Polymer Reservoir – Semi-solid drug containing polymer matrix, in direct contact with the skin, with an adhesive ring around the matrix to adhere to the skin. Multilaminate Solid-State Reservoir – Delivers two drugs at different release times. Commonly uses a bolus dose to begin, and follows with a maintenance dose. We can drill down further into variations of these four overall designs, but these typically comprise the starting point.
The approach you choose will be based on the specifications of the drug and the dosage. Step #3 – Selecting the Materials and the Equipment. This includes the liner, backing, membrane, overlaminate tapes — all of which must be balanced with the drug properties and the chosen design. The production equipment also factors into the material consideration. If a patch manufacturer has materials that require processing under low tension, they must also have the right transdermal patch manufacturing equipment on hand. “Compatibility between materials and equipment is essential for a smooth commercialization process,” Schubert notes. For example, if a component roll is 48” wide, it is better to run 12” rolls with no waste versus cutting materials into two (2) 17” rolls with a yield loss of 14”. The Transdermal Intangibles: Other Important Considerations. We’ve touched on a number of big-picture issues for you to ponder, but Schubert highlighted a number of other important areas of note to transdermal newcomers: Check for a Drug Master File.
As you’re reviewing material vendors, make sure they have a Drug Master File (DMF) established with the FDA. The Drug Master File is a confidential document provided from a material supplier to the FDA. It provides details on how a product is manufactured. When you’re producing a new transdermal product, you submit a request to the FDA, who then accesses the DMF and makes a ruling on whether or not the product is approved. Part of the design process above includes knowing the volumes you will be targeting. That can dictate the type of equipment to purchase and the materials you’ll use. Whether it’s your company or the vendors you’re working with, make sure a close eye is kept on the evolving FDA guidelines. As Schubert pointed out, they will not only dictate much of your design, but they can also lead to innovation. For example, at one point, the FDA was interested in patients’ abilities to clearly identify the difference between the liner and the patch itself. Regulations were being considered that would require differentiation between the patch and the liner. For example the patch would be opaque and the liner translucent. Opaque, writable backings also allow patients and providers to record the date the patch was applied. Even though the FDA did not enact the proposed regulations, 3M reacted to them and produced an innovative new backing. It’s a perfect example of how embracing and understanding the intent of regulation can lead to positive innovation. Work With Materials and Machine Vendors Throughout the Process. The entire transdermal patch development process is remarkably complicated and subject to multiple variables. The key is to align yourself with partners who understand the product, the process and its complexities. Take the time to understand who has travelled down that path before to better ensure the trip is successful. As with all transdermal patch components, however, it is the customer’s sole responsibility to determine the suitability of patch components for the intended use of their product and to ensure the necessary safety and toxicity standards are met. The markets of the world are replete with medications designed to ease and/or cure the symptoms associated with thousands of conditions. Traditional medication delivery methods, such as pills, capsules, liquids, powders, and intravenous needles, are often inefficient or invasive and can lead to undesirable side effects. Among the newer methodologies for administration of medicines is the use of transdermal approaches, including gels and patches for the treatment of many of the more common ailments. Transdermal technology is becoming more sophisticated as efficiencies are increased and patients are embracing the many benefits patches offer vs pills: Eliminate first pass metabolism Provide steady delivery/blood levels Increase compliance/convenience Reduce systemic drug interactions Minimize abuse/diversion Permit dose discontinuation via removal. Transdermal (Rx) Drug Delivery Systems by ProSolus, Inc.
We formulate and develop: All within our premier R&D and manufacturing facility, for optimal delivery technology. We endeavor to execute agreements with pharmaceutical marketing companies seeking to develop and commercialize TDDs. We evaluate FDA approved transdermal formulations to in-license and/or develop internally. Once engaged, we work with our partners to complete the requirements for clinical development and FDA approval. Transdermal patches comprise a method of delivering medication through the skin in a non-invasive manner.. During transdermal drug delivery, a patch is adhered to a patient’s skin. The patch contains the medication prescribed to the patient and is designed in such a way that the medication permeates the skin in a controlled fashion thus attaining more steady levels of the drug in the body.
Patches are presently being marketed which can be worn anywhere from as little as eight hours to as long as seven days, depending on their therapeutic indication.. These patches are secured with adhesives, which are designed to adhere comfortably to the skin which in turn allows a patient to use the patches for as long as is indicated by his or her physician. Transdermal patches are simple to use and constitute a simple albeit efficient idea for medication delivery.