STRATEGI PENINGKATAN STABILITAS BAHAN AKTIF FARMASI: PENDEKATAN DAN INOVASI

Abstrak

farmasi (API) dalam formulasi obat. Strategi seperti ko-kristalisasi, liofilisasi, nanoenkapsulasi, dan dispersipadat amorf digunakan untuk mengatasi tantangan seperti higroskopisitas, degradasi kimia, dan rendahnya bioavailabilitas API. Ko-kristalisasi terbukti efektif mengurangi higroskopisitas dan meningkatkan stabilitas API dengan penggunaan ko-former spesifik. Teknik liofilisasi memanfaatkan eksipien seperti trehalosa untuk meningkatkan stabilitas termal dan kelarutan API termolabil. Nanoenkapsulasi memberikan perlindungan jangka panjang terhadap oksidasi, sementara dispersi padat amorf secara signifikan meningkatkan kelarutan dan disolusi API. Selain itu, metode analisis modern seperti spektroskopi inframerah dekat (NIR) dan difraksi sinar-X memungkinkan pemantauan kualitas API secara real-time. Dengan pendekatan ini, formulasi farmasi yang lebih stabil, efektif, dan aman dapat dikembangkan untuk memenuhi kebutuhan regulasi dan industri.

This research discusses various innovative approaches to improve the stability of active pharmaceutical ingredients (APIs) in drug formulations. Strategies such as co-crystallization, lyophilization, nanoencapsulation, and amorphous dispersions are used to overcome challenges such as hygroscopicity, chemical degradation, and low bioavailability of APIs. Co-crystallization is proven to be effective in reducing hygroscopicity and improving the stability of APIs with the use of specific co-formers. Lyophilization techniques utilize excipients such as trehalose to improve the thermal stability and solubility of thermolabile APIs. Nanoencapsulation provides long-term protection against oxidation, while amorphous solid dispersions significantly improve the solubility and dissolution of APIs. In addition, modern analytical methods such as near infrared (NIR) spectroscopy and X-ray diffraction enable real-time monitoring of API quality. With this approach, more stable, effective and safe pharmaceutical formulations can be developed to meet regulatory and industry needs formulation strategies are essential for creating stable and effective pharmaceutical products.