Hot Melt Extrusion Method for Oral Thin Film Preparation

Hot melt extrusion technology is an increasingly attractive process for the manufacture of drug delivery systems and is widely used in the manufacture of oral thin films, which has great potential as a continuous pharmaceutical process. In the hot melt extrusion of pharmaceutical dosage forms, a mixture of active ingredients, thermoplastic polymer carriers, and other processing AIDS (including plasticizers and antioxidants) is heated and softened inside the extruder and then pressurized through a mold to form a film. New chemical entities that exhibit poor bioavailability due to solubility problems are prime candidates for hot melt extrusion. CD Formulation R&D team has established a complete hot melt extrusion technology platform and is committed to creating a professional, high-quality oral thin film preparation platform.

Fig.1 Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation. (Patil, H., et al., 2016)

The Advantages of the Hot Melt Extrusion Method for Oral Thin Film Preparation

Hot melt extrusion technology has many advantages over traditional methods, making hot melt extrusion an exciting challenge for pharmaceutical scientists.

• No solvent is required, shorter production time and high efficiency of the final product.
• There is no need to consider the environmental impact of solvents during processing.
• A variety of carriers and functional excipients are available.
• Easily industrially scalable, continuous process with few unit operations and better content uniformity.
• Hot melt extrusion produces a solid dispersion or solution to prepare the thin film, which can improve the solubility of the poor solubility of the drug.

Our Hot Melt Extrusion Process for Oral Thin Film Preparation

Hot melt extrusion is a technique for molding thin films from a raw material mixture in a molten state. During the preparation process, the drug, film-forming material, and other auxiliary materials are mixed and heated to their melting points to form a uniform molten mixture. External forces are then applied to push the mixture through a mold with holes, creating the required film. After the extruded film is cooled, it is cut and packaged to form the final film product.

 Fig.2 Workflow of Hot Melt Extrusion Method for Oral Thin Film Preparation. (CD Formulation)

What Problem Can We Solve?

• Extrudate expansion may occur in the hot melt extrusion process, mainly due to the viscoelastic properties of film-forming polymer, which is subject to high shear and high energy kneading during the extrusion process, which will affect the size of the final film agent. We can solve this problem by adjusting the process parameters.
• In the process of hot melt extrusion, chemical reactions such as hydrolysis occur under the action of high temperature, residual water and residual solvent, which will affect the quality control and stability of the final film agent. We control residual water as much as possible by excipients pretreatment.
• Under high temperature, pressure and strong mixing, the solubility of the API in the mixture may be increased, but after the temperature is lowered, the API in the mixture may recrystallize, which may affect the dissolution of the final film agent. We usually choose high viscosity film-forming materials to solve.

Why Choose Us for Preparing Oral Thin Films with the Hot Melt Extrusion Method?

• Traceability: We provide comprehensive process monitoring and equipment logging. These parameters include feed rate, temperature, screw speed, pressure, melt viscosity, drive current strength and torque, etc.
• Rich Experience: We have many years of experience in hot melt extrusion production of oral thin film, we can quickly help customers solve the possible problems in this preparation technology and speed up the development of oral thin film.
• Flexible: Flexible production capacity can meet the production needs of different scales and types.

Published Data

CD Formulation can help you solve any problems that arise in the hot melt extrusion method to prepare the oral thin film. If you have a requirement about our hot melt extrusion method for oral thin film preparation services, please contact us by phone or email, and our colleagues will reply to you within three working days.

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.