Mini Review on the Lyophilization: A Basic Requirement for Formulation Development and Stability Modifier.
Assay and drug development technologies（2025）
Department of Pharmaceutical Quality Assurance | Department of Pharmaceutics | Department of Pharmaceutical Chemistry
Abstract
Freeze-drying is popular for producing pharmaceutical formulations with structurally complicated active components and drug delivery system carriers. It is the process of eliminating water from ice crystals through the sublimation mechanism. Some formulations may require drug-specific excipients such as stabilizers, buffers, and bulking agents to maintain the appearance and assure the long-term stability of the drug product. This approach is utilized for therapeutic compounds that are moisture sensitive, thermolabile, and degrade in the atmosphere. Freezing and primary and secondary drying are critical processes in the lyophilization process because they directly impact the end result. This approach is effective for producing a variety of dosage forms, including oral, inhalation, and parenteral. As a result, lyophilization may be an important method for improving the therapeutic efficacy and delivery of various dosage forms delivered via different routes. Additionally, lyophilization is used in pharmacological research to preserve biological samples, stabilize reference/standards, and increase the solubility and bioavailability of poorly soluble drugs. Thus, lyophilization is critical for maintaining the stability, efficacy, and safety of pharmaceutical products throughout their development and lifecycles. This article includes a broad overview of the lyophilization process, principle, excipients for lyophilized medicine compositions, and new lyophilization technologies as well as their applications in a variety of fields.
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