Controlled delivery via hot-melt extrusion: A focus on non-biodegradable carriers for non-oral applications

Koutsamanis, Ioannis; Roblegg, Eva; Spoerk, Martin

doi:10.1016/j.jddst.2023.104289

Cited by 9 publications

(3 citation statements)

References 165 publications

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“…extreme pH values, various solvents, different temperature conditions) [117][118][119][120]. In addition, preliminary research findings suggested the suitability of this material for pharmaceutical applications and particularly for the formulation of DDSs intended for oral administration [24,27,[121][122][123][124][125][126][127][128][129]. As a further advantage, filaments based on TPUs with different mechanical characteristics are already available, favoring the use of FDM for manufacturing the umbrella-like skeleton.…”

Section: Manufacturingmentioning

confidence: 99%

Development of a multi-component gastroretentive expandable drug delivery system (GREDDS) for personalized administration of metformin

Uboldi,

Chiappa,

Rossi

et al. 2023

Expert Opinion on Drug Delivery

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Objectives Efficacy and compliance of type II diabetes treatment would greatly benefit from dosage forms providing controlled release of metformin in the upper gastrointestinal tract. In this respect, the feasibility of a new system ensuring stomach-retention and personalized release of this drug at its absorption window for multiple days was investigated. MethodsThe system proposed comprised of a drug-containing core and a viscoelastic umbrella-like skeleton, which were manufactured by melt-casting and 3D printing. Prototypes, alone or upon assembly and insertion into commercially-available capsules, were characterized for key parameters: thermo-mechanical properties, accelerated stability, degradation, drug release, deployment performance and resistance to simulated gastric contractions.Results Each part of the system was successfully manufactured using purposely-selected materials and the performance of final prototypes matched the desired one. This included: i) easy folding of the skeleton against the core in the collapsed administered shape, ii) rapid recovery of the cumbersome configuration at the target site, even upon storage and iii) prolonged release of metformin.Conclusions Composition, geometry and performance of the system developed in this work were deemed acceptable for stomach retention and prolonged as well as customizable release of metformin at its absorption window, laying promising bases for further development steps.

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Section: Manufacturingmentioning

confidence: 99%

Development of a multi-component gastroretentive expandable drug delivery system (GREDDS) for personalized administration of metformin

Uboldi,

Chiappa,

Rossi

et al. 2023

Expert Opinion on Drug Delivery

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“…The pharmaceutical industry is undoubtedly intrigued by hot-melt extrusion (HME) technology, as evidenced by the substantial increase in patents and publications. HME is rapidly becoming the preferred choice in the pharmaceutical industry due to its solvent-free and eco-friendly approach to continuous manufacturing [1,2]. HME has proven highly effective in improving the solubility and dissolution of poorly water-soluble drugs by creating amorphous solid dispersions.…”

Section: Introductionmentioning

confidence: 99%

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation—Where Are We Now?

Patil,

Vemula,

Narala

et al. 2024

AAPS PharmSciTech

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Hot-melt extrusion (HME) is a globally recognized, robust, effective technology that enhances the bioavailability of poorly soluble active pharmaceutical ingredients and offers an efficient continuous manufacturing process. The twin-screw extruder (TSE) offers an extremely resourceful customizable mixer that is used for continuous compounding and granulation by using different combinations of conveying elements, kneading elements (forward and reverse configuration), and distributive mixing elements. TSE is thus efficiently utilized for dry, wet, or melt granulation not only to manufacture dosage forms such as tablets, capsules, or granule-filled sachets, but also for designing novel formulations such as dry powder inhalers, drying units for granules, nanoextrusion, 3D printing, complexation, and amorphous solid dispersions. Over the past decades, combined academic and pharmaceutical industry collaborations have driven novel innovations for HME technology, which has resulted in a substantial increase in published articles and patents. This article summarizes the challenges and models for executing HME scale-up. Additionally, it covers the benefits of continuous manufacturing, process analytical technology (PAT) considerations, and regulatory requirements. In summary, this well-designed review builds upon our earlier publication, probing deeper into the potential of twin-screw extruders (TSE) for various new applications. Graphical Abstract

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“…For instance, Xu et al reported that PLA brushes have no visible degradation even after 400 h at pH 3, a pH value close to that of gastric fluids. While the degradation rate of PLA is dependent on its environmental usage conditions, its manufactured form, molecular structure, and average molecular weight are factors that can influence its rate. , Drug delivery systems are typically produced by microencapsulation, solvent casting, hot melt extrusion, − and 3D printing process . 3D printing, also known as additive manufacturing, is emerging as a popular manufacturing process as it offers advantages such as customization, which is particularly advantageous for tailored or personalized drug delivery .…”

Section: Introductionmentioning

confidence: 99%

Utilizing Food Waste in 3D-Printed PLA Formulations to Achieve Sustainable and Customizable Controlled Delivery Systems

Wang,

Yong,

Loo

2024

ACS Omega

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This is the first study that explores blending polylactic acid (PLA) with various biomasses, including food wastes�brewer's spent grain (BSG), spent coffee grounds (SCG), sesame cake (SC), and thermoplastic starch (TPS) biomass to create composite gastric floating drug delivery systems (GFDDS) through 3D printing. The aim is to investigate the influence of biomass percentage, biomass type, and printing parameters on their corresponding drug release profiles. 3D-printed (3DP) composite filaments were prepared by blending biomasses and PLA before in vitro drug release studies were performed using hydrophilic and hydrophobic model drugs, metoprolol tartrate (MT), and risperidone (RIS). The data revealed that release profiles were influenced by composite compositions and wall thicknesses of 3DP GFDDS capsules. Up to 15% of food waste could be blended with PLA for all food waste types tested. Delivery studies for PLA-food wastes found that MT was fully released by 4 h, exhibiting burst release profiles after a lag time of 0.5 to 1.5 h, and RIS could achieve a sustained release profile of approximately 48 h. PLA-TPS was utilized as a comparison and demonstrated variable release profiles ranging from 8 to 120 h, depending on the TPS content. The results demonstrated the potential for adjusting drug release profiles by incorporating affordable biomasses into GFDDS. This study presents a promising direction for creating delivery systems that are sustainable, customizable, and cost-effective, utilizing sustainable materials that can also be employed for agricultural, nutraceutical, personal care, and wastewater treatment applications.

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Controlled delivery via hot-melt extrusion: A focus on non-biodegradable carriers for non-oral applications

Cited by 9 publications

References 165 publications

Development of a multi-component gastroretentive expandable drug delivery system (GREDDS) for personalized administration of metformin

Development of a multi-component gastroretentive expandable drug delivery system (GREDDS) for personalized administration of metformin

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation—Where Are We Now?

Utilizing Food Waste in 3D-Printed PLA Formulations to Achieve Sustainable and Customizable Controlled Delivery Systems

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