title: Formulation studies for mirtazapine orally disintegrating tablets.
abstract: OBJECTIVE
  Orally disintegrating tablets (ODTs) recently have gained much attention to fulfill the needs for pediatric, geriatric, and psychiatric patients with dysphagia. Aim of this study was to develop new ODT formulations containing mirtazapine, an antidepressant drug molecule having bitter taste, by using simple and inexpensive preparation methods such as coacervation, direct compression and to compare their characteristics with those of reference product (Remereon SolTab).
  
  
  METHODS
  Coacervation method was chosen for taste masking of mirtazapine. In vitro characterization studies such as diameter and thickness, weight variation, tablet hardness, tablet friability and disintegration time were performed on tablet formulations. Wetting time and in vitro dissolution tests of developed ODTs also studied using 900 mL 0.1 N HCl medium, 900 mL pH 6.8 phosphate buffer or 900 mL pH 4.5 acetate buffer at 37 ± 0.2 °C as dissolution medium.
  
  
  RESULTS
  Ratio of Eudragit® E-100 was chosen as 6% (w/w) since the dissolution profile of A1 (6% Eudragit® E-100) was found closer to the reference product than A2 (4% Eudragit® E-100) and A3 (8% Eudragit® E-100). Group D, E and F formulations were presented better results in terms of disintegration time. Dissolution results indicated that Group E and F formulations showed optimum properties in all three dissolution media.
  
  
  CONCLUSIONS
  Formulations D1, D4, D5, E3, E4, F1 and F5 found suitable as ODT formulations due to their favorable disintegration times and dissolution profiles.
  
  
  CONCLUSIONS
  Developed mirtazapine ODTs were found promising in terms of showing the similar characteristics to the original formulation.
authors.affiliation: a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.
authors.forename: Simay
authors.initials: S
authors.lastname: Yıldız
authors.affiliation: a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.
authors.forename: Eren
authors.initials: E
authors.lastname: Aytekin
authors.affiliation: a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.
authors.forename: Burçin
authors.initials: B
authors.lastname: Yavuz
authors.affiliation: a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.
authors.forename: Sibel
authors.initials: S
authors.lastname: Bozdağ Pehlivan
authors.affiliation: a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.
authors.forename: Nurşen
authors.initials: N
authors.lastname: Ünlü
mesh_terms: D000179:Acrylates / Q000737:chemistry; D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D008803:Mianserin / Q000031:analogs & derivatives* / Q000737:chemistry; D000078785:Mirtazapine; D011108:Polymers / Q000737:chemistry; D012995:Solubility; D013607:Tablets / Q000737:chemistry*; D013649:Taste
chemical_list: D000179:Acrylates; C477020:Eudragit E100; D005079:Excipients; D011108:Polymers; D013607:Tablets; D008803:Mianserin; D000078785:Mirtazapine
keywords: Formulation development; microencapsulation; mirtazapine; orally disintegrating tablets; taste masking