CA1234761A - Chewable aspirin and buffering material tablet and method for producing same - Google Patents
Chewable aspirin and buffering material tablet and method for producing sameInfo
- Publication number
- CA1234761A CA1234761A CA000470086A CA470086A CA1234761A CA 1234761 A CA1234761 A CA 1234761A CA 000470086 A CA000470086 A CA 000470086A CA 470086 A CA470086 A CA 470086A CA 1234761 A CA1234761 A CA 1234761A
- Authority
- CA
- Canada
- Prior art keywords
- aspirin
- tablet
- buffering
- chewable
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Abstract
IN THE UNITED STATES
PATENT AND TRADEMARK OFFICE
PATENT APPLICATION
OF: HERBERT LAPIDUS
FOR: CHEWABLE ASPIRIN AND BUFFERING MATERIAL
TABLET AND METHOD FOR PRODUCING SAME.
ABSTRACT
A chewable aspirin and buffering material tablet and method for producing same is disclosed herein. In a single dosage form the aspirin and buffering materials are integrally dispersed and bound in a fatty material of chocolate, synthetic chocolate or hydrogenated tallow. The tablet is for gastrointestinal applications and is especially adopted for use with animals, particularly dogs, and can be molded into a variety of shapes including that of a miniature dog bone.
PATENT AND TRADEMARK OFFICE
PATENT APPLICATION
OF: HERBERT LAPIDUS
FOR: CHEWABLE ASPIRIN AND BUFFERING MATERIAL
TABLET AND METHOD FOR PRODUCING SAME.
ABSTRACT
A chewable aspirin and buffering material tablet and method for producing same is disclosed herein. In a single dosage form the aspirin and buffering materials are integrally dispersed and bound in a fatty material of chocolate, synthetic chocolate or hydrogenated tallow. The tablet is for gastrointestinal applications and is especially adopted for use with animals, particularly dogs, and can be molded into a variety of shapes including that of a miniature dog bone.
Description
I
.. . . I
.. . . I
2 This invention relate to a chewable tablet containing aspirin in an integral and dispersed combination with a buffering material and the method for producing same. The 5 tablets have use in those applications where aspirin is the 6 prescribed treatment but it associated undesirable and 7 potentially handful side effects are wanted to be avoided.
8 It has long been appreciated that the administration of 9 aspirin with a buffering material has certain distinct 10 advantages. One of these advantages is that the presence of 11 a buffering material serves to increase the rate at which the 12 aspirin is absorbed into the bloodstream. A second benefit is 13 that the buffering material tends to decrease any irritation to 14 the gastrointestinal mucus that aspirin may cause in some subjects. This is especially true with animals such as dogs 16 whose gastrointestinal tract is particularly sensitive to 17 aspirin irritation.
18 Although the benefits of the coadministration of aspirin 19 and a buffering material are recognized, the skill in the art for incorporation of these materials in a single dosage phony 21 has not developed a thoroughly acceptable product. The 22 principle problem is that aspirin is known to by hydrolyzed to 23 salicylic acid by the alkaline buffering material when moisture 24 is present. This results in an aspirin product with reduced analgesic effectiveness.
26 Us Patent No. 4,339,428 assigned to Bristol-Myers Co."
27 describes the current level of skill in the art for an aspirin 28 and alkaline tabulated combination. Therein, it is disclosed 29 that aspirin and buffering material tablets have tried to be made stable by worming the tablets in two layers, one layer 31 containing the aspirin and the other layer containing the 32 buffering material. This has only proven to be relatively *a trade mark used in association with acetylsalicylic acid.
ox-I, 749.020 I
1 successful in providing a table tablet, I one in which 'che~spirin is not readily hydrolyzed. However, even with the
8 It has long been appreciated that the administration of 9 aspirin with a buffering material has certain distinct 10 advantages. One of these advantages is that the presence of 11 a buffering material serves to increase the rate at which the 12 aspirin is absorbed into the bloodstream. A second benefit is 13 that the buffering material tends to decrease any irritation to 14 the gastrointestinal mucus that aspirin may cause in some subjects. This is especially true with animals such as dogs 16 whose gastrointestinal tract is particularly sensitive to 17 aspirin irritation.
18 Although the benefits of the coadministration of aspirin 19 and a buffering material are recognized, the skill in the art for incorporation of these materials in a single dosage phony 21 has not developed a thoroughly acceptable product. The 22 principle problem is that aspirin is known to by hydrolyzed to 23 salicylic acid by the alkaline buffering material when moisture 24 is present. This results in an aspirin product with reduced analgesic effectiveness.
