Novel Solvent-free Oral Thin Film Development

Oral thin films are a modern oral drug delivery method developed based on transdermal patch technology. Like tablets, the physical structure and low moisture content of the film make it an inhospitable environment for microbial growth, thus minimizing the need for preservatives and providing greater stability and shelf life. In the manufacture of oral thin films, solvent casting, and hot-melt extrusion are dominant. Hot-melt extrusion is a repeatable, continuous, which is often used to produce a novel solvent-free oral thin film. CD Formulation has a professional solvent-free mouth soluble film technology development platform, providing the whole process service from formula design, quality control to commercial production.

Why Develop Novel Solvent-free Oral Thin Film?

• The production process of the novel solvent-free oral thin film does not involve solvents such as ethanol, and the production process of this film is good repeatability, uniform content, fewer processing steps, more environmentally friendly, safer, and more cost-effective.
• The novel solvent-free oral thin film production process eliminates the use of water and other solvents, minimizing the impact of powder fluidity and compressibility.
• The novel solvent-free oral thin film achieves its special properties (increasing drug solubility, prolonging drug release, masking taste, etc.).

Our Novel Solvent-free Oral Thin Film Development Services

Formulation Design

In general, the preparation of oral thin film requires three main components, film-forming polymer, APIs, and plasticizer. To ensure the flexibility of the solvent-free oral thin film and easier to act on the application site, we will add other ingredients such as biological adhesives in the development process of the solvent-free oral thin film to ensure that the film can adhere to the action site within a certain period, allowing the drug to be absorbed or work.

Production Process

The production of solvent-free oral thin film is to heat the APIs and excipients after mixing, and then extrude the hot soluble substance through the mold hole to form a rod, and then press it into a film with a cooling roller. In this process, solvent-free heat treatment is used to realize the mixing and film formation of each component. Due to the high temperature involved in the production process, the thermal degradation of the drug or excipient used in the preparation may occur, so we perform a thermogravimetric analysis to evaluate the thermal behavior of the formula and select the appropriate processing temperature range.

Fig.1 The thermal degradation curves for raw materials and physical mixtures. (Jiaxiang Zhang., et al., 2021)

Quality Control

Our experienced technicians carry out comprehensive quality control, including appearance, film thickness, content and content uniformity, texture analysis, film disintegration, dissolution in simulated saliva, etc.

Manufacture

We have very rich experience in pilot transfer of solvent-free oral thin film, and we also have strong manufacturing capabilities.

Our Platforms for Novel Solvent-free Oral Thin Film Formulation Development

Our Advantages in Novel Solvent-free Oral Thin Film Development

• Our team of experts used this novel solvent-free oral thin film development technology that can effectively prevents bitter drugs from coming into contact with the patient's taste buds and improves patient compliance.
• We can skillfully combine HME with 3D printing technology to develop novel solvent-free oral thin film with better quality (such as faster dissolution of drugs).
• We can develop personalized solutions based on the characteristics and needs of customers' drugs.
• We provide end-to-end solutions for novel solvent-free oral film, from early project evaluation, formulation development to product launch.

Published Data

CD Formulation is at the forefront of innovative drug delivery system development, providing customized solutions for the development of novel drug delivery systems. Our expertise lies in the use of advanced technology and processes to design safe, efficient and reliable novel solvent-free oral thin film. If you have a requirement about our novel solvent-free oral thin film development 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.