Douglas CDMO is a specialist in the development and production of Softgel capsules and medicine fill.
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:
- 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.
- Potential for controlled or targeted release of the Softgel contents.
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.
Modified release
Modified release refers to a formulation of a medication that is designed to release the active ingredient in a controlled or extended manner over time, rather than all at once.
Douglas CDMO has extensive capabilities and deep expertise to be your partner for oral modified release delivery solutions. Our team will provide expert guidance on the key attributes that determine whether a compound is suitable for modified release formulation.
Modified release can be achieved through a number of approaches:
- Polymers are used to control the release of the API from the formulation through one of two approaches:
- Coating of tablets or multi-particulates.
- Development of matrix tablets or multi-particulates with or without additional coatings.
- Release of the API is dependent on the type of polymer and process used to produce the finished product.
Modified release types
There are a number of modified release types we are able to achieve using Softgel encapsulation:
- Extended release (XR) or long-acting (LA) – remaining in the body longer, allowing for medication to be taken less often.
- Sustained release (SR) – prolonged released, requiring fewer doses per day.
- Controlled release (CR) – release of the active ingredients at a specific rate to keep constant medication levels for a specified period of time.
- Delayed release (DR) – also known as enteric release. Technology used in the capsule protects the active ingredients from stomach acid, so they are released directly in the intestines.
- Repeat action – consisting of two single doses of medication, one for immediate release and one for delayed release.
- Pulsatile release – no release for a period of time, followed by a rapid and complete drug release.
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.
Commercial manufacturing
Douglas CDMO has two manufacturing sites, including state-of-the-art Softgel manufacturing equipment.
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