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Oral Thin Film Pharmaceuticals Routine Analysis

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The oral thin film is an advanced and novel drug delivery system that meets the requirements of patients. The acceptance of this ingenious dosage form is increasing day by day due to its several comparative advantages of being cost-effective, rapidly dissolving without water aid, and well as greatly compliant to both geriatric and pediatric patients in emergency conditions and specific diseases. However, ensuring the quality, efficacy, and stability of oral thin film pharmaceuticals requires comprehensive routine analysis services. CD Formulation provides routine analysis services tailored to oral thin film pharmaceuticals.

Fig.1 Stages of oral thin film development.Fig.1 Stages of oral thin film development. (Madiha Mushtaque, et al., 2021)

Advantages of Oral Thin Film Pharmaceuticals

The oral thin film is defined as a highly advanced type of solid dosage form with greater compliance. It promotes the effectiveness of pharmaceutical components, which dissolve rapidly in the oral cavity. This delivery system offers convenience to patients:

  • Rapid disintegration as well as dissolution.
  • Being flexible and handy, easy to store and transport
  • Each film strip assures accurate dose administration
  • It can be administered without water and the film dissolves quickly in the mouth
  • Escape of first-pass metabolism, reduce dose and side effects.
  • This dosage form is suitable for pediatrics, geriatrics, uncooperative and unconscious patients with different illnesses
  • It is exceptionally useful in cases where a local action and an ultra-rapid drug onset are needed

Our Oral Thin Film Pharmaceuticals Routine Analysis Services

Oral thin film pharmaceutical routine analysis is a crucial part of product quality control, which runs through the entire product development, manufacturing and storage process, and provides release standards for specific batches of oral thin film. It includes formulation analysis, physicochemical characterization, stability testing, release kinetics studies, etc., to ensure the overall quality and safety of the product.

Fig.2 Our Oral Thin Film Pharmaceuticals Routine Analysis Services.Fig.2 Our Oral Thin Film Pharmaceuticals Routine Analysis Services. (CD Formulation)

Formulation Analysis

The formulation analysis of oral thin film involves preparation process analysis, excipients ingredients analysis, the evaluation of the masking technology, etc.

Physicochemical Characterization

We conduct a thorough assessment of the physical and chemical properties of oral thin film, including appearance, organoleptic, surface pH, thickness, content uniformity, moisture content, solid states, mechanical properties, etc.

Dissolution Testing

Our team performs dissolution studies to evaluate the release of active pharmaceutical ingredients from oral thin film formulations and assess their biological properties.

Stability Testing

Our stability testing services assess the shelf-life and degradation profile of oral thin film formulations, providing vital information for product shelf-life determination and storage recommendations.

Release Kinetics Studies

Our laboratory provides the evaluation of release kinetics and drug release profiles from oral thin film pharmaceuticals, facilitating an understanding of thin film drug delivery characteristics.

Our Workflow of Oral Thin Film Pharmaceuticals Routine Analysis

Our team can quickly respond to customers' oral thin film analysis requirements to ensure thorough testing, and our service process is as follows:

Fig.3 Workflow of Oral Thin Film Pharmaceuticals Routine Analysis.Fig.3 Workflow of Oral Thin Film Pharmaceuticals Routine Analysis. (CD Formulation)

Advantages of Our Oral Thin Film Pharmaceuticals Routine Analysis

  • Our laboratory is equipped with advanced analytical capabilities to provide comprehensive routine analysis services for oral thin film pharmaceuticals, including HPLC, UV-Vis spectrophotometry, GC-MS, HPLC-MS, dissolution testing apparatus, etc.
  • We offer a wide range of oral thin film analytical services, including stability testing, dissolution profiling, content uniformity, and impurity identification. This comprehensive approach allows us to provide a holistic assessment of the oral thin film pharmaceuticals, ensuring their safety, efficacy, and quality.
  • We provide tailored analytical solutions to address specific needs, whether it's related to formulation optimization, batch-to-batch consistency, or troubleshooting unexpected issues.

Published Data

Technology: physicochemical characterizations

Journal: Pharmaceutics

IF: 4.9

Published: 2021

Results: In this study, advanced physicochemical characterizations revealed the presence of amorphous drugs in both HME and 3D printed films whereas some crystalline traces were visible in solvent and melt cast films. Moreover, advanced surface analysis conducted by Raman mapping confirmed a more homogenous distribution of amorphous drugs in 3D printed films compared to those prepared by other methods. In vitro dissolution studies of the 3D printed films demonstrated an improved drug release performance compared to the melt cast or extruded films.

Fig.4 Evaluation of Amorphous Oral Thin Films.Fig.4 Evaluation of Amorphous Oral Thin Films. (Jiaxiang Zhang, et al., 2021)

CD Formulation is committed to providing accurate, reliable, and actionable data that supports our clients in achieving oral thin film product development and quality objectives. If you require our oral thin film pharmaceuticals routine analysis services, please contact us by phone or email, and our colleagues will get back to you within three working days.

References

  1. Madiha Mushtaque, Iyad Naeem Muhmmad, et al. Novelty and Compliance of Oral Fast Dissolving Thin Film A Patient Friendly Dosage Form. Clinical Pharmacology & Biopharmaceutics. 2021, Vol 10 (2).
  2. Jiaxiang Zhang, Anqi Lu, et al. Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies. Pharmaceutics. 2021,13(10):1613.
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CD Formulation, an expert in novel oral thin film delivery systems, is dedicated to supporting pharmaceutical companies in developing and commercializing innovative drug formulations...

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