CA1157776A - Directly compressible acetaminophen granulation - Google Patents
Directly compressible acetaminophen granulationInfo
- Publication number
- CA1157776A CA1157776A CA000392780A CA392780A CA1157776A CA 1157776 A CA1157776 A CA 1157776A CA 000392780 A CA000392780 A CA 000392780A CA 392780 A CA392780 A CA 392780A CA 1157776 A CA1157776 A CA 1157776A
- Authority
- CA
- Canada
- Prior art keywords
- acetaminophen
- granulation
- weight
- lubricant
- nacmc
- 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
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 100
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 50
- 238000005469 granulation Methods 0.000 title claims abstract description 36
- 230000003179 granulation Effects 0.000 title claims abstract description 36
- 238000000034 method Methods 0.000 claims abstract description 35
- 239000000835 fiber Substances 0.000 claims abstract description 11
- 230000000202 analgesic effect Effects 0.000 claims abstract description 7
- 239000000314 lubricant Substances 0.000 claims description 11
- 239000011230 binding agent Substances 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 8
- 229920002472 Starch Polymers 0.000 claims description 7
- 235000021355 Stearic acid Nutrition 0.000 claims description 7
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 7
- 239000008107 starch Substances 0.000 claims description 7
- 235000019698 starch Nutrition 0.000 claims description 7
- 239000008117 stearic acid Substances 0.000 claims description 7
- 229920000881 Modified starch Polymers 0.000 claims description 5
- 239000006185 dispersion Substances 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000005243 fluidization Methods 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 15
- 238000007907 direct compression Methods 0.000 abstract description 11
- 238000004519 manufacturing process Methods 0.000 abstract description 6
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 abstract description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract description 2
- RGPDEAGGEXEMMM-UHFFFAOYSA-N Nefopam Chemical compound C12=CC=CC=C2CN(C)CCOC1C1=CC=CC=C1 RGPDEAGGEXEMMM-UHFFFAOYSA-N 0.000 abstract 1
- 239000000203 mixture Substances 0.000 description 21
- 229960001138 acetylsalicylic acid Drugs 0.000 description 14
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 13
- 238000009472 formulation Methods 0.000 description 10
- 239000000843 powder Substances 0.000 description 8
- 239000013078 crystal Substances 0.000 description 7
- 229940032147 starch Drugs 0.000 description 6
- 239000004615 ingredient Substances 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000005550 wet granulation Methods 0.000 description 3
- 229920002261 Corn starch Polymers 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 238000013019 agitation Methods 0.000 description 2
- 238000005056 compaction Methods 0.000 description 2
- 239000008120 corn starch Substances 0.000 description 2
- 229940099112 cornstarch Drugs 0.000 description 2
- 239000007884 disintegrant Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 238000007781 pre-processing Methods 0.000 description 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 2
- 229940001584 sodium metabisulfite Drugs 0.000 description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 229920002522 Wood fibre Polymers 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 229910052783 alkali metal Inorganic materials 0.000 description 1
- -1 alkali metal salts Chemical class 0.000 description 1
- 150000008051 alkyl sulfates Chemical class 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000009725 powder blending Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 238000009491 slugging Methods 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 150000003871 sulfonates Chemical class 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 239000002025 wood fiber Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pain & Pain Management (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US21929080A | 1980-12-22 | 1980-12-22 | |
