---
title: "Low-temperature FDM 3D printing of immediate-release glipizide tablets: formulation and dose custo"
id: "pubmed-42546995"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42546995"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42546995/"
doi: "10.1016/j.ijpharm.2026.127275"
published_at: "2026-09-05T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Low-temperature FDM 3D printing of immediate-release glipizide tablets: formulation and dose custo
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42546995
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42546995/)
- **DOI:** [10.1016/j.ijpharm.2026.127275](https://doi.org/10.1016%2Fj.ijpharm.2026.127275)
- **Published At:** 2026-09-05T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This study evaluated low-temperature hot-melt extrusion (HME) combined with fused deposition modeling (FDM) 3D printing to produce personalized immediate-release **glipizide (GPZ)** tablets, addressing GPZ’s low aqueous solubility and high melting point. - Filaments were prepared at 60 °C and printed at 90 °C using a polymer matrix based on **KVA64** with mannitol (MAN) and triethyl citrate (TEC) as excipients/plasticizer. - Six formulations were screened; the optimal filament composition was 12% w/w GPZ, 69% w/w KVA64, 10% w/w MAN, and 9% w/w TEC; this filament showed acceptable flexibility, feedability, and moisture resistance. - Solid-state characterization (DSC, PXRD, TGA) indicated a **partially amorphous GPZ dispersion** with residual crystalline domains and no detectable thermal degradation during processing. - A mixed-level factorial design tested effects of infill pattern, number of shells, and layer thickness on drug release at 10 minutes; after Bonferroni correction, infill pattern, number of shells, and the infill pattern × layer thickness interaction remained significant. - Generally, grid infill and fewer shells accelerated drug release; the influence of layer thickness depended on infill architecture. - Dose-adjusted tablets with 5, 7.5, 10, and 15 mg GPZ were produced by changing tablet thickness while keeping diameter constant; thinner tablets dissolved faster due to higher surface area-to-volume ratios. - The 15 mg tablet failed to meet the immediate-release dissolution criterion at 30 minutes, indicating that height-based scaling alone may not preserve immediate-release performance at higher doses. - Conclusion: Low-temperature HME-FDM can produce personalized immediate-release GPZ tablets, but both tablet geometry and internal printing architecture must be optimized across doses to maintain release performance.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 3. # Low-temperature FDM 3D printing of immediate-release glipizide tablets: formulation optimization, solid-state characterization, and dose customization [Kasitpong Thanawuth](https://pubmed.ncbi.nlm.nih.gov/?term=Thanawuth+K&cauthor_id=42546995)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#full-view-affiliation-1 "College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand."), [Supakij Suttiruengwong](https://pubmed.ncbi.nlm.nih.gov/?term=Suttiruengwong+S&cauthor_id=42546995)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#full-view-affiliation-2 "Sustainable Materials Laboratory, Department of Materials Science and Engineering, Faculty of Engineering and Industrial Technology, Silpakorn University, Nakhon Pathom 73000, Thailand."), [Kampanart Huanbutta](https://pubmed.ncbi.nlm.nih.gov/?term=Huanbutta+K&cauthor_id=42546995)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#full-view-affiliation-1 "College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand."), [Sontaya Limmatvapirat](https://pubmed.ncbi.nlm.nih.gov/?term=Limmatvapirat+S&cauthor_id=42546995)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#full-view-affiliation-3 "Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand."), [Pornsak Sriamornsak](https://pubmed.ncbi.nlm.nih.gov/?term=Sriamornsak+P&cauthor_id=42546995)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#full-view-affiliation-4 "Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand; Academy of Science, The Royal Society of Thailand, Bangkok 10300, Thailand; Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India. Electronic address: sriamornsak_p@su.ac.th.") Affiliations Expand ### Affiliations * 1 College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand. * 2 Sustainable Materials Laboratory, Department of Materials Science and Engineering, Faculty of Engineering and Industrial Technology, Silpakorn University, Nakhon Pathom 73000, Thailand. * 3 Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand. * 4 Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand; Academy of Science, The Royal Society of Thailand, Bangkok 10300, Thailand; Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India. Electronic address: sriamornsak_p@su.ac.th. * PMID: **42546995** * DOI: [ 10.1016/j.ijpharm.2026.127275 ](https://doi.org/10.1016/j.ijpharm.2026.127275) Item in Clipboard # Low-temperature FDM 3D printing of immediate-release glipizide tablets: formulation optimization, solid-state characterization, and dose customization Kasitpong Thanawuth et al. Int J Pharm. 2026. Show details Display options Display options Format Abstract PubMed PMID Int J Pharm Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Int+J+Pharm%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Int+J+Pharm%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42546995/) . 