Orodispersible films: Product transfer from lab-scale to continuous manufacturing

Thabet, Yasmin; Breitkreutz, Jörg

doi:10.1016/j.ijpharm.2017.11.021

Cited by 38 publications

(16 citation statements)

References 15 publications

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“…Thus, ink solutions with dynamic viscosities >3000 mPas (shear rate 10 s −1 ) were the most favorable formulations for stencil printing. Formulations with dynamic viscosities of at least 1000 mPas (shear rate 6 s −1 ) have been successfully used to produce ODFs by solvent casting [8]. The viscosity of the ink formulation is of major importance in solvent casting, since it affects the API content per cm 2 .…”

Section: Discussionmentioning

confidence: 99%

“…This study shows that a pull-driven and batchwise production of personalized doses utilizing stencil printing technology and a polymer-based ink formulation was possible. A printing speed of 259 mm/min was used to manufacture 15 doses at a time, while solvent casting speeds of 17-339 mm/min have been used to manufacture ODFs [8]. The solvent cast film needs to be cut to make personalized doses.…”

Section: Discussionmentioning

confidence: 99%

“…Orodispersible films are conventionally manufactured using solvent casting and the formulation Pharmaceutics 2020, 12, 33; doi:10.3390/pharmaceutics12010033 www.mdpi.com/journal/pharmaceutics Pharmaceutics 2020, 12, 33 2 of 15 development is usually done on a smaller scale [7]. However, the film composition and the processing conditions need to be tuned when the production is moved from a laboratory scale to a continuous manufacturing process [8]. When manufacturing ODFs by solvent casting, the dosing can be adjusted by varying the wet film thickness during the manufacturing process or by varying the API content of the solution [9].…”

Section: Introductionmentioning

confidence: 99%

“…In solvent casting, flexographic, inkjet, and extrusion printing different solvents are used in the ink formulation, and consequently the formulations need to be dried. The use of organic solvents and the drying step has shown to have an impact on the mechanical properties of the ODFs [8]. Furthermore, the manufacturing method has also shown to have an impact on the mechanical properties; the ODFs made by solvent casting were more durable compared to ODFs prepared by FDM [19].…”

Section: Introductionmentioning

confidence: 99%

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Stencil Printing—A Novel Manufacturing Platform for Orodispersible Discs

et al. 2020

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Stencil printing is a commonly used printing method, but it has not previously been used for production of pharmaceuticals. The aim of this study was to explore whether stencil printing of drug containing polymer inks could be used to manufacture flexible dosage forms with acceptable mass and content uniformity. Formulation development was supported by physicochemical characterization of the inks and final dosage forms. The printing of haloperidol (HAL) discs was performed using a prototype stencil printer. Ink development comprised of investigations of ink rheology in combination with printability assessment. The results show that stencil printing can be used to manufacture HAL doses in the therapeutic treatment range for 6–17 year-old children. The therapeutic HAL dose was achieved for the discs consisting of 16% of hydroxypropyl methylcellulose (HPMC) and 1% of lactic acid (LA). The formulation pH remained above pH 4 and the results imply that the drug was amorphous. Linear dose escalation was achieved by an increase in aperture area of the print pattern, while keeping the stencil thickness fixed. Disintegration times of the orodispersible discs printed with 250 and 500 µm thick stencils were below 30 s. In conclusion, stencil printing shows potential as a manufacturing method of pharmaceuticals.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Stencil Printing—A Novel Manufacturing Platform for Orodispersible Discs

et al. 2020

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“…Następnie taśma z mokrym filmem przesuwana jest do kanału suszącego. Po wysuszeniu filmy zwijane są w rolki, które są cięte na pojedyncze jednostki leku, a następnie pakowane po usunięciu warstwy pośredniej [14].…”

Section: Metody Wytwarzania Filmów Odfunclassified

Orodispersible films (ODF) in individualized therapy

Łyszczarz¹,

Niwiński²,

Jachowicz³

2019

Farm Pol.

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Orodispersible films (ODF) in individualized therapy • One of the mains factors affecting the effectiveness and safety of the therapy is the development of an appropriate dosage form adapted to the age of the patients and ease to administer as well as a dosing devices that provide flexible dosing. This approach is in accordance with the idea of patientcentered treatment. Given advantages such as safety, easy swallowing and flexible dose adjustment, special attention is paid to oral dosage forms such as orally disintegrating tablets, minitablets and orodispersible films (ODF). The ODF films are indicated as a suitable dosage form for pediatric, geriatric and uncooperative patients due to their fast disintegration in the mouth without need for water to facilitate swallowing, adhesion to the oral cavity to prevent spitting out the medicine and the ability to adjust the dose of the drug for an individual patient. According to many studies, orodispersible films are well accepted by infants and preschool children, their caregivers (nurses) and parents. They have the form of a postage stamp sized strip of thin polymeric film applied on the tongue. The ODF films can be manufactured using various methods, i.e. casting method, hot melt extrusion, electrospinning or printing (inkjet, flexographic and 3D printing) on an industrial scale and potentially in hospital pharmacies. Extemporaneous preparation of the ODF films create more dose flexibility affecting patient's adherence to pharmacotherapy. Innovative solutions in this area concern also designed specifically devices for storage and dosing of ODF, as well as methods of labeling and identification of single doses, for example Quick Response (QR) codes. The paper presents a review of the literature from recent years regarding new technology in the terms of the ODF films preparation, including manufacturing methods and modification of the drug release, as well as the possibilities of their application in individualization of the therapy especially in pediatric and geriatric population.

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Green Synthesis of Carbohydrate Polymer Based Gum Kondagogu/Hydroxypropyl Cellulose Blend Silver Nanocomposite Film and Their Antimicrobial Activity

Nagaraja,

2024

J Polym Environ

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Orodispersible films: Product transfer from lab-scale to continuous manufacturing

Cited by 38 publications

References 15 publications

Stencil Printing—A Novel Manufacturing Platform for Orodispersible Discs

Stencil Printing—A Novel Manufacturing Platform for Orodispersible Discs

Orodispersible films (ODF) in individualized therapy

Green Synthesis of Carbohydrate Polymer Based Gum Kondagogu/Hydroxypropyl Cellulose Blend Silver Nanocomposite Film and Their Antimicrobial Activity

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