Edition 2 / June 2020
CordenPharma’s Highly Potent & Oncology Platform encompasses both the development and manufacturing of Highly Potent APIs at two facilities in Boulder, Colorado, and its integrated supply relationship with our oral solid dosage Drug Product development & manufacturing facility CordenPharma Plankstadt, near Heidelberg, Germany.
We continue to expand our Highly Potent API capabilities in Colorado with a new laboratory scheduled to open in August of 2020, equipped to handle products with an OEL <50ng/m3. This lab will help expedite the familiarization steps and onboarding of new projects.
The team in CordenPharma Plankstadt, led by Dr. Oliver Schinzinger and his colleagues Dr. Eva Fahrländer and Dr. Christoph Rott, have written a new white paper entitled Pediatric Dosage Form Considerations for Highly Potent Compounds, which discusses the benefits of selecting mini-development of pediatric mini-tablets as an effective dosage form for pediatric formulations, especially when they incorporate highly potent compounds. Their experience and valuable insight highlights the wealth of expertise & capabilities available at CordenPharma Plankstadt. Below are some excerpts from the white paper.
The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. The draft European Regulation on medicinal products for pediatric use rightly states that children are not simply small adults and that pediatric treatments must thus be tailored to the specific needs of children of various age groups. This means that developers must carefully select a dosage form that is appropriate for young patients in terms of administration and palatability, especially in the case of highly potent medicines used for various indications such as oncology.
Dosing of mini-tablet formulations according to the child’s age and weight is significantly more flexible than with fixed systems. This simple incremental dosing of mini-tablets is advantageous for many applications, including therapeutic applications designed for smaller patient populations. This is especially the case when dealing with newer highly potent compounds that require advanced containment solutions during manufacturing.
The selection of effective excipients for pediatric drugs is an important and often undervalued aspect of the pharmaceutical development process. Since pediatric patient safety is of paramount importance, toxicologically harmless excipients are required, especially in highly potent formulations.
Masking bitter-tasting APIs is another important consideration for manufacturing effective pediatric dosage forms. Poor taste and texture are big deterrents to younger patients—and a common complaint of liquids.
If drug developers need to demonstrate they have a means to transition their traditional tablet formulation for adults to mini-tablets for children as part of a pediatric investigation plan, they can draw upon much of the data gained from stability and other similar studies of the adult formulation. Other areas, however, will be quite different, making the move from an adult formulation to smaller tablets less straightforward than one might realize. Thus, the development of pediatric mini-tablet formulations can benefit greatly from collaborating with knowledgeable CDMO experts like those at CordenPharma, who bring proven experience in the area of oral solid dosage formulation development & manufacturing, specializing in highly potent compound handling.
The use of pediatric mini-tablets for highly potent compounds has some specific challenges because the formula often requires a much lower dose when compared with other drugs. A special skillset is therefore needed to work with these very low-dose formats in order to ensure the highly potent APIs are distributed homogenously within the mini-tablets. While content uniformity is always a priority, the issue is even more challenging for mini-tablets with a low drug load.
The development of pediatric formulations requires special considerations to ensure compliance. Mini-tablets are an elegant way of delivering APIs to not only pediatric populations, but also other patient groups (e.g., geriatric) that would benefit from their advantages such as age-appropriate & accurate dosing and better patient acceptability. This delivery system, however, requires special expertise in terms of developing a suitable tableting process and adapting analytical methods to analyze these tiny tablets. Thus, working with a partner that is experienced in developing mini-tablet formulations will benefit innovators looking to offer this patient-friendly dosage form in their portfolio.
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