The prevalence of active pharmaceutical ingredients (APIs) with low water solubility has experienced a significant increase in recent years. These APIs present challenges in formulation, particularly for oral dosage forms, despite their considerable therapeutic potential. Therefore, the improvement of solubility has become a major concern for pharmaceutical enterprises to increase the bioavailability of APIs. A promising formulation approach that can effectively improve the dissolution profile and the bioavailability of poorly water-soluble drugs is the utilization of amorphous systems. Numerous formulation methods have been developed to enhance poorly water-soluble drugs through amorphization systems, including co-amorphous formulations, amorphous solid dispersions (ASDs), and the use of mesoporous silica as a carrier. Furthermore, the successful enhancement of certain drugs with poor aqueous solubility through amorphization has led to their incorporation into various commercially available preparations, such as ASDs, where the crystalline structure of APIs is transformed into an amorphous state within a hydrophilic matrix. A novel approach, known as ternary solid dispersions (TSDs), has emerged to address the solubility and bioavailability challenges associated with amorphous drugs. Meanwhile, the introduction of a third component in the ASD and co-amorphous systems has demonstrated the potential to improve performance in terms of solubility, physical stability, and processability. This comprehensive review discusses the preparation and characterization of poorly water-soluble drugs in ternary solid dispersions and their mechanisms of drug release and physical stability.

The pharmaceutical industry operates under a strict regulatory framework to ensure that the products produced are safe, of high quality, and effective. These regulations are continuously updated to keep up with advancements in science, technological developments, and global demands for higher quality standards. The pharmaceutical industry also faces the challenge of global regulatory harmonization, such as standards set by WHO and PIC/S. These regulations are designed to ensure drug quality from development to distribution. Changes in Good Manufacturing Practices (GMP) regulations are crucial for improving pharmaceutical production quality in Indonesia. This study aims to conduct a gap analysis between the 2018 GMP and the draft 2024 GMP Annex 1, particularly in terms of equipment, supporting facilities, and personnel. The method used is a comparative analysis by comparing the provisions of the 2018 GMP with the draft 2024 GMP. The gap analysis results between the 2018 GMP and the draft 2024 GMP Annex 1 in terms of equipment, supporting facilities, personnel, and sterile product completion indicate significant changes in the adopted standards. The proposed 2024 GMP revision introduces substantial improvements in sterile product manufacturing standards. As part of efforts to enhance global competitiveness, the Indonesian pharmaceutical industry must continue to adapt to dynamic technological and regulatory changes. By implementing various strategies—including substantial investments in modern equipment, adjustments to supporting facilities, and capacity building for personnel—the Indonesian pharmaceutical industry can meet global standards while ensuring the availability of safe, high-quality, and effective sterile products for the public.