Method and equipment for fractionation of granules for use in pharmaceutical compositions
Inventors
Vilhelmsen, Thomas • Hoeeg-Moeller, Carsten • Soerensen, Martin Nobert • Gaunoe, Mette Hoeg
Assignees
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Publication Number
US-12364663-B2
Publication Date
2025-07-22
Expiration Date
Abstract
A sieve guide assembly and a method of fractionation using a sieve guide assembly comprising a circular sieve screen (190) and a sieve guide 310 mountable in a fractionating device, wherein the fractionating device comprises a drive adapted for: (i) in combination with a sieve screen without a sieve guide, inducing a lateral flow of granules defining lateral streamlines 31a.1. 31b.1, 31c.1, 31d.1 and an orbital flow defining orbital streamlines 31a.2. 31b.2, 31c.2, 31d.2, 31d.3 on the sieve screen (190), and (ii) in combination with the sieve guide assembly, inducing a guided lateral flow of granules defining guided lateral streamlines (331.3) and a central guided orbital flow defining central orbital streamlines (331.2) on the sieve screen (190), whereby the sieve guide assembly is adapted to provide a uniform, controlled and effective exposure of the granules to the sieve screen.
Core Innovation
The sieve-guide assembly integrates a circular sieve screen with a sieve guide fixedly attached to the circular sieve screen. The sieve guide includes a circular guide portion positioned centrally on the circular sieve screen to define a central loading area, and the circular guide portion comprises a first radial opening extending from a first to a second side. The circular guide portion is adapted to guide a central guided orbital flow that defines an orbital downstream direction.
The same sieve guide assembly also includes a lateral guide portion adapted to guide a lateral guided flow of granules from the central loading area to an outlet. The lateral guide portion comprises at least a first lateral guide member extending in a lateral direction from the first side of the first radial opening to a periphery of the sieve screen. The sieve-guide assembly is adapted to be mounted in a fractionating device in a specific angular position with the first lateral guide member aligned with a first side of an outlet of the fractionating device, so that when the fractionating device induces an orbital and a lateral flow the lateral guided flow is guided along the first lateral guide member to the outlet.
In further configurations, the lateral guide portion includes additional lateral guide members, including a second lateral guide member extending from the second side of the first radial opening toward the periphery. The fractionating device further includes a sieve deck with an inlet and a tubular rim portion comprising an outlet, where the outlet has an opening extending from a first to a second side, and the first radial opening is arranged with an angular overlap with the outlet. When the fractionating device induces an orbital and a lateral flow, the granules are guided along the lateral guide member to the outlet.
The document further addresses fractionation of granules for solid dosage forms using the fractionating device to provide fractionated granules for preparing solid dosage forms. The granules comprise a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, including SNAC (salcaprozate sodium), and the solid dosage forms include tablets, capsules, and sachets prepared from the fractionated granules.
Claims Coverage
The document includes three independent claims. Across these independent claims, the inventive coverage centers on the structural cooperation of a fixed sieve guide with a circular sieve screen, the use of a central guided orbital flow via a radial opening, and the guidance of a lateral guided flow to a fractionating device outlet through a specific angular mounting and alignment.
Central guided orbital flow with central loading area
A circular guide portion fixedly attached to and positioned centrally on the circular sieve screen to define a central loading area, where the circular guide portion comprises a first radial opening extending from a first to a second side and is adapted to guide a central guided orbital flow defining an orbital downstream direction.
Lateral guided flow from central loading area to aligned outlet
A lateral guide portion comprising a first lateral guide member extending in a lateral direction from the first side of the first radial opening to a periphery of the sieve screen, where the sieve guide assembly is mountable in a fractionating device in a specific angular position with the first lateral guide member aligned with a first side of an outlet, so that in an induced orbital and lateral flow the lateral guided flow of granules is guided along the first lateral guide member to the outlet.
Specific angular position for outlet alignment
The sieve guide assembly is arranged to be mounted in a fractionating device in a specific angular position, with the first lateral guide member aligned with a first side of an outlet of the fractionating device.
Second lateral guide member for directing lateral guided flow
A lateral guide portion comprising a first lateral guide member extending from the first side of the first radial opening to a periphery of the sieve screen and a second lateral guide member extending from the second side of the first radial opening towards the periphery, so that when mounted in a fractionating device inducing orbital and lateral flow, the lateral guided flow of granules is guided along the first and second lateral guide members.
Fractionating device with sieve deck outlet opening and angular overlap
A fractionating device with a sieve deck comprising an inlet and a tubular rim portion comprising an outlet with an opening extending from a first to a second side, with a sieve screen and sieve guide received in the sieve deck where the sieve guide is fixedly attached to the sieve screen, the sieve guide includes a circular guide portion with a first radial opening extending from a first to a second side defining a central loading area, and the first radial opening is arranged with an angular overlap with the outlet.
Guided lateral flow to outlet under orbital and lateral flow
The sieve guide is arranged in a specific angular position with the first lateral guide member aligned with the first side of the outlet of the sieve deck, and when the fractionating device induces an orbital and a lateral flow the granules are guided along the first lateral guide member to the outlet.
Overall, the independent claims focus on a fixed sieve guide assembly that cooperates with a circular sieve screen by defining a central loading area and guiding a central guided orbital flow through a first radial opening, while also providing lateral guidance of granules from the central loading area to a fractionating device outlet via one or more lateral guide members. The claims further require a specific angular mounting and alignment relationship between the lateral guide member and the outlet, including an angular overlap between the first radial opening and the outlet in the fractionating device.
Stated Advantages
Improved yield for fractionated granules, including reported increases.
Altered particle size distribution.
Higher bulk/tap density and compressibility of the resulting granule products.
Reduced funnel flowability, reported using a 25 mm orifice.
Distinct near infra-red (NIR) spectral separation.
Improved tablet mechanical strength for tablets prepared from SNAC-containing granule products, including lower friability and higher resistance to crushing/breaking force.
Documented Applications
Fractionating granules for solid dosage forms, including tablets, capsules, and sachets, using the fractionating device and producing fractionated granules for preparing the solid dosage forms.
Preparing tablet mechanical properties, including friability and resistance to crushing/breaking force, using tablets prepared from SNAC-containing granule products after fractionation.
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