OSD
Enabling the next generation of oral biologics through cutting-edge formulations
The pharmaceutical market has traditionally been dominated by oral drug delivery methods, such as oral solid dosage (OSD) forms or liquid solutions and suspensions. Although these methods offer significant benefits for patients — including convenience — certain active pharmaceutical ingredients (APIs) are incompatible with oral formulation techniques, most notably for biologics.
As a result, developers have been exploring new formulation methods aimed at overcoming these obstacles by optimising the solubility, absorption, and stability of biologics to bring more patient-friendly OSD solutions to market.
However, there are certain challenges that pharmaceutical development and manufacturing companies face when formulating a biologic OSD, including:
- Drug instability
- Physicochemical properties
- Absorption issues
- Immune response
- Regulatory requirements
Various techniques are being explored to overcome these challenges, with one of the most promising being the addition of carefully selected excipients during product formulation.
Adding specific excipients can help alter the API’s characteristics to achieve the desired result. This includes adding new attributes, such as extended shelf-life or improved solubility for biologic OSD formulations.
Developers have also been exploring new tactics for protecting biologics from the harsh conditions of the stomach and gastrointestinal tract, including the use of coatings or capsules. These serve as protective shields for the biologics’ sensitive ingredients, preventing the product from degrading once administered orally.
Adding these coverings also provides the benefit of facilitating the controlled release of the drug product over a specific period, improving its effectiveness and safety for patients.
But how can you ensure that the excipients you choose are the right ones for your biologic, and how do you navigate the regulatory requirements of bringing these formulations to market?
In a recent piece with IPI Magazine, Dr Uwe Hanenberg, Head of Product Development in Oral Solid Dose at Recipharm, explores advances in biologics production and shares more on the formulation requirements to enable the safe creation of oral biologics.