Douglas are experts at SoftGel and have successfully developed 8 approved pharmaceutical SoftGels.
SoftGel technologies are a fit-for-purpose solution for medicinal compounds where solubility limits bioavailability.
We incorporate strategies in our SoftGel developments to optimize absorption and availability of the active pharmaceutical ingredient (API), or other active ingredients contained within the SoftGel capsule.
Enhancing bioavailability is important because it ensures that enough of the active ingredient reaches its target site in the body, leading to optimal therapeutic outcomes. By enhancing the bioavailability of the active ingredient in SoftGel capsules, these formulations can provide improved therapeutic efficacy, more consistent drug levels, and potentially lower required dosages, leading to better patient outcomes.
Bioavailability is a pharmacokinetic parameter that measures the fraction or percentage of an administered dose of a drug that enters the systemic circulation unchanged and becomes available for action.
Improved bioavailability is particularly beneficial when dealing with orally delivered drugs that have low solubility, high first-past metabolism, or poor permeability. By enhancing the bioavailability of a drug, its therapeutic efficacy can be maximised, and the required dosage may be reduced, resulting in better patient compliance, and potentially minimising side effects.
Enteric SoftGel technology incorporates the enteric properties directly into the gelatin shell. This avoids extra coating during manufacturing which enables an improved consistent enteric behavior. They can be produced as transparent SoftGels which are more appealing to patients.
The benefits of reduced risk of acid reflux and specific or targeted delivery, are already proven in existing prescription and nutraceutical products.
Chewable SoftGels have been approved for pharmaceutical use. They can be taken with water and are suitable for patients who find swallowing difficult and need a reliable method to ensure the right dosage. They are also ideal for paediatric and geriatric patients.
Twist off SoftGels
This technology can help reduce dosing errors and provides the exact amount of liquid in the capsule. Perfect for newborns and young infants, twist-offs are also suited for dermatologic products and are perfect for accuracy and uniformity in low dosage forms. The controlled individual dosing prevents recontamination and improves bioavailability.
Douglas has extensive capabilities and deep expertise to be your partner for oral modified release delivery solutions. Our teams provide expert guidance on the key attributes that determine whether a compound is suitable for modified release formulation, at every stage of development. By matching each project to a knowledgeable and experienced team, we can help develop the right solution to get your product into the clinical study. We’ll provide reliable ongoing supply and scale-up through development and commercialisation.
Our modified release process:
- 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
- Extended release (XR) or long-acting (LA)
- Sustained release (SR)
- Controlled release (CR)
- Delayed release (DR)
- Repeat action or pulsatile release
Suspension, Liquids and Semi-solids
Suspensions, liquids and semi-solids offer distinct advantages depending on the intended route of administration and the therapeutic goals. Semi-solids are suited for topical applications, providing localized effects and ease of application, while liquids offer flexibility in terms of dosage accuracy, route of administration, and ease of swallowing for oral use. The choice between these formulations depends on factors such as the desired drug release profile, patient preferences, therapeutic objectives, and the specific characteristics of the active pharmaceutical ingredients.
Suppositories are specialised pharmaceutical preparations designed for rectal or vaginal administration. They are commonly used in various medical conditions, including constipation, haemorrhoids, fissures, inflammatory bowel disease, vaginal infections, and hormone replacement therapy. Douglas manufactures these under strict quality control standards to ensure accurate dosing, stability, and compatibility with the intended route of administration. Suppositories provide targeted drug delivery and offer advantages for patients who cannot take medications orally or require localised treatment.
Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing to snort or dissolving in order to inject the drug substance. The science of abuse deterrence is relatively new, and the formulation technologies, as well as the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. Douglas can develop these formulations and has partnerships with laboratories that have specialist capability to evaluate abuse deterrent features of proprietary dosage forms.