title: Challenges and emerging solutions in the development of compressed orally disintegrating tablets.
abstract: BACKGROUND
  Orally disintegrating tablets (ODTs) provide several advantages over conventional tablets such as suitability for patients with swallowing difficulties and faster onset of action. The manufacture of ODTs by compression/tableting offers a practical and cost-effective strategy over the freeze drying (lyophilisation) method. Nonetheless, the FDA recommends a disintegration time of 30 s and a maximum weight of 500 mg for a tablet to be labelled as an ODT. These requirements, alongside other desirable product properties, have created a number of challenges for the formulator to overcome while developing compressed ODTs.
  
  
  METHODS
  The review discusses the main challenges of ODT manufacturing process and the emerging solutions featured at early drug development stages. The research specifically describes the methods reported for taste masking/assessment and solubilisation of unpalatable and poorly soluble drugs, respectively. Furthermore, this review highlights the techniques used for developing modified-release ODTs, an emerging area in the field. In addition, it also discusses the poor flowability and segregation problems of directly compressed powders. Moreover, the review describes the tests reported in the literature for ODT disintegration time assessment since a universal technique is still non-existent.
  
  
  CONCLUSIONS
  The approaches used to overcome the manufacturing challenges often have a bearing on the price of the end product. However, despite the technical and regulatory challenges, ODTs can offer many advantages over the conventional dosage forms if accompanied by suitable adjuvant technologies and in vitro analytical tools.
authors.affiliation: Aston University, Aston School of Pharmacy, Aston Research Centre for CHildren's and Young People's Health (ARCHY) , Birmingham , UK +0121 204 4183 ; a.u.r.mohammed@aston.ac.uk.
authors.forename: Ali
authors.initials: A
authors.lastname: Al-Khattawi
authors.forename: Afzal R
authors.initials: AR
authors.lastname: Mohammed
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000379:methods*; D005079:Excipients / Q000737:chemistry; D006801:Humans; D012995:Solubility; D013607:Tablets / Q000008:administration & dosage / Q000737:chemistry*; D013997:Time Factors
chemical_list: D005079:Excipients; D013607:Tablets
keywords: compression; dose capacity; modified release; orally disintegrating tablet; paediatric formulation development; taste masking