Orodispersible Film is one dissolvable film in which active pharmaceutical ingredients are incorporated, that can rapidly dissolve on the tongue or buccal cavity, usually within 30 seconds. The dissolved active pharmaceutical ingredients enter the blood via oral mucosa and esophagus, which can take effect very quickly. Orodispersible Film is especially suitable for the patient who has swallowing difficulty.
As per the action mechanism of the Orodispersible Film, the dissolvable film used for Orodispersible Film shall be non-toxic and have good biocompatibility so that the pharmaceutical ingredients can easily dissolve in and out. In practical use, the Orodispersible Film may be stretched or pulled when it is taken out of the package or applied on the patient. Therefore, the Orodispersible Film shall have sufficient tensile strength and flexibility. Otherwise it is liable to be broken or damaged. That’s why it
1. Testing Instruments
Link Testing’s LTS-05 Auto Tensile Tester is a professional tester that can be used to test the tensile properties, peel strength, deformation, tear strength, heat seal strength, hot tack strength and puncture force of plastic film, adhesive, pressure sensitive tape, medical plaster, protective film, compound cap, back panel, non-woven fabrics, rubber, paper and fiber, etc. The accuracy of this instrument reaches 0.5% of full scale, which can guarantee the testing accuracy. Seven independent test modes are available. The instrument is equipped with two types of load cells, 50N and 500N. Seven test speeds can meet the testing requirements of different customers. Intelligent software is convenient for the operators and provides data analysis and data comparison features.
Link Testing’s LTCHY-HS Thickness Tester can be used to measure the thickness of plastic films, sheeting, diaphragm, paper, foils, silicone chips and other materials. The thickness of the testing specimens shall be within the range of 0-12mm. This instrument uses mechanical contact method and conforms to related standards. The testing resolution of the instrument reaches 0.1μm.
2. Test Principle and Test Method
2.1 Tensile Strength, Elongation Rate at Break
Clamp the specimen in the upper and lower sample grips. Then select tensile strength and elongation rate as test item. Then start the test. The test results will be given by the system automatically.
2.2 Thickness Test
Contact method is used for thickness measurement. Firstly, power on the instrument and warm up for 30 minutes. Wipe off the pressure foot and anvil. Place the specimen on the test plane (The specimen should be free of creases or other defects. The width of the specimen should be 100mm). Set parameters and then start test. The system will calculate the test results automatically.
In Formulation and Quality Evaluation of Aripiprazole Orodispersible Films, Link Testing’s LTCHY-HS Thickness Tester and LTS-05 Auto Tensile Tester are used to test the mechanical properties and measure the thickness of Orodispersible Film. Effect of film-former, plasticizer and filler on the properties of the films are studied in the tests. For example, for the combined film-former of HPMC and maltodextrin （4：1）, the thickness of the film is 99.17±1.19μm, the elongation rate of the film is 14.87±7.29% and the tensile strength of the film is 18.36±2.69MPa (All the test data is from Formulation and Quality Evaluation of Aripiprazole Orodispersible Films).
Link Testing’s tensile testers and CHY series thickness testers are professionally designed for determination of mechanical properties and thickness of packaging materials, which are featured with high efficiency, accuracy and repeatability.
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