Publication detail

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.

Original Title

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

English Title

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

Type

journal article in Web of Science

Language

en

Original Abstract

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.

English abstract

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.

Keywords

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

RIV year

2014

Released

15.09.2014

Publisher

Hindawi Publishing Corporation

Location

New York, USA

ISBN

1110-7243

Periodical

JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY

Year of study

2014

Number

1

State

US

Pages from

1

Pages to

9

Pages count

9

URL

Full text in the Digital Library

Documents

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",
  annote="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.",
  address="Hindawi Publishing Corporation",
  chapter="109417",
  doi="10.1155/2014/929248",
  institution="Hindawi Publishing Corporation",
  number="1",
  volume="2014",
  year="2014",
  month="september",
  pages="1--9",
  publisher="Hindawi Publishing Corporation",
  type="journal article in Web of Science"
}