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Pharmacotechnical and analytical preformulation studies for cannabidiol orodispersible tablets

Authors
  • Vlad, Robert-Alexandru1
  • Antonoaea, Paula1
  • Todoran, Nicoleta1
  • Muntean, Daniela-Lucia2
  • Rédai, Emőke Margit1
  • Silași, Oana Alexandra1
  • Tătaru, Anamaria1
  • Bîrsan, Magdalena1, 3
  • Imre, Silvia2
  • Ciurba, Adriana1
  • 1 Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Târgu Mures, Romania
  • 2 Analytical Chemistry and Drug Analysis Department, Faculty of Pharmacy, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Târgu Mures, Romania
  • 3 Pharmaceutical Technology Department, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy of Iasi, 700115 Iasi, Romania
Type
Published Article
Journal
Saudi Pharmaceutical Journal : SPJ
Publisher
Elsevier
Publication Date
Jul 17, 2021
Volume
29
Issue
9
Pages
1029–1042
Identifiers
DOI: 10.1016/j.jsps.2021.07.012
PMID: 34588849
PMCID: PMC8463482
Source
PubMed Central
Keywords
Disciplines
  • Original Article
License
Unknown

Abstract

Obtaining orodispersible tablets (ODT) containing substances from the second Biopharmaceutical Class has raised concerns as the dissolution test is challenging. This study aimed to select suitable excipients for developing orodispersible tablets containing cannabidiol (CBD) by direct compression method. No similar studies were found in the literature. Excipients from different classes were characterized using the SeDeM-ODT tool: fillers – lactose (LCT) and microcrystalline cellulose (CelMC), sweeteners – sorbitol (SRB) and mannitol (MNT), disintegrants – sodium starch glycolate (SSG), sodium croscarmellose (CCS), soy polysaccharides (Emcosoy® – EMCS) and two co-processed excipients (Prosolv®-ODT G2 – PODTG2 and Prosolv® EasyTab sp – PETsp). Drug compatibility with excipients in binary mixtures (1:1) was verified by Differential Scanning Calorimetry (DSC) and Fourier Transform-Infrared (FTIR) spectroscopy. Using the SeDeM-ODT expert system, the fillers and the co-processed excipients showed good properties regarding compressibility and disintegration behavior. Also, the DSC and FTIR results showed that small or no interactions between the CBD and the excipients took place.

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