Oral thin film morphology is defined as the microscopic structural features, including surface shape and texture, component distribution, crystalline behavior, defects, and molecular spatial relationships. CD Formulation has professional scanning electron microscopy (SEM), transmission electron microscopy (TEM), and related imaging techniques to provide accurate topography analysis services to ensure the surface morphology, uniformity, and integrity of thin film.
Fig.1 FESEM image of oral film. (Malath H. Oudah, et al., 2021)
Morphology of oral thin film may affect film's active ingredient release, patient experience, production consistency, film stability and shelf life. Hence, assessing the surface morphology and texture is crucial to assure uniform distribution of drugs without any interaction with the polymers in thin film formulation.
Fig.2 The Importance of Oral Thin Film Morphology Testing. (CD Formulation)
Morphology can affect drug release profile, mechanical properties, and overall performance of oral thin film. We use light microscopy, SEM, TEM and related imaging techniques to observe a variety of surface characteristics such as surface texture (smooth or rough), thickness and drug distribution (aggregation or dispersion) to help our customers ensure the quality and performance of their oral thin film products. Our oral film morphology testing process is as follows:
Fig.3 Process of Oral Thin Film Morphology Testing. (CD Formulation)
Morphology Testing | Detailed Information |
Scanning Electron Microscopy (SEM) | SEM is a widely used technique to examine the surface morphology of oral thin film at high magnification. It provides detailed information on the surface topography, porosity, and the distribution of active pharmaceutical ingredients (APIs) and excipients within thin film. |
Transmission Electron Microscopy (TEM) | TEM is a technique that uses a beam of high-energy electrons to create an image of a specimen's internal structure. As the electrons pass through the specimen, they interact with it to form an image that is then magnified and focused onto an imaging device and providing morphology information of oral thin film. |
Technology: SEM analysis
Journal: Journal of Bioequivalence & Bioavailability
IF: 6.9
Published: 2017
Results: In this study, the surface morphology of the GLB pure drug and GLB thin film with low and high magnification respectively were represented. The SEM image of GLB pure drug showed irregular particle size of diameters in the range of 15-45 µm. SEM image of GLB thin film showed uniform surface morphology with homogenous distribution of GLB pure drug in PVP matrix. The SEM results of the study helped to understand PVP mechanism to formulate smaller drug particles with increased surface area and wet-ability, which in turn is advantageous to enhance the dissolution rate of a poorly soluble drug.
Fig.4 SEM images GLB (a & b) and PVP-GLB thin film (c & d) with low and high magnification. (Raghavendra HL, et al., 2017)
CD Formulation offers comprehensive oral thin film morphology testing services to assess the presence of smoothness, surface roughness or pores and particle distribution of thin film, helping our clients ensure the quality and performance of their oral thin film products. If you have a requirement about our oral thin film morphology testing services, please contact us by phone or email, and our colleagues will reply to you within three working days.
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