Detail publikace

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

BOJŇANSKÁ, E. KALINA, M. PAŘÍZEK, L. BARTONÍČKOVÁ, E. OPRAVIL, T. VESELÝ, M. PEKAŘ, M. JAMPÍLEK, J.

Originální název

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Typ

článek v časopise ve Web of Science, Jimp

Jazyk

angličtina

Originální abstrakt

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers.The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.

Klíčová slova

Critical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testing, Zeta potential; Particle size distribution; Specific surface area; Scanning electron microscopy

Autoři

BOJŇANSKÁ, E.; KALINA, M.; PAŘÍZEK, L.; BARTONÍČKOVÁ, E.; OPRAVIL, T.; VESELÝ, M.; PEKAŘ, M.; JAMPÍLEK, J.

Rok RIV

2014

Vydáno

15. 9. 2014

Nakladatel

Hindawi Publishing Corporation

Místo

New York, USA

ISSN

1110-7243

Periodikum

JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY

Ročník

2014

Číslo

1

Stát

Spojené státy americké

Strany od

1

Strany do

9

Strany počet

9

URL

http://dx.doi.org/10.1155/2014/929248

Plný text v Digitální knihovně

http://hdl.handle.net/11012/84159

BibTex

@article{BUT109417,
  author="Erika {Bojňanská} and Michal {Kalina} and Ladislav {Pařízek} and Eva {Bartoníčková} and Tomáš {Opravil} and Michal {Veselý} and Miloslav {Pekař} and Josef {Jampílek}",
  title="Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study",
  journal="JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY",
  year="2014",
  volume="2014",
  number="1",
  pages="1--9",
  doi="10.1155/2014/929248",
  issn="1110-7243",
  url="http://dx.doi.org/10.1155/2014/929248"
}