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

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.

Author(s):  
Gavin P Andrews

Currently, the pharmaceutical and healthcare industries are moving through a period of unparalleled change. Major multinational pharmaceutical companies are restructuring, consolidating, merging and more importantly critically assessing their competitiveness to ensure constant growth in an ever-more demanding market where the cost of developing novel products is continuously increasing. The pharmaceutical manufacturing processes currently in existence for the production of solid oral dosage forms are associated with significant disadvantages and in many instances provide many processing problems. Therefore, it is well accepted that there is an increasing need for alternative processes to dramatically improve powder processing, and more importantly to ensure that acceptable, reproducible solid dosage forms can be manufactured. Consequently, pharmaceutical companies are beginning to invest in innovative processes capable of producing solid dosage forms that better meet the needs of the patient while providing efficient manufacturing operations. This article discusses two emerging solid dosage form manufacturing technologies, namely hot-melt extrusion and fluidized hot-melt granulation.


Author(s):  
V. F. Kornushk ◽  
I. V. Bogunova ◽  
A. A. Flid ◽  
O. M. Nikolaeva ◽  
A. A. Grebenshchikov

The article deals with the application of the system approach for constructing informationalgorithmic support for the pharmaceutical development of solid dosage forms. Information modeling of the life cycle of pharmaceutical drug development has been carried out starting from the stage of studying the active pharmaceutical substance and ending with the utilization of the drug. These models are built in the IDEF0 nomination. A generalized block diagram is presented that reflects, in its most general form, the iterative process of developing a ready-made dosage form as applied to the further transfer of technology. The basis of the system approach is QbD - "Quality planned in the development". To implement the QbD principle on the basis of the system approach, systemic set-theoretic models of information support of pharmaceutical development in the nomenclature of Melentiev have been constructed. A model for controlling the pressing process is also provided, which takes into account all the technological stages in the development of a solid dosage form. Functional models in the IDEF0 nomenclature of the technological process are constructed from the preparation of premises, personnel and components of the dosage form to the stage of packing and packaging of the finished dosage form. The construction of an informational intellectual control system for pharmaceutical development has been considered in detail with particular attention paid to the construction of a database of medicinal and auxiliary substances using the example of solid dosage forms. In Melentiev's bracket notation, the database of auxiliary substances necessary for the design of a solid dosage form is filled. The "Entity-relationship" model and the relational model for the database of medicinal and auxiliary substances have been constructe


2021 ◽  
Vol 14 (4) ◽  
pp. 355
Author(s):  
Sameer Joshi ◽  
Rajnish Sahu ◽  
Vida A. Dennis ◽  
Shree R. Singh

Capsules are one of the major solid dosage forms available in a variety of compositions and shapes. Developments in this dosage form are not new, but the production of non-gelatin capsules is a recent trend. In pharmaceutical as well as other biomedical research, alginate has great versatility. On the other hand, the use of inorganic material to enhance material strength is a common research topic in tissue engineering. The research presented here is a combination of qualities of alginate and montmorillonite (MMT). These two materials were used in this research to produce a soft non-gelatin modified-release capsule. Moreover, the research describes a facile benchtop production of these capsules. The produced capsules were critically analyzed for their appearance confirming resemblance with marketed capsules, functionality in terms of drug encapsulation, as well as release and durability.


2018 ◽  
Vol 10 (6) ◽  
pp. 181
Author(s):  
Arif Budiman ◽  
Sandra Megantara ◽  
Putri Raraswati ◽  
Tazyinul Qoriah

Objective: The aim of this study was to develop a solid dosage form of glibenclamide with increasing the solubility properties of glibenclamide with cocrystallization method.Methods: Virtual screening was performed to investigate the interaction between glibenclamide and a co-former. Saccharin, the selected co-former, then co-crystallized with glibenclamide with equimolar ratios of 1:1 and 1:2 using the solvent evaporation method. Further characterization was performed using an infra-red (IR) spectrophotometer, differential scanning calorimetry (DSC), and powder x-ray diffraction (PXRD).Results: Co-crystals of 1:2 equimolar ratio were more highly soluble compared to pure glibenclamide (30-fold for 12 h and 24-fold for 24 h). The dissolution rate had also increased from 46.838% of pure glibenclamide to 77.655% of glibenclamide co-crystal in 60 min. There was no chemical reaction observed during the co-crystallization process based on the IR spectrum. However, there was a new peak in the X-Ray diffractogram and a reduction of melting point in the DSC curve, indicating the formation of co-crystals.Conclusion: The optimal co-crystal ratio of glibenclamide-saccharin was found to be 1:2, which was successful in improving the solubility of glibenclamide.


Pharmaceutics ◽  
2012 ◽  
Vol 4 (4) ◽  
pp. 531-550 ◽  
Author(s):  
Svetlana Ibrić ◽  
Jelena Djuriš ◽  
Jelena Parojčić ◽  
Zorica Djurić

Implementation of the Quality by Design (QbD) approach in pharmaceutical development has compelled researchers in the pharmaceutical industry to employ Design of Experiments (DoE) as a statistical tool, in product development. Among all DoE techniques, response surface methodology (RSM) is the one most frequently used. Progress of computer science has had an impact on pharmaceutical development as well. Simultaneous with the implementation of statistical methods, machine learning tools took an important place in drug formulation. Twenty years ago, the first papers describing application of artificial neural networks in optimization of modified release products appeared. Since then, a lot of work has been done towards implementation of new techniques, especially Artificial Neural Networks (ANN) in modeling of production, drug release and drug stability of modified release solid dosage forms. The aim of this paper is to review artificial neural networks in evaluation and optimization of modified release solid dosage forms.


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