Pharmacotechnical and Analytical Preformulation Studies for Cannabidiol Orodispersible Tablets

Obtaining orodispersible tablets (ODT) containing substances from the 2nd 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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Materials: The materials used were CBD (Trigal Pharma, Austria), LCT (DFE Pharma, New Zealand), CelMC (Alfa Aesar, Germany), MNT (VWR Pharmaceuticals, France), SRB (Roth, Germany), EMCS (JRS Pharma, Germany), SSG (JRS Pharma, Germany), CCS (JRS Pharma, Germany), PETsp (JRS Pharma, Germany), PODTG2 (JRS, Pharma), KBr (PharmaPeer, Germany), Magnesium stearate (Alfa Aesar, Germany), Hydrophilic fumed silica (Degussa, Germany).

Article information: Robert-Alexandru Vlad, Paula Antonoaea, Nicoleta Todoran, Daniela-Lucia Muntean, Emőke Margit Rédai, Oana Alexandra Silasi, Anamaria Tătaru, Magdalena Bîrsan, Silvia Imre, Adriana Ciurba, Pharmacotechnical and Analytical Preformulation Studies for Cannabidiol Orodispersible Tablets, Saudi Pharmaceutical Journal, 2021. https://doi.org/10.1016/j.jsps.2021.07.012.

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