Unlock instant, AI-driven research and patent intelligence for your innovation.

Process for producing pellets for pharmaceutical compositions

A composition and granule technology, applied in the field of granule production, can solve problems such as effective use and waste

Inactive Publication Date: 2011-07-13
TEMREL LTD
View PDF4 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pellets that are too large or too small cannot be used effectively in delayed-release and sustained-release capsules, and these granules are often discarded, resulting in a lot of waste

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Process for producing pellets for pharmaceutical compositions
  • Process for producing pellets for pharmaceutical compositions
  • Process for producing pellets for pharmaceutical compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: 5wt% prednisolone sodium m-benzenesulfonate

[0056] By preparing 5wt% prednisolone sodium m-benzenesulfonate, 40wt% microcrystalline cellulose (Avicel TM PH101), 35% lactose monohydrate (D80 200 mesh) and 20% croscarmellose sodium (Ac-Di-Sol TM ) dry mixture to prepare prednisolone m-benzenesulfonate granules. Purified water (185% by weight of dry mixture components) was added and the resulting mixture was mixed for 10 minutes to form an extrudable paste, which was then extruded and pelletized. Next, the granules were dried and sieved in a fluidized bed granulator to ensure the size of the granules was in the range of 800-1500 μm.

[0057] figure 1 The particles formed in Example 1 are shown. Most of these particles are in the desired 800-1500 μm range.

Embodiment 2

[0058] Embodiment 2: 5wt% prednisolone sodium m-benzenesulfonate

[0059] Granules were produced using the procedure described in Example 1, but using 180 wt% water instead of 185 wt%. The particle yield was 91% (after drying).

[0060] figure 2 Particles formed from Example 2 are shown. The photographs clearly show that when the water consumption is reduced, the particle size drops significantly.

Embodiment 3

[0061] Embodiment 3: 5wt% prednisolone sodium m-benzenesulfonate

[0062] Granules were produced using the procedure described in Example 1, but using 190 wt% water instead of 185 wt%.

[0063] image 3 Particles formed from Example 3 are shown. The photographs clearly show that the particle size increases significantly when the amount of water is increased.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
diameteraaaaaaaaaa
diameteraaaaaaaaaa
diameteraaaaaaaaaa
Login to View More

Abstract

Water is used to control particle size in a process comprising mixing water with a composition comprising a rheology modifying agent and possibly sugar and cellulose to produce a paste. The paste is extruded to form particles which are then spheronised and dried. One advantage of using water to control particle size is that the number of particles having a diameter within a required range, e.g. between from about 800 to about 1500 mum, may be increased.

Description

technical field [0001] The present invention relates to a method of producing granules, in particular granules for use in pharmaceutical compositions. In particular, the present invention relates to the use of water to control particle size. Background technique [0002] US-A-5834021 (Speirs; published November 10, 1998) discloses a non-disintegrable solid enteric composition comprising 5 wt % prednisolone m-benzenesulfonate in an excipient matrix (prednisolonemetasulphobenzoate, "Pred-MSB"), the matrix contains 40 wt% microcrystalline cellulose, 35 wt% lactose and 20 wt% croscarmellose sodium. This composition is in the form of granules with a diameter of 1000-1400 μm. The granules are formed by dry blending Pred-MSB, cellulose, lactose and croscarmellose sodium. Water was added to the mixture and stirred for 10 minutes to form an extrudable paste. The paste was then extruded at a rate of 100 mm / min through a 1 mm diameter, 5 mm long tube from a 25 mm diameter roller an...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/573A61K38/22A61K31/4164
Inventor 克里斯托弗·斯皮尔斯彼得·莫伊尔理查德·威廉斯迈克尔·克拉克
Owner TEMREL LTD