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.
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.
Compression tooling and tablet press manufacturers are faced with ongoing challenges in the tablet manufacturing environments. Providing support in all aspects of the tablet compression process should be expected from your tooling and tablet press partner. These services should include: press operator training, maintenance/calibration services, quick delivery of replacement parts, tooling, tablet design and powder formulation support.
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.
In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.