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Oral Thin Film In Vitro Disintegration Testing

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The in vitro disintegration time is the time taken by the film to undergo complete disintegration, to realize good patient compliance and acceptance of the oral thin film, one of the major quality aspects is the disintegration behavior of the films because a non-disintegration within a set time frame can result in choking or aspiration of the whole or parts of the film. CD Formulation provides different oral thin film in vitro disintegration testing methods to meet the different testing requirements of customers, thus promoting the development of oral thin film.

Fig.1 A disintegration test system of oral films. Fig.1 A new disintegration test system of oral films. (Yoshiko Takeuchi, et al., 2018)

Importance of Oral Thin Film In Vitro Disintegration Testing

Oral thin films have gained significant attention in the pharmaceutical industry due to convenience, ease of administration, and potential for improved patient compliance, especially in populations like pediatrics and geriatrics. In vitro disintegration testing plays a crucial role in assessing the quality and performance of formulations.

Fig.2 Benefits of Oral Thin Film In Vitro Disintegration Testing. Fig.2 The Importance of Oral Thin Film In Vitro Disintegration Testing. (CD Formulation)

Oral Thin Film In Vitro Disintegration Testing Services

In vitro disintegration testing is a necessary item in the quality control of oral dissolved film, but there is no universally recognized method at present. We usually use conventional disintegration methods, one-sided disintegration methods, double-sided disintegration methods, and in order to more closely match the situation in the human mouth, we have also developed a new disintegration device that is capable of mechanically dropping the test medium.

Our Oral Thin Film In Vitro Disintegration Testing Methods

In Vitro Disintegration Testing	Detailed Information
Disintegration Tester	Conventional disintegration method uses a disintegration tester, the medium is 1 L pH 6.8 phosphate buffer (PBS), the temperature is (37±0.5) ℃. The sample is allowed to rise and fall in the medium 29 to 32 times per minute, and the time required to completely pass through a 0.57 to 0.66 aperture sieve is recorded, which is the disintegration time.
One-sided Disintegration Method	The one-sided disintegration method adopted a vibrating water bath device. One side of the sample is attached to a polyethylene plate with a glue stick and placed in a petri dish with 20 ml pH 6.8 PBS at a temperature of (37 ± 0.5) ℃. The shaking speed is 70 r·min-1, and the disintegration time of the sample is recorded when completely dissolved.
Double-sided Disintegration Method	The double-sided disintegration method uses a vibrating water bath device, the samples are placed in a culture dish with 20 ml pH 6.8 PBS at a temperature of (37 ± 0.5) ℃, The shaking speed is 70 r·min-1, and record the disintegration time when the sample was completely dissolved.
The New Disintegration Device	We develop a new oral dissolution test system with a sensor that automatically determines the disintegration time. When testing with this device, the test medium automatically drips from a fixed height at a constant flow rate. When the oral thin film disintegrates, the on-net and off-net approach each other, and the disintegration time is determined at that point in time. This device we developed can well simulate the oral situation, and the test results are closer to the situation when patients take the medicine.

Our Advantages in Testing Oral Thin Film In Vitro Disintegration

Expertise: We have a team of experienced scientists and researchers who are well-versed in oral thin film technology and have extensive knowledge of in vitro disintegration testing methods.
Diversified Testing Methods: We not only have conventional in vitro disintegration testing equipment, but also newly developed equipment for customers to choose from.
Cost-effective: Our oral thin film in vitro disintegration testing services are competitively priced.

Published Data

Technology: Petri dish, the slide frame, slide frame and ball (SFaB) method

Journal: European Journal of Pharmaceutics and Biopharmaceutics

IF: 4.1

Published: 2018

Results: In this study, four disintegration methods described in the literature were applied to characterize the disintegration behavior of these formulations. They were the petri dish, the slide frame, slide frame and ball (SFaB) method as well as the PharmaTest® disintegration tester equipped with a film sample holder. All methods show similar tendencies, at which the disintegration time proportionally increases with increasing dry film thicknesses. Reduced disintegration times were observed for ODFs containing insoluble MCC particles compared to their corresponding particle-free formulations.

Fig.3 Disintegration methods for oral film preparations. Fig.3 Comparative study on disintegration methods for oral film preparations. (Isabell Speer, et al., 2018)

In vitro disintegration testing is essential for evaluating the quality and performance of oral thin film formulations, which can help to ensure the rapid disintegration and effectiveness of the thin film. CD Formulation offers professional in vitro disintegration testing services for oral thin films, providing a basis for formulation optimization and quality control of oral thin films. If you have a requirement about our oral thin film in vitro disintegration testing services, please contact us by phone or email, and our colleagues will reply to you within three working days.

References

Yoshiko Takeuchi, Misaki Kawamoto, et al. Design of a new disintegration test system for the evaluation of orally disintegrating films. International Journal of Pharmaceutics. 2018, Vol(553):281-289.
Isabell Speer, Denise Steiner, et al. Comparative study on disintegration methods for oral film preparations. European Journal of Pharmaceutics and Biopharmaceutics. 2018, Vol(132):50-61.

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