Combination of FDM 3D Printing and Compressed Tablet for Preparation of Baclofen as Gastro-Floating Drug Delivery System (Conference Paper )#

Authors

  • Nuha Mohammed Abdulkhaleq Department of Pharmaceutics, College of Pharmacy, University of Baghdad
  • Mowafaq M. Ghareeb Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq

DOI:

https://doi.org/10.31351/vol31issSuppl.pp18-24

Keywords:

Sustained-release; 3D printing; hot-melt extrusion; gastro-floating device; baclofen

Abstract

This study aimed to develop an oral drug delivery system for gastro-retentive sustained drug release of baclofen by using a 3D printed capsular device since baclofen has a short half-life of 2.5 to 4 hours and has a narrow absorption window. Firstly sustained-release tablets of baclofen were formulated through the hot-melt extrusion of various thermoplastic polymers and direct compression of the extrudate, then a capsular device was designed and 3D printed to contain two air pockets to enable floating of the device and has four windows for drug release.

3D printing of the capsular device was done by an FDM printer using biodegradable PLA filament, and the sustained release tablets were inserted into the device to allow the medicine to be released into the stomach over a longer period. An in vitro buoyance test and an in vitro dissolution test were used to examine the buoyancy and sustained-release features of the formulated gastro-floating system.

Five sustained release formulas were developed using different thermoplastic polymers in hot-melt extrusion. Produced tablets were assayed for drug content, hardness, and friability while a DSC study was done on the selected formula. F 5 which contains 20% baclofen, 55% Eudragit RS-100, 20% ethylcellulose, and 5% PEG 4000 showed sustained release where the complete dissolution of the drug occurred in 12 hours, and the gastro-floating device remained floating all the time.

This method has a great potential for developing various floating drug delivery systems with the required release profile.

References

Jeong HM, Weon KY, Shin BS, Shin S. 3D-printed gastroretentive sustained release drug delivery system by applying design of experiment approach. Molecules. 2020;25(10).

M. Jaimini ACR and YST. Formulation and Evaluation of Famotidine Floating Tablets. Current Drug Delivery. 2007;4:51–5.

Cooney G, Heydtmann M, Smith ID. Baclofen and the alcohol withdrawal syndrome-a short review. Frontiers in Psychiatry. 2019;10(JAN):1–5.

Wuis EW, Dirks MJM, Vree TB, Van der Kleijn E. Pharmacokinetics of baclofen in spastic patients receiving multiple oral doses. Pharmaceutisch Weekblad Scientific Edition. 1990;12(2):71–4.

Gande S, Rao YM. Sustained-release effervescent floating matrix tablets of baclofen: Development, optimization and in vitro-in vivo evaluation in healthy human volunteers. DARU, Journal of Pharmaceutical Sciences. 2011;19(3):202–9.

Davis SS. Formulation strategies for absorption windows. Drug Discovery Today. 2005;10(4):249–57.

Tiwari R, Agarwal SK, Murthy RSR, Tiwari S. Formulation and evaluation of sustained release extrudes prepared via novel hot melt extrusion technique. Journal of Pharmaceutical Innovation. 2014;9(3):246–58.

Doelker E, Bilati U, Nguyen CA, Galindo-Rodriguez S, Sarraf AG. Processing of polymeric dosage forms for advanced drug delivery: From melt-extrudates to nanoparticles. Chimia. 2005;59(6):336–9.

Alshetaili A, Almutairy BK, Alshehri SM, Repka MA. Development and characterization of sustained-released donepezil hydrochloride solid dispersions using hot melt extrusion technology. Pharmaceutics. 2021;13(2):1–21.

Verhoeven E, De Beer TRM, Van den Mooter G, Remon JP, Vervaet C. Influence of formulation and process parameters on the release characteristics of ethylcellulose sustained-release mini-matrices produced by hot-melt extrusion. European Journal of Pharmaceutics and Biopharmaceutics. 2008;69(1):312–9.

Kollamaram G, Croker DM, Walker GM, Goyanes A, Basit AW, Gaisford S. Low temperature fused deposition modeling (FDM) 3D printing of thermolabile drugs. International Journal of Pharmaceutics. 2018;545(1–2):144–52.

Arafat B, Wojsz M, Isreb A, Forbes RT, Isreb M, Ahmed W, et al. Tablet fragmentation without a disintegrant: A novel design approach for accelerating disintegration and drug release from 3D printed cellulosic tablets. European Journal of Pharmaceutical Sciences. 2018;118(October 2017):191–9.

Lu J, Obara S, Liu F, Fu W, Zhang W, Kikuchi S. Melt extrusion for a high melting point compound with improved solubility and sustained release. AAPS PharmSciTech. 2018;19(1):358–70.

Ibrahim M, Naguib YW, Sarhan HA, Abdelkader H. Preformulation-assisted design and characterization of modified release gastroretentive floating extrudates towards improved bioavailability and minimized side effects of baclofen. Journal of Pharmaceutical Sciences. 2021;110(3):1227–39.

Anjali Devi N, Hadi MA, Rajitha P, Sharma JVC, Srinivasa Rao A. Formulation and evaluation of floating controlled release tablets of Imatinib mesylate using hydrophilic matrix system. International Journal of Pharmacy and Pharmaceutical Sciences. 2013;5(1):271–7.

Gryczke A, Schminke S, Maniruzzaman M, Beck J, Douroumis D. Biointerfaces Development and evaluation of orally disintegrating tablets ( ODTs ) containing Ibuprofen granules prepared by hot melt extrusion. Colloids and Surfaces B: Biointerfaces. 2011;86(2):275–84.

Alshehri SM, Park JB, Alsulays BB, Tiwari R V, Almutairy B, Alshetaili AS, et al. Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology. Journal of drug delivery science and technology. 2015 Jun;27:18–27.

Li Q, Guan X, Cui M, Zhu Z, Chen K, Wen H, et al. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. International Journal of Pharmaceutics. 2018;535(1–2):325–32.

Ansari KA, Vavia PR, Trotta F, Cavalli R. Cyclodextrin-based nanosponges for delivery of resveratrol: In vitro characterisation, stability, cytotoxicity and permeation study. AAPS PharmSciTech. 2011;12(1):279–86.

Kyaw Oo M, Mandal UK, Chatterjee B. Polymeric behavior evaluation of PVP K30-poloxamer binary carrier for solid dispersed nisoldipine by experimental design. Pharmaceutical Development and Technology. 2017;22(1):2–12.

Wasilewska K, Winnicka K. Ethylcellulose-a pharmaceutical excipient with multidirectional application in drug dosage forms development. Materials. 2019;12(20).

Vanza JD, Patel RB, Dave RR, Patel MR. Polyethylene oxide and its controlled release properties in hydrophilic matrix tablets for oral administration. Pharmaceutical Development and Technology. 2020;0(0):000.

Downloads

Published

2023-02-16

How to Cite

1.
Abdulkhaleq NM, Ghareeb MM. Combination of FDM 3D Printing and Compressed Tablet for Preparation of Baclofen as Gastro-Floating Drug Delivery System (Conference Paper )#. Iraqi Journal of Pharmaceutical Sciences [Internet]. 2023 Feb. 16 [cited 2024 Nov. 5];31(Suppl.):18-24. Available from: https://bijps.uobaghdad.edu.iq/index.php/bijps/article/view/1925