Masked taste pharmaceutical granules/granulates
AssigneeEthypharm
InventorsCHRISTOPHE LEBON, SANDRINE SALLE, PASCAL SUPPLIE
Life of this patent
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Abstract
Granules and coated granules, characterized in that they contain the following: a core containing at least one active ingredient which is optionally associated with at least one waxlike compound and optionally at least one polymer and/or binding agent; at least three successive layers of coating from the core outwards; a functional polymer coating (1) optionally containing a waxlike compound, enabling immediate, delayed or prolonged release, which can have a structure which is different from that of the first but which has a complimentary release function and which conditions the suspension medium.
Claims18
Masked taste, solid dosage form granules and granulates stable for at least 2 months and adapted for the controlled release of an otherwise unpleasantly tasting pharmaceutical active agent therefrom into a liquid physiological medium, comprising central cores which contain said otherwise unpleasantly tasting pharmaceutical active agent and, optionally, at least one waxy compound, at least one polymer and/or at least one binding agent therein, said central cores being coated with at least three successive coating layers, the first and third of which comprising effective amounts of a polymeric functional coating, which may be the same or different, and, optionally, a waxy compound, said first and third coating layers permitting a controlled release of said otherwise unpleasantly tasting pharmaceutical active agent into such physiological medium, and the said intermediate second coating being hydrophobic in nature and which comprises at least one waxy compound having a low HLB and a melting point ranging from 35° to 53° C., thus isolating said otherwise unpleasantly tasting pharmaceutical active agent for such period of time as required to ensure stability of the masking of the taste, whereby suspensions thereof in a liquid physiological medium are stable for at least 24 hours and provide effective taste-masking by preventing solubilization therein of said otherwise unpleasantly tasting pharmaceutical active agent.
Masked taste, solid dosage form granules and granulates stable for at least 2 months and adapted for the controlled release of an otherwise unpleasantly tasting pharmaceutical active agent therefrom into a liquid physiological medium, comprising central cores which contain said otherwise unpleasantly tasting pharmaceutical active agent and, optionally, at least one waxy compound, at least one polymer and/or at least one binding agent therein, said central cores being coated with at least three successive coating layers, the first and third of which comprising effective amounts of a polymeric functional coating, which may be the same or different, and, optionally, a waxy compound, said first and third coating layers permitting a controlled release of said otherwise unpleasantly tasting pharmaceutical active agent into such physiological medium, and the said intermediate second coating being hydrophobic in nature and which comprises at least one hydrophobic waxy glycerol ester of a saturated C12-C18 fatty acid, thus isolating said otherwise unpleasantly tasting pharmaceutical active agent for such period of time as required to ensure stability of the masking of the taste, whereby suspensions thereof in a liquid physiological medium are stable for at least 24 hours and provide effective taste-masking by preventing solubilization therein of said otherwise unpleasantly tasting pharmaceutical active agent.
Masked taste, solid dosage form granules and granulates stable for at least 2 months and adapted for the controlled release of an otherwise unpleasantly tasting pharmaceutical active agent therefrom into a liquid physiological medium, consisting essentially of central cores which contain said otherwise unpleasantly tasting pharmaceutical active agent and, optionally, at least one waxy compound, at least one polymer and/or at least one binding agent therein, said central cores being coated with at least three successive coating layers, the first and third of which comprising effective amounts of a polymeric functional coating, which may be the same or different, and, optionally, a waxy compound, said first and third coating layers permitting a controlled release of said otherwise unpleasantly tasting pharmaceutical active agent into such physiological medium, and the said intermediate second coating being hydrophobic in nature and which comprises at least one waxy compound, thus isolating said otherwise unpleasantly tasting pharmaceutical active agent for such period of time as required to ensure stability of the masking of the taste, whereby suspensions thereof in a liquid physiological medium are stable for at least 24 hours and provide effective taste-masking by preventing solubilization therein of said otherwise unpleasantly tasting pharmaceutical active agent.
Masked taste, solid dosage form granules and granulates stable for at least 2 months and adapted for the controlled release of an otherwise unpleasantly tasting pharmaceutical active agent therefrom into a liquid physiological medium, consisting essentially of central cores which contain said otherwise unpleasantly tasting pharmaceutical active agent and, optionally, at least one waxy compound, at least one polymer and/or at least one binding agent therein, said central cores being coated with at least three successive coating layers, the first and third of which comprising effective amounts of a polymeric functional coating, which may be the same or different, and, optionally, a waxy compound, said first and third coating layers permitting a controlled release of said otherwise unpleasantly tasting pharmaceutical active agent into such physiological medium, and the said intermediate second coating being hydrophobic in nature and which comprises at least one hydrophobic waxy glycerol ester of a saturated C12-C18 fatty acid, thus isolating said otherwise unpleasantly tasting pharmaceutical active agent for such period of time as required to ensure stability of the masking of the taste, whereby suspensions thereof in a liquid physiological medium are stable for at least 24 hours and provide effective taste-masking by preventing solubilization therein of said otherwise unpleasantly tasting pharmaceutical active agent.
Dependencies are inferred from the claim text.