WO2000052447A1 - Device for evaluating granule hardness - Google Patents
Device for evaluating granule hardness Download PDFInfo
- Publication number
- WO2000052447A1 WO2000052447A1 PCT/US1999/004406 US9904406W WO0052447A1 WO 2000052447 A1 WO2000052447 A1 WO 2000052447A1 US 9904406 W US9904406 W US 9904406W WO 0052447 A1 WO0052447 A1 WO 0052447A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- granule
- base plate
- cover plate
- hardness
- mounting position
- Prior art date
Links
- 239000008187 granular material Substances 0.000 title claims abstract description 72
- 239000011230 binding agent Substances 0.000 claims abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 11
- 239000012780 transparent material Substances 0.000 claims description 4
- 230000007423 decrease Effects 0.000 claims description 2
- 239000011521 glass Substances 0.000 claims description 2
- 230000003247 decreasing effect Effects 0.000 claims 1
- 239000002245 particle Substances 0.000 description 7
- 239000000463 material Substances 0.000 description 4
- 230000002776 aggregation Effects 0.000 description 2
- 238000004220 aggregation Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 239000007916 tablet composition Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000003245 coal Substances 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000003337 fertilizer Substances 0.000 description 1
- 239000011152 fibreglass Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000013386 optimize process Methods 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229920001187 thermosetting polymer Polymers 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N3/40—Investigating hardness or rebound hardness
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0077—Testing material properties on individual granules or tablets
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N2203/0058—Kind of property studied
- G01N2203/0076—Hardness, compressibility or resistance to crushing
- G01N2203/0087—Resistance to crushing
Definitions
- the present invention relates to a device for evaluating granule hardness and methods of using the device.
- Hardness of pharmaceutical granules is a property that, in correlation with other granule attributes such as bulk density, porosity, and granule size, may be used as a characterizing tool to set and control processing parameters that can significantly affect the characteristics of the finished products which comprise the granules.
- Fig. 1 is a schematic view of a preferred embodiment of the device of the present invention.
- Fig. 1 there is shown a schematic view of a preferred embodiment of the device 10 of the present invention. As described herein, the device 10 is useful for evaluating granule hardness.
- the device is comprised of two plates, a base plate 20b and a cover plate
- the plates 20a and 20b may be joined using any suitable material known to those of skill in the art, for example, adhesive, fusion, tape, screws, bolts, etc.
- the plates 20a and 20b are preferably made from a transparent material, preferably from glass. This provides the user with the ability to observe the measuring process. This is often very important since wet granules tend to compress rather than fracture when placed between the plates. Such compression may compromise the precision of the measurement of the fracture strength of the granule. It is believed that when granules are wet, they tend to behave like a plastic material. Thus, the data obtained from measuring wet granules can be discarded, providing the user with the ability to obtain more consistent results.
- the plates 20a and/or 20b may be made from thermoset plastics, glass reinforced plastics, aluminum, or any other material available to those of skill in the art.
- the size of plates 20a and 20b may vary. For example, 30 mm to 160 mm in length or width is acceptable.
- the thickness of the plates may also vary, with 0.5 mm to 3.7 mm in thickness being suitable for use.
- the weight of each plate 20a, b that comprise the device 10 may suitably vary from about 3 grams to about 60 grams.
- the granule mounting position P is marked on the base plate 20b at a specified distance from the joining means 22. This position P may suitably vary from about 0.3 to about 0.9 times the length L of the base plate 20b. A granule is located between the base plate 20b and the cover plate 20a when placed at the granule mounting position P.
- the amount of weight 24 that is generally suitable for evaluating granule hardness herein varies depending on the type of granule that is being evaluated. In general, the weight will suitably vary from about 1 gram up to about 1000 grams for typical pharmaceutical grade granules.
- the operation of the device will now be described.
- a granule 26 whose fracture strength is to be measured is placed on the base plate 20b, at the granule mounting position P.
- Weight 24 is incrementally applied to the cover plate 20a as indicated by the arrow in Fig. 1 until the granule fractures.
- the fracture strength is a measure of the granule's hardness.
- the device 10 of the present invention is advantageous for its simple design and easy construction, ease of operation, extremely low cost, convenience and portability.
