Douglas CDMO has extensive expertise in formulation development, guided by quality by design (QbD) methodologies. Whether your product has technical, clinical or IP complexities, Douglas CDMO is well-equipped to address them.
We analyze drug substance properties, assist in dosage form selection, optimize formulations, and ensure product stability. You will receive a robust formulation, optimized to successfully scale-up into commercial manufacturing, that ensures consistent product quality, safety, and efficacy.
Our support also includes analytical method development, validation, and quality control testing, to assist in meeting regulatory compliance and achieving successful product commercialization. We can help accelerate your New Drug Approval (NDA), Amended New Drug Approval (ANDA) and 505(b)(2) programs through all phases of development and commercial launch.
With our commitment to quality, clients can trust that their products will meet stringent quality control measures, ensuring consistency and reliability for market supply in accordance with cGMP standards.
Dosage forms
We have the expertise, and a proven track record, to formulate a wide range of pharmaceutical products, such as:
- Oral liquids – solutions and suspensions, Softgel
- Oral solids – tablets, capsules, and multiparticulates
- Semi solids – topical creams, gels, lotions, pastes
Our pharmaceutical experts have a wide range of experience across numerous dosage forms and are happy to help you with other dosage forms than those listed.
Modified release
Modified release drug product is used to describe products that alter the release of 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 products that we are able to develop:
- Extended release – a dosage form that remains in the body longer, allowing for medication to be taken less often.
- Sustained release – a dosage form that has a prolonged release, requiring fewer doses per day.
- Delayed release – also known as enteric release. A dosage form that releases a discrete portion of the drug at a specific time following administration.
- Targeted release – a dosage form that releases drug at or near the intended physiologic site. Targeted-release dosage forms may have either immediate or extended-release characteristics.
- Repeat action – a dosage form consisting of two single doses of medication, one for immediate release and one for delayed release.
- Pulsatile release – a dosage form that has no release for a period of time, followed by a rapid and complete drug release.
Analytical services
Douglas CDMO provides a comprehensive range of analytical services across the product development lifecycle.
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