German CDMO tesa Labtec brings its years of experience in pharmaceutical thin film technology closer to clients in North America.

Rapid Expansion of the Oral Thin-Film Market

Thin-film drug delivery technologies enable the development of patient-centric drug formulations. For patients that have trouble swallowing, oral thin-film (OTF) drug delivery is an attractive alternative to traditional tablets, capsules and even syrups.

The OTF market is still in the early growth phase. As more formulators discover the benefits of the technology and regulatory authorities continue to expand requirements for patient centricity, the demand for OTF delivery solutions will increase.

Overcoming Formulation and Manufacturing Challenges

There are fundamental challenges in the development and manufacturing of OTF products that can only be overcome with extensive experience with this complex technology. tesa Labtec has focused on the development and production of film-based dosage forms for more than 25 years and has the expertise needed to provide solutions to our customers for even the most difficult APIs.

To overcome drug loading challenges, we have developed a proprietary approach that enables the loading of up to 150 mg of API on films small enough for oral delivery. We have also overcome issues with insufficient mucoadhesion and offer films that provide long-lasting formulations.

With respect to manufacturing, it is often necessary to achieve a balance between product performance and processability at commercial scale, which requires deep knowledge of both the technology and formulation, and are both areas of expertise at tesa Labtec. By running experiments at lab scale and in our pilot plant, we can identify optimal formulations and processing parameters that afford economic processes and high-performing products. tesa Labtec has received approval from regulatory authorities in both the United States and Europe. We have expertise in managing the complexities of the European supply chain, from dealing with large numbers of SKUs to communicating in multiple languages.

Range of Proprietary Technologies

The dosage forms developed by tesa Labtec have been used in dietary supplements, medical devices and drug products. Our orodispersible Rapidfilm^® technology is designed to meet the needs of patient groups that have difficulty swallowing by combining the convenience of a liquid with the stability and dosing accuracy of a tablet. Once placed on the tongue, Rapidfilm dissolves within seconds, and the API is swallowed with the saliva. A range of formulation alternatives is available depending on the specific target product profile, including fast-onset and slow-release forms and taste-masking solutions. Reformulation of existing oral products can typically be achieved using the same dose, providing a means for extending product life cycles.

tesa Labtec’s Mucofilm^® technology offers topical or transmucosal delivery. This mucoadhesive film is applied to the mucosa of the oral cavity, where it cannot be felt by the patient. The dosing of Mucofilm products can be as short as one minute or up to several hours– whatever is required for the specific product.

Mucofilm can be used to deliver an API unidirectionally for local treatment or bidirectionally to facilitate transmucosal delivery for systemic treatment. Transmucosal delivery avoids issues with first-pass metabolism and is therefore ideal for APIs and APIs that suffer from poor bioavailability. These OTFs can therefore often be formulated with lower doses.

One-Stop Shop

tesa Labtec is a full-service CDMO for transdermal therapeutic systems and oral films, offering end-to-end solutions for all stages of drug development, including portfolio screening, development strategies, feasibility assessments, formulation development and clinical and commercial manufacturing and packaging. We provide all of the regulatory support and analytical activities and testing required, including state-of-the-art ex vivo permeation studies.

As a wholly owned subsidiary of tesa SE, one of the world’s leading manufacturers of technical adhesive tapes and self-adhesive systems, tesa Labtec has access to deep resources while maintaining the flexibility, agility and close collaborations associated with smaller firms.