Twin-screw extrusion of sustained-release oral dosage forms and medical implants

Feng, Xinliang; Zhang, Feng

doi:10.1007/s13346-017-0461-9

Cited by 14 publications

(13 citation statements)

References 100 publications

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“…Most of the time, a twin-screw extruder will be starve fed with the raw materials. This means that the output rate of the extrudates will depend on the feeder and independent of the screw speed [24]. In a twin-screw extruder, the screws can either be co-rotating (screws rotate in the same direction) or counter-rotating (screws rotate in the opposite direction) (Figure 3).…”

Section: Mechanism Of Hot-melt Extrusion (Hme)mentioning

confidence: 99%

Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery

2018

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Three-dimensional printing, also known as additive manufacturing, is a fabrication process whereby a 3D object is created layer-by-layer by depositing a feedstock material such as thermoplastic polymer. The 3D printing technology has been widely used for rapid prototyping and its interest as a fabrication method has grown significantly across many disciplines. The most common 3D printing technology is called the Fused Deposition Modelling (FDM) which utilises thermoplastic filaments as a starting material, then extrudes the material in sequential layers above its melting temperature to create a 3D object. These filaments can be fabricated using the Hot-Melt Extrusion (HME) technology. The advantage of using HME to manufacture polymer filaments for FDM printing is that a homogenous solid dispersion of two or more pharmaceutical excipients i.e., polymers can be made and a thermostable drug can even be introduced in the filament composition, which is otherwise impractical with any other techniques. By introducing HME techniques for 3D printing filament development can improve the bioavailability and solubility of drugs as well as sustain the drug release for a prolonged period of time. The latter is of particular interest when medical implants are considered via 3D printing. In recent years, there has been increasing interest in implementing a continuous manufacturing method on pharmaceutical products development and manufacture, in order to ensure high quality and efficacy with less batch-to-batch variations of the pharmaceutical products. The HME and FDM technology can be combined into one integrated continuous processing platform. This article reviews the working principle of Hot Melt Extrusion and Fused Deposition Modelling, and how these two technologies can be combined for the use of advanced pharmaceutical applications.

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Section: Mechanism Of Hot-melt Extrusion (Hme)mentioning

confidence: 99%

Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery

2018

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“…From 1997 to 2009, Rezulin®, Kaletra®, and Norvir® were the only three ASD produced by HME that received FDA approval (48,49). In a similar period, from 2009 to 2019, six ASD products manufactured by HME received FDA approval.…”

Section: Hot-melt Extrusionmentioning

confidence: 99%

“…HME, in particular twin-screw extrusion, is a robust processing method in producing ASDs. The rotating screws in twin-screw extrusion provide dispersive and distributive mixing of the API with polymeric excipients, providing enhanced mixing in comparison to single-screw extrusion ( 49 ). Twin-screw HME is also easily scalable, ensuring cost-effective large volume production.…”

Section: Recent Innovation Formulations Via Hot-mementioning

confidence: 99%

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Tan

Davis

Miller³

et al. 2020

AAPS PharmSciTech

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Thermal processing has gained much interest in the pharmaceutical industry, particularly for the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical ingredients (APIs) with poor aqueous solubility. Formulation scientists have developed various techniques which may include physical and chemical modifications to achieve solubility enhancement. One of the most commonly used methods for solubility enhancement is through the use of amorphous solid dispersions (ASDs). Examples of commercialized ASDs include Kaletra®, Kalydeco®, and Onmel®. Various technologies produce ASDs; some of the approaches, such as spray-drying, solvent evaporation, and lyophilization, involve the use of solvents, whereas thermal approaches often do not require solvents. Processes that do not require solvents are usually preferred, as some solvents may induce toxicity due to residual solvents and are often considered to be damaging to the environment. The purpose of this review is to provide an update on recent innovations reported for using hot-melt extrusion and KinetiSol® Dispersing technologies to formulate poorly water-soluble APIs in amorphous solid dispersions. We will address development challenges for poorly water-soluble APIs and how these two processes meet these challenges.

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“…27 It is a continuous manufacturing technique that involves feeding, heating, mixing and shaping. 28 In recent years, it has proved that Hot melt extrusion capable to optimize the solubility and bioavailability of moderately soluble drugs. 29…”

Section: Hot Melt Extrusion (Hme)mentioning

confidence: 99%

3D Printing in Pharmaceutical Technology – A Review

Ponni

Swamivelmanickam

Sivakrishnan

2020

IJPI

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Three-dimensional printing is a revolutionary technique that uses computer aided design software and programming to create three dimensional objects by placing material on a substrate. 3D printing is an additive layer manufacturing techniques, where consecutive layers of material are deposited or solidified to form a 3D structure. Medicinal substances is configured in three dimensional with computer assisted design module and transformed to a machine legible form which suggests the exterior emerge of the 3D dose form, then it sliced this surface into number of different printable coats and convey these layers to the machine. The different 3D printing techniques has been developing and developed to fabricate novel solid dosage forms, which are among the most well-known and discrete products today. The 3D printing process desires to be espoused by pharmaceutical sector and capable of exploring the marvels fetched by the approach. 3D printing can include a very new possibilities to optimized medicine. The current review is an effort of briefing various methods

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Twin-screw extrusion of sustained-release oral dosage forms and medical implants

Cited by 14 publications

References 100 publications

Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery

Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

3D Printing in Pharmaceutical Technology – A Review

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