title: Development and evaluation of orally disintegrating tablets comprising taste-masked mirtazapine granules.
abstract: BACKGROUND
  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®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.
  
  
  METHODS
  Coacervation technique using Eudragit®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.
  
  
  CONCLUSIONS
  The disintegration time of the SGF were found as A1 < A2 < A3 < A5 < A4 (8% Eudragit®E-100), but all of the formulations dissolved under 30 seconds and friability values were less than 1%. In vitro taste masking efficiency studies demonstrated that C2 formulation (in FGF) had the most similar dissolution profile to Remeron SolTab.
  
  
  CONCLUSIONS
  According to these findings, B2 or C2 (with citric acid or sodium bicarbonate, respectively, with 6% Eudragit®E-100) formulations could be promising alternatives to Remeron SolTab.
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: Simay
authors.initials: S
authors.lastname: Yıldız
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: Eren
authors.initials: E
authors.lastname: Aytekin
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: Burçin
authors.initials: B
authors.lastname: Yavuz
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: Sibel
authors.initials: S
authors.lastname: Bozdağ Pehlivan
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: İmran
authors.initials: İ
authors.lastname: Vural
authors.affiliation: a Faculty of Pharmacy, Department of Pharmaceutical Technology , Hacettepe University , Ankara , Turkey.
authors.forename: Nurşen
authors.initials: N
authors.lastname: Ünlü
mesh_terms: D000179:Acrylates / Q000737:chemistry*; D000284:Administration, Oral; D000929:Antidepressive Agents, Tricyclic / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D018938:Caco-2 Cells; D004339:Drug Compounding; D065546:Drug Liberation; D005079:Excipients / Q000737:chemistry*; D006801:Humans; D008803:Mianserin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics; D000078785:Mirtazapine; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D013649:Taste
chemical_list: D000179:Acrylates; D000929:Antidepressive Agents, Tricyclic; C477020:Eudragit E100; D005079:Excipients; D011108:Polymers; D013607:Tablets; D008803:Mianserin; D000078785:Mirtazapine
keywords: Coacervation; mirtazapine; orally disintegrating tablets; stability; taste masking