13. September 2018
Orodispersible films (ODFs) provide high application comfort due to rapid disintegration in the oral cavity. They increasingly found the approval of pharmaceutical research and development and were added to the European Pharmacopeia in 2012. The European Pharmacopeia explicitly demands disintegration testing for ODFs, but does not refer to a suitable method. The aim of this study was to collect and evaluate existing disintegration methods regarding their suitability to investigate different ODF...
30. May 2018
The aim of this study was to develop a palatable donepezil (DP) orodispersible film (ODF) to facilitate the swallowing process and investigate the effect of cyclodextrin on taste-masking based on dynamic process and in vivo drug absorption. Complexation of DP with hydroxypropyl-β-cyclodextrin (HP-β-CD) was applied to mask the bitter taste then the prepared complexes were incorporated into ODF using solvent casting method. The taste-masking efficiency was evaluated by e-tongue; meanwhile the...
28. May 2018
Orodispersible films (ODFs) are an advantageous dosage form to accomplish patient convenience and compliance in oral drug delivery. They provide a number of special application features, such as the ease of administration without water and suitability for patients with swallowing problems. However, this promising dosage form has been limited to immediate release formulations so far. The aim of this study was to develop a thin film produced by solvent casting, which is rapidly disintegrating...
24. February 2018
Enalapril is an off-patent angiotensin-converting enzyme inhibitor for which no paediatric age-appropriate formulation is commercially available in Europe, and enalapril maleate (EM) orodispersible minitablets (ODMTs) have previously been formulated within the LENA (labelling enalapril from neonates to adolescents) project. In this study, a dilution method has been developed by dispersing the lowest dose strength ODMTs to enable flexible and precise EM dosing during the dose titration phase of...
12. May 2017
Pediatric, ibuprofen containing orodispersible tablets (ODTs) were prepared using the SeDeM expert system methodology. In order to facilitate formulation, directly compressible ibu- profen was employed (Ibuprofen DC 85TM) and character- ized using its SeDeM pro le. The mannitol based superdis- integrant Ludi ash® was characterized by the SeDeM-ODT expert system, which also allowed calculation of the opti- mal excipient concentration in order to obtain suitable tablet hardness and disintegration
02. May 2017
The first-in-class selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5), sildenafil, has become well established as a safe and effective treatment for male erectile dysfunction since the approval of Viagra® (Pfizer Ltd, Tadworth, UK) by the US Food and Drug Administration (FDA) in 1998. Guidelines on male sexual dysfunction established by the European Association of Urology recommend oral pharmacotherapy with PDE5 inhibitors as first-line therapy.
20. April 2017
Abstract The individualization of solid dosage forms to realize a flexible therapy for all patient groups is a topic which increasingly gains importance in pharmaceutical research. The goal of this study was to develop a nanoparticulate, instant orodispersible film (iODF) powder which can easily be reconstituted in water to cast ODFs containing an individualized concentration of an active pharmaceutical ingredient (API). It was shown that the processing of the film casing mass to iODF powders...
20. March 2017
Abstract Orodispersible films (ODF) hold promise as a novel delivery method, with the potential to deliver tailored therapies to different patient populations. Together with the current trends and potential therapeutic areas such technology can address, some of the unmet needs in terms of quality aspects and manufacturing of conventional and novel (printed) ODF are discussed. Overall, this article aims to stimulate further research to fill the current knowledge gap between manufacturing and...
04. August 2016
Objectives: To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without compromising their fast disintegration time. Methods: A quality by design approach was applied to screen three different formulations each one based on a different hydrophobic polymer: polyvinyl acetate, methacrylate-based copolymer and shellac. The screening formulations were characterized regarding their mechanical properties, residual...
04. August 2016
Abstract Orodispersible films possess a great potential as a versatile platform for nanoparticle-loaded oral dosage forms. In this case, poorly water-soluble organic materials were ground in a stirred media mill and embedded into a polymer matrix. The aim of this study was the shortening of this manufacturing process by the integration of several process steps into a stirred media mill without facing disadvantages regarding the film quality. Furthermore, this process integration is time...