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AAPS PharmSciTech

, 20:71 | Cite as

Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids

  • Ellen Hackl
  • Irina ErmolinaEmail author
Research Article
  • 17 Downloads

Abstract

Orally disintegrating tablets (ODTs) attract a great attention as this easy swallowing dosage form often improves patient compliance. In the current work, orally disintegrating tablets comprising mannitol, polyvinylpyrrolidone (PVP) and an amino acid (alanine, glycine or serine) with various PVP-to-amino acid ratios were formulated. The combination of mannitol and an amino acid was aimed to use the advantages of mannitol, the matrix-supporting and disintegration agent, and to reduce the total amount of sugar/polyol in tablets. Tablets were manufactured by freeze-drying and their properties (appearance, internal structure, disintegration, mechanical and texture properties, moisture uptake, shrinkage, thermal properties) were assessed. In the work, great emphasis was placed on illustrating the applicability of the Texture Analysis of the freeze-dried cakes directly in vials in formulation development. The results show that the appearance, mechanical properties, disintegration and shrinkage of the freeze-dried ODTs depend significantly on the excipient composition with PVP playing the leading role. Partial mannitol replacement with an amino acid has a limited impact on the tablet properties. The presence of an amino acid also has no impact on the PVP-mannitol interaction. The mechanical and texture properties of freeze-dried ODTs depend non-linearly on the PVP content. The transition between the different types of textures occurs in a narrow range of PVP concentrations regardless of the type of amino acid in a formulation. The non-linear effect of PVP on various tablet properties should be taken into account when designing ODT formulations as it can compromise the robustness of the manufacturing process.

KEY WORDS

orally disintegrating tablets freeze-drying texture analysis PVP amino acids 

Abbreviations

ODTs

Orally disintegrating tablets

RDTs

Rapid disintegrating tablets

AA

Amino acid

PVP

Polyvinylpyrrolidone

TA

Texture analysis

FD

Freeze-drying/freeze-dried

RH

Relative humidity

DSC

Differential scanning calorimetry

SEM

Scanning electron microscopy

CQA

Critical quality attributes

Notes

Acknowledgments

The authors would like to thank Dr. Rachel Armitage (De Montfort University) for the help in collecting SEM images.

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Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  1. 1.Leicester School of Pharmacy, Faculty of Health and Life SciencesDe Montfort UniversityLeicesterUK
  2. 2.School of PharmacyUniversity of ReadingReadingUK

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