Hot-stage microscopy for determination of API fragmentation: Comparison with other methods

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F15%3A43899831" target="_blank" >RIV/60461373:22310/15:43899831 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.3109/10837450.2015.1026608" target="_blank" >http://dx.doi.org/10.3109/10837450.2015.1026608</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3109/10837450.2015.1026608" target="_blank" >10.3109/10837450.2015.1026608</a>

Result language

angličtina

Original language name

Hot-stage microscopy for determination of API fragmentation: Comparison with other methods

Original language description

Although the fragmentation of the active pharmaceutical ingredient (API) is a phenomenon that is mentioned in many literature sources, no well-suited analytical tools for its investigation are currently known. We used the hot-stage microscopy method, already presented in our previous work, and studied the real fragmentation of the tadalafil particles in model tablets which were prepared under different compaction pressures. The morphology, spectral imaging and evaluation of plastic and elastic energies were also analyzed to support the hot-stage method. The prepared blend of tadalafil and excipients was compacted under a several forces from 5 to 35 kN to reveal the trend of fragmentation. The exact fragmentation of tadalafil with increased compaction pressure was revealed by the hot-stage microscopic method and it was in good agreement with plastic and elastic energies. Conversely, spectral imaging, which is being used for this analysis, was considered to be inaccurate methodology as mainly agglomerates, not individual particles, were measured. The availability of the hot-stage microscopic method equips pharmaceutical scientists with an in vitro assessment technique that will more reliably determine the fragmentation of the API in finished tablets and the behavior of the particles when compacted.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FR - Pharmacology and apothecary chemistry

OECD FORD branch

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Project

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Continuities

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Pharmaceutical Development and Technology

ISSN

1083-7450

e-ISSN

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Volume of the periodical

21

Issue of the periodical within the volume

5

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

583-589

UT code for WoS article

000375462900008

EID of the result in the Scopus database

2-s2.0-84969204015