This case study showed that hydroxypropyl methyl cellulose was the most suitable film-forming material for drug-free and caffeine-loaded films, providing fast dissolution films that were not sticky and were easy to handle.
Orodispersible dosage forms are promising new approaches for drug delivery. They enable an easy application, as there is no need to drink high amounts of liquids or swallow large solid dosage forms. The aim of the study was to develop an orodispersible film (ODF) as an alternative to tablets, syrups or suppositories for the treatment of vomiting and nausea, especially for the pediatric population. Formulations were investigated by X-ray diffraction, scanning electron and polarized light microscopy. Additionally, two commercially available electronic taste sensing systems were used to investigate the applied taste-masking strategies. Results obtained from X-ray-diffraction and polarized light microscopy showed no recrystallization of dimenhydrinate in the formulation when cyclodextrin or maltodextrin were used as solubilizing and complexing agent. All ODFs showed fast disintegration depending on the characterization method. In order to get taste information, the dimenhydrinate formulations were analytically compared to pure drug and drug-free formulations by electronic tongues. Results obtained from both systems are comparable and were used together for the first time. It was possible to develop an ODF of dimenhydrinate that is fast disintegrating even in small volumes of liquid. Furthermore, in vitro taste assessment by two electronic tongues revealed taste-masking effects by the excipients.
The enantiomer migration order of the chiral anaesthetic drug ketamine [RS‐2‐(2‐chlorophenyl)‐2‐(methylamino)cyclohexanone] was studied by capillary electrophoresis using various cyclodextrins as chiral selectors. The opposite migration order of the enantiomers of ketamine was observed when native α‐ and β‐cyclodextrins were used as chiral selectors in capillary electrophoresis. The possible mechanisms of the opposite enantiomer migration order were investigated by employing electrospray ionization mass spectrometry, 1H‐NMR spectrometry, one dimensional rotating frame nuclear Overhauser and exchange spectroscopy, X‐ray crystallography, and molecular modeling techniques. As this study indicates, capillary electrophoresis can be used as a reliable experimental technique for examination of the correctness of the results of molecular modeling calculations. In addition, based on X‐ray crystallographic analysis it was confirmed that (–)‐ketamine as a free base possesses S configuration.
The effect of the amount of the chiral selector, cellulose tris(3,5-dichlorophenylcarbamate) (CDCPC) on the separation characteristics of enantiomers of some charged and neutral analytes was studied in capillary electrochromatography (CEC). For better understanding of the effect of the loading of the chiral selector on the particles and pore size of the packing material, laser-beam particle size analyzer and scanning electron microscopy (SEM) were used. As shown in this study, CDCPC can be used for CEC enantioseparations of a wide range of chiral charged and neutral analytes with high efficiency. The loading of the polysaccharide derivative on the surface of silica materials even in high amounts does not markedly affect the particle size and porous structure of the packing material. The separation characteristics are strongly affected by the loading of CDCPC onto silica gel in both CEC and capillary liquid chromatography (CLC).
Child‐appropriate drug formulations are a prerequisite of successful drug therapy in children. Efficacy and safety must be given for the active pharmaceutical ingredient, but safety also for the used excipients, components of primary packaging materials, and devices. We are presently experiencing exciting times for pediatric drug development, stimulated by previous governmental incentives in both the European Union and the United States. The most important advances in pediatric drug formulation development are reviewed and evaluated in this article. Scientific publications and recent industry strategies indicate a clear shift from liquid dosage forms to novel solid dosage forms. Solid formulations are usually composed from excipients generally regarded as safe, whereas many liquid formulations contain excipients such as preservatives, antioxidants, or taste‐masking agents that raise concerns. Further, some recent clinical studies on swallowability, acceptability, and preference indicate superiority for small‐sized tablets, so‐called mini‐tablets, over conventional liquids. In general, multiparticulate solid dosage forms could partly replace the liquids and provide more stable and cheaper alternatives to existing drug products or new developments. Dispersible solid drug dosage forms like orodispersible tablets, mini‐tablets and films are even better opportunities for efficient and safe use in pediatrics. Novel measuring and administration devices may facilitate the handling and drug administration of these modern drug dosage forms. Combination products (drug‐device combinations) can easily be linked with new e‐health technologies in near future to further improve pediatric drug therapy.
Introduction: Oromucosal films, comprising mucoadhesive buccal films (MBFs) and orodispersible films (ODFs), are considered patient-centric dosage forms. Target groups are patients with special needs. Various active pharmaceutical ingredients have been shown to be suitable for oromucosal film production. A shift is seen in the production techniques, from conventional solvent casting to printing techniques. Areas covered: In this review, the patient acceptability of oromucosal films is discussed. An overview is given of the small molecule drugs, biopharmaceuticals and herbal extracts that have been incorporated so far. Finally, the current state of 2D and 3D printing techniques for production purposes is discussed. Expert opinion: The patient-centric features are important for the further development and acceptance of this oral solid dosage form. Oromucosal films perfectly fit in the current attention for personalized medicine. Both MBFs and ODFs are intended for either a local or a systemic effect. For buccal absorption, sufficient mucoadhesion is one of the most important criteria an oromucosal film must comply with. For the preparation, the solvent casting technique is still predominately used. Some limitations of this production method can be tackled by printing techniques. However, these novel techniques introduce new requirements, yet to be set, for oromucosal film preparation.
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