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All Journal Bandung Conference Series: Pharmacy
Fitrianti Darusman
Prodi Farmasi, Fakultas Farmasi dan Sains, Universitas Islam Bandung, Indonesia
Chemistry Medicine & Pharmacology Public Health

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Kajian Metode Top Down dalam Pembuatan Nanokristal Obat Antidiabetika Oral Nina Renata; Fitrianti Darusman; Hanifa Rahma
Bandung Conference Series: Pharmacy 501 - 508
Publisher : UNISBA Press

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.29313/bcsp.v6i2.25145

Abstract

Abstract. Type 2 diabetes mellitus remains one of the most prevalent non-communicable diseases in Indonesia, and most first-line oral antidiabetic agents such as glibenclamide, glimepiride, and gliclazide belong to Biopharmaceutics Classification System (BCS) class II, characterized by poor aqueous solubility and consequently limited and variable oral bioavailability. Nanocrystal technology has emerged as a practical formulation strategy to overcome this limitation by reducing drug particle size to the nanometer range, thereby increasing the surface area available for dissolution. This article aims to review top-down methods used to produce nanocrystals of oral antidiabetic drugs through a literature review approach. Sources were obtained from international scientific databases, including PubMed, ScienceDirect, and MDPI, focusing on publications from the last ten years. The review shows that wet media milling and high-pressure homogenization are the most widely applied top-down techniques, either alone or combined with cocrystallization to form nano-cocrystals. Each method has distinct mechanisms, critical process parameters, and stabilizer requirements that determine the final particle size and dissolution performance. Overall, top-down nanocrystallization offers a scalable and solvent-minimal approach for improving the solubility, dissolution rate, and potential bioavailability of poorly soluble oral antidiabetic drugs. Abstract. Type 2 diabetes mellitus remains one of the most prevalent non-communicable diseases in Indonesia, and most first-line oral antidiabetic agents such as glibenclamide, glimepiride, and gliclazide belong to Biopharmaceutics Classification System (BCS) class II, characterized by poor aqueous solubility and consequently limited and variable oral bioavailability. Nanocrystal technology has emerged as a practical formulation strategy to overcome this limitation by reducing drug particle size to the nanometer range, thereby increasing the surface area available for dissolution. This article aims to review top-down methods used to produce nanocrystals of oral antidiabetic drugs through a literature review approach. Sources were obtained from international scientific databases, including PubMed, ScienceDirect, and MDPI, focusing on publications from the last ten years. The review shows that wet media milling and high-pressure homogenization are the most widely applied top-down techniques, either alone or combined with cocrystallization to form nano-cocrystals. Each method has distinct mechanisms, critical process parameters, and stabilizer requirements that determine the final particle size and dissolution performance. Overall, top-down nanocrystallization offers a scalable and solvent-minimal approach for improving the solubility, dissolution rate, and potential bioavailability of poorly soluble oral antidiabetic drugs. Abstrak. . Diabetes melitus tipe 2 masih menjadi salah satu penyakit tidak menular dengan prevalensi tertinggi di Indonesia, dan sebagian besar obat antidiabetika oral lini pertama seperti glibenklamid, glimepirid, dan gliklazid termasuk ke dalam Biopharmaceutics Classification System (BCS) kelas II yang memiliki kelarutan dalam air rendah sehingga bioavailabilitas oralnya terbatas dan bervariasi. Teknologi nanokristal menjadi salah satu strategi formulasi yang banyak dikembangkan untuk mengatasi keterbatasan tersebut dengan mengecilkan ukuran partikel obat hingga skala nanometer sehingga luas permukaan yang tersedia untuk disolusi meningkat. Artikel ini bertujuan untuk mengkaji metode-metode top-down yang digunakan dalam pembuatan nanokristal obat antidiabetika oral melalui pendekatan studi literatur. Sumber pustaka diperoleh dari basis data ilmiah internasional seperti PubMed, ScienceDirect, dan MDPI dengan fokus pada publikasi sepuluh tahun terakhir. Hasil kajian menunjukkan bahwa wet media milling dan high pressure homogenization merupakan teknik top-down yang paling banyak diterapkan, baik secara tunggal maupun dikombinasikan dengan pendekatan kokristalisasi untuk membentuk nano-kokristal. Setiap metode memiliki mekanisme, parameter proses kritis, dan kebutuhan stabilizer yang berbeda, yang menentukan ukuran partikel akhir serta kinerja disolusinya. Secara keseluruhan, nanokristalisasi top-down menawarkan pendekatan yang scalable dan minim pelarut untuk meningkatkan kelarutan, laju disolusi, dan potensi bioavailabilitas obat antidiabetika oral yang sukar larut.
Kajian Metode Bottom-Up pada Pembuatan Nanokristal Obat Antidiabetika Oral BCS Kelas II Santy Juliarti; Fitrianti Darusman; Hanifa Rahma
Bandung Conference Series: Pharmacy 527 - 534
Publisher : UNISBA Press

