1. Taste Masking Challenge of Solubility Enhancing Excipients

    Taste-Masking-Challenge-of-Solubility-Enhancing-Excipients

    The client was developing a pediatric dosage form of a poorly soluble API. A number of effective solubility enhancing excipients had been identified but the client was concerned about their potential effects on palatability of the oral liquid. The sensory effects of the candidate excipients were measured over their functional usage levels to prioritize those with the lowest flavor impact for advancement.

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  2. Optimizing Tablet Coating to Reduce Bitterness

    Commercial eszopiclone film-coated tablets produce an unpleasant bitter taste. Senopsys developed and applied methods to measure the effects of film coatings and process variables on bitterness perceived during tablet administration.

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  3. Mini-Tablet Taste Assessment

    A client was developing a pediatric dosage form of a poorly soluble API. To improve bioavailability, a hot melt extrudate was developed that had a strong intensity, lingering bitterness. The extrudate was compressed into mini-tablets and the taste masking effectiveness of tablet film coatings was explored.

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  4. Measurement of In-vivo Disintegration Times of Orally Disintegrating Tablets

    Orally disintegrating tablets (ODTs) are a popular dosage form for patients who have difficulty swallowing (dysphagia). However ODT disintegration times may not meet FDA guidance (<30 seconds). Senopsys has developed protocols to reproducibly measure in-vivo disintegration time that have been used to benchmark prototypes against commercial products.

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  5. Overcoming Multidimensional Taste Challenges of a Pediatric Oral Drug Product

    Overcoming multidimensional taste challenges of a pediatric oral drug product

    A client’s drug achieved strong positive clinical results in adults and a pediatric dosage form was urgently required. Senopsys’ initial taste assessment indicated that the API represented a difficult, multidimensional taste challenge, specifically strong intensity bitterness, tongue/throat burn and tannin mouthfeels that lingered for over 30 minutes. A mimetic system was developed to facilitate taste optimization.

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  6. Masking Offensive Odor of a Pediatric Oral Solution

    masking odor

    A client was reformulating a drug product to improve palatability as part of a lifecycle management program. The API was characterized by a strong intensity, repugnant odor. Senopsys applied a sensory-directed headspace evaluation technique to develop a custom blend of aroma chemicals that effectively masked the offensive odor.

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  7. Guiding Taste Masking Technology Optimization

    The client was developing an orally disintegrating tablet (ODT) form of an approved drug known to be extremely bitter. Senopsys conducted dose-response sensory analysis to establish the maximum free API concentration that could be effectively delivered in a palatable ODT and to evaluate the taste masking effectiveness of adsorption technology.

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  8. Taste Optimization of an Oral Spray Drug Product

    Oral spray dosing technology is capable of delivering a broad range of APIs to the systemic circulation through the highly perfused lining of the oral cavity. Senopsys followed a sensory-directed process to develop a palatable oral spray containing an extremely bitter drug in combination with a solvent system that produced trigeminal irritation.

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  9. Novel Dosage Form Feasibility Assessment

    The client needed to develop an oral dosage form to deliver an insoluble API with high loading (5gm per unit dose) at TID dosing. For chronic conditions, palatability – taste, aroma, mouthfeel and texture – takes on a particular importance. Senopsys applied its FlavorOptSM formulation development process to develop a series of palatable proof-of-concept formulations of traditional and novel dosage forms.

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  10. Salt Masking of a Liquid Drug Product

    A large dose volume, liquid drug product was rejected by a significant number of adult clinical trial subjects due to its poor palatability. Senopsys’ initial taste assessment found the drug product to be highly salty. Senopsys reduced the perceived saltines through judicious balancing of the complementary basic tastes.

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