- the device 10 is useful for measuring the fracture strength of the small-sized pharmaceutical granules that are usually desired for use in subsequent tableting processes. It is believed that the devices previously known in the art may be useful for measuring fracture strength of granules that are of relatively high particle sizes, e.g. 6-8 mesh. However, particles of such high sizes are usually discarded in pharmaceutical compositions, especially for pharmaceutical tablet compositions. Such particles are considerably oversized and when incorporated into pharmaceutical tablet compositions, will result in significant finished tablet weight and tablet hardness variation. The lower mesh size particles, e.g. 6-8 mesh, are also undesirable from the standpoint of inhibiting the uniform mixing of minor ingredients.
- the device 10 of the present invention provides a convenient means of measuring the fracture strength of the small granules, e.g., those passing through higher than 6-8 mesh, that desirably comprise many pharmaceutical compositions.
- the data that is obtained from the device 10 is also useful for understanding the optimum process factors in pharmaceutical tableting operations such as mixing time, binder type, and the amount of liquid to be included in the formulation during a wet granulation process.
- the device 10 of the present invention may also be used for evaluating the granule hardness of other products such as detergents, foods, fertilizers, etc., where this technical measure is desired in order to optimize process parameters.
- binding concentration refers to the amount of liquid added containing binding agents such as: sucrose, pregel starch, gelatin, gums and others.
- fracture strength refers to the weight 24 in grams that is required to fracture the granule 26 that is placed between the base plate 20b and the cover plate 20a.
- Std. Dev refers to the average amount of the difference of each fracture value determined on granules having same mean particle size from the mean.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Analytical Chemistry (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Investigating Strength Of Materials By Application Of Mechanical Stress (AREA)
Abstract
Disclosed is a device for evaluating granule hardness, comprising: (a) a base plate having a granule mounting position marked on one surface of the base plate; (b) a cover plate; and (c) a joining means for securing the base plate and the cover plate at an end of each of the base plate and the cover plate; wherein a granule is located between the base plate and the cover plate when placed at the granule mounting position. Methods for measuring granule hardness and optimizing binder solution concentration using the device are also disclosed.
Description
DEVICE FOR EVALUATING GRANULE HARDNESS
FIELD
The present invention relates to a device for evaluating granule hardness and methods of using the device.
BACKGROUND
Hardness of pharmaceutical granules is a property that, in correlation with other granule attributes such as bulk density, porosity, and granule size, may be used as a characterizing tool to set and control processing parameters that can significantly affect the characteristics of the finished products which comprise the granules.
The fracture strength of a granule is a measure of its hardness. Several methods have previously been described in the literature to measure the hardness of granules based upon impact strength. One such method involves the tumbler test for the friability of coal, and variants of this test. See ASTM Designation, D 441-45, 1945.
Hardness described as breaking strength of granules has also been previously investigated. For example, a granule may be placed between anvils, weight incrementally added, and weight required to cause fracture of the granule is described as the granule hardness. See Carr, Chem. Eng. 72, 163 (Jan. 1965); Harwood and Pilpel, J. Pharm. Sci. 57, 478 (1968).
However, the previously-described methods and apparatus for measuring breaking strength require elaborate preparation and extreme care during operation and granule hardness evaluation. In addition, the previously-known devices are believed to be limited to use with granules of relatively large particle sizes, which are frequently not the most desirable for pharmaceutical tableting use.
Thus, there remains a desire to provide a device for measuring granule hardness that is reliable and accurate, easy to use, and that can be used for a wide range of particle sizes. None of the existing art provides all of the advantages and benefits of the present invention.
SUMMARY
The present invention relates to a device for evaluating granule hardness comprising: (a) a base plate having a granule mounting position marked on one surface of the base plate; (b) a cover plate; and (c) a joining means for securing the base plate and the cover plate at an end of each of the base plate and the cover plate; wherein a granule is located between the base plate and the cover plate when placed at the granule mounting position. Methods for measuring granule hardness and optimizing binder solution concentration using the device are also disclosed.
These and other features, aspects, and advantages of the invention will become evident to those skilled in the art from a reading of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description of preferred embodiments taken in conjunction with the accompanying drawing in which: Fig. 1 is a schematic view of a preferred embodiment of the device of the present invention.
DETAILED DESCRIPTION
Referring to Fig. 1 , there is shown a schematic view of a preferred embodiment of the device 10 of the present invention. As described herein, the device 10 is useful for evaluating granule hardness.
The device is comprised of two plates, a base plate 20b and a cover plate
20a, preferably of identical dimension, and joined together at one end of each plate by a joining means 22. The plates 20a and 20b may be joined using any suitable material known to those of skill in the art, for example, adhesive, fusion, tape, screws, bolts, etc.
