Skyepharma has many years of experience in inhalation product development, both for Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs).

Inhalation product development is complex requiring considerable knowledge and expertise to ensure project success in the context of rapidly changing technical, IP, regulatory and market factors. In this field up to date know-how and expertise is crucial.

At Skyepharma we adopt a Quality by Design (QbD) approach together with optimised project activities (Design of Experiments, DoE etc). We take into account the drug characteristics, target dose range, formulation and drug delivery performance together with device and materials compatibility and patient use factors. We also consider analytical methodology, process validation and manufacturing needs in order to prepare a robust data package for international regulatory approvals.

The combination of our know-how, expertise and experience with our broad range of capabilities, resources and technologies means that we are able to provide expert management of a complete inhalation product development programme.

Our expert services include formulation and process development in our GMP facilities, together with our considerable experience in inhaler device technologies. Our GMP pilot plant is available for the manufacture of clinical trial materials, and our experienced scientists are skilled in the transfer of methods and processes to the chosen site of commercial manufacture. We are also able to provide support in clinical development and regulatory affairs.

The following table shows how Skyepharma’s proven capabilities can complement those of our partners as part of an integrated inhalation product development programme.

CapabilitiesSkyepharmaPartner
Drug discovery and/or API supplyBullet Orange 4
Dosage form and formulationBullet Orange 4
Device selection and development Bullet Orange 4
Analytical development and method transferBullet Orange 4
Process developmentBullet Orange 4
GMP pilot-scale manufacture for clinical suppliesBullet Orange 4
Scale-up and technology transferBullet Orange 4
Clinical developmentBullet Orange 4Bullet Orange 4
Project management and quality system Bullet Orange 4Bullet Orange 4
Regulatory affairsBullet Orange 4Bullet Orange 4
Commercial manufacturing and supply*Bullet Orange 4
Sales and marketingBullet Orange 4

* in conjunction with CMOs

Contact us to find out how we can help with your inhalation development.

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