Extend Your Product's Reach Royalty-Free
Fast dispersible tablets are designed to disintegrate quickly in the mouth or disperse in a spoonful of water to become a suspension. They are also divided into two or four parts for easy dose titration, and taste masked for patient compliance. These features make them a perfect dose form to extend your product into the pediatric and geriatric markets.
Continue the Success of Your Product With New Applications
Pediatric Taste masked and easily divided for dose titration based on age and weight of the child
Geriatric Easy dosage that dissolves in mouth with a pleasant taste-masked flavor
Sublingual or Buccal Faster release and absorption through the oral mucosa with a rapid onset of action, or controlled release bypassing gastric degradation or entero-hepatic recirculation
The benefits of fast dispersible tablets come with significant formulation challenges. Patheon has the resources and expertise to help you overcome them:
Drug Loading Low or high dose, and their impact on dispersion
API Properties Density, solubility, wettability, compressibility, taste and mouth feel
Granulation Wet and dry granulation, flowability, and excipient selection
Performance Chemical stability, dispersion/disintegration time, particle size distribution, balancing hardness and friability vs. disintegration
Excipient Selection Chemical and organoleptic stability, manufacturability, and flavor development
Taste Masking Alliance with Senopsys for assessment and optimization, and use of non-proprietary processes
Moisture Sensitivity Controlling humidity during processing and packaging
Case Study: Fast Dispersible Tablets – A Royalty-Free Line Extension Solution
The Challenge Patheon developed a coated tablet product for a medium-sized pharmaceutical company (which we still manufacture for the global market.) The customer later requested that we develop a pediatric line extension: A fast dispersible tablet with the possibility of a divided dose, for titrating the dose to the age of the child.
The Solution Based on our knowledge and experience of the API, a strategy for fast dispersible tablet development was proposed. Prototype formulations were developed, followed by statistical design of experiments (DoE) to confirm the robustness of the product.
The Outcome A fast dispersible tablet was registered and successfully launched as a pediatric line extension upon NDA approval. Through flawless execution of a well-designed strategy, a suitable fast dispersible tablet was developed and commercialized successfully using a non-proprietary, royalty-free process.