Microencapsulation process and product

Inventors

Goll, DianePropst, Cecil W.

Assignees

SPI Pharma Inc

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Publication Number

US-11723877-B2

Patent

Publication Date

2023-08-15

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

A microencapsulated oral dosage form includes a core material having a taste value that is taste masked in the oral cavity and then provides controlled release in the gastrointestinal tract. The composition comprises a core material substantially surrounded by a polymeric coating.

The polymeric coating comprises a coacervated polymer material that includes a cationic polymer comprising gelatin and an anionic polymer mixture comprising a long chain polyphosphate in combination with a medium chain polyphosphate. The cationic polymer to anionic polymer mixture ratio is defined within a specified range.

The polymeric coating has a thickness selected between 1 µm to 20 µm, with uniform thickness that varies over a specified range. The composition provides taste masked controlled release of a portion of the core material over 0.5 minute to 2 minutes in the oral cavity and releases the remaining core material in a gastrointestinal tract.

Claims Coverage

The partial content provides one independent claim directed to a taste-masked, controlled-release composition based on a coacervated gelatin/polyphosphate coating with defined coating thickness uniformity and oral-to-gastrointestinal release behavior.

Coacervated gelatin and long/medium chain polyphosphate coating with defined ratio

A polymeric coating substantially surrounding a core material, the polymeric coating comprising a coacervated polymer material comprising a cationic polymer comprising gelatin and an anionic polymer mixture comprising a long chain polyphosphate in combination with a medium chain polyphosphate.

Uniform coating thickness for the coacervated polymer coating

The polymeric coating has a thickness selected from between 1 µm to 20 µm, wherein the thickness of the polymeric coating is uniform and varies over a range from 0.2 µm to 2.0 µm.

Oral taste-masked controlled release followed by gastrointestinal tract release

The composition provides a 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 release of the remaining core material in a gastrointestinal tract.

Overall, the claim coverage centers on a taste-masked core substantially surrounded by a coacervated gelatin (cationic) and long/medium chain polyphosphate (anionic) coating with a defined cationic:anionic ratio and uniform coating thickness. The composition is defined by oral taste-masked controlled release for 0.5 minute to 2 minutes and subsequent release in the gastrointestinal tract.

Stated Advantages

Provides taste masking of a portion of the core material over 0.5 minute to 2 minutes in the oral cavity.

Provides release of the remaining core material in a gastrointestinal tract.

Documented Applications

Oral dosage forms and formulations using microcapsule form and controlled-release behavior transitioning from the oral cavity to the gastrointestinal tract.

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