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PENANGANAN PERMASALAHAN SIFAT HIGROSKOPIS PADA FORMULASI SEDIAAN TABLET Ratih, Hestiary; Gosepa, Oke Setiawan
Kartika : Jurnal Ilmiah Farmasi Vol 9 No 2 (2024)
Publisher : Fakultas Farmasi Universitas Jenderal Achmad Yani, Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.26874/kjif.v9i2.728

Abstract

Sebagian besar bahan aktif farmasi (BAF) bersifat sangat higroskopis dalam bentuk padatan. Higroskopisitas yang tinggi dapat menimbulkan beberapa permasalahan antara lain terjadinya perubahan sifat fisikokimia pada bahan aktif.  Perubahan sifat fisiko kimia tersebut dapat berdampak pada usia simpan sediaan tablet sehingga menjadi lebih singkat. Kajian literatur ini bertujuan untuk memberikan informasi mengenai penanganan pada proses produksi sediaan tablet yang memiliki sifat padatan bahan baku higroskopis. Metode penyusunan kajian literatur ini bersumber dari 42 artikel yang berasal dari artikel jurnal nasional maupun internasional yang telah terbit pada sepuluh tahun terakhir (2014-2024), artikel yang terkumpul dilakukan seleksi dan identifikasi berdasarkan kriteria inklusi dan eksklusi. Hasil kajian penelusuran pustaka terkait dengan upaya yang dapat dilakukan dalam penanganan permasalahan sifat higroskopis padatan farmasi pada formulasi sediaan tablet, antara lain yaitu, dengan teknik penyalutan film, teknik enkapsulasi (dengan spray-drying/freeze-drying dan koaservasi kompleks), teknik ko-proses (co-process), dan rekayasa kristal (co-crystal). Berdasarkan kajian literatur yang telah dilakukan dapat disimpulkan bahwa beberapa teknik dalam memodifikasi sifat fisik bahan aktif farmasi pada formulasi sediaan tablet dapat menangani permasalahan sifat higroskopis bahan aktif dengan meningkatkan pengendalian higroskopisitas suatu padatan sehingga dapat meningkatkan stabilitas bahan aktif. Kata kunci:  Formulasi, higroskopis, penanganan, sediaan, tablet.   Abstract The majority of active pharmaceutical ingredients (API) are highly hygroscopic in solid form. High hygroscopicity can cause several problems, including changes in the physicochemical properties of active ingredients which can cause difficulties in formulating a preparation such as tablets, so that this can affect the shelf life of tablet preparations which become shorter. This literature review aims to find out the formulation handling in the production process of tablet preparations that have the characteristics of highly hygroscopic solids. The method of preparing this literature review comes from 42 articles originating from national and international journal articles that have been published in the last ten years (2014 - 2024), the collected articles were selected and identified based on the inclusion and exclusion criteria. The results of the literature search review related to efforts that can be made in handling the problem of hygroscopic properties of pharmaceutical solids in tablet dosage formulations, including film coating techniques, encapsulation techniques (by spray-drying/freeze-drying and complex coacervation), co-process techniques, and crystal engineering (co-crystal). Based on the literature review that has been conducted, it can be concluded that several techniques in modifying the physical properties of active pharmaceutical ingredients in tablet formulations can handle the problem of the hygroscopic nature of active ingredients by increasing the control of hygroscopicity of a solid so as to increase the stability of active ingredients. Keywords: Formulation, hygroscopic, handling, preparation, tablets.  
Formulation Strategy to Prevent Sticking in Calcium Carbonate–Cholecalciferol Chewable Tablets: The Role of Citric Acid Ratih, Hestiary; Gosepa, Oke Setiawan; Alatas, Fikri; Sutarna, Titta Hartyana
JURNAL INFO KESEHATAN Vol 24 No 1 (2026): JURNAL INFO KESEHATAN
Publisher : Research and Community Service Unit, Poltekkes Kemenkes Kupang

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.31965/infokes.Vol24.Iss1.2325

Abstract

The sticking phenomenon is a critical issue in the production of calcium carbonate–cholecalciferol (vitamin D3) chewable tablets, primarily driven by the hygroscopicity and reactivity of citric acid, which is used as a flavor-masking agent. This study aims to evaluate and determine the optimal method for mitigating sticking by modifying citric acid excipients using two approaches: granulation with mannitol (F1: 0.5%, F2: 1%) and coating with HPMC (F3: 0.5%, F4: 1%). The evaluation was conducted on the properties of the granule mass and quantitatively measured the percentage of sticking in industrial-scale modifications for 24 hours. The results showed that the control formula (F0), without modification, had the lowest sticking percentage (10.88%) and the highest moisture content (3.36%), as indicated by a "passable" flow property with a compressibility index of 21.47%. The 1% HPMC coating modification method (F4) was successful in eliminating stickiness to 0%, supported by moisture-control data (2.25%) and a significant improvement in powder-flow properties to “fair,” with a compressibility index of 17.06%. Although the 1% mannitol granulation method (F2) is relatively effective in reducing stickiness (0.85%), the 1% HPMC coating (F4) is more effective at physically isolating citric acid. This study concludes that the HPMC coating method is superior to the granulation method for physically isolating citric acid, yielding stable, non-sticking calcium carbonate–cholecalciferol chewable tablets.