Development of Orodispersible Films Containing Benzydamine Hydrochloride Using a Modified Solvent Casting Method

Abstract

The aim of this study was to develop benzydamine hydrochloride-loaded orodispersible films using the modification of a solvent casting method. An innovative approach was developed when the drying process of a small-scale production was used based on a heated inert base for casting the film. During this process, two types of film-forming maltodextrins for rapid drug delivery were used. They were plasticized with two different polyols (xylitol and sorbitol). Superdisintegrant Kollidon® CL-F was tested as an excipient that can induce faster disintegration of the prepared films. The influence of the formulation parameters (dextrose equivalent of film-forming maltodextrins, a type of plasticizer, and the presence of superdisintegrant) on the disintegration time, mechanical properties, and moisture content of films was statistically evaluated using a multivariate data analysis. Orodispersible films containing maltodextrin with lower dextrose equivalent value showed better mechanical properties (tensile strength ranged from 886.6 ± 30.2 to 1484.2 ± 226.9 N cm), lower moisture content (0.5 ± 0.0 to 1.2 ± 0.2%), and shorter disintegration time (17.6 ± 2.9 to 27.8 ± 2.8 s). Films plasticized with xylitol showed shorter disintegration time (17.6 ± 2.9 to 29.2 ± 3.8 s) than films containing sorbitol (23.8 ± 2.9 to 31.7 ± 3.9 s). With the addition of superdisintegrant Kollidon® CL-F, a significant influence on disintegration time was not observed. The modified solvent casting method shows great promise in a small-scale laboratory production of orodispersible films, e.g., in a pharmacy lab.

Towards Printed Pediatric Medicines in Hospital Pharmacies: Comparison of 2D and 3D-Printed Orodispersible Warfarin Films with Conventional Oral Powders in Unit Dose Sachets

“…The surface pH of ODFs is commonly investigated to ensure that the pH of the dosage form is in the range of physiological saliva (5.8–7.4). An ODF with a pH largely differing from this may cause local mucosal irritation and discomfort for the patient [39]. The ODFs prepared in this study all revealed a neutral pH (Table 5) indicating that no local side effects should be encountered at the administration site.…”

“…The printed formulations consisted of as few excipients as possible as a preference expressed by the medical doctors at HUS, however, disintegrants, saliva stimulating agents, sweeteners, taste masking agents, flavors, colorants, etc., may be introduced in the formulation to further tailor the properties of the ODF or to fulfill individual preferences of a patient. The amounts used of these types of ingredients are typically quite low in ODFs [37,38,39], and it is, therefore, unlikely that addition of these materials dramatically would change the printability nor the quality of the printed ODFs. As EXT and IJP nonetheless are techniques that require different properties of the formulation to be printable, the idea was to use the same HPC solution (15% w / w ) as a substrate for IJP which subsequently was imprinted with a drug ink and which in the case of EXT was drug-loaded and printed into ODFs in a single step.…”

“…Additionally, plasticizers have a tendency to absorb water, which is why a very high amount of plasticizer added to the formulation may result in similar stability issues as discussed above due to the absorbed water. ODFs with a too high a moisture content have also been described as sticky [39].…”

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

“…As the thickness of wet strip cast, the rheological and physicochemical properties of the cast solution affect the drying speed. [83,84] These limit the scale-up process, which could affect the final thickness of the dried strip. Furthermore, the selection of solvents depends on the solubility of the API, its stability in the solvents and its heat sensitivity during the drying process.…”

3D-Printed Veterinary Dosage Forms – A Comparative Study of Three Semi-Solid Extrusion Printers

“…The surface pH of an ODF should preferably be as close to physiological saliva (5.8-7.4) as possible to ensure a comfortable mouthfeel. Local mucosal irritation and discomfort may occur with the administration of an ODF with pH outside this range [42]. UL and DL films without LP had a surface pH of 4.83 ± 0.15 and 4.63 ± 0.65 respectively, which is too acidic for an ODF and may cause discomfort upon administration.…”