| US219,290 | 1988-07-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1157776A true CA1157776A (en) | 1983-11-29 |
Family
ID=22818680
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000392780A Expired CA1157776A (en) | 1980-12-22 | 1981-12-21 | Directly compressible acetaminophen granulation |
Country Status (10)
| Country | Link |
|---|---|
| JP (1) | JPS57130913A (is") |
| AR (1) | AR226763A1 (is") |
| AU (1) | AU545475B2 (is") |
| BE (1) | BE891557A (is") |
| CA (1) | CA1157776A (is") |
| DE (1) | DE3150557A1 (is") |
| FR (1) | FR2496461B1 (is") |
| GB (1) | GB2090739B (is") |
| MY (1) | MY8600144A (is") |
| PH (1) | PH18488A (is") |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4600579A (en) * | 1983-06-07 | 1986-07-15 | Mallinckrodt, Inc. | N-acetyl-p-aminophenol compositions containing partially gelatinized starch and method for preparing same |
| US4661521A (en) * | 1984-04-30 | 1987-04-28 | Mallinckrodt, Inc. | Direct tableting acetaminophen compositions |
| JPS61145111A (ja) * | 1984-12-20 | 1986-07-02 | Lion Corp | アセトアミノフェン含有錠剤の製造方法 |
| US4757090A (en) * | 1986-07-14 | 1988-07-12 | Mallinckrodt, Inc. | Direct tableting acetaminophen compositions |
| DE3636209A1 (de) * | 1986-10-24 | 1988-04-28 | Lentia Gmbh | Verfahren zur herstellung eines bindemittelfreien tablettierfaehigen celiprololhydrochlorid-granulates |
| IE61676B1 (en) * | 1987-07-08 | 1994-11-30 | American Home Prod | Spray dried ibuprofen composition |
| JP2804048B2 (ja) * | 1987-09-11 | 1998-09-24 | イー・アール・スクイブ・アンド・サンズ・インコーポレイテッド | 高薬物含量医薬組成物およびその製造法 |
| FR2638971B1 (fr) * | 1988-11-15 | 1993-01-08 | Vacher Dominique | Comprime a delitement et/ou dissolution instantane |
| FR2672212B1 (fr) * | 1991-02-04 | 1993-05-28 | Lille Ii Universite | Cristaux de paracetamol pour compression directe, procede de preparation de ces cristaux et comprime obtenu avec ces cristaux. |
| JPH0656659A (ja) * | 1992-06-10 | 1994-03-01 | Natl Sci Council | 直接打錠できる薬学組成物及びその錠剤の製造法 |
| DE4327462A1 (de) * | 1993-08-16 | 1995-02-23 | Carl Heinrich Dr Weischer | Neue N-Acetyl-p-Aminophenol-Derivate zur Bekämpfung von Schmerzzuständen |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1390032A (en) * | 1971-08-27 | 1975-04-09 | Sterling Winthrop Group Ltd | Pharmaceutical compositions |
| JPS535725B2 (is") * | 1973-03-05 | 1978-03-01 | ||
| US3873694A (en) * | 1973-09-27 | 1975-03-25 | Cpc International Inc | Direct compression tabletting composition and pharmaceutical tablets produced therefrom |
| US4097606A (en) * | 1975-10-08 | 1978-06-27 | Bristol-Myers Company | APAP Tablet containing an alkali metal carboxymethylated starch and processes for manufacturing same |
| JPS5344618A (en) * | 1976-10-04 | 1978-04-21 | Takeda Chem Ind Ltd | Preparation of tablet |
| DE2713197A1 (de) * | 1977-03-25 | 1978-10-05 | Bayer Ag | Neues paracetamol-granulat |
-
1981
- 1981-12-18 AR AR287856A patent/AR226763A1/es active
- 1981-12-21 GB GB8138417A patent/GB2090739B/en not_active Expired
- 1981-12-21 JP JP56206798A patent/JPS57130913A/ja active Granted
- 1981-12-21 PH PH26660A patent/PH18488A/en unknown
- 1981-12-21 CA CA000392780A patent/CA1157776A/en not_active Expired
- 1981-12-21 FR FR8123864A patent/FR2496461B1/fr not_active Expired
- 1981-12-21 DE DE19813150557 patent/DE3150557A1/de active Granted
- 1981-12-21 BE BE0/206891A patent/BE891557A/fr not_active IP Right Cessation
- 1981-12-21 AU AU78720/81A patent/AU545475B2/en not_active Expired
-
1986
- 1986-12-30 MY MY144/86A patent/MY8600144A/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GB2090739B (en) | 1984-09-19 |
| AR226763A1 (es) | 1982-08-13 |
| GB2090739A (en) | 1982-07-21 |
| JPS57130913A (en) | 1982-08-13 |
| BE891557A (fr) | 1982-06-21 |
| JPH044297B2 (is") | 1992-01-27 |
| AU7872081A (en) | 1982-07-01 |
| DE3150557A1 (de) | 1982-09-02 |
| FR2496461A1 (fr) | 1982-06-25 |
| MY8600144A (en) | 1986-12-31 |
| DE3150557C2 (is") | 1991-10-02 |
| AU545475B2 (en) | 1985-07-18 |
| FR2496461B1 (fr) | 1985-07-12 |
| PH18488A (en) | 1985-08-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry | ||
| MKEX | Expiry |
Effective date: 20001129 |