On the influence of raw material attributes on process behaviour and product quality in a continuous WET granulation tableting line

Zupančič, Ožbej; Doğan, Aygün; Fraga, R.; Demiri, Valjon; Paudel, Amrit; Khinast, Johannes G.; Spoerk, Martin; Sacher, Stephan

doi:10.1016/j.ijpharm.2023.123097

Cited by 5 publications

(1 citation statement)

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“…In order to design and develop a robust drug product that has the intended CQAs, the physical, chemical, and biological properties of the drug substance must be carefully considered. Mechanical and physical properties, although often not studied in detail during the development of drug substances and in the pre-formulation steps, can have a profound impact on the formulation development and processing of solid dosage forms [ 18 , 19 ]. A good early understanding of the critical material mechanical properties and variability of the drug substance allows for a rational, risk-based selection of the drug product formulation and manufacturing process.…”

Section: Introductionmentioning

confidence: 99%

SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening

Figuera-Figuera,

Suñé-Pou,

Pérez-Lozano

et al. 2023

Pharmaceutics

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During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product’s manufacturability, critical quality attributes, and bioavailability. The objective of this study was to validate the manufacturing process of the drug Linezolid from three different sources at both the pilot and industrial scale and to identify differences in critical material attributes between the API manufacturers. Furthermore, the scalability factor between the pilot and industrial scale and the suitability of a process for direct compression were also evaluated. In the present study, the different sources of API were characterized by SeDeM methodology, particle size distribution, and scanning electron microscopy determinations. The statistical analysis revealed that no statistically significant differences were found for any of the parameters under study for the same API source analyzed on both scales. On the other hand, for most of the parameters evaluated, statistical differences were observed between the different sources. It was concluded that SeDeM was able to successfully validate the API manufacturing process, assess scalability, and distinguish between sources. Therefore, it could be highly valuable in the formulation phase to select the best API source.

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Section: Introductionmentioning

confidence: 99%