Pharmaceutical Solid Forms: From Crystal Structure to Formulation
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".
Deadline for manuscript submissions: 30 June 2024 | Viewed by 3801
Special Issue Editor
Interests: pharmaceutical compound; solid state; relative stability; phase diagrams; thermodynamics; thermal analyses
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
Before it becomes beneficial for the patient, a drug must go through several phases of development. Its final formulation, where the active ingredient is mixed with the other components (excipients), must take into account various factors, such as its solid state, pH, solubility, etc. Indeed, in the solid state, the active ingredient can exist in different forms: anhydrous or solvated crystalline, non-crystalline (amorphous), or even in the form of salts or, more rarely, in the form of co-crystals. It should be remembered that more than 80% of drugs exist in solid form and that almost all of the active ingredients are solid in the raw material state. The solid form may affect the chemical and physical properties of the drug, mostly physical and/or chemical stability (including pharmaceutical operations), solubility, bioavailability, etc. Consequently, the identification and control of the API solid form in the final drug must be ensured throughout the development, including final packaging. Indeed, the active substance may interact physically or chemically with the excipients, or with the container, which may modify its activity.
For stability reasons, it is always preferable to formulate a drug from its most stable solid form. Relative stability is assessed based on various parameters, such as temperature, pressure, water content, pH, etc. However, due to insufficient bioavailability, it may be necessary to formulate a less stable solid form. It will then be necessary to seek to stabilize this metastable form using the right excipients. The physical properties of the active ingredient, and then its crystal structure, have to be characterized using various techniques (X-ray powder diffraction, thermal analyses, etc.) to determine which solid form will be formulated.
Dr. Philippe Espeau
Guest Editor
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Keywords
- solid state
- characterization techniques
- polymorphism
- solvates
- hydrates
- preformulation
- drug stability
