (2012). Stability indicating spectrophotometric method for the estimation of glimepiride in bulk and various marketed brands of tablets

Ammar, H. O., Salama, H. A., Ghorab, M., & Mahmoud, A. A. (2006). Formulation and biological evaluation of glimepiride–cyclodextrin–polymer systems. International Journal of Pharmaceutics, 309(1–2), 129–138.

Calahan, J. L., Paul, S., Yanez, E. G., DeNeve, D., Sun, C. C., & Munson, E. J. (2020). The impact of solid state form, water content and surface area of magnesium stearate on lubrication efficiency, tabletability, and dissolution. Pharmaceutical Development and Technology, 26(2), 150–156

Chattoraj, S., Saha, S., & Saha, S. (2019). Evaluation of talc as a lubricant in tablet formulations. Journal of Pharmaceutical Sciences and Research, 11(5), 1234–1240

Departemen Kesehatan Republik Indonesia. (2020). Farmakope Indonesia (Edisi ke-6, Vol. VI). Jakarta: Departemen Kesehatan Republik Indonesia.

Ekambaram, P., & Abdul, H. S. A. (2017). Solid lipid nanoparticles of ramipril improve dissolution and bioavailability. Journal of Young Pharmacists, 9(3), 336–342.

Husni, P., Fadhiilah, M. L., & Hasanah, U. (2020). Formulasi dan uji stabilitas fisik granul instan serbuk kering tangkai genjer (Limnocharis flava (L.) Buchenau.) sebagai suplemen penambah serat. Jurnal Ilmiah Farmasi Farmasyifa, 3(1), 1–8.

Kumar, I., & Verma, S. (2023). Ramipril solid dispersion with PEG/PVP: Enhancement of solubility and dissolution. Journal of Drug Delivery and Therapeutics, 13(1), 35–40.

Kuncahyo, I., & Choiri, S. (2015). The influence of magnesium stearate, purified talc and combination of both on ternary/quaternary interactive mixture of freely and poorly water-soluble drug. [Nama Jurnal], 7(1)

Octavia, M. D., Halim, A., & Indriyani, R. (2020). Pengaruh besar ukuran partikel terhadap sifat–sifat tablet metronidazol. Jurnal Farmasi Higea, 4(2).

Patel, S., Kaushal, A. M., & Bansal, A. K. (2018). Effect of lubricant type and concentration on the flowability of pharmaceutical granules. Pharmaceutical Development and Technology, 23(2), 189–196.

Puckhaber, D., Kwade, A., & Finke, J. H. (2023). Investigation of dispersion kinetics of particulate lubricants and their effect on the mechanical strength of MCC tablets. Pharmaceutical Research, 40(10), 2479–2492

Puspitasari, D., & Kuncahyo, I. (2019). Optimasi proporsi campuran polivinil pirolidon dan Avicel PH 101 dalam formulasi tablet asam mefenamat secara simplex lattice design. Jurnal Farmasi (J. Pharm.), 6(1), 1–5.

Pratiwi, P. D., Citrariana, S., & Gemantari, B. M. (2023). Bahan tambahan dalam sediaan tablet: Review. Sinteza, 3(2), 41–48.

Shahba, A. A. W., Aburahma, M. H., & Mahmoud, A. A. (2020). Self-nanoemulsifying ramipril tablets: A novel delivery system for enhancement of drug dissolution and stability. International Journal of Nanomedicine, 15, 313–328.

Susanti, I. (2019). Review: Pengaruh medium disolusi dan upaya peningkatan permeabilitas metformin. Jurnal Farmasi Indonesia, 17.

Veronica, N., Heng, P. W. S., & Liew, C. V. (2024). Magnesium stearate fatty acid composition, lubrication performance and tablet properties. AAPS PharmSciTech, 25(8), 262.

Zulfa, E., & Prihantini, M. (2019). Formulasi tablet paracetamol dengan bahan pengikat pati umbi gembili (Dioscorea esculenta L). Jurnal Pharmascience, 6(2), 55.




DOI: https://doi.org/10.31596/cjp.v10i2.419

Refbacks

  • There are currently no refbacks.


Journal Indexed by:

Google ScholarGarudaSINTA Dimensions Crossref

Copyright of Cendekia Journal of Pharmacy. ISSN: 2599-2163 (Print) dan 2599-2155 (Online).

Creative Commons License
This work is licensed under a Creative Commons Attribution 2.0 Generic License. Web
Analytics View My Stats