Excipients for Orally Disintegrating Tablets: Compaction Data Analysis and Study of Tableting Properties of Lubricated Co-processed Excipients

Onayo M. M., Özalp Y., Jiwa N., MESUT B., GÜNGÖR S.

Latin American Journal of Pharmacy, cilt.42, sa.8, ss.1655-1665, 2023 (SCI-Expanded) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 42 Sayı: 8
  • Basım Tarihi: 2023
  • Dergi Adı: Latin American Journal of Pharmacy
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, International Pharmaceutical Abstracts
  • Sayfa Sayıları: ss.1655-1665
  • Anahtar Kelimeler: co-processed excipients, compactibility, orally disintegrating tablets, tabletability
  • İstanbul Üniversitesi Adresli: Evet

Özet

Selecting the most suitable co-processed excipient (CPE) is crucial in orally disintegrating tablets (ODTs) development. The study evaluated five CPE’s (Ludiflash®, Ludipress®, Ludipress® LCE, Pearlitol® 200 SD, and GalenIQ™721) that are commonly used in ODT formulations by dynamic compaction data analysis. Heckel plots, Force-displacement (F-D) curves and compaction energy data generated by a compaction simulator upon powder compression were studied. Compaction force and CPE composition exerted the most significant influence on the properties of the tablet and the energies required for compaction. According the Heckel analysis all investigated CPE’s had relatively higher resistance to plastic deformation, therefore they can be considered to be intermediate or brittle. F-D analysis revealed GalenIQTM 721 to be plastically leaning. Conclusively, this research suggests that the key characteristics of excipients that impact the critical quality attributes of ODTs are their ability to deform, their compressibility, and their tabletability capacity.