Pediatric Drug Formulation Expertise
CoreRx understands the important variables when formulating pediatric dosage forms such as dose flexibility, palatability, and ease of administration. We have experience and expertise in all aspects of pediatric drug formulation development. This experience, along with an assortment of technologies, allows CoreRx to overcome the many challenges pediatric products present while providing you with a distinct development solution.
Using CoreRx as your pediatric drug development partner, you gain access to our extensive development, testing and manufacturing expertise in pediatric dosage forms. Our pediatric capabilities support clinical to commercial manufacturing, all while keeping regulatory requirements in mind.
How CoreRx can ensure your pediatric program success:
- We are experts in formulations and excipient selection for this unique patient population
- We are experienced in proper dose development for various pediatric age groups, i.e., suitable dosage form and acceptable inactive ingredients list and quantity for each
- We ensure palatability through taste masking techniques
- We have technologies that address the challenges associated with dose flexibility when dealing with the pediatric population
- We have experience and capabilities to develop modified release formulations that can help address unique patient compliance or pharmacokinetic requirements.
Suggested Formulation Considerations:
There is often better acceptability and ease of administration through these unique solid oral approaches:
- Chewable tablet or Orally Disintegrating Tablet (ODT)
- Directly dose (via Vehicle) Powders, Granules, and Mini-tabs
- Formulated powders in sachets or capsules
- Sprinkles and mini-tablets delivered in capsules or through NG tubes
- Benefits from ease of administration for young pediatric patients.
- A single formulation could provide dose titration for patients ranging from 1-12 years of age.
- Nano-suspensions and nano-emulsions
- Standard Emulsions, Solutions or Suspensions
CoreRx has unique packaging capabilities suited to pediatric populations, with considerations for patient convenience and compliance, including carry anywhere, ready-to-deliver unit dose packaging:
- Sachet Packaging for Powders, Granules, and Mini-Tablets
- Automated liquid lines to support mixing, dispensing and filling, weight checks, packaging, labelling, kitting, serialization, storage and shipping
- Pediatric patients are defined as patients aged from birth to less than 16 or 18 years, depending on the country
- Choose a suitable route of administration and dosage form
- Identify any special population needs
- Short term or chronic use
- Expected dose range and frequency, and consider dosing accuracy
- Excipient selection/safety assessment, anti-microbial effectiveness, and flavor/palatability
- Define timeline & product development strategy before committing to clinical trial initiation
- Build the regulatory strategy around the product
And importantly, chose an experienced pediatric drug development partner…
Learn more about CoreRx’s expertise in pediatric drug development, and in other areas of specialized expertise: