Sublingual Thin Film Development

Sublingual drug delivery refers to the placement of a drug under the tongue and is prized by drug development staff as well as patients for its rapid onset of action and high bioavailability. Sublingual thin films are absorbed into the bloodstream under the tongue, making them a fast-acting method of drug delivery that is easy to penetrate and absorb. In addition, for low doses and small molecules, sublingual thin films offer a viable alternative to injections.

CD Formulation is dedicated to the development of sublingual films based on an advanced technology platform and specialized drug development expertise. We develop sublingual thin films as a new drug delivery method to provide an effective alternative to the traditional tablet and injection drug delivery methods.

Figure 1. Scanning electron microscope images of formulation of orodispersible sublingual film. (Islam N, et al., 2021)

Advantages of Sublingual Thin Films

• High precision. Each film is given a precise dose of medication to ensure patient safety.
• Fast onset of action. Compared with other routes of administration, the drug is absorbed faster.
• Mucosal tissues absorb the drug directly into the body circulation, avoiding the first-pass effect, and improving the bioavailability.
• Compliance, higher safety. The sublingual films for better patient compliance with dysphagia and higher safety.
• Easy to use, will not produce pain like injection, easy to carry.

Our Process of Sublingual Thin Film Development

Formulation Design

During the formulation design phase, we identify polymers, plasticizers, active pharmaceutical ingredients, sweeteners, saliva stimulants, flavoring agents, colorants, stabilizers, and thickeners based on the desired characteristics of the sublingual film being achieved. We have developed sublingual films for drug delivery that not only promote rapid drug release but also maintain stability over time.

Development Phase

This phase involves the precise execution of the formulation design into sublingual thin film. It is very important that the manufacturing accuracy is determined during this phase.

Pilot Stage

We focus on performance testing and safety evaluation.

• Average weight measurement. The average weight was calculated. The homogeneity of the weight of the films indicated the accuracy of the sublingual film dosage.
• Thickness. The uniformity of film thickness is related to the accuracy of sublingual film dosing.
• Fold durability. Folding durability indicates the mechanical strength of the buccal film.
• Tensile strength. Tensile strength indicates the mechanical strength of oral films.
• Tensile percentage. By determining the percentage elongation of the strip.
• Content uniformity and in vitro dissolution studies.

In the safety assessment phase, we focus on biocompatibility studies and toxicology assessments.

Manufacturing Phase and Project Closeout

• Manufacturing. A rigorous quality control system is mainly carried out to ensure a high degree of consistency in film thickness, drug content and other important characteristics. It is used to scale up production.
• Project closeout. The project enters a full closeout phase to ensure that all regulatory and quality benchmarks are met prior to market launch.

Applications of Our Sublingual Thin Film Development Services

• Rapid pain management. Patients experiencing acute pain can receive fast relief with sublingual thin films, which are perfect for the rapid release of analgesics. Because it doesn't need gastrointestinal processing, it responds quickly, which makes it a better option for managing pain.
• Cardiovascular medications. In the field of cardiovascular medicine, accurate dosage and quick onset are critical. For patients in need of prompt attention, our sublingual thin film development offers a viable substitute for the formulation of cardiovascular drugs.
• Pediatrics and geriatrics. Administering medication to vulnerable populations demands careful consideration. Sublingual thin films offer a convenient and palatable solution, making drug administration more manageable for both pediatric and geriatric patients.

Highlights of Our Sublingual Thin Film Development Services

• Professional research team. Our research teams all have extensive drug development experience.
• Efficient development process. We have our own efficient development process in drug development.
• One-stop development services. Our one-stop service can help customers save research time to a great extent.
• Customized solutions. We can provide customized solutions according to customer requirements.
• Rich service experience. We have many years of research and service experience in drug development.

CD Formulation is committed to sublingual film development. Based on the support of our advanced technology platform and our specialized R&D team, we have continuously overcome difficulties and explored innovations to provide effective development services for sublingual film drug systems. If you are interested in us, please feel free to contact us.

Reference

1. Islam N, et al. Poloxamer-188 and d-α-Tocopheryl Polyethylene Glycol Succinate (TPGS-1000) Mixed Micelles Integrated Orodispersible Sublingual Films to Improve Oral Bioavailability of Ebastine; In Vitro and In Vivo Characterization. Pharmaceutics. 2021, 13(1):54.