Is your API Suitable for a Softgel Formulation?

Softgel capsules offer numerous benefits, such as enhanced bioavailability, improved patient compliance, and protection of sensitive ingredients. However, not all APIs are suitable for this dosage form. Here are some key factors to consider when determining if your API is a good fit for a softgel formulation manufacturing:

You should think about:?

• Lipophilicity: as liquid lipid systems are most suitable for encapsulation into softgel capsules, lipophilic drugs are generally well suitable for such formulations. Many marketed drugs have a logP value >4.
• Solubility: softgel formulations are well suitable for poorly water soluble drugs, as significant solubility enhancement can be achieved using the appropriate excipient palette of lipids, surfactants and solvents for oral use
• Permeability: permeability enhancement can be achieved in liquid formulations suitable for softgel formulations, therefore APIs with low permeability can be good candidates for softgel formulations
• Aggregate state: liquid drug substances such as omega-3 fatty acids or derivatives, essential oils and others are worth exploring
• Positive food effect: drug substances exhibiting pronounced food effect can be formulated in liquid, lipid systems well suitable for encapsulation

If your API meets these criteria, a formulation in a softgel capsule could be an excellent choice for your product.

Equally as important though is to know when a drug substance is not a good fit for a softgel formulation. This could be the case if the API:

• Is a hydrophilic or hygroscopic small molecule
• Has a stability optimum in extreme pH values
• Undergoes hydrolytic degradation
• Has aldehyde groups which can cause crosslinking of the gelatin shell
• Exhibits incompatible physical behavior

Working with an experienced partner can help you navigate the formulation and development process, ensuring a successful and efficient process.

Do you have experience with selection of softgel formulations for APIs? Share your insights in the comments below!

If you'd like to learn more about fill formulation development for softgel, read our article here: https://www.softcaps.science/softgel-capsules-fill-development

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