Disintegrant Screening of Oral Thin Film
Inquiry
As a new preparation, the oral thin film can quickly disintegrate and release drugs in the mouth without the need for water delivery. It has the advantages of fast dissolution and is easy to take. Disintegrant is the key factor in achieving the rapid disintegrant effect of oral thin film. CD Formulation provides disintegrant screening service based on the preparation method of oral thin film and the properties of active pharmaceutical ingredients (APIs).
Why Use Disintegrants in Oral Thin Film?
The FDA recommends that the dissolution time of oral thin film in the mouth should be less than 30s, and the use of disintegrants can accelerate the disintegration of oral dissolved film in the mouth.
Types and Peculiarity of Disintegrant for Oral Thin Film
| Type of Disintegrant |
Peculiarity |
| Non-ionic Surfactants |
Due to their strong hydrophilic properties, substances such as polysorbate 80 and polysorbate 20 enable the thin film to quickly dissolve in the mouth. |
| Mannitol and Sorbitol |
They have strong hydrophilic ability, can be used as disintegrant of oral thin film, and can also take into account the effect of taste modification. |
| Lactose |
Lactose is often used as a pore-causing agent in solid coating powder, can also be used as a disintegrant here. |
| Silica |
Silica is often used in solid preparations for the role of flow aid and antistatic and can be used as a pore-causing agent in the oral thin film. |
Our Disintegrant Screening for Oral Thin Film Development
CD Formulation based on the preparation process and API properties of oral thin film comprehensively evaluates and screens the most suitable disintegrant from the following aspects to ensure the quality and efficacy of oral thin films and achieve good therapeutic effects:
Drug Content Determination
Oral thin films have high porosity and can disintegrate and dissolve rapidly in the oral cavity. The surface area of the drug increases with the disintegration of the thin film, and the dissolution rate is accelerated to form a drug solution. We usually use content determination as an important index for the disintegrant screening of the thin film.
Folding Endurance and Tensile Strength
The oral thin film should have good folding endurance and tensile strength, and will not be easily broken during use.
Friability
Disintegrants used in oral thin films should be non-toxic, non-irritating free of impurities, readily available, and relatively inexpensive. In addition, the obtained thin film should also be strong enough to avoid any physical damage during handling or transportation.
In Vitro Determination of Disintegration Time
The disintegration time is a key indicator in the development of oral thin film. Different preparation processes use different disintegrants, and the properties of APIs will also affect the choice of disintegrants.
Fig.1 Schematic diagram of devices to determine the disintegration behavior of the oral soluble films. (Di Gao, et al., 2023)
Our Platforms for Disintegrant Screening of Oral Thin Film
| Technologies & Platform |
Description |
| In-vitro Disintegration Platform |
Disintegration refers to the process in which all oral solid preparations disintegrate or dissolve into fragments under specified conditions. Disintegration is an indispensable research project in the process of product development and quality evaluation of oral thin films. It is very important to select a suitable method for the determination of dissolution time in vitro to effectively guarantee the quality of oral dissolved films. Different methods for determining the disintegration time of oral dissolved film are different, including the frame method, petri dish method, sponge method, frame-pellet method, and pharmacopeia disintegration method. |
Advantages of Our Disintegrant Screening Services
- Efficient: We have an efficient screening process for disintegrants to speed up your oral thin film development.
- Experience: We have a professional accessories selection team, and they are familiar with the properties of various raw materials and excipients and can adjust the disintegrant at any time according to the preparation process of oral thin films.
- Reliable Partners: We are also a reliable manufacturer of excipients, serving the pharmaceutical industry to help it improve the performance of its products.
Published Data
Technology: Effect of Superdisintegrants
Journal: International Journal of Pharmacy and Pharmaceutical Sciences
IF: 6
Published: 2014
Results: Both the formulations were compared by their in vitro release studies. The results revealed that 4% crospovidone was found to be more promising superdisintegrant in the preparation of FDOFs and FDTs.
Fig.2 In vitro release profile of Cinnarizine FDOFs. (DEEPAK HEER, et al., 2014)
CD Formulation can provide the most professional disintegrant screening technical guidance for customers. If you have a requirement about our disintegrant screening of oral thin film services, please contact us by phone or email, and our colleagues will reply to you within three working days.
References
- Di Gao, Guoxiang Li, et al. Comparative study on evaluation methods of dissolution time limit of oral dissolved film. Acta Pharmacologica Sinica. 2023.
- DEEPAK HEER, GEETA AGGARWA, et al. DEVELOPMENT OF FAST DISSOLVING ORAL FILMS AND TABLETS OF CINNARIZINE: EFFECT OF SUPERDISINTEGRANTS. International Journal of Pharmacy and Pharmaceutical Sciences. 2014, Vol (6):186-191.
How It Works
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STEP 3
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