Method and equipment for fractionation of granules for use in pharmaceutical compositions

Patent metadata

Field	Value
Publication number	US-12364663-B2
Application number	US-202017639600-A
Country	US
Kind code	B2
Filing date	Sep 4, 2020
Priority date	Sep 6, 2019
Publication date	Jul 22, 2025
Grant date	Jul 22, 2025

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 31 a. 1. 31 b. 1, 31 c. 1, 31 d. 1 and an orbital flow defining orbital streamlines 31 a. 2. 31 b. 2, 31 c. 2, 31 d. 2, 31 d. 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.

First claim

The invention claimed is:

1. A sieve guide assembly a circular sieve screen and a sieve guide,
wherein the sieve guide is fixedly attached to the circular sieve screen;
wherein the circular sieve guide comprises:
(a) a circular guide portion adapted to guide a central guided orbital flow, wherein the central guided orbital flow defines an orbital downstream direction,
wherein the circular guide portion is positioned centrally on the circular sieve screen and defines a central loading area of the sieve screen,
wherein the circular guide portion comprises a first radial opening extending in an upstream orbital direction from a first to a second side, and
wherein the upstream orbital direction is opposite a downstream orbital direction, and
(b) a lateral guide portion adapted to guide a lateral guided flow of granules from the central loading area of the sieve screen,
wherein the lateral guide portion comprises a first lateral guide member extending in a lateral direction from the first side of the first radial opening and to a periphery of the sieve screen;
wherein 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; and
wherein when the sieve guide assembly is mounted in the specific angular position in the fractionating device and when the fractionating device induces an orbital and a lateral flow, the lateral guided flow of the granules is guided along the first lateral guide member to the outlet.

2. The sieve guide assembly according to claim 1 , wherein the first lateral guide member is curved.

3. The sieve guide assembly according to claim 1 , further comprising a second lateral guide member extending in the lateral direction from the second side of the first radial opening.

4. The sieve guide assembly according to claim 3 , wherein the second lateral guide member is curved.

5. The sieve guide assembly according to claim 1 , wherein the sieve guide assembly comprises a key or a key-hole adapted to ensure the sieve guide assembly is mounted in the specific angular position.

6. The sieve guide assembly according to claim 1 , wherein the sieve guide assembly is adapted to be angularly adjustable, and wherein the sieve guide further is adapted to be fixed or clamped at the specific angular position.

7. A sieve guide assembly, comprising:
a circular sieve screen and a sieve guide;
wherein the sieve guide is fixedly attached to the sieve screen,
wherein the sieve guide comprises:
(a) a circular guide portion comprising a first radial opening extending from a first to a second side wherein the circular portion is positioned centrally on the circular sieve screen and defines a central loading area of the sieve screen for granules to be fractionated,
(b) a lateral guide portion comprising (i) a first lateral guide member extending from a first side of the first radial opening to a periphery of the sieve screen, and (ii) a second lateral guide member extending from a second side of the first radial opening towards the periphery;

wherein when the sieve guide assembly is mounted in a fractionating device and when the fractionating device induces an orbital and a lateral flow, the lateral guided flow of the granules are guided along the first and second lateral guide members.

8. A fractionating device adapted to fractionate granules for solid dosage forms, comprising: (a) the sieve guide assembly according to claim 1 or claim 7 , and (b) a tubular rim portion adapted to receive the sieve guide assembly,
wherein the tubular rim portion comprises an outlet;
wherein the outlet comprises an opening in the tubular rim portion extending in the upstream orbital direction from a first to a second side.

9. A fractionating device adapted to fractionate granules, comprising:
(a) a sieve deck comprising an inlet and a tubular rim portion comprising an outlet, wherein the outlet comprises an opening extending from a first to a second side, and
(b) a sieve screen and a sieve guide received in the sieve deck, wherein the sieve guide is fixedly attached to the sieve screen;
wherein the sieve guide comprises:
(i) a circular guide portion comprising a first radial opening extending from a first to a second side, wherein the circular guide portion is positioned centrally on the sieve screen and defines a central loading area of the sieve screen adapted to receive granules through the inlet, and
(ii) a lateral guide portion comprising a first guide member extending from the first side of the first radial opening to a periphery of the sieve screen;
wherein the outlet of the sieve deck comprises an opening extending from a first to a second side;
wherein 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;
wherein the first radial opening is arranged with an angular overlap with the outlet; and
wherein when the fractionating device induces an orbital and a lateral flow, the granules are guided along the first lateral guide member to the outlet.

10. The fractionating device according to claim 9 , wherein the first lateral guide member is curved.

11. The fractionating device according to claim 9 , further comprising a second lateral guide member extending in the lateral direction from the second side of the first radial opening.

12. A method of fractionating granules for solid dosage forms comprising;
a) loading the granules to be fractionated onto the central loading area of the screen of the fractionating device according to claim 8 ,
b) fractionating the granules; and
c) collecting the fractionated granules at the outlet.

13. A method of producing a solid dosage form comprising;
a) obtaining granules comprising a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid (NAC);
b) fractionating the granules using the fractionation device according to claim 8 and
c) preparing the solid dosage form using the fractionated granules.

14. The method according to claim 13 , wherein the solid dosage form comprises one or more pharmaceutical active ingredients and optionally one or more pharmaceutically acceptable excipients.

15. The fractionating device according to claim 11 , wherein the second lateral guide member is curved.

16. The method according to claim 12 , wherein the solid dosage form is selected from the group consisting of a tablet, capsule, and sachet.

17. The method according to claim 13 , wherein the solid dosage form is selected from the group consisting of a tablet, capsule, and sachet.

18. The method according to claim 14 , wherein the solid dosage form is selected from the group consisting of a tablet, capsule, and sachet.

Assignees

• Novo Nordisk As

Inventors

• Vilhelmsen Thomas
• Hoeeg-Moeller Carsten
• Soerensen Martin Nobert
• Gaunoe Mette Hoeg

Classifications

• B07B2230/04

  The screen or the screened materials being subjected to ultrasonic vibration · CPC title

• B07B13/16

  Feed or discharge arrangements · CPC title

• B07B1/38 Primary

  oscillating in a circular arc in their own plane; Plansifters · CPC title

• A61K31/609

  Amides, e.g. salicylamide {(labetalol, metoclopramide A61K31/166)} · CPC title

• A61K9/146

  with organic macromolecular compounds · CPC title