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.29313/bcsp.v6i2.25164

Abstract

Abstract. Oral antidiabetic drugs included in the Biopharmaceutics Classification System (BCS) class II have high permeability but low solubility, thus limiting the dissolution rate and oral bioavailability. One approach developed to overcome this problem is nanocrystal technology using the bottom-up method. This study aims to assess the effectiveness of the bottom-up method in the manufacture of nanocrystals of oral antidiabetic drugs BCS class II in improving physicochemical characteristics. This study was conducted using a literature review method of scientific articles obtained through Google Scholar, ResearchGate, and other scientific sources. Data were analyzed descriptively and presented in narrative form. The results of the study indicate that the bottom-up method is able to produce nanocrystals measuring less than 1000 nm, thereby increasing the specific surface area of ​​the particles, which has an impact on increasing solubility, dissolution rate, and potentially increasing oral bioavailability. The sonication-precipitation method is the most widely used method because it produces smaller particle sizes, a more homogeneous size distribution, and better stability. The success of this method is influenced by the selection of solvents, antisolvents, stabilizers, and process parameters. Thus, the bottom-up method is an effective approach in the development of BCS class II oral antidiabetic drug nanocrystals. Abstract. Oral antidiabetic drugs included in the Biopharmaceutics Classification System (BCS) class II have high permeability but low solubility, thus limiting the dissolution rate and oral bioavailability. One approach developed to overcome this problem is nanocrystal technology using the bottom-up method. This study aims to assess the effectiveness of the bottom-up method in the manufacture of nanocrystals of oral antidiabetic drugs BCS class II in improving physicochemical characteristics. This study was conducted using a literature review method of scientific articles obtained through Google Scholar, ResearchGate, and other scientific sources. Data were analyzed descriptively and presented in narrative form. The results of the study indicate that the bottom-up method is able to produce nanocrystals measuring less than 1000 nm, thereby increasing the specific surface area of ​​the particles, which has an impact on increasing solubility, dissolution rate, and potentially increasing oral bioavailability. The sonication-precipitation method is the most widely used method because it produces smaller particle sizes, a more homogeneous size distribution, and better stability. The success of this method is influenced by the selection of solvents, antisolvents, stabilizers, and process parameters. Thus, the bottom-up method is an effective approach in the development of BCS class II oral antidiabetic drug nanocrystals. Abstrak. Obat antidiabetika oral yang termasuk dalam Biopharmaceutics Classification System (BCS) kelas II yang memiliki permeabilitas tinggi, namun kelarutan rendah sehingga membatasi laju disolusi dan bioavailabilitas oral. Salah satu pendekatan yang dikembangkan untuk mengatasi permasalahan tersebut adalah teknologi nanokristal menggunakan metode bottom-up. Penelitian ini bertujuan untuk mengkaji efektivitas metode bottom-up dalam pembuatan nanokristal obat antidiabetika oral BCS kelas II terhadap peningkatan karakteristik fisikokimia. Penelitian ini dilakukan menggunakan metode literature review terhadap artikel ilmiah yang diperoleh melalui Google Scholar, ResearchGate, serta sumber ilmiah lainnya. Data dianalisis secara deskriptif dan disajikan dalam bentuk naratif. Hasil kajian menunjukkan bahwa metode bottom-up mampu menghasilkan nanokristal berukuran kurang dari 1000 nm sehingga mampu meningkatkan luas permukaan spesifik partikel, yang berdampak pada peningkatan kelarutan, laju disolusi, dan berpotensi meningkatkan bioavailabilitas oral. Metode sonikasi–presipitasi merupakan metode yang paling banyak digunakan karena menghasilkan ukuran partikel yang lebih kecil, distribusi ukuran yang lebih homogen, serta stabilitas yang lebih baik. Keberhasilan metode ini dipengaruhi oleh pemilihan pelarut, antisolvent, stabilizer, dan parameter proses. Dengan demikian, metode bottom-up merupakan pendekatan yang efektif dalam pengembangan nanokristal obat antidiabetika oral BCS kelas II.
Co-Authors Hanifa Rahma Nina Renata Santy Juliarti