Evaluation of the effect of different particle sizes of Mannitol on dissolution and tablet properties in the framework of QbD Dissolution Technologies

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Mesut B., Pirinçci Tok Y., Alkan B., Al-Mohaya M., Kara M., Erginer Y.

DISSOLUTION TECHNOLOGIES, cilt.2, sa.1, ss.1, 2023 (SCI-Expanded)

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 2 Sayı: 1
  • Basım Tarihi: 2023
  • Doi Numarası: 10.14227/dt300123p12
  • Dergi Adı: DISSOLUTION TECHNOLOGIES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, International Pharmaceutical Abstracts
  • Sayfa Sayıları: ss.1
  • İstanbul Üniversitesi Adresli: Evet

Özet

The objective of the current study was to develop orally disintegrating tablet (ODT) formulations containing Melatonin drug. Mannitol in different particle sizes were also used to study its effect on dissolution and tablet properties within the framework of quality by design (QbD) approach and obtain the optimum formula. First, the quality target product profile (QTPP) was identified, and critical quality attributes (CQAs) were determined. Risk assessment was performed using the Failure Mode Effect Analysis Method (FMEA) to define critical material attributes (CMAs) and critical process parameters (CPPs). 34 formulations were prepared and tested within the framework of quality by design. Box-Behnken design (BBD) with Response Surface Methodology (RSM) was applied to assess the effect of independent factors on CQAs of ODTs. Finally, the most suitable formulation in terms of tablet properties were determined with Minitab™. Specification tests were applied to the optimum formula and it was checked whether it met the required specifications. Based on the results, mannitol with a small particle size provided a low disintegration time and a high dissolution rate. Therefore, excipient selection according to the desires determined in QTPP is critical, even between the same excipient types.