Five Takeaways from the University of Maryland CERSI Pediatric Conference
Surprising takeaways from the recent University of Maryland CERSI workshop, Shaping the Future of Pediatric Formulation Development.
Explore expert perspectives, scientific advances, and practical strategies to help develop medicines that patients are willing to take.
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Surprising takeaways from the recent University of Maryland CERSI workshop, Shaping the Future of Pediatric Formulation Development.
Taste, aroma, mouthfeel, texture, and aftertaste remain uniquely human—and uniquely measurable through validated sensory science methodologies developed over decades.
The increasing use of flavored, chewable, and rapidly dissolving dosage forms has transformed the patient experience of taking medicines—particularly for pediatric and geriatric populations. At the same time, these innovations have raised an important regulatory question: When does a medicine become “too much like candy”?
Listerine® PocketPaks® – the postage stamp-size strips that melt in your mouth – became an instant hit after their market debut with more than 100 million units sold. Named a “Best Innovation” by Time Magazine, audiences and critics raved about their portability and ability to take without water. Not only did Listerine PocketPaks create a popular sensation, they established a new genre for oral drug delivery!
Regulations in the EU and US require the development of pediatric dosage forms of every new drug. Pediatric Investigation Plans (for EMA) and Pediatric Study Plans (for FDA) should be submitted early in development, but frequently are filed late and lack specificity. A savvy applicant should take a proactive approach by proposing scientific, stage-gate study plans to fulfill regulatory requirements while mitigating technical and economic risks.
Captain’s Log, Star Date 11.6.17: Mini-tablets are taking over the market for pediatric medicines.
Many believe that all good things come in small packages – and pediatric medicines should be no exception. However, while mini-tabs are de rigueur, they may not represent the silver bullet solution they are purported to be.
Senopsys and First Aid Shot Therapy (FAST) collaborated to improve the taste and consumption experience of common OTC products. This resulted in a series of great tasting, single dose liquid medicine shots that start working in minutes.
By: Jeff Worthington – Senopsys President and Founder Regulations in the United States and European Union are incentivizing (via pediatric exclusivity) and requiring the development of pediatric medicine. These regulations are designed to ensure that every new drug will be evaluated for use in pediatric patients and studied in this population when appropriate. A key
By: Jeff Worthington – Senopsys President and Founder Many drug actives are bitter or have other aversive attributes that require effective taste masking. Senopsys penned an article for Contract Pharma that describes the framework for developing palatable drug products advanced by the AAPS Pediatric Formulations Task Force. The framework is a decision-tree that identifies the