26 Us Patent No. 4,339,428 assigned to Bristol-Myers Co."
27 describes the current level of skill in the art for an aspirin 28 and alkaline tabulated combination. Therein, it is disclosed 29 that aspirin and buffering material tablets have tried to be made stable by worming the tablets in two layers, one layer 31 containing the aspirin and the other layer containing the 32 buffering material. This has only proven to be relatively *a trade mark used in association with acetylsalicylic acid.
ox-I, 749.020 I
1 successful in providing a table tablet, I one in which 'che~spirin is not readily hydrolyzed. However, even with the
3 layering of the aspirin and buffering material, the effective
4 aspirin content in a single tablet is reduced by the hydrolysis surrounding the aspirin alkaline interface.
6 In addition, such layering greatly increases the 7 production costs of the tablets. Tablets are normally made by 8 direct compression of the tabulating products in the die 9 chamber of a tablet press. With layered aspirin and buffer lo tablets, this requires a two-layered tablet press which is 11 slower than a conventional single-layer machine and requires 12 two separate and distinct compression steps, wherein each layer 13 is separately formed and are then joined.
14 In the administration of medication to animals, there is extreme difficulty in administering tablets and inducing 16 swallowing, and also problems of controlling dosage; it is i 17 therefore desirable to have aspirin containing products in a 18 fixed dosage; palatable, and chewable form with an undetectable lo aspirin odor. While many pharmaceutical tablets are designed to be chewed to permit rapid activity in the digestive or 21 circulatory system by increasing the available surface area for 22 absorption of the drug, chewable aspirin buffering material 23 combinations are known to cause an unpleasant oral reaction and 24 leave an unpalatable taste due to chalkiness, grittiness, dryness and astringent properties of these materials. These 26 palatability and taste problems are also associated with such 27 products administered in non chewable tablet form, as the 28 tablet tends to dissolve in the mouth before swallowing.
29 Furthermore, in the production of chewable tablets, additional process steps and costs are necessarily encountered. In the 31 production thereof, a disintegrating agent, such as alginic 32 acid, can be added to the pre-tablet mix, and/or reduced 749.020 ' ' I
~3~7~
1 compaction temperatures can be employed However, these 2 techniques cause undesirable mixture adhesion to the die chamber, and cause the tablets to be fragile and bitter.
4 So Patent No. 4,327,077 assigned to Life Savers, Inc., describes the current skill in the art to overcome taste and 6 palatability problems. This it primarily accomplished by 7 employing flavorings with the pharmaceuticals. While the 8 flavorings do mask the unpleasant taste, they have not solved 9 any of the associated palatability problems. To overcome palatability problems this same patent discloses a compressed 11 chewable antacid tablet, formed by binding the antacid in a 12 fatty material. The fatty material and antacid are mixed and 13 then recrystallized into a powder form and then compacted into 14 a chewable tablet. This chewable tablet is disclosed us disintegrating quickly to a smooth, creamy, pleasant tasting 16 emulsion devoid of grittiness. While the patent discloses a 17 separate embodiment for aspirin and a fatty material, a 18 combined aspirin buffering material tablet is not disclosed and 19 the man skilled in the art would conclude it is not practicable since the disclosed recrystallization into powder form would 21 only serve to integrate the aspirin and alkaline materials 22 causing ultimate hydrolysis and reduction of aspirin into 23 non-analgesic salicylic acid which is sought to be avoided 24 US. Patent No 4,339,428 discloses the current skill in the art for mixing aspirin and alkaline material in a capsule 26 product wherein a high dosage of aspirin in powder our 27 granulated form is mixed with an alkaline tablet. The capsules 28 are produced by filling them first with the tabulated alkaline 29 material, and then adding thereto the aspirin composition in powder or granulated form. However, oven with tabulating the 31 alkaline material separately from the aspirin, when the 7~9.020 ~3~7~
products are mixed in the capsule hydrolysis problems of the 2 aspirin are realized.
4 It is accordingly an object of the present invention to provide a unique chewable tablet wherein aspirin and a 6 buffering material are combined in a single dosage form. The 7 aspirin-buffering materials are combined with a fatty material 8 so that the aspirin and buffering materials are integrally 9 dispersed and bound in said fatty material without significant reduction in the analgesic effectiveness of the aspirin.
11 It is a further object of the present invention to provide 12 a method for making the above chewable tablet. This method 13 includes the steps of melting the fatty material, admixing the 14 aspirin and buffering materials to the melted fatty material batter and then pouring said batter into the tablet molds for 16 solidification and final tablet form.
17 Other and more detailed objects and features of this 18 invention will be obvious from the following description and 19 claims.
DETAILED DESCRIPTION OF THE INVENTION
21 In accordance with the present invention a unique chewable 22 aspirin and buffering material tablet is provided. The aspirin and buffering materiels are combined with a fatty material SOD
24 that the aspirin and buffering materials are individually coated and integrally dispersed and bound in said fatty 26 material.
