In 2014, the contract manufacturing market for solid dosage forms is anticipated to be $19.6B, representing 58% of the total CMO market value of $33.7B. While the market value percentage for solid dose has been drifting downward — likely related to the shift towards biologics, which are more expensive to develop and manufacture — the propensity to outsource oral solid dosage forms continues to grow modestly.
ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy. The overall result was a marked improvement in patient tolerability, preference and compliance.
Natoli Engineering Company recently completed a successful Factory Acceptance Test (FAT) with a top-tier cosmetics company.
When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scale- up and performance of the formulation at production levels. By Chuck Kettler, Director, Natoli Scientific of Natoli Engineering Company, Inc.
Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
Providing support in all aspects of the tablet compression process should be expected from your tooling and tablet press partner.
Clinical studies on solid dose products may require a placebo. The placebo, in the case of a tablet, should possess the same shape and color compared to the active product.