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Publication Number
US-10561621-B2
Publication Date
2020-02-18
Expiration Date
Abstract
A composition comprising a core material, having a taste value and a polymeric coating. The polymeric coating substantially surrounds the core material and comprises a cationic polymer and optionally an anionic polymer. The polymeric coating has a uniform thickness ranging from 2 μm to 20 μm. The composition provides release of a portion of the core material which is taste masked over a time period ranging from 0.5 minute to 2 minutes in the oral cavity and provides a modified-release of the remaining core material in a gastrointestinal tract.
Core Innovation
The invention relates to microcapsules and a composition in which a core material consisting of one or more active pharmaceutical ingredients has a taste value. A polymeric coating substantially surrounds the core material, where the coating comprises a coacervated polymer material made from a cationic polymer and an anionic polymer mixture, and the anionic polymer mixture includes medium chain polyphosphates and long chain polyphosphates in a ratio of about 60:40.
The polymeric coating is defined to have a uniform thickness ranging from 1 bcm to 20 bcm. The composition provides controlled release of a portion of the core material which is taste masked over a time period ranging from 0.5 minute to 2 minutes in the oral cavity, and after the oral cavity phase provides modified-release of the remaining core material in a gastrointestinal tract.
The disclosure further includes conditions that relate taste masking to material properties, including a water-solubility taste threshold with an associated pH, and a compatibility condition in which the polymeric coating is derived from a material having a pH value less than or equal to the associated pH. The coacervated polymer coating formation is related to coating droplet formation and time reduction, and drying approaches and coating morphology are described using SEM.
Claims Coverage
The provided independent claim coverage is directed to a taste-masked pharmaceutical composition/microcapsule with a substantially surrounding coacervated polymer coating. It includes one core inventive set of features, with dependent refinements that further constrain drug selection, polymer ratios, core loading, coating thickness sub-ranges, and pH/taste-threshold compatibility.
Coacervated polymer taste-masked microcapsule composition
A composition comprising a core material consisting of one or more active pharmaceutical ingredients, the core material having a taste value; and a polymeric coating substantially surrounding the core material, the polymeric coating comprising a coacervated polymer material comprising a cationic polymer and an anionic polymer mixture including medium chain polyphosphates and long chain polyphosphates in a ratio of about 60:40.
Uniform-thickness coacervated coating with defined oral and GI release
The polymeric coating has a uniform thickness ranging from 1 bcm to 20 bcm, wherein the composition provides controlled release of a portion of the core material which is taste masked over a time period ranging from 0.5 minute to 2 minutes in the oral cavity and provides modified-release of the remaining core material in a gastrointestinal tract.
Across the independent claim coverage, the inventive concept is a taste-masked oral release followed by gastrointestinal modified release achieved by a substantially surrounding coacervated polymeric coating made from a cationic polymer and an anionic polymer mixture containing medium chain and long chain polyphosphates in a defined ratio, with a specified uniform coating thickness and an oral cavity taste-masking controlled release time window.
Stated Advantages
Provides controlled release of a portion of the core material which is taste masked over a time period ranging from 0.5 minute to 2 minutes in the oral cavity.
Provides modified-release of the remaining core material in a gastrointestinal tract.
Documented Applications
Pharmaceutical formulations/dosage forms including microcapsules for oral administration in solid stick pack formats such as ODT/ODP stick packs.
Use involving taste masking in the oral cavity and modified-release in the gastrointestinal tract.
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