A simplified approach to determine effective surface area and porosity of low bulk density active pharmaceutical ingredients in early development.
Sharif S, Dimemmo LM, Thommes M, Hubert M, Sarsfield BA (2015)
Publication Type: Journal article, Original article
Subtype: other
Publication year: 2015
Journal
Publisher: Elsevier B.V.
Book Volume: 26
Pages Range: 337-348-348
Journal Issue: 2
DOI: 10.1016/j.apt.2014.11.002
Abstract
It can be difficult to accurately measure true d. of low bulk d. materials, which are frequently used in drug products. This was demonstrated on a cryst. model API. Uncertainty was related to insufficient sample vol. The error function was theor. described by assuming an inverse relation to the sample vol. Hence, an easy to implement guideline to increase accuracy was established. Verification was performed using spray dried dispersions, SDDs. Practically, bulk d. rather than sample vol. was used for risk evaluation. Procedures such as compacting a sample into a pellet or using a low vol. instrumental calibration mode were implemented. Risk assessment of morphol. or crystal form change was included in the guideline. Furthermore, a simplified approach using true d. as a central parameter was developed to assess surface area and porosity. For spherically shaped SDDs, surface area can be estd. from true d. and particle size, and porosity can be estd. from true and bulk densities. A surface roughness parameter, theor. derived, leads to a surface area scale factor of 2.28, which provides results in good agreement with the exptl. obtained surface areas. Also, SDD porosities follow a trend similar to those obtained by mercury porosimetry. [on SciFinder(R)]
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Germany (DE)How to cite
APA:
Sharif, S., Dimemmo, L.M., Thommes, M., Hubert, M., & Sarsfield, B.A. (2015). A simplified approach to determine effective surface area and porosity of low bulk density active pharmaceutical ingredients in early development. Advanced Powder Technology, 26(2), 337-348-348. https://dx.doi.org/10.1016/j.apt.2014.11.002
MLA:
Sharif, Shasad, et al. "A simplified approach to determine effective surface area and porosity of low bulk density active pharmaceutical ingredients in early development." Advanced Powder Technology 26.2 (2015): 337-348-348.
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