Douglas CDMO has world-class expertise in the development and manufacturing of softgel capsules and medicine fill.
Decades of softgel excellence
Douglas CDMO has extensive expertise in the development and manufacturing of softgel capsules and is recognised for its role in supporting many of the softgel products approved in the EU and U.S. markets.
With decades of experience, Douglas CDMO has excelled in the development, manufacturing, and commercialisation of softgel capsules by maintaining high standards of safety and efficacy, leveraging technical expertise, and advanced technological capabilities.
Encapsulate your formula within a softgel
Soft gelatin capsules are a delivery platform, containing an inner fill with an API. They lend themselves to various applications, including over-the-counter medications, dietary supplements, vitamins, nutraceuticals, and prescription pharmaceuticals. They are particularly suitable for liquid or semi-solid formulations, and commonly used for oil-based or lipid-soluble drugs.
The benefits of softgel include:
- Enhanced absorption rate, and overall bioavailability of the drug to ensure the lowest effective dose is used to achieve its full therapeutic effect.
- Addressing solubility issues.
- Protection of ingredients from exposure to light, air and moisture.
- Easier to swallow than hardshell capsules and tablets.
- A consistent and precise dose of the active ingredient.
- Enhanced shelf life.
The complex nature of softgel manufacturing, involving specialized equipment and proprietary formulations, also presents significant barriers to their generic production. This complexity ensures the preservation of product quality and efficacy, safeguarding your investment.
Improved bioavailability
Softgel capsules stand out for their remarkable capability to enhance the bioavailability of certain compounds, guaranteeing optimal delivery of the active ingredient to its target site within the body. This enhanced bioavailability not only boosts therapeutic effectiveness but also maintains steady drug levels and may even reduce necessary dosages, ultimately leading to superior patient outcomes.
Abuse deterrent
Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing to snort or dissolving to inject the drug substance. The field of abuse deterrence is emerging, with formulation technologies and evaluation methods evolving. Douglas CDMO has experience in developing these formulations and has laboratory partnerships with specialist capability to evaluate abuse deterrent features of proprietary dosage forms.
Why choose Douglas for your softgel contract development and manufacturing?
Douglas has over 30 years of experience in handling high-potency small molecule formulations with successful registrations. We have the capability and procedures to manage light-sensitive retinoids, hormones, cytotoxics, and immunosuppressants. Our high success rate in developing complex softgels and securing approvals in the US and Europe underscores our expertise.
Proven at commercial scale
Douglas CDMO held an estimated 30% share of the US pharmaceutical softgel market as of February 2024 and was the first company in the world to manufacture a generic isotretinoin softgel. Some of our customers have relied on Douglas CDMO for more than 20 years, with continuous product supply across the US, EU and global markets.
Our softgel technologies and processes
Douglas CDMO develops and manufactures softgels using rotary die encapsulation.
High-potency and specialist handling: Established procedures and facilities for light-sensitive retinoids, hormones, cytotoxics and immunosuppressants, backed by more than 30 years of high-potency small molecule experience.
Liquid and suspension fills: Solutions, suspensions and semi-solid fills for poorly soluble and lipid-soluble compounds, formulated to improve bioavailability.
Abuse-deterrent platforms: Formulation approaches that target known routes of abuse, with laboratory partnerships for evaluating abuse-deterrent features.
Enteric and delayed-release softgels: Coatings that carry the capsule through the stomach so it releases in the small intestine.
Softgel FAQs
What types of products can be manufactured in softgel capsules?
Softgel capsules can be used for a wide range of pharmaceutical products, including oncology therapies, dermatology medicines, immunology treatments, hormone therapies, and products containing poorly soluble active pharmaceutical ingredients (APIs). Douglas CDMO has experience with complex and high-potency formulations.
Why choose softgel capsules for drug delivery?
Softgel capsules can improve bioavailability, enhance patient compliance, enable delivery of poorly soluble compounds, and support complex liquid or suspension formulations. Softgels are often selected when traditional tablet or capsule formats may not provide optimal performance.
Can Douglas CDMO work with high-potency pharmaceutical compounds?
Yes. Douglas CDMO has capabilities for high-potency small molecules, including compounds such as retinoids, steroid hormones, immunosuppressants, and cytotoxic products. The company operates established procedures and facilities designed for these specialised products.
What is a softgel capsule?
A softgel capsule is an oral dosage form with a soft, gelatin-based shell surrounding a liquid or semi-solid fill containing the active ingredient. Softgels are commonly used where an active is poorly soluble, unstable when exposed to air or light, or better delivered in an oil-based fill.
How are softgel capsules manufactured?
Our commercial softgels are made by rotary die encapsulation. Two continuous gelatin ribbons pass between rotating dies while the liquid fill is injected between them; the dies cut and seal each capsule in a single step, and the capsules are then dried to their final specification.
Why are softgels difficult to manufacture?
Softgel manufacturing requires specialised encapsulation equipment, proprietary shell and fill formulations, and tight control of encapsulation, drying and stability. This technical complexity can create significant barriers to generic development, making softgels a challenging dosage form to replicate consistently at commercial scale.
Commercial manufacturing
Douglas CDMO has two manufacturing sites, including state-of-the-art softgel manufacturing equipment.
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