Development and evaluation of orally disintegrating tablets comprising taste-masked mirtazapine granules

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Yildiz S., AYTEKİN E., Yavuz B., Pehlivan S. B., VURAL İ., UNLU N.

PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol.23, no.5, pp.488-495, 2018 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 23 Issue: 5
  • Publication Date: 2018
  • Doi Number: 10.1080/10837450.2017.1315670
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.488-495
  • Keywords: Coacervation, mirtazapine, orally disintegrating tablets, taste masking, stability, VITRO/IN-VIVO EVALUATION, DICLOFENAC SODIUM, DRUG-DELIVERY, FORMULATION, DEPRESSION, RELEASE, MASKING, PHARMACEUTICALS, SYSTEM
  • Hacettepe University Affiliated: Yes


Introduction: Orally disintegrating tablets (ODTs) provide an important treatment option for pediatric, geriatric and psychiatric patients. In our previous study, we have performed the initial studies for the formulation development and characterization of new ODT formulations containing a bitter taste drug, mirtazapine, coated with 6% (w/w) Eudragit((R)) E-100 (first group of formulations, FGF) without taste evaluation. In present study, coating ratio of the drug was increased to 8% (w/w) (second group of formulations, SGF) to examine the effect of increased coating ratio of drug on in vitro characterization of the formulations including in vitro taste masking study.Materials and methods: Coacervation technique using Eudragit((R)) E-100 was employed to obtain taste-masked mirtazapine granules. FGF and SGF were compared to original product (Remeron SolTab, an antidepressant drug which produced by pellet technology) in terms of in vitro permeability, in vitro taste masking efficiency which was performed by dissolution studies in salivary medium and dissolution stability. Also, the other tablet characteristics (such as diameter, thickness) of SGF were examined.Results and discussion: The disintegration time of the SGF were found as A1