Carrier pellets, method for production thereof and use thereof
Inventors
Weigt, Antje • Kempe, Wolfgang • Schlütermann, Burkhard
Assignees
ADD Advanced Drug Delivery Technologies AG • Ipc Process-Center & Co KG GmbH
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Publication Number
US-11191726-B2
Publication Date
2021-12-07
Expiration Date
Abstract
The invention relates to a method for the production of carrier pellets for pharmaceutical active substances. Likewise, the invention relates to such carrier pellets and also to pharmaceutical formulations containing these. The carrier pellets according to the invention are used for transporting and releasing pharmaceutical active substances, in particular in the human body.
Core Innovation
The invention relates to a method for the production of carrier pellets for a pharmaceutically active substance by spray granulation in an empty fluidized bed or spouted bed unit. A liquid formulation is produced by dissolving, dispersing, or combining dissolving and dispersing at least one pH regulator in at least one solvent, and the liquid formulation contains 30 to 80% by weight of the pH regulator and 15 to 69.5% by weight of the solvent.
The liquid formulation is introduced into the fluidized bed or spouted bed unit using at least one nozzle, and essentially spherical carrier pellets are formed by spray granulation in the unit. The solvent is evaporated by a drying gas flow, and the carrier pellets are discharged from the unit. The fluidized bed or spouted bed unit is empty so that the carrier pellets are formed only from the liquid formulation.
The disclosed approach further defines pH regulator embodiments and pellet-forming characteristics for the carrier pellets. pH regulators include organic acids, basic/acidic salts, buffer systems, and organic bases, and the liquid formulation may optionally include a binder to support the formation of dense pellets with narrow size distributions. The invention also specifies essentially spherical pellets with defined sphericity and example pellet types such as D/L-malic-acid pellets produced in a spouted bed (ProCell).
Claims Coverage
The partial content provides one independent claim describing the overall method. The independent claim includes four inventive features: formulation composition, empty fluidized- or spouted-bed operation, nozzle-based introduction, and spray granulation to form essentially spherical carrier pellets with drying-gas solvent evaporation.
Empty fluidized- or spouted-bed pellet formation from only the liquid formulation
The fluidized bed or spouted bed unit is empty so that the carrier pellets are formed in step c) from only the liquid formulation.
pH regulator/solvent liquid formulation composition
Producing a liquid formulation by dissolving, dispersing, or a combination of dissolving and dispersing at least one pH regulator in at least one solvent, wherein the liquid formulation contains 30 to 80% by weight of the at least one pH regulator and 15 to 69.5% by weight of the at least one solvent.
Nozzle introduction into a fluidized bed or spouted bed unit
Introducing the liquid formulation into a fluidized bed or spouted bed unit using at least one nozzle.
Spray granulation to form essentially spherical carrier pellets with drying-gas solvent evaporation
Forming essentially spherical carrier pellets by spray granulation in the unit wherein the solvent is evaporated by a drying gas flow, and discharging the carrier pellets from the unit.
Across the independent claim, the inventive concept is directed to producing essentially spherical carrier pellets for a pharmaceutically active substance by spray granulation in an empty fluidized- or spouted-bed unit, using a specific pH regulator/solvent liquid formulation introduced via nozzles, with solvent removal by a drying-gas flow.
Stated Advantages
Improved taste/absorption profiles.
Controlled release.
Documented Applications
Carrier pellets for a pharmaceutically active substance for oral administration, including formation in the gastro-intestinal tract.
Production of D/L-malic-acid pellets in a spouted bed (ProCell).
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