Reprint of “Characterisation and modelling of the thermorheological properties of pharmaceutical polymers and their blends using capillary rheometry: Implications for hot melt processing of dosage forms”

2015 ◽  
Vol 496 (1) ◽  
pp. 86-94 ◽  
Author(s):  
David S. Jones ◽  
Daniel N. Margetson ◽  
Mark S. McAllister ◽  
Gavin P. Andrews
Keyword(s):  
Dosage Forms ◽  
Melt Processing ◽  
Capillary Rheometry ◽  
Hot Melt

scholarly journals Heat Treatment Induced Specified Aggregation Morphology of Metoprolol Tartrate in Poly(ε-caprolactone) Matrix and the Drug Release Variation

Polymers ◽  
2021 ◽  
Vol 13 (18) ◽  
pp. 3076
Author(s):  
Zhiyu Liu ◽  
Hangling Song ◽  
Xia Chen ◽  
Aichun Han ◽  
Guiting Liu ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Drug Release ◽  
Controlled Drug Release ◽  
Treatment Method ◽  
Melt Processing ◽  
Metoprolol Tartrate ◽  
Release Behavior ◽  
Drug Release Behavior ◽  
Phosphate Buffered Saline ◽  
Hot Melt

Hot-melt blending has been widely used in the pharmaceutical industry to produce drug delivery systems, however, realizing the controlled drug release behavior of a hot-melt blended medicament it is still a tough challenge. In this study, we developed a simple and effective heat treatment method to adjust the drug release behavior, without the addition of any release modifiers. Thin metoprolol tartrate (MPT)/poly(ε-caprolactone) (PCL) tablets were prepared through hot-melt processing, and different morphologies of MPT were obtained by altering processing temperatures and the following heat treatment. MPT particles with different particle sizes were obtained under different processing temperatures, and fibrous crystals of MPT were fabricated during the following heat treatment. Different morphological structures of MPT adjusted the drug diffusion channel when immersed in phosphate-buffered saline (PBS), and various drug release behaviors were approached. After being immersed for 24 h, 7% of the MPT was released from the blend processed at 130 °C, while more than 95% of the MPT were released after the following heat treatment of the same sample. Thus, flexible drug release behaviors were achieved using this simple and effective processing manufacture, which is demonstrated to be of profound importance for biomedical applications.

scholarly journals Hot-Melt 3D Extrusion for the Fabrication of Customizable Modified-Release Solid Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 738 ◽  
Author(s):  
Jaemin Lee ◽  
Chanwoo Song ◽  
Inhwan Noh ◽  
Sangbyeong Song ◽  
Yun-Seok Rhee
Keyword(s):  
Dissolution Rate ◽  
Dosage Form ◽  
Amorphous State ◽  
Dosage Forms ◽  
Modified Release ◽  
Solid Dosage Forms ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Enhanced Solubility ◽  
Hot Melt

In this work, modified-release solid dosage forms were fabricated by adjusting geometrical properties of solid dosage forms through hot-melt 3D extrusion (3D HME). Using a 3D printer with air pressure driving HME system, solid dosage forms containing ibuprofen (IBF), polyvinyl pyrrolidone (PVP), and polyethylene glycol (PEG) were printed by simultaneous HME and 3D deposition. Printed solid dosage forms were evaluated for their physicochemical properties, dissolution rates, and floatable behavior. Results revealed that IBF content in the solid dosage form could be individualized by adjusting the volume of solid dosage form. IBF was dispersed as amorphous state with enhanced solubility and dissolution rate in a polymer solid dosage form matrix. Due to absence of a disintegrant, sustained release of IBF from printed solid dosage forms was observed in phosphate buffer at pH 6.8. The dissolution rate of IBF was dependent on geometric properties of the solid dosage form. The dissolution rate of IBF could be modified by merging two different geometries into one solid dosage form. In this study, the 3D HME process showed high reproducibility and accuracy for preparing dosage forms. API dosage and release profile were found to be customizable by modifying or combining 3D modeling.

Ethylene vinyl acetate as matrix for oral sustained release dosage forms produced via hot-melt extrusion

2011 ◽  
Vol 77 (2) ◽  
pp. 297-305 ◽  
Author(s):  
A. Almeida ◽  
S. Possemiers ◽  
M.N. Boone ◽  
T. De Beer ◽  
T. Quinten ◽  
...  
Keyword(s):  
Sustained Release ◽  
Vinyl Acetate ◽  
Ethylene Vinyl Acetate ◽  
Hot Melt Extrusion ◽  
Dosage Forms ◽  
Melt Extrusion ◽  
Hot Melt

scholarly journals Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1613
Author(s):  
Jiaxiang Zhang ◽  
Anqi Lu ◽  
Rishi Thakkar ◽  
Yu Zhang ◽  
Mohammed Maniruzzaman
Keyword(s):  
Thin Films ◽  
3D Printing ◽  
Drug Release ◽  
Hot Melt Extrusion ◽  
Dosage Forms ◽  
Solvent Free ◽  
Melt Extrusion ◽  
Physico Chemical ◽  
3D Printed ◽  
Hot Melt

