Enantia commissions new dedicated facilities to work with Highly Potent APIs (HPAPI)
High Potency Active Pharmaceutical Ingredients, also called Highly Potent API (HPAPI), exert their activity at a very low dosage. Though the definition of a HPAPI is yet to be harmonized [1], HPAPIs can be defined based on the therapeutic dose as a pharmacologically-active ingredient with biological activity at approximately 15 μg/kg of body weight or below in humans, or a daily dose of 1 mg/day or below [2].
The global market of Highly Potent compounds is forecasted to grow from 21.2 USD billions in 2021 to 32.17 USD billions in 2026 at an annual increase of 8.7% [3]. Within this category of compounds, the generic drug segment is the one expected to be the fastest growing [4]. Some of the factors attributing to its growth are patent expiry of HPAPI branded drugs, and the rising number of patients in developing economies.
Picture: Enantia’s HPAPIs dedicated XRPD working in transmission and reflection modes
Therefore, undertaking a solid form screening to develop a new, non-infringing alternative solid form of a HPAPI can be a highly convenient strategy when developing new generics. Likewise, it is key to extend IP rights for new chemical entities (NCE).
Hence, screening for new cocrystals, polymorphs, solvates and salts is a powerful tool that allows to competitively market new forms of a drug. In this sense, FDA and EMA’s regulatory guidelines have set a clear and simple path to the filing of both NDA and ANDA using cocrystals as the solid form of the API.
Enantia’s new facilities allow working with HPAPIs having Operational Exposure Limits (OEL) down to 100 ng/m3, which comprises the overwhelming majority of HPAPIs. Moreover, an additional new X-ray powder diffractometer, working both in transmission and reflection mode, has been installed specifically for HPAPI analysis.
This means that Enantia also offers for high potency APIs its expertise in:
- Solid form screening including polymorphs, cocrystals, solvates, salts and amorphous forms.
- Solid form development to optimize and scale-up the preparation method of a given solid form.
- Analysis and characterisation of solid forms with the state-of-the-art equipment, including, for example, long-term stability, hygroscopicity and solubility studies.
- Design scalable purification and resolution processes through crystalline forms.
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[1] Walsh, Andrew & Barle, Ester. (2017). Are high potency active pharmaceutical ingredients (HPAPI) also high risks for cross-contamination? Chemistry Today. 35
[2] NTP1104. Industria farmacéutica: clasificación de principios activos en categorías. Actualiza NTP798
[4] High Potency Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Product (Synthetic, Biotech), By Manufacturer Type (In-house, Outsourced), By Drug Type, By Application, By Region, And Segment Forecasts, 2021 – 2028. Published Date: Sep, 2021, Report ID: 978-1-68038-563-2, Number of Pages: 140