Abstract
Complete characterization and mechanistic understanding of physicochemical interactions in solid dosage forms are not only important for consistent manufacturability, stability, and bioavailability of the drug product, but are also expected under the quality-by-design paradigm of drug development. Lack of this understanding can impact successful and timely development, scale-up, and commercial manufacture of dosage forms. This article highlights the stability and bioavailability implications of physicochemical interactions in dosage forms citing a couple of examples where such interactions necessitated the recall of commercial drug products.
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REFERENCES
Gerber C, Toelle HG. What happened: the chemistry side of the incident with EMS contamination in Viracept tablets. Toxicol Lett. 2009;190:248–53.
Bauer J, Spanton S, Henry R, Quick J, Dziki W, Porter W, Morris J. Ritonavir: an extraordinary example of conformational polymorphism. Pharmaceut Res. 2001;18:859–66.
Narang AS, Rao VM, Raghavan K. Excipient compatibility. In: Qiu Y, Chen Y, Zhang GGZ, Liu L, Porter W, editors. Developing solid oral dosage forms: pharmaceutical theory and practice. Burlington: Elsevier; 2009. p. 125–46.
Wu Y, Levons J, Narang AS, Raghavan K, Rao VM. Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility. AAPS PharmSciTech. 2011;12:1248–63.
Narang AS, Yamniuk A, Zhang L, Comezoglu SN, Bindra DS, Varia S, Doyle ML, and Badawy S. Reversible and pH-dependent Weak Drug-Excipient Binding Does Not Affect Oral Bioavailability of High Dose Drugs. Journal of Pharmacy and Pharmacology. In press 2012.
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Narang, A.S., Desai, D. & Badawy, S. Physicochemical Interactions in Solid Dosage Forms. Pharm Res 29, 2635–2638 (2012). https://doi.org/10.1007/s11095-012-0867-5
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DOI: https://doi.org/10.1007/s11095-012-0867-5