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Semisolid Extrusion 3D Printing of Propranolol Hydrochloride Gummy Chewable Tablets: an Innovative Approach to Prepare Personalized Medicine for Pediatrics

  • Research Article
  • Theme: Novel Advances in 3D Printing Technology in Drug Delivery
  • Published:
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Abstract

The demand for personalized medicine has received extensive attention, especially in pediatric preparations. An emerging technology, extrusion-based 3D printing, is highly attractive in the field of personalized medicine. In this study, we prepared propranolol hydrochloride (PR) gummy chewable tablets tailored for children by semisolid extrusion (SSE) 3D printing technology to meet personalized medicine needs in pediatrics. In this study, the effects of critical formulation variables on the rheological properties and printability of gum materials were investigated by constructing a full-factorial design. In addition, the masticatory properties, thermal stability, and disintegration time of the preparations were evaluated. Bitterness inhibitors were used to mask the bitterness of the preparations. The results of the full-factorial design showed that the amount of gelatin and carrageenan were the key factors in the formulation. Gelatin can improve printability and masticatory properties, carrageenan can improve thermal stability, and accelerate the disintegration of preparations; therefore, a reasonable combination of both could satisfactorily meet the demand for high-quality 3D printing. γ-Aminobutyric acid can reduce the bitterness of gummy chewable tablets to improve medication compliance and the determined formulation (F7) met the quality requirements. In conclusion, the gum material has excellent potential as an extrusion material for 3D printing. The dosage can be adjusted flexibly by the model shape and size. 3D printing has broad prospects in pediatric preparations.

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Abbreviations

API:

Active pharmaceutical ingredient

AS:

Appearance scoring

ASTM:

American Society for Testing and Materials

BCS:

Biopharmaceutics classification system

CMS-Na:

Sodium carboxymethyl starch

CQAs:

Critical quality attributes

DoE:

Design of experiments

DT:

Disintegration time

G*:

Complex modulus

LVR:

Linear viscoelastic region

ML:

Melting level

PR:

Propranolol hydrochloride

PT:

Printing temperature

QR:

Oscillating rheometer

SSE:

Semisolid extrusion

TA:

Texture analyzer

TPA:

Texture profile analysis

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Funding

This work was supported by the National Natural Science Foundation of China (No. 82073793) and the Beijing Natural Science Foundation of China (No. L202043).

Author information

Authors and Affiliations

  1. Department of Pharmaceutics, School of Pharmacy, Qingdao University, 308th Ningxia Road, Shinan District, Qingdao, 266073, China

    Chunxiao Zhu & Yong Sun

  2. State Key Laboratory of Toxicology and Medical Countermeasures, Beijing Institute of Pharmacology and Toxicology, 27th Taiping Road, Haidian District, Beijing, 100850, China

    Chunxiao Zhu, Yang Tian, Xiang Gao, Hui Zhang, Nan Liu, Xiaolu Han, Zengming Wang & Aiping Zheng

  3. Pharmacy Department, the 967th Hospital of the Joint Logistic Support Force, DaLian, 116000, China

    Enhui Zhang

Authors
  1. Chunxiao Zhu
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  2. Yang Tian
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  3. Enhui Zhang
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  4. Xiang Gao
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  5. Hui Zhang
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  6. Nan Liu
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  7. Xiaolu Han
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  8. Yong Sun
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  9. Zengming Wang
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  10. Aiping Zheng
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Contributions

Chunxiao Zhu: carried out the experiments, performed data analysis and wrote the paper. Yang Tian, Enhui Zhang, Xiang Gao, Hui Zhang, Nan Liu, Xiaolu Han: participated in part of the experiments. Yong Sun, Zengming Wang and Aiping Zheng: designed the research and modified the paper.

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Correspondence to Yong Sun.

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Zhu, C., Tian, Y., Zhang, E. et al. Semisolid Extrusion 3D Printing of Propranolol Hydrochloride Gummy Chewable Tablets: an Innovative Approach to Prepare Personalized Medicine for Pediatrics. AAPS PharmSciTech 23, 166 (2022). https://doi.org/10.1208/s12249-022-02304-x

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  • DOI: https://doi.org/10.1208/s12249-022-02304-x

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