2026 Sep 5:702:127275. doi: 10.1016/j.ijpharm.2026.127275. Epub 2026 Aug 3. ### Authors [Kasitpong Thanawuth](https://pubmed.ncbi.nlm.nih.gov/?term=Thanawuth+K&cauthor_id=42546995)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#short-view-affiliation-1 "College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand."), [Supakij Suttiruengwong](https://pubmed.ncbi.nlm.nih.gov/?term=Suttiruengwong+S&cauthor_id=42546995)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#short-view-affiliation-2 "Sustainable Materials Laboratory, Department of Materials Science and Engineering, Faculty of Engineering and Industrial Technology, Silpakorn University, Nakhon Pathom 73000, Thailand."), [Kampanart Huanbutta](https://pubmed.ncbi.nlm.nih.gov/?term=Huanbutta+K&cauthor_id=42546995)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#short-view-affiliation-1 "College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand."), [Sontaya Limmatvapirat](https://pubmed.ncbi.nlm.nih.gov/?term=Limmatvapirat+S&cauthor_id=42546995)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#short-view-affiliation-3 "Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand."), [Pornsak Sriamornsak](https://pubmed.ncbi.nlm.nih.gov/?term=Sriamornsak+P&cauthor_id=42546995)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42546995/#short-view-affiliation-4 "Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand; Academy of Science, The Royal Society of Thailand, Bangkok 10300, Thailand; Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India. Electronic address: sriamornsak_p@su.ac.th.") ### Affiliations * 1 College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand. * 2 Sustainable Materials Laboratory, Department of Materials Science and Engineering, Faculty of Engineering and Industrial Technology, Silpakorn University, Nakhon Pathom 73000, Thailand. * 3 Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand. * 4 Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand; Academy of Science, The Royal Society of Thailand, Bangkok 10300, Thailand; Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India. Electronic address: sriamornsak_p@su.ac.th. * PMID: **42546995** * DOI: [ 10.1016/j.ijpharm.2026.127275 ](https://doi.org/10.1016/j.ijpharm.2026.127275) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract Glipizide (GPZ), a biopharmaceutics classification system Class II antidiabetic drug with low aqueous solubility and a high melting point, presents challenges for fused deposition modeling (FDM) 3D printing due to the elevated processing temperatures commonly required. This study investigated low-temperature hot-melt extrusion (HME) and FDM 3D printing for the fabrication of personalized immediate-release GPZ tablets using vinylpyrrolidone-vinyl acetate copolymer (KVA64)-based filaments. GPZ-loaded filaments containing KVA64, mannitol (MAN), and triethyl citrate (TEC) were successfully prepared at 60 °C and printed at 90 °C. Among six formulations investigated, the filament composed of 12% w/w GPZ, 69% w/w KVA64, 10% w/w MAN, and 9% w/w TEC exhibited suitable flexibility, feedability, and moisture resistance. DSC, PXRD, and TGA findings were consistent with a partially amorphous GPZ dispersion containing residual crystalline domains, with no detectable thermal degradation under the processing conditions. A mixed-level factorial design was used to investigate the effects of infill pattern, number of shells, and layer thickness on GPZ release at 10 min. After Bonferroni adjustment for multiple comparisons, infill pattern, number of shells, and the infill pattern × layer thickness interaction remained statistically significant, whereas the main effect of layer thickness did not. Grid infill and fewer shells generally promoted faster drug release, while the effect of layer thickness depended on the infill architecture. Dose-adjusted tablets containing 5, 7.5, 10, and 15 mg GPZ were produced by modifying tablet thickness while maintaining a constant diameter. Thinner tablets exhibited faster dissolution because of their higher surface area-to-volume ratios. However, the 15 mg tablet did not meet the immediate-release dissolution criterion at 30 min, indicating that height-based scaling alone is insufficient for maintaining immediate-release performance at higher doses. These findings demonstrate the potential of low-temperature HME-FDM printing for personalized GPZ tablets while emphasizing the need to optimize both tablet geometry and internal architecture across the intended dose range. **Keywords:** Dose customization; Factorial design; Fused deposition modelling; Glipizide; Hot-melt extrusion; KVA64; Triethyl citrate. Copyright © 2026 Elsevier B.V. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ## Similar articles * [ Low temperature fused deposition modeling (FDM) 3D printing of thermolabile drugs. ](https://pubmed.ncbi.nlm.nih.gov/29705104/) Kollamaram G, Croker DM, Walker GM, Goyanes A, Basit AW, Gaisford S.Kollamaram G, et al.Int J Pharm. 2018 Jul 10;545(1-2):144-152. doi: 10.1016/j.ijpharm.2018.04.055. Epub 2018 Apr 26.Int J Pharm. 2018.PMID: 29705104 * [ Preparation and characterization of immediate release 3D printed tablets using hot melt extruded amorphous cyclosporine a filament. ](https://pubmed.ncbi.nlm.nih.gov/40024886/) Jeong JH, Han CS, Kang JH, Yoo KH, Jung WY, Park YS, Kim DW, Park CW.Jeong JH, et al.Pharm Dev Technol. 2025 Mar;30(3):295-305. doi: 10.1080/10837450.2025.2472893. Epub 2025 Mar 6.Pharm Dev Technol. 2025.PMID: 40024886 * [ Hot-Melt Extrusion of Bupropion with Three Ethylcellulose Grades for Pellet Feedstock Preparation and Screw-Based 3D Printing of Sustained-Release Tablets. ](https://pubmed.ncbi.nlm.nih.gov/42410104/) Protopapa C, Junqueira LA, Kolipaka SS, Economidou S, Pappas D, Douroumis D, Vlachou M.Protopapa C, et al.AAPS PharmSciTech. 2026 Jul 6;27(5):251. doi: 10.1208/s12249-026-03494-4.AAPS PharmSciTech. 2026.PMID: 42410104 * [ 3D-printed immediate release solid dosage forms: a patent evaluation of US11622940B2. ](https://pubmed.ncbi.nlm.nih.gov/39316578/) Sharma A, Rathi R, Sharma S, Sangnim T, Huanbutta K, Singh I.Sharma A, et al.Pharm Pat Anal. 2024;13(1-3):45-51. doi: 10.1080/20468954.2024.2389774. Epub 2024 Sep 4.Pharm Pat Anal. 2024.PMID: 39316578Free PMC article.Review. * [ Challenges, current status and emerging strategies in the development of rapidly dissolving FDM 3D-printed tablets: An overview and commentary. ](https://pubmed.ncbi.nlm.nih.gov/36778904/) Serajuddin ATM.Serajuddin ATM.ADMET DMPK. 2023 Jan 1;11(1):33-55. doi: 10.5599/admet.1622. eCollection 2023.ADMET DMPK. 2023.PMID: 36778904Free PMC article.Review. 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