MODERN TECHNOLOGIES FOR THE PRODUCTION OF SOFT PHARMACEUTICAL DOSAGE FORMS

Abstract

Soft pharmaceutical dosage forms are an important group of medicines used for topical, local, and, in selected cases, systemic drug delivery. Creams, ointments, gels, pastes, and related semisolid systems combine the advantages of direct application with the ability to modify drug release, improve residence time, and influence drug penetration through biological barriers. Modern pharmaceutical technology has moved beyond traditional mixing and fusion methods toward rational formulation design, advanced rheological characterization, nanocarrier incorporation, controlled-release systems, and Quality by Design approaches. This article reviews contemporary technologies used in the production and development of soft pharmaceutical dosage forms, focusing on formulation principles, excipient selection, manufacturing methods, emulsion systems, gels, oleogels, nano-enabled semisolids, process control, quality evaluation, stability, and future perspectives. Particular attention is given to the relationship between microstructure and product performance. Modern analytical methods such as rheology, microscopy, spectroscopy, particle-size analysis, and in vitro release testing can improve understanding and control of semisolid products. The application of Quality by Design and risk-based development can further improve robustness, scalability, and reproducibility. Despite significant progress, challenges remain in physical and chemical stability, scale-up, bioequivalence, patient acceptability, and regulatory evaluation. Continued integration of formulation science, advanced manufacturing, and analytical technology is expected to support the development of safer, more effective, and patient-oriented soft pharmaceutical dosage forms.