Driving successful Drug/Delivery combination products in the market
For decades, silicone has been used for both short- and long-term implantable applications, due to its high level of biocompatibility. As the patient begins to realize the potential of long-term silicone-based drug-eluting implants to improve outcomes, today, even more exceptional permeability is crucial for next-generation combination products. However, these drug/delivery combination products are very challenging to design, manufacture and shepherd through the control process. In this article, we will examine the potential pitfalls and develop a strategy to ensure a successful product launch.
Growth of combination products–
Long-lasting implantable combination products (which last longer than 29 days in the body) developed with one or more active pharmaceutical ingredients (APIs) are currently being used to improve lives. For example, some such products may eliminate the need for daily administration of contraceptives or APIs to prevent retroviral infections. Since silicone-based intraturine combination products have more than one API, the combination product can provide the exact dosage and hormone of antiviral drugs simultaneously.
Cancer-tumor reduction is another area of immense promise for long-term drug-eluting combination products that can be implanted. Small combination products that can deliver the exact amount of cytostatics used in chemotherapy can be placed exactly where needed, significantly reducing the cost of care while significantly reducing side effects.
Better patient results can ultimately be a great driver, while combination products can simultaneously increase treatment efficiency and reduce costs — all important health care is a sweet spot. Furthermore, the combination products allow pharmaceutical companies to use FDA-approved formulations in novel ways, to expand drug use and to extend patient life.
The design, manufacturing and approval processes for combination products can be very challenging but very rewarding when successful. Some of the great challenges faced by product manufacturers are related to resolving the technical and scalability issues associated with their manufacture before the start of clinical trials.
To address these issues, it is important to understand the relationships and interactions between drug, device, silicone and manufacturing processes among all parties involved in terms of technical feasibility, regulatory compliance and functionality and effectiveness in treatment. These variables affect each other. The design and manufacturing process It is very important to find the right balance before freezing. Silicon extraction, molding and other manufacturing methods use heat to cure silicon. If the API is heat sensitive, silicone selection and curing method are critical factors. Newer, lower-temperature curing silicones or alternative curing technologies may provide better solutions, e.g.
Substantial skill is required to create the desired release rate for a specific solution of the specified silicon type. The silicon matrix has a polymer structure. During the development process, the silicon matrix matched the molecular structure of the API, ensuring optimal illusion over the desired time frame. Success requires expertise on how Silicon and API interact.
Finally, scale-up is often overlooked for the overall success of a product. During the development phase, a small scale possible process can lead to inefficient or prohibitively expensive full-scale manufacturing. Understanding both lab scale development and commercial production to a very large extent is important for partner market potential.
In general partnership, the combination product owner will focus on development drug development, clinical strategy and coordination, control submissions, features and design control. The combination of development and production partner focuses on the effective preparation of production and planning for scalability from bench scale to commercial production, including certification in line with the planned control route for production.
4 Important Questions
Here are some questions to ask yourself when choosing manufacturing and supply chain partners for your combination product development:
What experience do you have with the government regulatory review process for combination products? Combination product creators who are unfamiliar with the dual control route of combination products can benefit from this experience by being able to select a manufacturer and assist in developing the project plan. Underestimating the time required for product development and testing (e.g., illusion rate study), conducting a series of clinical trials, and guiding combination production through multiple control reviews easily and quickly derailed such a project.
Can you recommend the best process for the drug drug-dispensing system we are designing? First, an experienced production partner must have extensive processing experience to recommend the optimal production process for a combination product. Second, the partner must have experience in joint engineering and have a DfM (Design for Manufacturing) mentality. Third, the partner must be able to contribute to early development decisions, provide the necessary design and processing input related to the compatibility, form and performance of the combination product so that scalability and commercialization are fully considered.
What is the range of knowledge of your materials? Look for a manufacturer with strong base development and processing experience and long-term relationships with material manufacturers on a global basis. Understanding the processing properties of materials and how they can be affected and controlled is crucial to the successful validation and launch of the final product. Technical cooperation between components and materials manufacturers simplifies the process of adapting existing materials or developing new ones as needed.What is the full range of your abilities? Depending on the specific needs of your project, it may help to choose a productive partner who is capable of providing a range of services in addition to the product of the combination. To ensure a thin supply chain, it can be beneficial to choose a manufacturing partner that can deliver a fully integrated product including all aspects of post-manufacturing processes, packaging, labeling and steri