27 The principal ingredient on a weight basis of the chewable 28 tablet will be the fatty material The fatty material employed 29 herein will preferably be in the form of chocolate or a synthetic chocolate such as "Ice-Cap" (a synthetic chocolate 31 manufactured by Nestle, formed of hydrogenated fat emulsifier, 32 flavor, sugar and milk solids 749.020 I I
1 This fatty material is preferred because the solid 2 "Ice-Cap" provides excellent flavor, sweetness, aroma and mouth 3 feel. The "Ice-Cap" is also easy to handle and admix thereto 4 and when melted is readily parboil having a comparable consistency to that of pancake batter. The "Ice-Cap" disclosed 6 also assumes the shape of a mold without any sticking.
7 Typically, the "Ice-Cap" is employed in an amount up to about 8 38~ by weight of the finished chewable tablet.
9 Other fatty materials which may be employed herein in the amounts set out above are those which may be melted, mixed and 11 molded as described and exhibit the same excellent flavor, 12 sweetness, aroma and mouth feel characteristics. Examples of 13 those materials suitable for use herein are natural chocolate 14 and hydrogenated tallow. However, these materials are in no way to be taken as defining the whole class of suitable fatty 16 materials limited for use herein.
17 To be added to the fatty material described herein above 18 is aspirin (acetylsalicylic acid) which can be in the form of a 19 powder or dry granulation that may vary widely in particle size. Preferably, a form of aspirin known in the art as 21 "micronized aspirin" will be employed. This is aspirin ground 22 to a size of about 325 mesh aspirin. Another aspirin material 23 suitable for use herein is known in the art as "micro-24 encapsulated" aspirin. Such a product may be obtained from Errand America, Inc. of Dayton, Ohio. This is a micronizecl 26 aspirin which has been encapsulated in a coating ox 27 ethyl-cellulose. Typically the aspirin content contained in a I single dosage form will be 250 my. or approximately 4 grains.
29 However, this content can vary depending on tablet size but the amount of aspirin in a tablet will be about 10~ of the total 31 tablet weight.
749.020 ~J3L~ 76~
1 Also to be added to the fatty material it the buffering 2 material which takes the form of an antacid. Examples of 3 antacids suitable for use herein comprise any relatively 4 water-insoluble antacid acceptable to the Food & Drug Administration, such as, aluminum carbonate, aluminum hydroxide 6 (or as aluminum hydroxide-hexitol stabilized polymer, aluminum 7 hydroxide magnesium hydroxide codeword gel, aluminum 8 hydroxide-magnesium trisilicate codeword gel, aluminum 9 hydroxide-sucrose powder hydrated), aluminum phosphate, lo aluminum hydroxy carbonate, dihydroxy aluminum sodium 11 carbonate, aluminum magnesium glycinate, dihydroxyaluminum 12 amino acetate, dihydroxyal.uminum amino acetic acid, bismuth 13 acuminate, bismuth carbonate, bismuth sub carbonate, bismuth 14 subgallate, bismuth sub nitrate, calcium carbonate, calcium phosphate, hydrated magnesium acuminate activated sulfate, 16 magnesium acuminate, magnesium aluminosilicates, magnesium 17 carbonate, magnesium glycinate, magnesium hydroxide, magnesium 18 oxide and magnesium trisilicate! and or mixtures thereof. .
19 Preferred antacids include aluminum hydroxide, koalas carbonate, magnesium carbonate and mixtures thereof as well as 21 magnesium hydroxide.
22 Typically the antacid content contained in a single dosage 23 form will be 50 my. or approximately 1 grain. However, it is 24 noted again that this content can vary depending on the table size but the amount of antacid in a tablet will be about 2% of--26 the total tablet weight.
27 While the aspirin, buffering and fatty material constitute 28 the principal ingredients of the invention, other ingredients 29 may ye added to the tablet to improve its physical or organoleptic characteristics or to facilitate the manufacture 31 of the aspirin and buffering material tablet.
I 749.020 1 ~3':~'7~
1 ¦ In carrying out the method of the present invention, each 2 ¦ ingredient (Aspirin and buffering material) will be dispersed 3¦ within the fatty material separately. Thus the aspirin and the 4 ¦ buffering material will be added to the fatty vehicle with
6 In addition, such layering greatly increases the 7 production costs of the tablets. Tablets are normally made by 8 direct compression of the tabulating products in the die 9 chamber of a tablet press. With layered aspirin and buffer lo tablets, this requires a two-layered tablet press which is 11 slower than a conventional single-layer machine and requires 12 two separate and distinct compression steps, wherein each layer 13 is separately formed and are then joined.
14 In the administration of medication to animals, there is extreme difficulty in administering tablets and inducing 16 swallowing, and also problems of controlling dosage; it is i 17 therefore desirable to have aspirin containing products in a 18 fixed dosage; palatable, and chewable form with an undetectable lo aspirin odor. While many pharmaceutical tablets are designed to be chewed to permit rapid activity in the digestive or 21 circulatory system by increasing the available surface area for 22 absorption of the drug, chewable aspirin buffering material 23 combinations are known to cause an unpleasant oral reaction and 24 leave an unpalatable taste due to chalkiness, grittiness, dryness and astringent properties of these materials. These 26 palatability and taste problems are also associated with such 27 products administered in non chewable tablet form, as the 28 tablet tends to dissolve in the mouth before swallowing.
