Expertise in successfully developing hydrophilic solutions
Softgels utilizing hydrophilic solutions are ideal for many OTC products, as the polyethylene glycol (PEG) used in these formulations facilitates the encapsulation of APIs as clear solutions with bioavailability enhancement potentials. However, hydrophilic solutions can be much more challenging to formulate and manufacture than lipophilic suspensions or solutions, particularly for companies who don’t have experience with them.
A PEG-based fill material can’t be encapsulated in a softgel the same way as an oil-based one, since polyethylene glycol behaves in a different way than an oil when it comes into contact with the shell material. This results in different challenges that demand a deep expertise to overcome.
Hydrophilic fills readily absorb water from the shell, which then migrates back out during drying. Therefore, additional steps need to be taken during formulation and manufacturing to keep the drug from precipitating out of the fill and forming crystals which aren’t as bioavailable.
Overcoming Water Migration Challenges
To accommodate the water migration challenge, different plasticizer systems are needed than those used for lipophilic formulations, as well as gels with a lower viscosity so that lower amounts of water can be used in the formulation. A different sized capsule may also be needed for a hydrophilic solution.
Finally, even the drying process can also be challenging for hydrophilic softgels. An increased drying time is often required to avoid stability issues.
CAPTEK’s team of experts have the skill, techniques, and knowledge needed to successfully formulate hydrophilic fills. Members of our team were instrumental in pioneering this technique, and we leverage that deep experience on every hydrophilic softgel we develop.
Ensuring The Stability Of Your Product
Our process involves numerous preformulation studies designed specifically to overcome the challenges inherent to hydrophilic solutions. CAPTEK formulation experts perform rigorous testing to ensure compatibility with the shell and complete dissolution of API within. Our experts determine the right excipients needed to inhibit the crystal growth and enhance the solubility of the formulation.
Don’t take chances with a company that doesn’t have CAPTEK’s long history of encapsulating hydrophilic solutions. You don’t want to risk a product that either can’t maintain its stability during manufacturing or, worse, loses its stability months later. CAPTEK has a proven track record of successfully developing hydrophilic solutions for our customers’ products, creating formulations that fully encapsulate their API in a quality softgel.
Speak With An Expert
Product Development Specialist
Over his 25 year career, Tim Chiprich has led teams developing softgel pharmaceuticals, dietary supplements, and cosmetic products. In addition, he’s participated in gelatin research and new technology projects and has several pending and granted patents. Tim is happy to leverage his thorough understanding of softgel development to discuss any challenges on your upcoming project.