Achieving faster formulation of solid oral dosage forms for First-In-Human supplies using drug-in-capsule approach

In this whitepaper, Almac discusses the principal approaches used to achieve faster formulation for FIH supplies including:

• The direct and indirect cost savings associated with the “exploratory formulation approach”
• How systems such as the Xcelodose®️ 600S mitigate against some of the risks associated with using the “commercial formulation approach” in early development

You will also learn how Almac’s innovative solutions supported two very different programmes:

1. An initial request for less than 1000 capsules of two different dosage strengths for a FIH study and a subsequent re-supply of 10,000 x 25mg and 5,500 x 100mg capsules.
2. A request for the Xcelodose manufacture of a substantial re-supply of capsules for an ongoing clinical trial – 80,000 capsules of a low dose and 60,000 capsules of a high dose.

From developing a fit-for-purpose formulation for FIH trials, to scaling up for late phase trials, registration and ultimately ongoing commercial supply, Almac Pharma Services’ solid oral dose pharmaceutical development and manufacturing solutions are tailored to meet your needs.

We will offer you the most appropriate, effective, and timely solution to develop your clinical candidate into an optimum formulation as well as supporting manufacture for all phases of your clinical trial programmes.

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