29 Furthermore, in the production of chewable tablets, additional process steps and costs are necessarily encountered. In the 31 production thereof, a disintegrating agent, such as alginic 32 acid, can be added to the pre-tablet mix, and/or reduced 749.020 ' ' I
~3~7~
1 compaction temperatures can be employed However, these 2 techniques cause undesirable mixture adhesion to the die chamber, and cause the tablets to be fragile and bitter.
4 So Patent No. 4,327,077 assigned to Life Savers, Inc., describes the current skill in the art to overcome taste and 6 palatability problems. This it primarily accomplished by 7 employing flavorings with the pharmaceuticals. While the 8 flavorings do mask the unpleasant taste, they have not solved 9 any of the associated palatability problems. To overcome palatability problems this same patent discloses a compressed 11 chewable antacid tablet, formed by binding the antacid in a 12 fatty material. The fatty material and antacid are mixed and 13 then recrystallized into a powder form and then compacted into 14 a chewable tablet. This chewable tablet is disclosed us disintegrating quickly to a smooth, creamy, pleasant tasting 16 emulsion devoid of grittiness. While the patent discloses a 17 separate embodiment for aspirin and a fatty material, a 18 combined aspirin buffering material tablet is not disclosed and 19 the man skilled in the art would conclude it is not practicable since the disclosed recrystallization into powder form would 21 only serve to integrate the aspirin and alkaline materials 22 causing ultimate hydrolysis and reduction of aspirin into 23 non-analgesic salicylic acid which is sought to be avoided 24 US. Patent No 4,339,428 discloses the current skill in the art for mixing aspirin and alkaline material in a capsule 26 product wherein a high dosage of aspirin in powder our 27 granulated form is mixed with an alkaline tablet. The capsules 28 are produced by filling them first with the tabulated alkaline 29 material, and then adding thereto the aspirin composition in powder or granulated form. However, oven with tabulating the 31 alkaline material separately from the aspirin, when the 7~9.020 ~3~7~
products are mixed in the capsule hydrolysis problems of the 2 aspirin are realized.
4 It is accordingly an object of the present invention to provide a unique chewable tablet wherein aspirin and a 6 buffering material are combined in a single dosage form. The 7 aspirin-buffering materials are combined with a fatty material 8 so that the aspirin and buffering materials are integrally 9 dispersed and bound in said fatty material without significant reduction in the analgesic effectiveness of the aspirin.
11 It is a further object of the present invention to provide 12 a method for making the above chewable tablet. This method 13 includes the steps of melting the fatty material, admixing the 14 aspirin and buffering materials to the melted fatty material batter and then pouring said batter into the tablet molds for 16 solidification and final tablet form.
17 Other and more detailed objects and features of this 18 invention will be obvious from the following description and 19 claims.
DETAILED DESCRIPTION OF THE INVENTION
21 In accordance with the present invention a unique chewable 22 aspirin and buffering material tablet is provided. The aspirin and buffering materiels are combined with a fatty material SOD
24 that the aspirin and buffering materials are individually coated and integrally dispersed and bound in said fatty 26 material.
27 The principal ingredient on a weight basis of the chewable 28 tablet will be the fatty material The fatty material employed 29 herein will preferably be in the form of chocolate or a synthetic chocolate such as "Ice-Cap" (a synthetic chocolate 31 manufactured by Nestle, formed of hydrogenated fat emulsifier, 32 flavor, sugar and milk solids 749.020 I I
1 This fatty material is preferred because the solid 2 "Ice-Cap" provides excellent flavor, sweetness, aroma and mouth 3 feel. The "Ice-Cap" is also easy to handle and admix thereto 4 and when melted is readily parboil having a comparable consistency to that of pancake batter. The "Ice-Cap" disclosed 6 also assumes the shape of a mold without any sticking.
7 Typically, the "Ice-Cap" is employed in an amount up to about 8 38~ by weight of the finished chewable tablet.
9 Other fatty materials which may be employed herein in the amounts set out above are those which may be melted, mixed and 11 molded as described and exhibit the same excellent flavor, 12 sweetness, aroma and mouth feel characteristics. Examples of 13 those materials suitable for use herein are natural chocolate 14 and hydrogenated tallow. However, these materials are in no way to be taken as defining the whole class of suitable fatty 16 materials limited for use herein.
17 To be added to the fatty material described herein above 18 is aspirin (acetylsalicylic acid) which can be in the form of a 19 powder or dry granulation that may vary widely in particle size. Preferably, a form of aspirin known in the art as 21 "micronized aspirin" will be employed. This is aspirin ground 22 to a size of about 325 mesh aspirin. Another aspirin material 23 suitable for use herein is known in the art as "micro-24 encapsulated" aspirin. Such a product may be obtained from Errand America, Inc. of Dayton, Ohio. This is a micronizecl 26 aspirin which has been encapsulated in a coating ox 27 ethyl-cellulose. Typically the aspirin content contained in a I single dosage form will be 250 my. or approximately 4 grains.
