Manufacturing transdermal patches and oral films at commercial scale requires a controlled and well-established process, from the preparation of raw materials to the final packaged product.
While each product has its own formulation and design requirements, manufacturing relies on a series of carefully controlled operations to ensure consistent processing, product quality and traceability.
At AdhexPharma, commercial-scale manufacturing of transdermal patches and oral films is structured around five main steps: blending, coating, slitting, converting and primary packaging, and secondary packaging.
1. Blending: preparing the formulation
The manufacturing process begins with the blending of raw materials.
Depending on the product, different components are required to prepare the formulation. Each raw material is precisely weighed according to the required batch size. Critical weighing operations are performed in accordance with the four-eyes principle, providing an additional level of control during preparation.
The components are then introduced into dedicated vessels and mixed to obtain a homogeneous formulation.
Once the mixture has reached the required characteristics, it can proceed to the coating stage.
2. Coating: forming the film layer
The prepared formulation is transferred directly from the vessel to the coating equipment.
During coating, the formulation is applied onto a process liner to form a homogeneous layer. The coating thickness can be adapted to the specific requirements of the product and its intended final design.
The coated material then passes through a drying process consisting of individually temperature-controlled ovens. Each oven can be controlled separately to establish the appropriate drying conditions and achieve the target product profile.
Depending on the product configuration, a backing layer can subsequently be laminated onto the coated structure.
The material is then wound into a jumbo roll, ready for the next stage of manufacturing.
3. Slitting: preparing the jumbo roll for further processing
The jumbo roll is subsequently processed through slitting.
During this operation, the large roll is divided into smaller mother rolls that can be handled during the subsequent converting operations.
The width of the mother rolls can be adjusted according to the final dimensions and design of the transdermal patch or oral film.
Slitting therefore provides the appropriate format for the next manufacturing stage while maintaining control over the continuous material produced during coating.
4. Converting and primary packaging: from rolls to individual products
Once the mother rolls have been prepared, they are transferred to the converting process.
This is where the continuous material is transformed into individual transdermal patches or oral films. The converting process can accommodate different product requirements, including specific sizes and shapes.
Depending on the product design, the material can be printed, punched and separated to obtain the individual units.
The finished patches or oral films are then introduced into their primary packaging, such as individual pouches.
Each pouch is marked with a unique matrix code, supporting product identification and traceability throughout the manufacturing process.
Quality controls are integrated into the process, including camera-based inspections during punching and pouching operations. These automated controls help verify the conformity of the products and packaging.
Following the primary packaging operation, additional quality checks are performed by experienced teams.
5. Secondary packaging: identification, verification and final checks
The individually packaged products then move to the secondary packaging stage.
Before labelling, camera systems verify the matrix code on each pouch. Customer-specific information and variable data, such as the batch number and expiry date, are then applied.
The packaging process also includes verification of the appropriate package leaflet before the pouch is placed into its folded box.
Relevant variable data and, where applicable, the unique identifier required for pharmaceutical traceability are printed on the box.
The finished boxes are subsequently weighed to verify their completeness. Additional quality checks are performed by the manufacturing team before the products proceed to release and distribution.
A controlled process from formulation to finished product
The manufacturing of transdermal patches and oral films involves multiple interconnected operations, each contributing to the quality, consistency and traceability of the finished product.
At AdhexPharma, our expertise extends beyond commercial manufacturing. As a full-service CDMO for complex dosage forms, we support projects from development through to commercial manufacturing, combining development expertise, analytical capabilities and manufacturing know-how for transdermal patches and oral films.
Whether you are starting with an idea or preparing a product for commercial production, our integrated services are designed to support your journey from idea to market, designed around patient needs.
Discover our Contract Development services and Analytical Services