One of the biggest challenges in pharmaceutical research and development is to complete development projects as quickly as possible. More and more drugs fall into the category of 'unmet medical need' and therefore qualify for accelerated approval. But developers need time to optimise the formulation of the sensitive or highly potent compounds that dominate the current pipeline of drug candidates.

Finding the right balance between speed and thoroughness is a challenge. But it can be solved by choosing microdosing technology in capsules. Manufacturers can dose small amounts of pure active pharmaceutical ingredients (APIs) or mixtures directly into hard capsules. Microdosing of less than 5 mg or low doses of 5 mg to 100 mg in hard capsules is a good option that allows manufacturers to get new drugs into research and development or onto the market faster.

The direct, precise and reliable filling of low-dose hard capsules can be scaled up in an industrial process. This means that processes developed for initial studies can be used for commercial production, eliminating some study and development work and bringing a drug to market faster.

Learn more about low-dose capsule technology in Aenova's white paper "Accelerating drug product launches using low-dose capsule technology" in collaboration with the renowned expert platform c&en of the American Chemical Society (ACS).

The Aenova sales team will be happy to advise you if you have any questions. Please contact us here.

You can download the white paper directly here: Aenova c&en Whitepaper Accelerating pharmaceuticals´ time to market: applications of capsule low-dosing technology