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Challenges and emerging solutions in the development of compressed orally disintegrating tablets.
Expert Opin Drug Discov. 2014 Oct; 9(10):1109-20.EO

Abstract

INTRODUCTION

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.

AREAS COVERED

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.

EXPERT OPINION

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+Show Affiliations

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.No affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

25045997

Citation

Al-Khattawi, Ali, and Afzal R. Mohammed. "Challenges and Emerging Solutions in the Development of Compressed Orally Disintegrating Tablets." Expert Opinion On Drug Discovery, vol. 9, no. 10, 2014, pp. 1109-20.
Al-Khattawi A, Mohammed AR. Challenges and emerging solutions in the development of compressed orally disintegrating tablets. Expert Opin Drug Discov. 2014;9(10):1109-20.
Al-Khattawi, A., & Mohammed, A. R. (2014). Challenges and emerging solutions in the development of compressed orally disintegrating tablets. Expert Opinion On Drug Discovery, 9(10), 1109-20. https://doi.org/10.1517/17460441.2014.941802
Al-Khattawi A, Mohammed AR. Challenges and Emerging Solutions in the Development of Compressed Orally Disintegrating Tablets. Expert Opin Drug Discov. 2014;9(10):1109-20. PubMed PMID: 25045997.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Challenges and emerging solutions in the development of compressed orally disintegrating tablets. AU - Al-Khattawi,Ali, AU - Mohammed,Afzal R, Y1 - 2014/07/21/ PY - 2014/7/22/entrez PY - 2014/7/22/pubmed PY - 2015/5/27/medline KW - compression KW - dose capacity KW - modified release KW - orally disintegrating tablet KW - paediatric formulation development KW - taste masking SP - 1109 EP - 20 JF - Expert opinion on drug discovery JO - Expert Opin Drug Discov VL - 9 IS - 10 N2 - INTRODUCTION: 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. AREAS COVERED: 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. EXPERT OPINION: 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. SN - 1746-045X UR - https://www.unboundmedicine.com/medline/citation/25045997/Challenges_and_emerging_solutions_in_the_development_of_compressed_orally_disintegrating_tablets_ L2 - http://www.tandfonline.com/doi/full/10.1517/17460441.2014.941802 DB - PRIME DP - Unbound Medicine ER -