Trends in the production methods of orodispersible films

Musazzi, Umberto M.; Khalid, Garba M.; Selmin, Francesca; Minghetti, Paola

doi:10.1016/j.ijpharm.2019.118963

Cited by 83 publications

(82 citation statements)

References 107 publications

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“…ODFs are composed of water-soluble polymers, such as pullulan [ 11 , 12 ], poly(vinyl alcohol) (PVA) [ 6 , 13 , 14 , 15 , 16 ] cellulose derivates (hydroxypropyl methylcellulose, hydroxypropyl cellulose) [ 17 , 18 , 19 , 20 ], or starch [ 21 , 22 ] in which an active pharmaceutical ingredient (API) and other excipients, such as plasticizers, taste-masking agents or surfactants are incorporated [ 4 , 23 ]. They can be manufactured using various methods, i.e., solvent casting, hot melt extrusion, electrospinning, or printing techniques, i.e., inkjet, flexographic, and 3D printing [ 2 , 24 ]. The solvent casting method is the most common technique applied for the preparation of single or multilayer films on a lab-scale as well as industrial continuous production [ 18 , 24 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

et al. 2021

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Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already been investigated. The decision on the manufacturing method is of crucial importance because it affects film properties. This study aimed to compare electrospun ODFs containing aripiprazole and polyvinyl alcohol with films prepared using casting and 3D printing methods. Characterization of films included DSC and XRD analysis, microscopic analysis, the assessment of mechanical parameters, disintegration, and dissolution tests. Simplified stability studies were performed after one month of storage. All prepared films met acceptance criteria for mechanical properties. Electrospun ODFs disintegrated in 1.0 s, which was much less than in the case of other films. Stability studies have shown the sensitivity of electrospun films to the storage condition resulting in partial recrystallization of ARP. These changes negatively affected the dissolution rate, but mechanical properties and disintegration time remained at a desirable level. The results demonstrated that electrospun fibers are promising solutions that can be used in the future for the treatment of patients with swallowing problems.

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Section: Introductionmentioning

confidence: 99%

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

et al. 2021

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“…Oral dispersible films are among the most favored dosage forms of patients [ 62 , 63 ]. The unique properties of electrospun nanofibers reflect their potential applicability to oral dispersible films with great commercial value [ 64 , 65 ]. The reported KET-PVP films immediately dissolve when they encounter water ( Figures S2 and S3 in the Supplementary Information ) and may be fine candidates as dispersible films for fast trans-membrane drug delivery.…”

Section: Resultsmentioning

confidence: 99%

Energy-Saving Electrospinning with a Concentric Teflon-Core Rod Spinneret to Create Medicated Nanofibers

et al. 2020

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Although electrospun nanofibers are expanding their potential commercial applications in various fields, the issue of energy savings, which are important for cost reduction and technological feasibility, has received little attention to date. In this study, a concentric spinneret with a solid Teflon-core rod was developed to implement an energy-saving electrospinning process. Ketoprofen and polyvinylpyrrolidone (PVP) were used as a model of a poorly water-soluble drug and a filament-forming matrix, respectively, to obtain nanofibrous films via traditional tube-based electrospinning and the proposed solid rod-based electrospinning method. The functional performances of the films were compared through in vitro drug dissolution experiments and ex vivo sublingual drug permeation tests. Results demonstrated that both types of nanofibrous films do not significantly differ in terms of medical applications. However, the new process required only 53.9% of the energy consumed by the traditional method. This achievement was realized by the introduction of several engineering improvements based on applied surface modifications, such as a less energy dispersive air-epoxy resin surface of the spinneret, a free liquid guiding without backward capillary force of the Teflon-core rod, and a smaller fluid–Teflon adhesive force. Other non-conductive materials could be explored to develop new spinnerets offering good engineering control and energy savings to obtain low-cost electrospun polymeric nanofibers.

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“…The work of Edinger et al ( 37 ), for example, demonstrates the potential combination of 2D inkjet printing and the Quick-Response code (QR) technology to produce dosage forms with important information for the patient and/or healthcare professionals encoded in the dosage form itself. Moreover, a clear definition of non-destructive methods for QC and the availability of printers suitable for the use in a pharmacy setting, along with an introduction of a regulatory path that permits the development and use of personalized medical products, are required for future developments ( 9 ). Real-time monitoring of printed dosage forms is another aspect, especially also in the context of continuous manufacturing applications, towards more reliable and traceable pharmaceutical inkjet printing.…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, the possibility to print on many porous or non-porous substrates and biodegradable films has opened a new perspective for on-demand pharmaceutical manufacturing of personalized oral solid dosage forms ( 7 , 8 ). For inkjet printing, an introduction of a regulatory pathway that permits the development and use of personalized medical products via inkjet printing is required ( 9 ), also with regard to standardizing the characterization and quality control ( 10 ).…”

Section: Introductionmentioning

confidence: 99%

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

et al. 2021

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This study evaluates the potential use of near-infrared hyperspectral imaging (NIR-HSI) for quantitative determination of the drug amount in inkjet-printed dosage forms. We chose metformin hydrochloride as a model active pharmaceutical ingredient (API) and printed it onto gelatin films using a piezoelectric inkjet printing system. An industry-ready NIR-HSI sensor combined with a motorized movable linear stage was applied for spectral acquisition. Initial API-substrate screening revealed best printing results for gelatin films with TiO2 filling. For calibration of the NIR-HSI system, escalating drug doses were printed on the substrate. After spectral pre-treatments, including standard normal variate (SNV) and Savitzky-Golay filtering for noise reduction and enhancement of spectral features, principal component analysis (PCA) and partial least squares (PLS) regression were applied to create predictive models for the quantification of independent printed metformin hydrochloride samples. It could be shown that the concentration distribution maps provided by the developed HSI models were capable of clustering and predicting the drug dose in the formulations. HSI model prediction showed significant better correlation to the reference (HPLC) compared to on-board monitoring of dispensed volume of the printer. Overall, the results emphasize the capability of NIR-HSI as a fast and non-destructive method for the quantification and quality control of the deposited API in drug-printing applications. Graphical abstract

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Trends in the production methods of orodispersible films

Cited by 83 publications

References 107 publications

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

Energy-Saving Electrospinning with a Concentric Teflon-Core Rod Spinneret to Create Medicated Nanofibers

Near-Infrared Hyperspectral Imaging as a Monitoring Tool for On-Demand Manufacturing of Inkjet-Printed Formulations

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