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Oral Thin Film Surface pH Testing

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The surface pH of films is determined to investigate possible side effects due to pH changes in vivo, as acidic or alkaline pH levels may cause irritation to the buccal mucosa. Testing the pH of oral thin films allows us to determine their suitability for use in the human body. CD Formulation offers professional surface pH testing for oral thin films.

Why Test the Surface pH of Oral Thin Films?

The surface pH of the buccal cavity is between 5.5 and 7.4. The oral thin film is designed to dissolve quickly in the mouth after being placed on the tongue, so the oral thin film pH must be within the buccal cavity pH range, as preparations with alkaline or extremely acidic pH can cause mucosal irritation.

Factors Affecting the pH Testing of Oral Thin Films

In the process of determining the surface pH of the oral dissolved film, we should pay attention to the effect of temperature on pH.

  • When the temperature changes, the internal components of pH and reference electrode tend to thermal equilibrium and the result will be shifted.
  • When the pH electrode and temperature probe are placed in a sample with drastic temperature changes, the measurement results will drift.
  • Buffer and sample pH will change with temperature.

Our Oral Thin Film Surface pH Testing Services

Sample Preparation

The surface pH of the films was determined to inspect the possible secondary effects due to an in vivo pH change. The pH of the dry oral thin film cannot be determined, so, first, the oral thin film is dissolved in an appropriate amount of distilled water to change the film state to measure the pH.

Temperature Compensation

The pH value varies with the temperature of the solution in the measuring cell. Therefore, our pH meter is equipped with a temperature compensation knob, before the measurement, the temperature compensation is adjusted.

Positioning

The instrument is pre-calibrated (positioned) with the standard buffer and adjusted with the positioning knob so that the pH indication is the same as that of the standard buffer.

Measurement

After the temperature compensation adjustment and positioning adjustment, the electrode of the pH meter was brought into contact with the surface of the film for 60 seconds, and the pH of the film was noted.

Published Data

Technology: Surface pH testing

Journal: PHARMA SCIENCE MONITOR

IF: 0.2

Published: 2013

Results: The oral film was slightly wet with the help of water. The pH was measured by bringing the electrode in contact with the surface of the oral film. The procedure was performed in triplicate and an average with standard deviation was reported. The surface pH of the films was ranging from 6.86 to 7.16. Since the surface pH of the films was found to be around the neutral pH, there will not be any kind of irritation to the mucosal lining of the oral cavity.

Table 1. pH Evaluation Parameter of Sublingual Film. (Yatin D. Kapadia, et al.,2013)

Table.1 pH Evaluation Parameter of Sublingual Film.

CD Formulation is very experienced in the surface pH detection of oral dissolved films and can help you solve the problems that arise during the pH detection process, such as pH instability, how the sample is prepared, etc. If you have a requirement about surface pH testing services, please contact us by phone or email, and our colleagues will reply to you within three working days.

References

  1. Yatin D. Kapadia, Hiten P. Sodha, et al. FORMULATION DEVELOPMENT AND EVALUATION OF SUBLINGUAL FILM OF ASENAPINE MALEATE. PHARMA SCIENCE MONITOR. 2013:190-209.
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