29 However, this content can vary depending on tablet size but the amount of aspirin in a tablet will be about 10~ of the total 31 tablet weight.
749.020 ~J3L~ 76~
1 Also to be added to the fatty material it the buffering 2 material which takes the form of an antacid. Examples of 3 antacids suitable for use herein comprise any relatively 4 water-insoluble antacid acceptable to the Food & Drug Administration, such as, aluminum carbonate, aluminum hydroxide 6 (or as aluminum hydroxide-hexitol stabilized polymer, aluminum 7 hydroxide magnesium hydroxide codeword gel, aluminum 8 hydroxide-magnesium trisilicate codeword gel, aluminum 9 hydroxide-sucrose powder hydrated), aluminum phosphate, lo aluminum hydroxy carbonate, dihydroxy aluminum sodium 11 carbonate, aluminum magnesium glycinate, dihydroxyaluminum 12 amino acetate, dihydroxyal.uminum amino acetic acid, bismuth 13 acuminate, bismuth carbonate, bismuth sub carbonate, bismuth 14 subgallate, bismuth sub nitrate, calcium carbonate, calcium phosphate, hydrated magnesium acuminate activated sulfate, 16 magnesium acuminate, magnesium aluminosilicates, magnesium 17 carbonate, magnesium glycinate, magnesium hydroxide, magnesium 18 oxide and magnesium trisilicate! and or mixtures thereof. .
19 Preferred antacids include aluminum hydroxide, koalas carbonate, magnesium carbonate and mixtures thereof as well as 21 magnesium hydroxide.
22 Typically the antacid content contained in a single dosage 23 form will be 50 my. or approximately 1 grain. However, it is 24 noted again that this content can vary depending on the table size but the amount of antacid in a tablet will be about 2% of--26 the total tablet weight.
27 While the aspirin, buffering and fatty material constitute 28 the principal ingredients of the invention, other ingredients 29 may ye added to the tablet to improve its physical or organoleptic characteristics or to facilitate the manufacture 31 of the aspirin and buffering material tablet.
I 749.020 1 ~3':~'7~
1 ¦ In carrying out the method of the present invention, each 2 ¦ ingredient (Aspirin and buffering material) will be dispersed 3¦ within the fatty material separately. Thus the aspirin and the 4 ¦ buffering material will be added to the fatty vehicle with
5 ¦ continuous stirring until all the powdered material is ¦ completely dispersed and thereby coated. thereafter, the 7 dispersion can be poured onto Teflon coated sheets and allowed 8 to cool, until solidified, at which time the product sheets swan 9 be cut into any shape. Or, the dispersion may instead be fed into preformed molds where the dosage will solidify and remain 11 discreet.
12 The following examples are given to further illustrate 13 this invention. It is to be understood however, that the b 14 invention is not limited thereto.
A chewable aspirin-buffering material tablet having the 16 following composition is prepared as described below.
17 Ingredient Parts by Weight icecap" coating (Nestle) 88.0 fat, emulsifier, artificial flyover, sugar, milk solids) 20Microencapsulated Aspirin HO #1 10.0 errand America, Ionic calcium Carbonate 2.0 24 The following preparation is for approximately 7.65 kg. of the aspirin-buffering material product. The "Ice Cap" coating 26 (6.75 kg.) is melted in a jacketed mixing kettle at 120 F.
27 The melt is then transferred to a Hubert type mixer and under 28 agitation .75 kg. of the micro encapsulated aspirin is added.
29 Mixing is continued for several minutes until all the aspirin material is mixed into the "Ice-Cap". This mixture is then 31 removed from the mixer and 0.15 kg. of calcium carbonate is 32 added. The mixture is mixed vigorously by hand, making sure 749.020 ?
,.
1 that the calcium carbonate is uniformly distributed. The 2 mixture it then poured onto teflon-coa~ed cookie sheets to a 3 height of approximately 1/4 inch. The mixture is covered, 4 allowed to cool and kept away from any flounce of moisture.
When solidified the mixture is cut into squares, each weighing S 2.50 gym. Each square contains: 88% or 2.20 gym. of "Ice-cap", 7 10% or 0.25 gym. of aspirin, and 2% or 0.0~0 gym. of calcium 8 carbonate.
9 EXAMPLE ?
A preparation of 50 kg. of the buffered aspirin product is 11 prepared as follows: To a stainless steel jacketed mixing 12 kettle is added 44.0 kg. of "Ice-Cap" base. The "Ice-Cap" is 13 heated slowly at a low mixer speed until it reaches 40-50C.
