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Oral Thin Film Content Uniformity Testing

Inquiry

The purpose of oral thin film content uniformity testing is to ensure that the drug components can be evenly distributed throughout the oral thin film. In the production process of oral thin film, the content of active pharmaceutical ingredients may cause differences between batches due to the preparation process, preparation method, solubility of raw materials, etc., thus affecting the efficacy and safety of oral thin film drugs. CD Formulation provides professional oral thin film content uniformity testing methods, assisting the development and quality control of oral thin film drugs.

Fig.1 Impact of Mixing on Content Uniformity of Thin Polymer Films Containing Drug Micro-Doses. (Guluzar G. Buyukgoz, et al., 2021)

The Importance of Oral Thin Film Content Uniformity Testing

Content uniformity is an important test index to ensure the quality and safety of oral thin film, and its importance is reflected in efficacy reliability, therapeutic effect, safety, quality control, etc.

Our Oral Thin Film Content Uniformity Testing Services

Oral thin film content uniformity testing is an essential process in the pharmaceutical industry to ensure that each dose of oral thin film product contains the correct and uniform amount of active pharmaceutical ingredients. We have gained extensive hands-on experience in conducting oral thin film content uniformity testing, and our oral thin film content testing process is as follows:

Fig.2 Process of Oral Thin Film Content Uniformity Testing. (CD Formulation)

Representative Sampling: Select a random sample from the entire population or batch to minimize biases.

Establish Testing Method: Establish an analytical method based on analytical objectives and requirements.

Sample Preparation: Selecting an appropriate solvent to dissolve oral thin film samples.

Calibration and Standard Preparation: According to the selected analysis method, prepare the standard solution and standard curve.

Analysis and Validation: After establishing the analytical method, optimize and validate. It involves determining analytical conditions, and evaluating the reliability, accuracy, specificity, system suitability, etc.

Evaluation of Content Uniformity: A comprehensive report is generated, detailing the findings of the content uniformity testing.

Our Oral Thin Film Content Uniformity Testing Methods

Content Testing Method	Detailed Information
UV-Visible spectrophotometry	UV-Visible spectroscopy is a non-destructive method used to measure the absorption of ultraviolet or visible light by a sample. It can be utilized to determine the concentration of API and other compounds in an oral thin film by measuring their absorbance at specific wavelengths.
High-performance liquid chromatography (HPLC)	HPLC is widely used to detect the content uniformity of drugs, including oral thin film. It is a sensitive and selective technique that can separate, identify, and quantify individual components present in a mixture. HPLC is suitable for analyzing the concentration of APIs and other compounds in oral thin films.

Advantages of Our Oral Thin Film Content Uniformity Testing

Our team consists of highly skilled and experienced professionals with in-depth knowledge of pharmaceutical analysis. We have a track record of successfully performing content uniformity testing for varieties of oral thin film formulations, and we stay updated on the latest industry developments and regulations.
We have invested in advanced analytical instrumentation and state-of-the-art facilities dedicated to pharmaceutical testing, such as HPLC, UV-Vis spectrophotometers, etc.
Our oral thin film content uniformity testing process is relatively simple, which helps to quickly confirm your project needs and sample information and provide you with the testing scheme and report promptly.

Published Data

Technology: Drug Content Uniformity Testing

Journal: Pharmaceutics

IF: 4.4

Published: 2021

Results: In this study, to assess the homogeneity of drug dispersion in precursors, samples were removed from five different locations of the precursor container, namely middle, left-upward, right-upward, front bottom, and back bottom. To maintain consistency between the film precursor sample amount and the content uniformity testing for the dried films, their theoretical drug amounts were kept the same. Accordingly, the precursor sample was 50 mg, which was equivalent to the theoretical drug amount in a test sample sized ~ 0.7 cm2 of the dried films. The collected samples from precursor suspension were transferred to solvent bottles containing 50 mL of 7.2 g/L SDS solution and stirred for at least 3h to allow complete dissolution of the drug particles. Subsequently, the drug amount was tested using a UV–Vis spectrophotometer at a wavelength of 290 nm. The relative standard deviations (RSDs%) for the corresponding drug amounts were calculated, with lower RSD% values indicative of a homogeneous product.

Fig.3 The Procedures Schematic of Oral Thin Film Content Uniformity Testing.
(Guluzar G. Buyukgoz, et al., 2021)

Our content uniformity of oral thin film test services meets the highest standards of quality, accuracy, and regulatory compliance, providing pharmaceutical companies with the assurance they need in the formulation development and manufacturing of oral thin film products. If you require our oral thin film content testing services, please contact us by phone or email, and our colleagues will get back to you within three working days.

References

Guluzar G. Buyukgoz, Jeremiah N. Castro, et al. Impact of Mixing on Content Uniformity of Thin Polymer Films Containing Drug Micro-Doses. Pharmaceutics. 2021, 13(6):812.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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