Related Experiment Video
Updated: Oct 6, 2025

Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Implementing the Design of Experiments (DoE) Concept into the Development Phase of Orodispersible Minitablets (ODMTs)
Arkadiusz Hejduk1,2, Michał Teżyk3, Emilia Jakubowska3
1Chair and Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780, Poznan, Poland. arkadiusz.hejduk@student.ump.edu.pl.
Abstract:
Development of orodispersible minitablets (ODMTs) requires consideration of aspects related to small dimensions, while ensuring short disintegration time with sufficient mechanical stability. In order to meet these and other critical quality attributes (CQAs), quality by design is encouraged. According to this approach, formulation and compression process factors were systematically studied using design of experiments (Plackett-Burman for screening purposes, full and fractional factorial design for in-depth characterization) to understand their influence on CQAs of orodispersible minitablets containing melatonin. Mathematical models describing the relationships between processing variables and attributes such as resistance to crushing and disintegration time were successfully developed, characterized by high coefficients of determination (R2adj = 0.90-0.97) and prediction errors in the range (+2.4 to -10.8%). In conclusion, based on these models, the design space was created for melatonin ODMTs, ensuring the product's quality and process robustness. Moreover, the study demonstrated the suitability of texture analysis as an alternative to compendial measurement methods of resistance to crushing and disintegration time. Graphical abstract.
More Related Videos
05:59Author Spotlight: Overcoming Challenges in Drosophila Sleep Measurement Using DAM System
Published on: October 20, 2023
04:28Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals
Published on: March 23, 2016
Related Concept Videos
Management of Insomnia
Factors Influencing Drug Absorption: Pharmaceutical Parameters
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Factors Affecting Dissolution: Particle Size and Effective Surface Area
Sedatives and Hypnotics Drugs: Miscellaneous Agents
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
In Vitro Drug Dissolution: Alternative Methods