The plates 20a and 20b are preferably made from a transparent material, preferably from glass. This provides the user with the ability to observe the measuring process. This is often very important since wet granules tend to compress rather than fracture when placed between the plates. Such
compression may compromise the precision of the measurement of the fracture strength of the granule. It is believed that when granules are wet, they tend to behave like a plastic material. Thus, the data obtained from measuring wet granules can be discarded, providing the user with the ability to obtain more consistent results.
However, transparency is not essential to the operation of the device 10, and the plates could be formed from a translucent or opaque material. Thus, the plates 20a and/or 20b may be made from thermoset plastics, glass reinforced plastics, aluminum, or any other material available to those of skill in the art.
The size of plates 20a and 20b may vary. For example, 30 mm to 160 mm in length or width is acceptable. The thickness of the plates may also vary, with 0.5 mm to 3.7 mm in thickness being suitable for use. The weight of each plate 20a, b that comprise the device 10 may suitably vary from about 3 grams to about 60 grams.
The granule mounting position P is marked on the base plate 20b at a specified distance from the joining means 22. This position P may suitably vary from about 0.3 to about 0.9 times the length L of the base plate 20b. A granule is located between the base plate 20b and the cover plate 20a when placed at the granule mounting position P.
The amount of weight 24 that is generally suitable for evaluating granule hardness herein varies depending on the type of granule that is being evaluated. In general, the weight will suitably vary from about 1 gram up to about 1000 grams for typical pharmaceutical grade granules. The operation of the device will now be described. A granule 26 whose fracture strength is to be measured is placed on the base plate 20b, at the granule mounting position P. Weight 24 is incrementally applied to the cover plate 20a as indicated by the arrow in Fig. 1 until the granule fractures. The fracture strength is a measure of the granule's hardness. Thus the device 10 of the present invention is advantageous for its simple design and easy construction, ease of operation, extremely low cost, convenience and portability.
In addition, it is believed that the device 10 is useful for measuring the fracture strength of the small-sized pharmaceutical granules that are usually desired for use in subsequent tableting processes. It is believed that the devices
previously known in the art may be useful for measuring fracture strength of granules that are of relatively high particle sizes, e.g. 6-8 mesh. However, particles of such high sizes are usually discarded in pharmaceutical compositions, especially for pharmaceutical tablet compositions. Such particles are considerably oversized and when incorporated into pharmaceutical tablet compositions, will result in significant finished tablet weight and tablet hardness variation. The lower mesh size particles, e.g. 6-8 mesh, are also undesirable from the standpoint of inhibiting the uniform mixing of minor ingredients.
Thus, it can be seen that the device 10 of the present invention provides a convenient means of measuring the fracture strength of the small granules, e.g., those passing through higher than 6-8 mesh, that desirably comprise many pharmaceutical compositions.
The data that is obtained from the device 10 is also useful for understanding the optimum process factors in pharmaceutical tableting operations such as mixing time, binder type, and the amount of liquid to be included in the formulation during a wet granulation process. Numerous technical reports exist in the literature to show that increasing the amount of binder produce granules of greater strength. It is well known in the art of tablet making that increase in the binder concentration and the mixing time increases tablet hardness and dissolution time. Therefore it can be inferred that increasing granule hardness will increase tablet hardness and therefore the dissolution time of the tablet.
The device 10 of the present invention may also be used for evaluating the granule hardness of other products such as detergents, foods, fertilizers, etc., where this technical measure is desired in order to optimize process parameters.
EXAMPLES
The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations hereof are possible without departing from the spirit and scope of the invention.
The following examples represent the effect of binder concentration on the fracture strength of the granules. The granule strength increases as the binder
solution concentration increases up to a particular point, and then it decreases. Without being bound by theory, it is believed that with increase in the binder solution the granules formed are more compact and dense. With further increase in the binder solution concentration, more aggregation of irregular shape is formed from the granules and fines, resulting in the loss of granule fracture strength. Thus, the aggregates formed are more prone to produce fines during subsequent handling stages. The device described in this invention will help in optimizing the binder solution concentration to arrive at granules having acceptable level of aggregation and mechanical handling property.
Herein, "binder concentration" refers to the amount of liquid added containing binding agents such as: sucrose, pregel starch, gelatin, gums and others. Herein, "fracture strength" refers to the weight 24 in grams that is required to fracture the granule 26 that is placed between the base plate 20b and the cover plate 20a.
Herein, "Std. Dev." refers to the average amount of the difference of each fracture value determined on granules having same mean particle size from the mean.