14 When the "Ice-Cap" is molten, 5.0 kg. of micro encapsulated aspirin (Easily) is added and mixing is continued at a medium 16 mixer speed until the aspirin is completely dispersed. One 17 kilogram of calcium carbonate is then added and the mixing 18 continued until uniformly dispersed.
19 While the preceding mouthed has disclosed spreading the batter mixture on Teflon coated cookie sheets, it is also 21 possible to practice the subject invention by pouring said 22 batter into a mold and allowing the preparation to wool to 23 kiwi The solidifying product should be kept away from 24 moisture but may be allowed to cool in air, preferably at a relative humidity of 50% and at a temperature of 18-21C.
26 When the preparation has cooled it should be removed from the 27 molds and immediately packaged in an airtight container.
28 In this case the told that was used was in the shape of a 29 dog bone, and each molded tablet weighed 2.50 gym. comprised of the same percentage of components as described above.
32 Yale my 749.020 1 ~23~7~
1¦ The preparation from Example 1 was comparatively tested 21 for shell life and decomposition of aspirin to free salicylic 31 acid against an unbuffered aspirin product. The testing was 4 ¦ conducted using standard industry procedure for measuring free 5 ¦ salicylic acid in aspirin products.
12 The following examples are given to further illustrate 13 this invention. It is to be understood however, that the b 14 invention is not limited thereto.
A chewable aspirin-buffering material tablet having the 16 following composition is prepared as described below.
17 Ingredient Parts by Weight icecap" coating (Nestle) 88.0 fat, emulsifier, artificial flyover, sugar, milk solids) 20Microencapsulated Aspirin HO #1 10.0 errand America, Ionic calcium Carbonate 2.0 24 The following preparation is for approximately 7.65 kg. of the aspirin-buffering material product. The "Ice Cap" coating 26 (6.75 kg.) is melted in a jacketed mixing kettle at 120 F.
27 The melt is then transferred to a Hubert type mixer and under 28 agitation .75 kg. of the micro encapsulated aspirin is added.
29 Mixing is continued for several minutes until all the aspirin material is mixed into the "Ice-Cap". This mixture is then 31 removed from the mixer and 0.15 kg. of calcium carbonate is 32 added. The mixture is mixed vigorously by hand, making sure 749.020 ?
,.
1 that the calcium carbonate is uniformly distributed. The 2 mixture it then poured onto teflon-coa~ed cookie sheets to a 3 height of approximately 1/4 inch. The mixture is covered, 4 allowed to cool and kept away from any flounce of moisture.
When solidified the mixture is cut into squares, each weighing S 2.50 gym. Each square contains: 88% or 2.20 gym. of "Ice-cap", 7 10% or 0.25 gym. of aspirin, and 2% or 0.0~0 gym. of calcium 8 carbonate.
9 EXAMPLE ?
A preparation of 50 kg. of the buffered aspirin product is 11 prepared as follows: To a stainless steel jacketed mixing 12 kettle is added 44.0 kg. of "Ice-Cap" base. The "Ice-Cap" is 13 heated slowly at a low mixer speed until it reaches 40-50C.
14 When the "Ice-Cap" is molten, 5.0 kg. of micro encapsulated aspirin (Easily) is added and mixing is continued at a medium 16 mixer speed until the aspirin is completely dispersed. One 17 kilogram of calcium carbonate is then added and the mixing 18 continued until uniformly dispersed.
19 While the preceding mouthed has disclosed spreading the batter mixture on Teflon coated cookie sheets, it is also 21 possible to practice the subject invention by pouring said 22 batter into a mold and allowing the preparation to wool to 23 kiwi The solidifying product should be kept away from 24 moisture but may be allowed to cool in air, preferably at a relative humidity of 50% and at a temperature of 18-21C.
26 When the preparation has cooled it should be removed from the 27 molds and immediately packaged in an airtight container.
28 In this case the told that was used was in the shape of a 29 dog bone, and each molded tablet weighed 2.50 gym. comprised of the same percentage of components as described above.
32 Yale my 749.020 1 ~23~7~
1¦ The preparation from Example 1 was comparatively tested 21 for shell life and decomposition of aspirin to free salicylic 31 acid against an unbuffered aspirin product. The testing was 4 ¦ conducted using standard industry procedure for measuring free 5 ¦ salicylic acid in aspirin products.
6 ¦ The percentage values tabled below wore calculated as
7 I follows:
8 l 1) my. Free Salicylic Academy. sample
9 ¦ (avg. peak area owe the sample) l lava. peak area ox the standard)
10 I amount of standard used (100 l/lo)
11 I sample weight (go) my x
12 ¦ 2) % Free Salicylic Acid
13 ¦ my. Free Salic~lic Academy. sample x 100%
14 ¦ my. Total Salicylate/~m
15 ¦ The results from the test:
16 ¦ Unbuffered Aspirin/ Buffered Aspirin/
¦ "Ice-Cap'` Icecap
¦ "Ice-Cap'` Icecap
17 ¦ Time Tempt % Free % % Free %
¦ Salicylic Aspirin Salicylic Aspirin
¦ Salicylic Aspirin Salicylic Aspirin
18 I Acid Acid
19 ¦ 1 month 370C 1.94 9.60 2.00 9.66 1 2 months 37 C 3.33 3.43
20 l
21 I The data presented shows no significant difference between
22 ¦ the buffered and unbuffered products in the stability profile.
