4.7 Article

A Potential Alternative Orodispersible Formulation to Prednisolone Sodium Phosphate Orally Disintegrating Tablets

Journal

PHARMACEUTICS
Volume 13, Issue 1, Pages -

Publisher

MDPI
DOI: 10.3390/pharmaceutics13010120

Keywords

electrospinning; electrospun nanofibers; solvent-casting; orodispersible films (ODFs); prednisolone; disintegration; dissolution; e-tongue

Funding

  1. National Industrial Development and Logistics Program (NIDLP) through the Health Initiative and the Technology Leader Program Initiative [20-0103, 20-0051]
  2. Research Centre for Pharmaceutical Engineering GmbH (RCPE) Graz, Austria
  3. Pfizer Ltd., Kent, UK [173803]
  4. UCL Impact Awards grants
  5. Medical Research Council (iCASE award) [170156]
  6. MRC [1789601] Funding Source: UKRI

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The study explores the potential of orally disintegrating tablets and the issue of masking the bitterness of active ingredients, using electrospun nanofibers and solvent-cast oral dispersible films (ODFs) as potential OD formulations, focusing primarily on prednisolone sodium phosphate (PSP).
The orally disintegrating tablet (ODT) has shown vast potential as an alternative oral dosage form to conventional tablets wherein they can disintegrate rapidly (<= 30 s) upon contact with saliva fluid and should have an acceptable mouthfeel as long as their weight doesn't exceed 500 mg. However, owing to the bitterness of several active ingredients, there is a need to find a suitable alternative to ODTs that maintains their features and can be taste-masked more simply and inexpensively. Therefore, electrospun nanofibers and solvent-cast oral dispersible films (ODFs) are used in this study as potential OD formulations for prednisolone sodium phosphate (PSP) that is commercially available as ODTs. The encapsulation efficiency (EE%) of the ODFs was higher (approximate to 100%) compared to the nanofibers (approximate to 87%), while the disintegration time was considerably faster for the electrospun nanofibers (approximate to 30 s) than the solvent-cast ODFs (approximate to 700 s). Hence, accelerated release rate of PSP from the nanofibers was obtained, due to their higher surface area and characteristic surface morphology that permitted higher wettability and thus, faster erosion. Taste-assessment study using the electronic-tongue quantified the bitterness threshold of the drug and its aversiveness concentration (2.79 mM). Therefore, a taste-masking strategy would be useful when further formulating PSP as an OD formulation.

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