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Lactose powder bed three dimensional printing

A powder bed, lactose technology, used in organic active ingredients, pill delivery, additive processing, etc., can solve problems such as limiting the applicability of controlled release

Pending Publication Date: 2022-01-04
DFE PHARMA GMBH & CO KG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some (polymeric) excipients create a dense structure, limiting their suitability for controlled release rather than immediate release formulations

Method used

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  • Lactose powder bed three dimensional printing
  • Lactose powder bed three dimensional printing
  • Lactose powder bed three dimensional printing

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0055] Lactose Characterization

[0056] All ingredients were commercially available from DFE Pharma GmbH, Germany, except povidone K30, which was obtained from Duchefa Farma.

[0057] All lactose grades for 3D printing are measured based on particle size as well as bulk and tap density.

[0058] Method used to determine particle size:

[0059] Particle sizing experiments were performed using a Helos laser diffraction unit, both from Synpatec GmbH (Clausthal-Zellerfeld, Germany), and Windox 5 software (5.10.0.04). The optical bench was equipped with an R5 Fourier lens for focusing the diffraction patterns of particles of the same size to the same location on the detector ring array. The lens covers a particle size range between 4.5 μm and 850 μm. Windox soft is performing the analysis according to the free mode in order to calculate the particle size distribution from the raw scattering data. Lactose powder was dispersed using a Rodos dry powder disperser and a Vibri d...

example 2

[0068] print square

[0069] To assess whether a formulation is suitable for tablet printing, a square (one powder layer) can be printed and evaluated for wetting, consolidation and exudation. Square printing is performed as follows.

[0070] The formulations as given in the table were mixed on a roller set until homogeneous. Formulations were printed with a Sideswipe printer using Pronterface software. The powder blend was spread manually on the printing table with the help of a hand screen (700 microns) and rolled out automatically with rollers on the printer. A water / ethanol (95 / 5 vol. / vol.) mixture was sprayed over the powder bed in nine 1.4 cm 2 square. For each square, a different line spacing (as indicated in Table 3) was used, resulting in 9 different wetting squares.

[0071] Table 3: Print settings for printing squares in a single powder layer

[0072] sample Line distance(mm) Droplet / mm 1 0.2 5 2 0.25 4 3 0.3 3.3 4 0.35...

example 3

[0089] print tablet

[0090] The formulations as given in Table 8 were mixed on a roller set until a homogeneous mixture was obtained. Formulations were printed with a Sideswipe printer using Pronterface software.

[0091] The powder blend was spread manually on the printing table with the help of a hand screen (700 microns) and rolled out automatically with rollers on the printer. A water / ethanol (95 / 5 vol. / vol.) mixture was sprayed onto the powder using a 0.165 mm print head (Lee's) at 0.175 bar with a line spacing of 0.45 mm and at 2.22 drops / mm in a 9 mm circular shape. bed. Powder deposition and solution spraying were repeated 7 times to form flat tablets with a diameter of 9 mm and a height of 3 mm. The tablets were removed from the powder bed and dried in an oven at 50°C overnight. Suitable tablets of dimensions and masses as indicated in Table 9 were obtained.

[0092] Table 8: Tablet formulation (wt%)

[0093] 1 2 3 4 Lactohale 206 80 ...

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Abstract

Disclosed is the 3D printing of pharmaceutical formulations, such as tablets, wherein a binder liquid is deposited dropwise on a layer of powder, with these steps being repeated, in one or more patterns, in order to generate a solid drug product. In accordance with the invention, the powder comprises lactose particles having a particle size distribution characterized by a D10 of at least 6 micrometers.

Description

technical field [0001] The present invention relates to the production of pharmaceutical compositions by three-dimensional printing. In particular, the invention relates to tablets produced by 3D printing onto suitable lactose particles. Background technique [0002] Three-dimensional (3D) printing is a relatively new field of technology for the manufacture of solid pharmaceutical dosage forms. Since the FDA approved the first 3D printed tablet in 2015 (for the treatment of epilepsy), ), people have become more and more interested in 3D printing. The 3D printing technology used in it is an inkjet-based 3D printing process called binder jetting. The process works in a layer-by-layer manner, where droplets of a binder-containing liquid are selectively dispensed onto thin layers of powder by a print head. A liquid can be a solution of the drug in a solvent, mixed with an excipient to form a liquid paste. Liquids can also be devoid of drug, with the drug provided to be ble...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20
CPCA61K9/2095A61K9/2018A61K9/2027A61K9/2054A61K9/2059B33Y10/00B33Y30/00B33Y70/00B33Y80/00A61K9/209A61K31/7016
Inventor K·范登赫维尔
Owner DFE PHARMA GMBH & CO KG
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