Posted by Jeff Worthington on May 11, 2018
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.
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Posted by David Tisi on January 9, 2018
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.
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Posted by Jeff Worthington on November 6, 2017
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.
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Posted by David Tisi on September 8, 2017
To a sensory scientist “flavor” refers to all tastes, aromas, mouthfeels and textures of a product. To a formulator, a flavor is a commercial ingredient that is a blend of volatile chemicals responsible for imparting the aroma of a product. In this post, we’ll focus on the formulator’s view, describing how these commercial “flavors” are created.
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Posted by David Tisi on July 3, 2017
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.
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Posted by David Tisi on May 1, 2017
Sensory analysis is a scientific discipline used to evoke, measure, analyze, and interpret those responses to products that are perceived by the senses of sight, smell, touch, taste, and hearing. In our latest blog post we describe the methods most commonly employed to guide the development of palatable, taste-masked drug products.
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Posted by Jeff Worthington on January 27, 2017
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.
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Posted by David Tisi on January 10, 2017
By FDA regulation, flavor excipients are divided into four categories. What are the practical differences between these categories and which are appropriate for pharmaceutical formulations? In our latest post, we hope to answer these questions.
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Posted by Jeff Worthington on November 18, 2016
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
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Posted by David Tisi on November 14, 2016
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
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