All cited references are incorporated herein by reference in their entireties.
Citation of any reference is not an admission regarding any determination as to its availability as prior art to the claimed invention.
Herein, "comprising" means that other steps and other components which do not affect the end result can be added. This term encompasses the terms "consisting of and "consisting essentially of."
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to one of skill in the art without departing from the scope of the present invention.
Claims
1. A device for evaluating granule hardness, comprising:
(a) a base plate having a granule mounting position marked on one surface of the base plate;
(b) a cover plate;
(c) a joining means for securing the base plate and the cover plate at an end of each of the base plate and the cover plate; wherein a granule is located between the base plate and the cover plate when placed at the granule mounting position.
2. The device of Claim 1 wherein at least the base plate is formed from a transparent material.
3. The device of Claim 2 wherein the base plate and the cover plate are formed from a transparent material.
4. The device of either of Claims 2 or 3 wherein the transparent material is glass.
5. The device of Claim 1 wherein the plates are about 50 mm in length.
6. The device of Claim 5 wherein the granule mounting position is located on the base plate at a distance of about 30 mm from the secured end of the base plate.
7. The device of Claim 1 wherein the granule is greater than 8 mesh size.
8. The device of claim 1 wherein the granule mounting position is located from joining means at a distance of about 0.3 to about 0.9 times the length of the base plate.
9. A method for measuring granule hardness comprising:
(a) placing a granule between a base plate and a cover plate at a granule mounting position marked on one surface of the base plate, the base plate and the cover plate being secured at an end of each of the base plate and the cover plate by a joining means, and wherein the granule is located between the base plate and the cover plate when placed at the granule mounting position; (b) incrementally increasing a weight applied to the cover plate until the granule fractures; wherein the amount of weight at the time of fracture is the measure of the granule hardness.
10. A method of optimizing the amount of binder solution concentration in granules comprising:
(a) measuring the fracture strength of the granules according to Claim 9; and (b) decreasing the binder solution concentration if a decrease in the fracture strength of the granules is observed.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU28841/99A AU2884199A (en) | 1999-03-01 | 1999-03-01 | Device for evaluating granule hardness |
| PCT/US1999/004406 WO2000052447A1 (en) | 1999-03-01 | 1999-03-01 | Device for evaluating granule hardness |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US1999/004406 WO2000052447A1 (en) | 1999-03-01 | 1999-03-01 | Device for evaluating granule hardness |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2000052447A1 true WO2000052447A1 (en) | 2000-09-08 |
Family
ID=22272276
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1999/004406 WO2000052447A1 (en) | 1999-03-01 | 1999-03-01 | Device for evaluating granule hardness |
Country Status (2)
| Country | Link |
|---|---|
| AU (1) | AU2884199A (en) |
| WO (1) | WO2000052447A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112903457A (en) * | 2021-01-21 | 2021-06-04 | 王友玲 | Bionic detection robot and detection method for physical properties of food |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4054050A (en) * | 1976-06-01 | 1977-10-18 | Reid Luther J | Apparatus for measuring the crush strength of solid particles |
| US4173826A (en) * | 1978-08-17 | 1979-11-13 | Heinrich William P | Apparatus for cutting pills |
| GB2120797A (en) * | 1982-05-28 | 1983-12-07 | Patrick Bleuse | Dynamometric pliers |
| DE19744227A1 (en) * | 1997-05-23 | 1998-11-26 | Norbert Kraemer | Device and method for carrying out a hardness test on test specimens, in particular tablets or pills |
-
1999
- 1999-03-01 WO PCT/US1999/004406 patent/WO2000052447A1/en active Application Filing
- 1999-03-01 AU AU28841/99A patent/AU2884199A/en not_active Abandoned
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4054050A (en) * | 1976-06-01 | 1977-10-18 | Reid Luther J | Apparatus for measuring the crush strength of solid particles |
| US4173826A (en) * | 1978-08-17 | 1979-11-13 | Heinrich William P | Apparatus for cutting pills |
| GB2120797A (en) * | 1982-05-28 | 1983-12-07 | Patrick Bleuse | Dynamometric pliers |
| DE19744227A1 (en) * | 1997-05-23 | 1998-11-26 | Norbert Kraemer | Device and method for carrying out a hardness test on test specimens, in particular tablets or pills |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112903457A (en) * | 2021-01-21 | 2021-06-04 | 王友玲 | Bionic detection robot and detection method for physical properties of food |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2884199A (en) | 2000-09-21 |
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