Consistency of Pharmaceutical Products: An FDA Perspective on Hot-Melt Extrusion Process

2013 ◽  
pp. 435-445
Author(s):  
Abhay Gupta ◽  
Mansoor A. Khan
Keyword(s):  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Pharmaceutical Products ◽  
Melt Extrusion ◽  
Hot Melt

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

Pharmaceutics ◽  
2018 ◽  
Vol 10 (4) ◽  
pp. 203 ◽  
Author(s):  
Deck Tan ◽  
Mohammed Maniruzzaman ◽  
Ali Nokhodchi
Keyword(s):  
3D Printing ◽  
Hot Melt Extrusion ◽  
Pharmaceutical Products ◽  
Fused Deposition Modelling ◽  
Melt Extrusion ◽  
3D Object ◽  
3D Printing Technology ◽  
Fused Deposition ◽  
Pharmaceutical Applications ◽  
Hot Melt

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.

Global approach for the validation of an in-line Raman spectroscopic method to determine the API content in real-time during a hot-melt extrusion process

Talanta ◽  
2017 ◽  
Vol 171 ◽  
pp. 45-52 ◽  
Author(s):  
L. Netchacovitch ◽  
J. Thiry ◽  
C. De Bleye ◽  
E. Dumont ◽  
J. Cailletaud ◽  
...  
Keyword(s):  
Real Time ◽  
Spectroscopic Method ◽  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Global Approach ◽  
Melt Extrusion ◽  
Raman Spectroscopic ◽  
Hot Melt

scholarly journals Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion

Polymers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2950
Author(s):  
Ioannis Koutsamanis ◽  
Martin Spoerk ◽  
Florian Arbeiter ◽  
Simone Eder ◽  
Eva Roblegg
Keyword(s):  
Material Selection ◽  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Controlled Delivery ◽  
Application Site ◽  
Melt Extrusion ◽  
Average Pore ◽  
Porous Carrier ◽  
Good Patient Compliance ◽  
Hot Melt

Implantable drug delivery systems (IDDSs) offer good patient compliance and allow the controlled delivery of drugs over prolonged times. However, their application is limited due to the scarce material selection and the limited technological possibilities to achieve extended drug release. Porous structures are an alternative strategy that can overcome these shortcomings. The present work focuses on the development of porous IDDS based on hydrophilic (HPL) and hydrophobic (HPB) polyurethanes and chemical pore formers (PFs) manufactured by hot-melt extrusion. Different PF types and concentrations were investigated to gain a sound understanding in terms of extrudate density, porosity, compressive behavior, pore morphology and liquid uptake. Based on the rheological analyses, a stable extrusion process guaranteed porosities of up to 40% using NaHCO3 as PF. The average pore diameter was between 140 and 600 µm and was indirectly proportional to the concentration of PF. The liquid uptake of HPB was determined by the open pores, while for HPL both open and closed pores influenced the uptake. In summary, through the rational selection of the polymer type, the PF type and concentration, porous carrier systems can be produced continuously via extrusion, whose properties can be adapted to the respective application site.

scholarly journals Hot-melt extrusion process impact on polymer choice of glyburide solid dispersions: The effect of wettability and dissolution

2019 ◽  
Vol 559 ◽  
pp. 245-254 ◽  
Author(s):  
Maen Alshafiee ◽  
Mohammad K. Aljammal ◽  
Daniel Markl ◽  
Adam Ward ◽  
Karl Walton ◽  
...  
Keyword(s):  
Solid Dispersions ◽  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Melt Extrusion ◽  
Hot Melt

Fabrication of Indomethacin-Loaded Polyvinyl Alcohol Filaments through Hot-Melt Extrusion

2020 ◽  
Vol 859 ◽  
pp. 247-251
Author(s):  
Kasitpong Thanawuth ◽  
Pornsak Sriamornsak
Keyword(s):  
Polyvinyl Alcohol ◽  
Drug Loading ◽  
Analysis Data ◽  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Melt Extrusion ◽  
Scanning Calorimetry ◽  
Yellow Color ◽  
Model Drug ◽  
Hot Melt

The main objective of this study was to prepare the drug-loaded filament by hot-melt extrusion technique. Indomethacin (IND) was used as a model drug and polyvinyl alcohol (PVA) was used to produce the filament. The IND-PVA filament had clear yellow color and rough surface. Drug loading in the filament that was determined from three segments of the filament was similar, indicating that IND was homogeneously distributed in the filament.This finding was confirmed by differential scanning calorimetry and powder X-ray diffraction. In addition, thermogravimetric analysis data suggested that the drug and polymer were not degraded at temperature used in extrusion process. The filament could be further developed as dosage form or applied as starting material for 3D-printed dosage forms.

The effect of pressurized carbon dioxide as a plasticizer and foaming agent on the hot melt extrusion process and extrudate properties of pharmaceutical polymers

2006 ◽  
Vol 38 (3) ◽  
pp. 383-391 ◽  
Author(s):  
Geert Verreck ◽  
Annelies Decorte ◽  
Hongbo Li ◽  
David Tomasko ◽  
Albertina Arien ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Hot Melt Extrusion ◽  
Extrusion Process ◽  
Melt Extrusion ◽  
Foaming Agent ◽  
Hot Melt
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