23 ¦ This indicates that the dispersed buffering material is not
24 ¦ accelerating the hydrolysis of the aspirin, and that the I ¦ materials are separate. The unbuffered aspirin product is the 26 ¦ same preparation as described in Example 1 with the exception 27 ¦ that the calcium carbonate was omitted from the mixture.
28 ¦ Although the invention has been described with reference 29 ¦ to specific forms thereof, it will be understood that many 30 ¦ changes and modification may be made without departing from 31 ¦ the spirit of this invention.
l -10-I
28 ¦ Although the invention has been described with reference 29 ¦ to specific forms thereof, it will be understood that many 30 ¦ changes and modification may be made without departing from 31 ¦ the spirit of this invention.
l -10-I
Claims (24)
1. A chewable aspirin bufferin tablet comprising:
a fatty material selected from a class consisting of chocolate, synthetic chocolate and hydroginated tallow, a buffering material, and aspirin wherein said aspirin and buffering materials are individually coated with and integrally dispersed and bound in said fatty material in a tablet form comprised mainly of said fatty material so as to prevent chemical reac-tion therebetween and produce a tablet with an accept-able shelf life.
a fatty material selected from a class consisting of chocolate, synthetic chocolate and hydroginated tallow, a buffering material, and aspirin wherein said aspirin and buffering materials are individually coated with and integrally dispersed and bound in said fatty material in a tablet form comprised mainly of said fatty material so as to prevent chemical reac-tion therebetween and produce a tablet with an accept-able shelf life.
2. A chewable aspirin buffering tablet according to Claim 1 wherein said fatty material is present in an amount up to about 88% by weight of said chewable tablet.
3. A chewable aspirin buffering tablet according to Claim 2 wherein said fatty material contains up to about 40% by weight hydrogenated fats based on the weight of the tablet.
4. A chewable aspirin buffering tablet according to Claim 1 wherein said buffering material is any relatively water-insoluble antacid.
5. A chewable aspirin buffering tablet according to Claim 4 wherein said antacid is comprised of aluminum carbonate, aluminum hydroxide (or as aluminum hydroxide-hexitol stabilized polymer, aluminum hydroxide-magnesium hydroxide codried gel, aluminum hydroxide-magnesium trisilicate codried gel, aluminum hydroxide-sucrose powder hydrated),
5. A chewable aspirin buffering tablet according to Claim 4 wherein said antacid is comprised of aluminum carbonate, aluminum hydroxide (or as aluminum hydroxide-hexitol stabilized polymer, aluminum hydroxide-magnesium hydroxide codried gel, aluminum hydroxide-magnesium trisilicate codried gel, aluminum hydroxide-sucrose powder hydrated),
Claim 5 continued aluminum phosphate, aluminum hydroxy carbonate, dihydroxy aluminum sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, calcium carbonate, calcium phosphate, hydrated magnesium aluminate activated sulfate, magnesium aluminate, magnesium aluminosilicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide and magnesium trisilicate, and mixtures thereof.
6. A chewable aspirin buffering tablet according to Claim 5 wherein said antacid is present in an amount up to 2% by weight of said tablet.
7. A chewable aspirin buffering tablet according to Claim 1 wherein said aspirin is present in powder or granulated form.
8. A chewable aspirin buffering tablet according to Claim 7 wherein said aspirin is micro-encapsulated in a porous but water insoluble material.
9. A chewable aspirin buffering tablet according to Claim 8 wherein said micro-encapsulated material is ethyl cellulose.
10. A chewable aspirin buffering tablet according to Claim 1 wherein said aspirin is present in an amount up to 10%
weight of said tablet.
weight of said tablet.
11. A chewable aspirin buffering tablet according to Claim 1 wherein said tablet is intended for use with animals.
12. A chewable aspirin buffering tablet according to Claim 11 wherein said tablet is intended for use with dogs.
13. A chewable aspirin buffering tablet according to Claim wherein said tablet is molded in the shape of a dog bone~
14. A chewable aspirin buffering table~ comprising:
"Ice-Cap" coating present in an amount of 88~ by weight of the tablet, ethyl cellulose coated micro-encapsulated aspirin present in an amount of 10% by weight of the tablet, and calcium carbonate present in an amount of 2%
by weight of the tablet wherein said aspirin and buffering materials are integrally dispersed and bound in said fatty material.
"Ice-Cap" coating present in an amount of 88~ by weight of the tablet, ethyl cellulose coated micro-encapsulated aspirin present in an amount of 10% by weight of the tablet, and calcium carbonate present in an amount of 2%
by weight of the tablet wherein said aspirin and buffering materials are integrally dispersed and bound in said fatty material.
