Manufacturing pharmaceuticals can be a difficult and time-consuming process. The complexity of today’s FDA and GMP regulations coupled with the steep costs associated with creating a new formulation or testing a potential manufacturing process often results in companies rethinking their approach to manufacturing pharmaceuticals and instead opting for a more cost-effective, less stringent alternative. One such alternative is sub-micron encapsulation technology (SME) which, as the name suggests, involves encapsulating pharmaceutical ingredients within tiny microcapsules that are then blended into a suspension before being filtered through an ultrafiltration membrane to produce a final solution. From there, the solution is ready for storage, further processing and dispensing as part of your finished dosage form. In this article, we will explore how submicron encapsulation technology can help you manufacture your products in ways that are cost-effective and also maintain compliance with both GMP regulations and current Good Manufacturing Practices (cGMP).
What is submicron encapsulation?
Submicron encapsulation refers to the process of forming microencapsulated ingredients into a suspension and then filtering them through ultrafiltration membranes. The encapsulation process takes place in a high-shear liquid chromatography (HSLC) system which, similar to a normal HPLC, separates ingredients from each other and from the ultrafiltration membrane by applying shear forces. The suspension is then ready for further processing and storage. SME is a perfect fit for many pharmaceutical companies looking to reduce manufacturing costs and increase their profits by scaling up their production of active ingredients. For example, many ingredients are best produced in bulk. Microencapsulation, however, does allow for the production of smaller batches that are then easily scaled up to meet the needs of a larger production run. Furthermore, many ingredients are best produced in granulation form. SME allows you to granulate your ingredients and then evenly mix them in the suspension before filtering through ultrafiltration membranes.
How does sub-micron encapsulation help with manufacturing?
Sub-micron encapsulation is a low-cost manufacturing process that allows you to produce pharmaceuticals in smaller batches, at lower costs. It’s a great alternative to GMP for companies looking to switch from manufacturing their products under GMP regulations (cGMP) to manufacturing in lower volumes and at lower costs. Additionally, the sub-micron method can also reduce the number of active ingredients in your finished pharmaceuticals, resulting in a less potent finished drug product.
Steps to take to manufacture using SME
It’s important to note that while sub-micron encapsulation can be an effective process for manufacturing pharmaceuticals, it’s also important to keep in mind that it’s no replacement for GMP or cGMP regulations. When using sub-micron encapsulation, you must adhere to manufacturing requirements such as using a certified manufacturing facility and adhering to Good Manufacturing Practices (cGMP). It’s important to understand that sub-micron encapsulation is not just a manufacturing process; it’s a manufacturing technology that can be used in conjunction with cGMP and GMP manufacturing as well. With that being said, there are a few steps you can take to get started with sub-micron encapsulation. First, confirm that your facility and equipment are suitable for the sub-micron method. Next, look at your finished drug product and its ingredients to determine if sub-micron encapsulation is the best method for manufacturing your finished pharmaceuticals. If it is, you can then move forward with sub-micron manufacturing.
Raphe Pharmaceutique Product engineering technology
In an effort to ensure that your manufacturing process is as seamless as possible, it’s important to consider developing a product engineering strategy. A product engineering strategy is designed to create processes that are as fluid and seamless as possible, while also preventing any issues that could arise as a result of re-engineering and harmonizing processes. Product engineering strategies can be applied while using any manufacturing method, but they are especially helpful when manufacturing pharmaceuticals via sub-micron encapsulation. While product engineering strategies may not be able to completely replace the sub-micron manufacturing method, they can be used to harmonize the sub-micron method with cGMP requirements and to create a process that is as seamless as possible.
Submicron encapsulation is a low-cost, quick, and scalable method for manufacturing a variety of ingredients and active pharmaceuticals. It’s also a great alternative to cGMP for companies looking to switch from manufacturing their products under GMP to manufacturing in lower volumes and at lower costs. However, it’s important to note that while sub-micron encapsulation is an effective process, it’s also important to keep in mind that it’s no replacement for GMP or cGMP regulations.
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