Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development
An understanding of material properties and processing effects on solid dosage forms performance is required within the Quality-by-design approach to pharmaceutical development. Several research groups have developed mathematical approaches aiming to facilitate the selection of formulation compositi...
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| Format: | Article |
| Language: | srp |
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Pharmaceutical Association of Serbia, Belgrade, Serbia
2022-01-01
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| Series: | Arhiv za farmaciju |
| Subjects: | |
| Online Access: | https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2022/0004-19632206637V.pdf |
| _version_ | 1797938645080997888 |
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| author | Vasiljević Ivana Turković Erna Aleksić Ivana Parojčić Jelena |
| author_facet | Vasiljević Ivana Turković Erna Aleksić Ivana Parojčić Jelena |
| author_sort | Vasiljević Ivana |
| collection | DOAJ |
| description | An understanding of material properties and processing effects on solid dosage forms performance is required within the Quality-by-design approach to pharmaceutical development. Several research groups have developed mathematical approaches aiming to facilitate the selection of formulation composition and the manufacturing technology. These approaches are based on material particulate, bulk and compression-related properties. This paper provides theoretical assumptions and a critical review of different mathematical approaches for processability characterization of powders and multiparticulate units. Mathematical approaches have mainly been developed for directly compressible materials, but sometimes other manufacturing technologies, such as roller compaction and wet granulation, are also considered. The obtained compact tensile strength has been implemented in the majority of approaches, as an important characteristic describing compact mechanical properties. Flowability should be also evaluated, since it affects sample processability. Additionally, particle size and shape, material density and compressibility, compactibility and tabletability profiles have been also distinguished as relevant properties for solid dosage form development. The application of mathematical approaches may contribute to the mechanistic understanding of critical material attributes and facilitate dosage form development and optimization. However, it is essential to select the appropriate one, based on the intended dosage form characteristics, in order to ensure that all relevant powder/multiparticulate units characteristics are implemented and critically evaluated. |
| first_indexed | 2024-04-10T19:04:01Z |
| format | Article |
| id | doaj.art-fb54b3fb3f204884bf888a86aaacb42e |
| institution | Directory Open Access Journal |
| issn | 0004-1963 2217-8767 |
| language | srp |
| last_indexed | 2024-04-10T19:04:01Z |
| publishDate | 2022-01-01 |
| publisher | Pharmaceutical Association of Serbia, Belgrade, Serbia |
| record_format | Article |
| series | Arhiv za farmaciju |
| spelling | doaj.art-fb54b3fb3f204884bf888a86aaacb42e2023-01-31T07:50:28ZsrpPharmaceutical Association of Serbia, Belgrade, SerbiaArhiv za farmaciju0004-19632217-87672022-01-0172663766010.5937/arhfarm72-409610004-19632206637VMathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical developmentVasiljević Ivana0Turković Erna1Aleksić Ivana2https://orcid.org/0000-0001-6510-2364Parojčić Jelena3https://orcid.org/0000-0001-8074-6221Univerzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaAn understanding of material properties and processing effects on solid dosage forms performance is required within the Quality-by-design approach to pharmaceutical development. Several research groups have developed mathematical approaches aiming to facilitate the selection of formulation composition and the manufacturing technology. These approaches are based on material particulate, bulk and compression-related properties. This paper provides theoretical assumptions and a critical review of different mathematical approaches for processability characterization of powders and multiparticulate units. Mathematical approaches have mainly been developed for directly compressible materials, but sometimes other manufacturing technologies, such as roller compaction and wet granulation, are also considered. The obtained compact tensile strength has been implemented in the majority of approaches, as an important characteristic describing compact mechanical properties. Flowability should be also evaluated, since it affects sample processability. Additionally, particle size and shape, material density and compressibility, compactibility and tabletability profiles have been also distinguished as relevant properties for solid dosage form development. The application of mathematical approaches may contribute to the mechanistic understanding of critical material attributes and facilitate dosage form development and optimization. However, it is essential to select the appropriate one, based on the intended dosage form characteristics, in order to ensure that all relevant powder/multiparticulate units characteristics are implemented and critically evaluated.https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2022/0004-19632206637V.pdfdrug manufacturingsolid dosage formstensile strengthflowabilitymaterial classification |
| spellingShingle | Vasiljević Ivana Turković Erna Aleksić Ivana Parojčić Jelena Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development Arhiv za farmaciju drug manufacturing solid dosage forms tensile strength flowability material classification |
| title | Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| title_full | Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| title_fullStr | Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| title_full_unstemmed | Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| title_short | Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| title_sort | mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development |
| topic | drug manufacturing solid dosage forms tensile strength flowability material classification |
| url | https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2022/0004-19632206637V.pdf |
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