15. A chewable aspirin buffering tablet according to Claim wherein said tablet is intended for use with animals.
16. A chewable aspirin buffering tablet according to Claim 15 wherein said tablet is intended for use with dogs.
17. A chewable aspirin buffering tablet according to Claim 16 wherein said tablet is molded in the shape of a dog bone.
18. A chewable aspirin tablet comprising: a fatty material present in an amount up to about 88% by weight of said chewable tablet, a buffering material present in an amount up to 2% by weight of said tablet, and aspirin present in an amount up to 10% by weight of said tablet wherein said aspirin and buffering materials are integrally dispersed and bound in said fatty material.
19. A chewable aspirin buffering tablet according to Claim 18 wherein said tablet is intended for use with animals.
20. A chewable aspirin buffering tablet according to Claim 19 wherein said tablet is intended for use with dogs.
21. A chewable aspirin buffering tablet according to Claim 20 wherein said tablet is molded in the shape of a dog bone.
22. A method for producing the chewable tablet as defined in Claim 1 which comprises melting the fatty material, transferring said melt to a mixer, admixing to said melt the aspirin, removing said mixture from the mixer, adding the buffering material to said mixture and stirring vigorously by hand, pouring said mixture onto a sheet and cutting the solidified sheet into unit dosage forms.
23. A method for producing the chewable tablet as defined in Claim 1 which comprises melting the fatty material, transferring said melt to a mixer, admixing to said melt the aspirin, removing said mixture from the mixer, adding the buffering material to said mixture and stirring
23. A method for producing the chewable tablet as defined in Claim 1 which comprises melting the fatty material, transferring said melt to a mixer, admixing to said melt the aspirin, removing said mixture from the mixer, adding the buffering material to said mixture and stirring
Claim 23 continued vigorously by hand, pouring said mixture into a mold and allowing the mixture to cool and solidify into single dosage form.
24. A method for producing the chewable tablet as defined in Claim 23 wherein the mold is in the shape of a miniature dog bone.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US64004284A | 1984-08-10 | 1984-08-10 | |
| US06/640,042 | 1984-08-10 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1234761A true CA1234761A (en) | 1988-04-05 |
Family
ID=24566596
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000470086A Expired CA1234761A (en) | 1984-08-10 | 1984-12-13 | Chewable aspirin and buffering material tablet and method for producing same |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1234761A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1989007439A1 (en) * | 1988-02-16 | 1989-08-24 | Neuvonen Pertti J | Process for regulating the absorption rate of drugs and a pharmaceutical formulation |
-
1984
- 1984-12-13 CA CA000470086A patent/CA1234761A/en not_active Expired
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1989007439A1 (en) * | 1988-02-16 | 1989-08-24 | Neuvonen Pertti J | Process for regulating the absorption rate of drugs and a pharmaceutical formulation |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US4937076A (en) | Chewable aspirin and buffering material tablet and method for producing same | |
| CA1199581A (en) | Compressed chewable tablet and method for forming same | |
| EP0587744B1 (en) | Chewable drug-delivery composition | |
| US4271142A (en) | Portable liquid antacids | |
| US4327076A (en) | Compressed chewable antacid tablet and method for forming same | |
| US5753255A (en) | Chewable molded tablet containing medicinally active substances | |
| US5503846A (en) | Base coated acid particles and effervescent formulation incorporating same | |
| US6340471B1 (en) | Method for preparing solid delivery system for encapsulated and non-encapsulated pharmaceuticals | |
| CA1272134A (en) | Drug delivery system | |
| US3965256A (en) | Slow release pharmaceutical compositions | |
| US4938967A (en) | Pharmaceutical formulations | |
| US3279998A (en) | Method of preparing sustained release tablets | |
| EP1246615B1 (en) | Method for preparing solid delivery system for encapsulated and non-encapsulated pharmaceuticals | |
| JPH10510817A (en) | Chewable preparation | |
| US5525352A (en) | Confectionery delivery system for pharmaceutically active substances | |
| JPH07509479A (en) | Solid drug dosage forms with prolonged two-stage release and their manufacture | |
| KR20040037203A (en) | Edible composition and dosage form comprising an edible shell | |
| JPS6322032A (en) | Gellatin-enclosed slow release composition and manufacture | |
| EP1161941A1 (en) | Quickly disintegrating tablets and process for producing the same | |
| EA000047B1 (en) | Oral formulations of s(+)-etodolac | |
| US7887832B2 (en) | Popping oral pharmaceutical compositions | |
| US5958450A (en) | Method of drug delivery and coated oral dosage forms for use in the method | |
| KR20030047675A (en) | A solid fomulation disintegrable in the mouth and preparing process thereof | |
| CA1234761A (en) | Chewable aspirin and buffering material tablet and method for producing same | |
| JPH0952850A (en) | Gummy preparation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |