Mucoadhesive Sustained-Release Film Development

Mucoadhesive sustained-release film gradually releases the active ingredient of the drug over a specific period. The drug in these tablets is not released and absorbed immediately after ingestion but is steadily distributed in the body to ensure long-lasting efficacy. The aim is to maintain a constant drug concentration in the blood, thereby reducing the frequency of dosing and minimizing peaks and troughs in plasma drug concentration. This drug delivery system offers several advantages, including improved patient compliance, minimized side effects, and improved therapeutic efficacy.

Mucoadhesive sustained-release film developed by CD Formulation, as a new type of drug delivery method, refers to the local application of drugs in the oral cavity with the help of adhesive materials, which prolongs the time of action of the materials and promotes drug absorption. It is not only convenient and non-invasive to use, but also conducive to the maintenance of local drug concentration, which helps to enhance drug efficacy. In addition, the mucoadhesive sustained-release film we developed has the characteristics of disintegration without water, avoiding first-pass metabolism, precise dosage, easy to handle, pleasant taste, rapid onset of action, and sustained or regulated release of the drug.

Advantages of Mucoadhesive Sustained-Release Film

• Mucosal adhesion. Increases the retention time of the active ingredient at the target site for local or systemic delivery. Not only does it increase bioavailability, but the drug in the mucoadhesive sustained-release film is released and absorbed immediately after ingestion and is instead stably distributed throughout the body to ensure long-lasting efficacy.
• Improved patient compliance. Patients can usually take fewer doses than with traditional immediate-release medications, helping to improve patient adherence to their treatment regimen, especially in patients with chronic conditions that require long-term medication.
• Reduced side effects. The mucoadhesive sustained-release film maintains stable drug concentrations in the body, minimizing the risk of side effects associated with high peak drug concentrations.
• Enhanced therapeutic effect. Mucoadhesive sustained-release film ensures stable drug delivery over time, thereby improving overall efficacy by maximizing absorption and prolonging the duration of action.

Our Process of Mucoadhesive Sustained-Release Film Development

Formulation Design Phase

The formulation design phase is critical in determining the basic structure of the film for optimal drug release. In addition, we need to optimize the design for percent drug content, folding resistance, mucosal adhesion strength and percent swelling index. In formulation design, we focus on polymer selection, drug-polymer compatibility, and controlled release mechanisms.

Development Phase

Once the formulation design is finalized, the project enters the development phase. During this phase, it is important to determine the manufacturing accuracy, such as Employing state-of-the-art casting techniques to ensure uniformity and reproducibility in film thickness. In addition, we implement strict quality control protocols throughout the manufacturing process to ensure product consistency.

Pilot Stage

During this phase of performance testing, we utilize drug release kinetics, which are used to thoroughly evaluate drug release kinetics to validate the extended release profile. In addition, we utilize mechanical strength analysis to evaluate the mechanical strength of the film to ensure integrity during application. In this phase of safety assessment, we focused on biocompatibility studies and toxicology assessment. We also developed a fast and reliable in vitro method that can differentiate the adhesive strength of various oral thin films using a texture analyzer.

Upon successful completion of the pilot phase, the manufacturing process will be scaled up to meet commercial production requirements.

Applications of Mucoadhesive Sustained-Release Film

• Periodontal disease. Mucoadhesive sustained-release film has the ability to adhere to mucosal surfaces, which has been shown to help treat oral diseases. This targeted delivery mechanism ensures optimal drug concentration at the affected site, resulting in improved therapeutic efficacy. Mucoadhesive sustained-release film retains the dose of the drug at the time of administration will contribute to sustained release and more effective treatment.
• Pain management. By providing prolonged and controlled release of analgesic agents, these films offer sustained relief for individuals grappling with chronic pain conditions. The localized delivery ensures targeted efficacy, minimizing systemic side effects and enhancing patient comfort.
• Dermatological applications. Mucoadhesive sustained-release films find applications in dermatological therapies, offering enhanced penetration and sustained release of therapeutic agents. This not only improves the overall efficacy of topical treatments but also minimizes the need for frequent applications.

Figure 1. Rizatriptan mucoadhesive buccal film has enhanced buccal permeability. (Jacob S, et al., 2021)

Highlights of Our Mucoadhesive Sustained-Release Film Development Services

• New drug delivery service system. We are committed to the research of drug delivery systems and to providing advanced new drug delivery service systems.
• Advanced technology platform. We have a strict drug development environment, high-tech instruments and equipment, and a complete experimental platform.
• First-class expertise. Our researchers have extensive expertise in drug discovery and development.
• Experienced technical team. Our technical team has extensive service experience in drug research and development.

CD Formulation develops mucoadhesive sustained-release film that will continue to drive more effective treatments, superior patient outcomes, and overall improvements in healthcare delivery. If you are interested in us, please feel free to contact us.

Reference

1. Jacob S, et al. An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems. Pharmaceutics. 2021, 13(8):1206.