Key acceptability attributes of orodispersible films

Mariagiovanna Scarpa, Amrit Paudel, Frank Kloprogge, Wen Kai Hsiao, Massimo Bresciani, Simon Gaisford, Mine Orlu

Research output: Contribution to journalArticleResearchpeer-review

Abstract

The features rendering orodispersible films (ODFs) patient-centric formulations are widely discussed in the scientific literature. However there is a lack of research studies exploring ODF characteristics with a potential impact on end-user acceptability. The aim of this study was to identify the key ODF characteristics affecting end-user acceptability by developing in vitro test methods for the prediction of ODFs acceptability and correlate these formulation characteristics with the data obtained from a human panel study. Four drug-free single-polymer films were prepared by solvent casting. Solutions of poly(vinyl) alcohol (PVOH) 39 KDa (P1), PVOH 197 KDa (P2), carboxymethylcellulose (CMC) 395 KDa (C1), and CMC 725 KDa (C2) were prepared. Texture analysis and Dynamic Mechanical Analysis (DMA) were used to assess film tack. Petri dish and drop methods were used to assess disintegration time. A human panel of 24 healthy young adults was employed to identify end-user acceptability criteria of the four study film samples. Texture analysis data of ODF tack were not found to be in agreement with the in vivo perceived stickiness in the mouth. However, measurement of the area under the adhesive force curve obtained by DMA correlated with in vivo perceived stickiness data for all samples. The disintegration times obtained by drop method were more comparable to human panel data than the petri dish method. Hence DMA and drop methods proved to be promising methodologies for the prediction of the end-user acceptability. The type and molecular weight of the film-forming polymer had a strong influence on stickiness perception, whereas only polymeric molecular weight influenced perceived disintegration time. The human panel study showed that Participant Reported Outcomes (PROs) for the perceived stickiness in the mouth and disintegration time of test films received significantly different scores between samples, and thus were identified as the key attributes with the potential to affect the end-user acceptability. ODF stickiness and disintegration time should therefore be evaluated at an early stage of the drug product design.
Original languageEnglish
Pages (from-to)131-140
Number of pages9
JournalEuropean journal of pharmaceutics and biopharmaceutics
Volume125
DOIs
Publication statusPublished - Apr 2018

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Carboxymethylcellulose Sodium
Mouth
Polymers
Molecular Weight
Literature
Drug Design
Adhesives
Young Adult
Alcohols
Research
Pharmaceutical Preparations
In Vitro Techniques

Keywords

  • Orodispersible film
  • Acceptability
  • Stickiness
  • Disintegration time
  • In vitro method
  • Human panel

Cite this

Key acceptability attributes of orodispersible films. / Scarpa, Mariagiovanna; Paudel, Amrit; Kloprogge, Frank; Hsiao, Wen Kai; Bresciani, Massimo; Gaisford, Simon ; Orlu, Mine.

In: European journal of pharmaceutics and biopharmaceutics, Vol. 125, 04.2018, p. 131-140.

Research output: Contribution to journalArticleResearchpeer-review

Scarpa, Mariagiovanna ; Paudel, Amrit ; Kloprogge, Frank ; Hsiao, Wen Kai ; Bresciani, Massimo ; Gaisford, Simon ; Orlu, Mine. / Key acceptability attributes of orodispersible films. In: European journal of pharmaceutics and biopharmaceutics. 2018 ; Vol. 125. pp. 131-140.
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AU - Gaisford, Simon

AU - Orlu, Mine

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AB - The features rendering orodispersible films (ODFs) patient-centric formulations are widely discussed in the scientific literature. However there is a lack of research studies exploring ODF characteristics with a potential impact on end-user acceptability. The aim of this study was to identify the key ODF characteristics affecting end-user acceptability by developing in vitro test methods for the prediction of ODFs acceptability and correlate these formulation characteristics with the data obtained from a human panel study. Four drug-free single-polymer films were prepared by solvent casting. Solutions of poly(vinyl) alcohol (PVOH) 39 KDa (P1), PVOH 197 KDa (P2), carboxymethylcellulose (CMC) 395 KDa (C1), and CMC 725 KDa (C2) were prepared. Texture analysis and Dynamic Mechanical Analysis (DMA) were used to assess film tack. Petri dish and drop methods were used to assess disintegration time. A human panel of 24 healthy young adults was employed to identify end-user acceptability criteria of the four study film samples. Texture analysis data of ODF tack were not found to be in agreement with the in vivo perceived stickiness in the mouth. However, measurement of the area under the adhesive force curve obtained by DMA correlated with in vivo perceived stickiness data for all samples. The disintegration times obtained by drop method were more comparable to human panel data than the petri dish method. Hence DMA and drop methods proved to be promising methodologies for the prediction of the end-user acceptability. The type and molecular weight of the film-forming polymer had a strong influence on stickiness perception, whereas only polymeric molecular weight influenced perceived disintegration time. The human panel study showed that Participant Reported Outcomes (PROs) for the perceived stickiness in the mouth and disintegration time of test films received significantly different scores between samples, and thus were identified as the key attributes with the potential to affect the end-user acceptability. ODF stickiness and disintegration time should therefore be evaluated at an early stage of the drug product design.

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KW - Stickiness

KW - Disintegration time

KW - In vitro method

KW - Human panel

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