Double-Layer Oral Thin Film Development

Double-layer oral thin film technology offers a potential way to reduce the patient's medication burden, as this drug delivery system not only eliminates chemical incompatibilities between APIs through physical separation, but the double-layer OTF has an adhesive layer to ensure that the drug is released through the buccal mucosa and a backing layer to prevent the drug from being released in the oral cavity and being carried into the gastrointestinal tract with the flow of saliva, thereby achieving more sustained drug delivery. CD Formulation has advanced development technology of double-layer oral thin film, which can develop double-layer oral thin film with an extremely thin appearance, good adhesion, and optimal biocompatibility.

Why Develop Double-Layer Oral Thin Film?

• To separate incompatible APIs from each other and use the functional properties of the other layer (such as permeability properties) to control the release of the API from one layer.
• To control the delivery rate of a single or two different APIs.
• To modify the total surface area available for the APIs layer either by sandwiching with one or two inactive layers to achieve fast disintegration/swellable/erodible barriers for modified release.
• The double-layer oral thin film is biologically safe, can stimulate cell proliferation, and deliver targeted drugs.

Our Double-Layer Oral Thin Film Development Services

Preparation of Films

The solvent casting method is usually our common method for preparing double-layer oral thin film. We can also choose other preparation methods based on the property and type of APIs.

Optimization of the Thin Films

We usually use the evolutionary operation (EVOP) method for optimization. The production of films depends on many factors, such as the type and concentration of film-forming agents, the type and concentration of plasticizers, the type and concentration of super disintegrants, the type of production method and the type of solvent system, etc. Among all factors, we select the following three most important factors for process optimization.

• Selection of Film Forming Agents.
• Selection of Plasticizers.
• Selection of Super disintegrating agent.

Our first optimization is to optimize the thin films without the use of drugs. The overall appearance, thickness, folding durability, tensile strength, elongation and disintegration time are used as indicators to optimize the factors.

Characterization of Double-layer Oral Thin Film

• Determination of Thickness: The thickness of the film is the most important parameter, because the uniformity of the thickness determines the content uniformity of the double-layer oral thin film. We usually use a thickness meter to determine the thickness of the double-layer film after it is properly dried. To ensure thickness uniformity, thickness determination was taken at 9 different places.
• Disintegration Time: We usually use a pharmacopoeia disintegration instrument to determine its in vitro disintegration time.
• Folding Endurance: We usually use automatic folding endurance apparatus to test the folding durability of the film.
• Drug Content and Content Uniformity: We usually choose appropriate testing methods to detect drug content and content uniformity based on the properties of the raw materials.
• In-vitro Dissolution Studies: A modified shaking water bath dissolution method was employed to determining the drug release profile of the film.
• Manufacture: Our double-layer oral thin film has a low minimum order quantity, and we will produce according to your requirements.

Our Technologies for Double-Layer Oral Thin Film Development

Our Advantages in Double-Layer Oral Thin Film Development

• First-Class Facilities: We have first-class facilities and equipment for developing and analytical double-layer oral thin film.
• Extensive Expertise: We have extensive expertise and a full range of services to quickly manage and execute multiple projects. Double-layer oral thin film is mostly used for the treatment of oral mucosal diseases, and we have several expert teams familiar with the development of oral mucosal drug delivery systems.
• Professional Team: Our team has years of experience at hand to serve our customers' needs, we can manage fixed-dose combinations of different APIs, extend drug life cycles, and create new drug delivery systems.

Published Data

CD Formulation brings innovative solutions and cross-industry best practices to oral thin film development. If you have any requests for our double-layer oral thin film development services, please contact us by phone or email and one of our colleagues will get back 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.