Affiliation:
1. Department of Pharmacy, The Sixth Affiliated Hospital, Sun Yat-sen University, No. 26
Yuancunerheng Road, Guangzhou 510655, China
2. Experiment and Practice Training Center, Guangdong Food and Drug Vocational College, No.321 Longdongbei Road,
Guangzhou 510520, China
Abstract
Background:
The orally disintegrating tablets (ODTs) are especially suitable for elders and children with dysphagia, who need to be customized dosages.
Objectives:
This study aimed to prepare orally disintegrating tablets (ODTs) which can be customized as drug content by using semi-solid 3D printing pressure extrusion technology, with water insoluble and thermally unstable drug loratadine.
Methods:
The influence of binder concentration, disintegrating agent dosage and ratio mannitol: cellulose on formability and disintegration time was investigated. The properties of orally disintegrating tablets were investigated by ATR-FTIR, XRPD, DSC and SEM. The correlation formula between tablet bottom area and drug content was established.
Results:
The formulation was optimized, and contained loratadine 3 g, cellulose 4 g, mannitol 2 g, carboxy methyl starch sodium 1g, 6% PVP K30 16 ml. The disintegration time was less than 60 s with a infilling percentage of 60%, and the disintegration time was less than 30 s with a infilling percentage of 40%. There was no detectable interaction between loratadine and the selected excipients by the analysis of ATR-FTIR, DSC and XRPD. The structure of the tablets was porous, and the drug was dissolved completely within 10 min. The drug content (x) of the tablet and the bottom area (y) of the tablet showed a linear fitting relationship, y = 3.8603x - 0.7176, r2 = 0.9993.
Conclusion:
Semi-solid extrusion of 3D printing technology was applied to prepare loratadine orally disintegrating tablets with customized drug content, which provides an alternative method for the research of customized preparation.
Funder
Medical Scientific Research Foundation of Guangdong Province, China
Natural Science Foundation of Guangdong Food and Drug Vocational College
Publisher
Bentham Science Publishers Ltd.
Cited by
2 articles.
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