World Orphan Drug Congress USA 2016
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APL whitepaper: It is never too early to think “drug product”

Key features of drug product formulation:

The orphan drug product (DP) you develop is what the patients will encounter and what medicinal agencies will approve. What you develop will most probably influence patients’ lives in a tremendous way, potentially curing them and improving quality of their lives like nothing else has done before. The formulation of the DP will thus play a big role in how patients perceive the drug, how it becomes a part of their lives, and how they structure their life around it.


The formulation you choose will influence following key features of your DP:

  •  Efficacy: DP is absorbed in a body and acts in line with its purpose
  •  Safety: DP is non-toxic for patients, minimizes risk for local side effects and may adjust for therapeutic windows of drug substance
  •  Stability: Drug substance does not decompose
  •  Uniformity of dosage: Same dosage with same effect is administered at every occasion
  •  Appearance: DP is compliant to patients
  •  Price: The cost of the final product is accepted by healthcare systems
  •  Patient acceptability: It is easy to use and dose the product both by patients and potentially healthcare providers
  •  Patentability: The formulation provides novelty, rising possibility to protect your invention for a certain part of its commercial lifetime.

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