Terahertz-spectroscopy for non-destructive determination of crystallinity of L-tartaric acid in smartFilms® and tablets made from paper

Ornik, Jan; Knoth, Daniel; Koch, Martin; Keck, Cornelia M.

doi:10.1016/j.ijpharm.2020.119253

Cited by 16 publications

(7 citation statements)

References 50 publications

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“…Porosity and drug mass fraction Indomethacin [217] Crystallinity L-tartaric acid [218] Analysis of inner structure of tablets incorporated with pellets Theophylline [219] Nuclear magnetic resonance imaging…”

Section: Terahertz Pulsed Imagingmentioning

confidence: 99%

“…Terahertz pulsed imaging utilizes non-ionizing radiations to record the refractive index and physicochemical features of the tablet mass without inducing thermal stress within the sample. Terahertz pulsed imaging has been employed to evaluate crystallinity, polymorphism, density distribution, hardness, porosity, drug content and microstructure of tablets [192,218,238,239]. Moreover, terahertz pulsed imaging has been used to measure tablet coating thickness (Figure 4D) [240].…”

Section: Terahertz Pulsed Imagingmentioning

confidence: 99%

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A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

Arshad

Zafar

Yousef

et al. 2021

Advanced Drug Delivery Reviews

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Section: Terahertz Pulsed Imagingmentioning

confidence: 99%

Section: Terahertz Pulsed Imagingmentioning

confidence: 99%

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

Arshad

Zafar

Yousef

et al. 2021

Advanced Drug Delivery Reviews

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“…The production of smartFilms includes three main steps: first, the dissolution of the API in an appropriate (organic) solvent; second, the application of the solution on a cellulose-based paper matrix; and, finally, the drying of the obtained smartFilms. The resulting smartFilms can be easily transferred into convenient oral dosage forms, such as capsules or tablets, fulfilling the requirements of the European Pharmacopoeia [ 8 , 9 , 10 ]. The key problem of amorphous formulations is the physical instability of the amorphous state which can lead to recrystallization and consequently unpredictable and decreased solubility and, thus, insufficient bioavailability [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Terahertz Spectroscopy for Non-Destructive Solid-State Investigation of Norfloxacin in Paper Tablets after Wet Granulation

et al. 2023

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(1) Background: Amorphous drug systems are an intensively studied approach to overcome the insufficient bioavailability of poorly soluble drugs. Here, paper tablets were studied, which were made from cellulose-based paper matrices loaded with norfloxacin. Moreover, wet granulation was introduced as an additional processing step for improving the flowability of the solids, which is necessary when considering production on an industrial scale. (2) Methods: The possible impact of the wet granulation on the crystallinity of norfloxacin was studied by examining granulated and non-granulated samples. Crystallinity investigations were performed using X-ray powder diffraction (XRD) and terahertz time-domain spectroscopy (THz TDS). (3) Results: THz TDS allowed for a more straightforward crystallinity assessment than XRD. Moreover, using THz TDS, it was possible to detect minor changes in the crystallinity of the API after the granulation, whereas this was not possible with the XRD analysis. (4) Conclusions: THz TDS results indicate a partial crystallization of norfloxacin due to the wet granulation. Depending on the formulation, THz TDS can serve as a beneficial and advantageous tool to determine the crystallinity of an API.

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“…Due to this, the transfer of the smartFilms into appropriate oral dosage forms is important for improving patient compliance. Several studies already reported the successful compression of drug-loaded smartFilms into tablets without the addition of any excipients and demonstrated that the produced tablets fulfilled all requirements of the European Pharmacopeia [ 4 , 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Tablets Made from Paper—An Industrially Feasible Approach

et al. 2022

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Many orally administrated drugs exhibit poor bioavailability due to their limited solubility. The smartFilm technology is an innovative approach to improve the drug aqueous solubility, where the drug is embedded within the matrix of cellulose-based paper in an amorphous state, hence increasing its solubility. Despite its proven effectiveness, smartFilms, i.e., pieces of paper, exhibit limited flowability and are not easy to swallow, and thus oral administration is not convenient. In addition, there is a lack of knowledge of their mechanical behavior under compression. This study aimed to transform unloaded smartFilms, i.e., paper, into a flowable physical form and investigated its mechanical behavior when compressed. Granules made of paper were prepared via wet granulation and were compressed into tablets. The influence of using different amounts and forms of sucrose, as a binder, on the pharmaceutical properties of the produced granules and tablets was studied and the most suitable composition was identified by using instrumented die experiments. For this, the Poisson’s ratio and Young’s modulus were determined for different compaction force levels and the deformation behavior was estimated with the Heckel mathematical model. All granule batches showed good flowability with angle of repose values between 25–35°. Granule batches with ≤30% dry sucrose content produced tablets that fulfilled the European Pharmacopeia requirements, and the compaction behavior of the granules was found to be comparable to the behavior of classical binders and compression enhancers. Paper can be transferred into granules. These granules can be used as suitable intermediate products for the production of tablets made of paper in large, industrial scale.

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Terahertz-spectroscopy for non-destructive determination of crystallinity of L-tartaric acid in smartFilms® and tablets made from paper

Cited by 16 publications

References 50 publications

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

Terahertz Spectroscopy for Non-Destructive Solid-State Investigation of Norfloxacin in Paper Tablets after Wet Granulation

Tablets Made from Paper—An Industrially Feasible Approach

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