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Differential Scanning Calorimetry (DSC) Analysis for Oral Thin Film

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The differential scanning calorimetry (DSC) is a principal technique used in determining the thermal behavior of constituents in oral thin film. Therefore, solid state transformations such as crystallization and melting, indicated by exothermic and endothermic peaks, were evaluated within the optimized film. CD Formulation provides professional DSC analytical techniques to predict any possible physicochemical interactions that might affect the drug release rate or drug release mechanism from oral thin film formulations.

Fig.1 Differential scanning calorimetry thermograms.Fig.1 DSC thermograms of pure drugs, optimum formulations, and physical mixtures.
(Emrah Özakar, et al., 2023)

What is Oral Thin Film DSC Analysis?

The DSC analysis is performed to demonstrate the compatibility of the drug with other auxiliary substances. The reference and sample are brought to the same temperature, and the interactions in the sample are examined depending on the heat exchange. For this purpose, a certain amount of oral thin film sample is cut, placed in the alumina pan, and analyzed under a certain flow of atmospheric nitrogen (mL/min).

The Importance of Oral Thin Film DSC Analysis

  • Understanding the thermal properties of oral thin films
  • Predicting the stability and effectiveness of the formula under different temperature conditions
  • Assessing the compatibility of the components within the oral thin film formulation.

Our Oral Thin Film DSC Analysis Services

We use state-of-the-art DSC equipment and expertise to provide comprehensive insights into the thermal properties and behaviors of oral thin film formulations, including:

  • Thermal Analysis
    Measuring the relationship between the physical properties of the oral thin film and the temperature, studying its physical changes (crystal transformation, melting, etc.) and chemical changes (dehydration, decomposition, oxidation, reduction, etc.).
  • Polymorphic Form
    Our DSC analysis enables the identification and characterization of the polymorphic form of the active pharmaceutical ingredients in the oral thin film products.
  • Compatibility
    Evaluate the compatibility of excipient-API and between excipients to provide the basis for formulation development.
  • Stability Assessment
    Evaluate the stability of the sample to ensure the quality of the oral film products.

Our Workflow of Oral Thin Film DSC Analysis

To ensure thorough and accurate analysis of the thermal properties of oral thin film formulations, we developed a detailed analysis process. Our DSC analysis services involve a comprehensive understanding of the customer's needs, pre-treatment of samples, setting of analytical parameters, analysis and interpretation of experimental data, and other key steps.

Fig.2 Our workflow for oral thin film differential scanning calorimetry (DSC) analysis.Fig.2 Our Workflow for Oral Thin Film DSC Analysis Services. (CD Formulation)

Advantages of Our Oral Thin Film DSC Analysis

  • We can help our clients quickly determine the glass transition temperature, melting point, crystallization behavior, and other thermal properties of oral thin films from a professional perspective.
  • We can assess the thermal stability of oral thin film formulations, helping our clients to identify potential storage and handling issues.
  • Based on the results of DSC, we can help clients evaluate the compatibility of oral thin film formulation with different excipients and active ingredients.
  • Our DSC analysis can provide valuable information for optimizing the formulation and manufacturing process of oral thin films.

Published Data

Technology: Differential Scanning Calorimeter (DSC)

Journal: Journal of Bioequivalence & Bioavailability

IF: 2.3

Published: 2017

Results: In this study, the DSC analysis was performed to assess the thermal behavior of the GLB pure drug, PVP thin film, and GLB thin film. The DSC thermograms of GLB pure drug indicated the melting onset, peak and end set at 173.84, 177.38 and 181.32℃ respectively, which in turn showed the corresponding melting behavior of the stable anhydrous form of crystalline GLB. The DSC thermograms of PVP thin film indicated melting onset, peak and end set at 146.22, 147.85 and 156.05℃ respectively. However, the DSC of GLB thin film indicated the GLB and PVP endothermic peaks at 172.80 and 122.61℃ respectively, with a slight decrease in the melting point.

Fig.3 Differential scanning calorimetry plots of GLB, PVP thin film and PVP-GLB thin film.Fig.3 DSC plots of (a) GLB, (b) PVP thin film and (c) PVP-GLB thin film. (Raghavendra HL, et al., 2021)

CD Formulation has been focusing on the development of oral thin films for many years and is very experienced in the analysis of oral thin films, we have professional oral thin film DSC analysis equipment to help our clients with oral thin film DSC analysis services. If you require our oral thin film DSC analysis services, please contact us by phone or email, and our colleagues will get back to you within three working days.

References

  1. Emrah Özakar, Rukiye Sevinç-Özakar, et al. Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin. Gels. 2023, 9(2).
  2. Raghavendra HL, Prem Kumar G. Development and Evaluation of Polymer-bound Glibenclamide Oral Thin Film. Journal of Bioequivalence & Bioavailability. 2017, Vol (9): 324-330.
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