Many dosage forms and pharmaceutical technologies trace their origins to the food industry, where taste is paramount. In this blog our formulation and sensory scientists share practical concepts and techniques for developing palatable drug products.
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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”?
A neighbor slipped and fell in his driveway. He was unable to get up and was taken to the hospital by ambulance. Before medical treatment could be initiated, the hospital needed to run diagnostic tests, e.g., x-ray, MRI. The same is true for developing palatable formulations – it’s not enough to know that it tastes “yucky” as there’s no universal “yummy” excipient.
It is widely recognized that young children cannot swallow traditional tablets, but difficulty in swallowing tablets (dysphagia) is not limited to children. An estimated 40% of adults report difficulty in swallowing tablets, which is increasingly common among older patients. How can the formulation scientist address these important patient needs, and how can “swallowability” even be quantitatively measured?
An estimated 80% of new drug actives are classified as poorly soluble. There are a number of approaches for enhancing solubility – alternative salt forms, particle size reduction and solubility-enhancing excipients, among others. Like APIs, many excipients are known to be bitter or have other aversive sensory attributes including aromatic off-notes (malodor) and trigeminal irritation (e.g., tongue sting and mouth or throat burn). In some cases, the taste masking challenge of the excipient system can be greater than for the API itself.
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!
If you’re a Disney fan of a certain age, you probably can sing the lyrics to Mary Poppins Spoonful of Sugar Makes the Medicine Go Down. Many APIs are known to be bitter, some extremely so. The addition of flavor – orange, grape, berry, chocolate – cannot reduce bitterness as taste and smell have different perception pathways. Rather bitterness is reduced by blending with the complementary basic tastes – sweet, sour and salty – through the mechanism of taste/taste interaction. When properly blended, the result is a neutral tasting (“white”) base in which the basic tastes are not separately perceived.
Recently, a strange noise from my car required a trip to the mechanic. Before the garage can start repairs, they need to diagnose the problem – is it a worn clutch or an exhaust? The same is true for developing palatable formulations – it’s not enough to know that it tastes “yucky” as there’s no universal “yummy” ingredient.
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
Senopsys and Bristol-Myers Squibb presented results of a process used to develop palatable pediatric chewable tablet formulations for two APIs with different taste masking challenges. Development followed a two-stage design: Stage 1 – Taste Assessment to quantify the taste masking challenge. Stage 2 – Taste Optimization following a sensory-directed formulation development approach. Click here to