Manufacturing Transdermal Patches for the Nutraceutical and CBD Market
Since the 1970s, transdermal patches have been used to aid motion sickness, hypertension, hormone replacement, nicotine, and most recently, cannabis consumption. Transdermal patches, also known as Transdermal Delivery Systems TDS, deliver a specific steady dose of medicine into the skin, which absorbs directly into the bloodstream. Pharmaceutical drugs such as nicotine, fentanyl, and hormones used to corner the market. With the deregulation of CBD, the nutraceutical market is seeing a boom. Now, transdermal patches are being used to deliver CBD, CBN, B12, Vitamin E, and caffeine, among other treatments to manage pain, anxiety, and sleep disturbances. Transdermal patches offer a safe, easy, effective, and discreet way to deliver nutraceutical ingredients.
The Manufacturing Process
The manufacturing process of transdermal patches involves mixing biocompatible, FDA-approved medical adhesive with the desired deliverable formula in powder form, coating the formulation onto a backing material, and then die-cutting the material into a usable product based upon the customer’s design. A knowledgeable full-service contract converter has the connections and capabilities to formulate, coat, convert and package, which in turn, reduces time, energy, and cost to get the product to market.
Types of Patches
Depending on the structure of the patch, the carrier and adhesive components should be carefully selected and evaluated for their intended performance requirements by the seller. In a multi-layer composite system, there is a multitude of options when selecting a carrier, backing, or overlay. The drug or ingredient can be compounded in the adhesive or separated with a membrane or laminate material.
Transdermal Delivery Systems come in different configurations, matrix, pre-dose, and reservoir patches.
Matrix patches are typically composed of five distinct layers; peel-off liner, matrix layer, separating layer, adhesive layer, and backing layer. The patch starts working instantly because the ingredient is infused directly into the matrix layer that touches the skin. These patches offer a tapered release of the active ingredient, starting with higher concentrations and releasing less and less active ingredients as the drug concentration gradient comes to equilibrium.
Pre-dosed patches have fewer layers because the ingredient is compounded into the adhesive and not infused into the patch itself. The drug level is controlled and evenly distributed on the patch to release a steadier drug delivery rate compared to the tapered release experienced with matrix patches. Also, the pre-dosed CBD patches are absorbed by the skin and avoid the “first-pass effect” by not utilizing the GI tract.
Reservoir patches have a peel-off liner and an adhesive, but they hold the active ingredient in a reservoir covered by a permeable release membrane. This membrane helps control the rate at which the active ingredient penetrates the skin. This ensures that the active ingredient is released at a steady, controlled pace.
The type of design used can impact product performance. So, engineers need to think critically and work closely with an experienced converter rep to discuss product goals before choosing a specific type of patch and end design. They also need to consider the types of stick-to-skin adhesives and materials that will be used, keeping in mind, skin comfort, removability, wear-times, moisture management, and breathability.
The selection of the right components is critical when finding the best fit for the transdermal system. Different types of foams and non-woven materials were typically used in the past. As technology and materials continue to advance, often films, membranes, and different types of liners are becoming more commonly used to provide additional integrity, stability, and protection to the drug formulation
For example, 3M offers a multitude of release liners and backings, in which material use is determined by customer needs and what the end-user is trying to accomplish. New materials include clear, breathable, comfortable, conformable, and printable polyethylene films for the backing material and lidding and pouching films to hold the ingredients. Tape converters who source 3M materials gain regulatory and technical expertise when crafting transdermal patches.
3M Materials found in the MBK online catalog include:
- 3M 1022-Scotchpak-Liner-Fluoropolymer-Polyester-Film
- 3M 9709-Scotchpak-Liner-Fluorosilicone-Polyester-Film
- 3M 9718-CoTran-Polyethylene-Film
- 3M 9720-CoTran-Polyethylene-Film
- 3M 9735-Scotchpak-Polyester-Film
Partner with a Medical Converter
As the nutraceutical market grows, it is important to choose an experienced converter who has a reputation for innovation and trustworthiness. Because the transdermal industry is an unregulated market, there are several different types of permeation enhancers or materials that may cause skin irritation. To avoid pitfalls during development, partner with an experienced medical converter who complies with medical standards uses high-quality materials, tailors the product to the customer, and offers a scalable manufacturing and packaging process.
The team at MBK Tape Solutions has the knowledge, experience, and converting capabilities to help get your product to market quickly, efficiently, and cost-effectively.
Contact MBK today to discuss your transdermal patch project and to request samples and prototypes. To learn more, view our online medical catalog and our converting capabilities.