Encapsulation for API Drug Development – A Better Choice
As drug development progresses and batch sizes increase to meet the requirements of larger clinical studies, companies must scale up their manufacturing capacity while preserving the integrity and performance of their product. When conducting substance testing during the manufacturing process, encapsulation is an easy, versatile method that can significantly increase the chances of commercial success.
Delivery Forms & Methods
In preparing for a clinical study, developers will likely test several different delivery forms across a range of methods to determine which is the most effective and the least toxic form of a drug. These early-stage baseline studies help set the stage for later approval in larger scale human trials. Encapsulation facilitates the ability to administer and test multiple ranges of dosages through the exact same delivery form.
Viability & Versatility
Capsules can also provide insight into drugs that have the potential for future failure down the development pipeline. If a drug is lacking efficacy in the manner in which it is being administered, reformulating it into a capsule offers a different consumption method altogether, which gives developers the opportunity to explore new methods that could potentially yield better and more effective results. Encapsulation also allows for planned dissolution, a big plus for highly potent and poorly soluble drugs. If it is known, for instance, that a new API being tested is sensitive to gastric acids, drug developers can test both enteric and gastric releases of the API using two varieties of the hard-shell capsules, enteric and a standard dissolution capsule.
Scaling up production to accommodate a much larger patient population involves an increase in medicine, administration tools and other resources. Encapsulation lends itself to a reliable scale up model, as it affords developers the ability to manually fill a small number of capsules, semi-automatically fill several capsules, and automatically scale up to full production levels. Capsules can also be color coded so that they can be easily identified without the need to engrave each one its contents, as is the case with many similar looking pressed pills, soft-gel capsules and vial based delivery forms.
To learn more about encapsulation for API drug development and how encapsulation can potentially save failing research projects, contact us today at 1(800) 852-9238 or email us at Info@thecapsulegroup.com