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Polymorphism is the ability of solid materials to exist in two or more crystalline forms with different arrangements or conformations of the constituents in the crystal lattice. Polymorphic forms of a drug substance can have different chemical and physical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapor pressure and density. These properties can directly affect the ability to process and/or manufacture drug substance and drug product, as well as affect the stability, dissolution and bioavailability of drug product. Thus, polymorphism can affect the quality, safety, and efficacy of the drug product.
As a leading global pharmaceutical analysis services company, Alfa Chemistry provides polymorphic characterization and other preformulation analysis services. Alfa Chemistry is the perfect partner for bringing expertise, flexibility, and reliability to your pharmaceutical formulation project.
Influence of polymorphism on drug substance and drug product:
Solubility, Dissolution, Bioavailability (BA) and Bioequivalence (BE)
Manufacture of the Drug Product: Polymorphic forms of drug substance can also exhibit different physical and mechanical properties, including hygroscopicity, particle shape, density, flowability, and compactibility, which in turn may affect the processing of the drug substance and/or the manufacture of the drug product.
Raza, K., Kumar, P., Ratan, S., Malik, R., & Arora, S. (2014). Polymorphism: The Phenomenon Affecting the Performance of Drugs. SOJ Pharm Pharm Sci, 1 (2), 10. Polymorphism: The Phenomenon Affecting the Performance of Drugs.
Apparent solubility refers to the concentration of material at apparent equilibrium (supersaturation). Apparent solubility is distinct from true thermodynamic solubility, which is reached at infinite equilibrium time.