Conventional oral dosage forms may not always be optimal especially for those patients suffering from dysphasia or difficulty swallowing. Development of suitable oral thin films (OTFs), therefore, can be an excellent alternative to conventional dosage forms for these patient groups. Hence, the main objective of the current investigation is to develop oral thin film (OTF) formulations using novel solvent-free approaches, including additive manufacturing (AM), hot-melt extrusion, and melt casting. AM, popularly recognized as 3D printing, has been widely utilized for on-demand and personalized formulation development in the pharmaceutical industry. Additionally, in general active pharmaceutical ingredients (APIs) are dissolved or dispersed in polymeric matrices to form amorphous solid dispersions (ASDs). In this study, acetaminophen (APAP) was selected as the model drug, and Klucel™ hydroxypropyl cellulose (HPC) E5 and Soluplus® were used as carrier matrices to form the OTFs. Amorphous OTFs were successfully manufactured by hot-melt extrusion and 3D printing technologies followed by comprehensive studies on the physico-chemical properties of the drug and developed OTFs. Advanced physico-chemical characterizations revealed the presence of amorphous drug in both HME and 3D printed films whereas some crystalline traces were visible in solvent and melt cast films. Moreover, advanced surface analysis conducted by Raman mapping confirmed a more homogenous distribution of amorphous drugs in 3D printed films compared to those prepared by other methods. A series of mathematical models were also used to describe drug release mechanisms from the developed OTFs. Moreover, the in vitro dissolution studies of the 3D printed films demonstrated an improved drug release performance compared to the melt cast or extruded films. This study suggested that HME combined with 3D printing can potentially improve the physical properties of formulations and produce OTFs with preferred qualities such as faster dissolution rate of drugs.

scholarly journals Hot-melt extrusion and prilling as contemporary and promising techniques in the solvent free production of solid oral dosage forms, based on solid dispersions

2016 ◽  
Vol 62 (1) ◽  
pp. 3-24 ◽  
Author(s):  
Aleksandar Aleksovski ◽  
Chris Vervaet ◽  
Rok Dreu
Keyword(s):  
Drug Delivery ◽  
Hot Melt Extrusion ◽  
Dosage Forms ◽  
Solvent Free ◽  
Oral Dosage ◽  
Drug Dissolution ◽  
Melt Extrusion ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Hot Melt

Hot melt extrusion and prilling are gaining importance as solvent free and continuous techniques in the production of solid oral dosage forms with added value, by incorporating active compound in a molten carrier which is further solidified to form solid dispersion. This article reviews these two techniques in terms of understanding process basics, equipment characteristics, required properties of processed materials and application of the processes for development of solid oral dosage forms. Studies revealed that both hot-melt extrusion and prilling are regarded as simple, robust and continuous methods for processing different types of materials and production of solid dosage forms based on solid matrices. However, understanding of their concepts and requirements together with careful material selection is crucial for stable material processing and obtaining stable products of high-quality. Hot-melt extrusion proved to be a suitable method for production of modified release dosage forms, taste masked dosage forms and dosage forms offering improved drug dissolution rate and solubility. Prilling till now has been successfully applied just in the production of multiple unit drug delivery systems for immediate and sustained drug delivery. Further studies on product development and process understanding are required for full implementation of prilling in the pharmaceutical field.

scholarly journals Rheological, Thermal, and Degradation Properties of PLA/PPG Blends

Materials ◽  
2019 ◽  
Vol 12 (21) ◽  
pp. 3519 ◽  
Author(s):  
Dong Xie ◽  
Yang Zhao ◽  
Yuan Li ◽  
Anna Marie LaChance ◽  
Jinqing Lai ◽  
...  
Keyword(s):  
Melt Processing ◽  
Polypropylene Glycol ◽  
Melt Viscosity ◽  
Pseudoplastic Fluid ◽  
Capillary Rheometry ◽  
Torque Rheometry ◽  
Fluid Behavior ◽  
Degradation Degree ◽  
Degradation Properties ◽  
The Relationship

The work presented herein focuses on simulating the compounding process via a torque rheometer, as well as the relationship between the melt viscosity and the polymer molecular weight (MW). We aim to predict the plasticization of polylactic acid (PLA) using polypropylene glycol (PPG) with different MWs. The rheological properties of the PLA/PPG composites containing PPG with different MWs were systematically studied by capillary rheometry and torque rheometry. The initial degradation of PLA/PPG composites during melt processing was monitored in real time. The results indicate that PPG can significantly reduce the melt viscosity of PLA/PPG composites, leading to obvious pseudoplastic fluid behavior. The lower the MW of PPG, the lower the viscosity of the PLA/PPG composite. The addition of PPG was favorable for the degradation of PLA during processing, and the degradation degree of the composite materials increased as the MW of PPG was decreased.

scholarly journals Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 511 ◽  
Author(s):  
Hanna Ponsar ◽  
Raphael Wiedey ◽  
Julian Quodbach
Keyword(s):  
Process Analysis ◽  
Hot Melt Extrusion ◽  
Quality Attributes ◽  
Dosage Forms ◽  
Melt Extrusion ◽  
Critical Quality Attributes ◽  
Filament Diameter ◽  
3D Printed ◽  
The Impact ◽  
Hot Melt

Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM is favored to allow the production of pharma-grade filaments for the printing of medicines. Filament diameter consistency is a quality of great importance to ensure printability and content uniformity of 3D-printed drug delivery systems. A systematical process analysis referring to filament diameter variations has not been described in the literature. The presented study aimed at a process setup optimization and rational process analysis for filament fabrication related to influencing parameters on diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality attributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage forms was investigated. Process optimization by implementing a winder with a special haul-off unit was necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for conduction of rational extrusion analysis. The results revealed that an increased screw speed led to diameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass uniformity of printed dosage forms. The specific feed load was identified as a key parameter for filament diameter consistency.

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