PENANGANAN PERMASALAHAN SIFAT HIGROSKOPIS PADA FORMULASI SEDIAAN TABLET
Isi Artikel Utama
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.
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