DE2614020C2 - Method for isolating pellets - Google Patents
Method for isolating pelletsInfo
- Publication number
- DE2614020C2 DE2614020C2 DE19762614020 DE2614020A DE2614020C2 DE 2614020 C2 DE2614020 C2 DE 2614020C2 DE 19762614020 DE19762614020 DE 19762614020 DE 2614020 A DE2614020 A DE 2614020A DE 2614020 C2 DE2614020 C2 DE 2614020C2
- Authority
- DE
- Germany
- Prior art keywords
- compacts
- isolating
- pellets
- coating
- coated tablets
- 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
- 238000000034 method Methods 0.000 title claims description 4
- 239000008188 pellet Substances 0.000 title description 3
- 238000000576 coating method Methods 0.000 claims description 9
- 239000002904 solvent Substances 0.000 claims description 4
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 6
- 239000011248 coating agent Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 229960005070 ascorbic acid Drugs 0.000 description 3
- 235000010323 ascorbic acid Nutrition 0.000 description 3
- 239000011668 ascorbic acid Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 239000001993 wax Substances 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 239000004359 castor oil Substances 0.000 description 2
- 235000019438 castor oil Nutrition 0.000 description 2
- 229940099371 diacetylated monoglycerides Drugs 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- DSEKYWAQQVUQTP-XEWMWGOFSA-N (2r,4r,4as,6as,6as,6br,8ar,12ar,14as,14bs)-2-hydroxy-4,4a,6a,6b,8a,11,11,14a-octamethyl-2,4,5,6,6a,7,8,9,10,12,12a,13,14,14b-tetradecahydro-1h-picen-3-one Chemical compound C([C@H]1[C@]2(C)CC[C@@]34C)C(C)(C)CC[C@]1(C)CC[C@]2(C)[C@H]4CC[C@@]1(C)[C@H]3C[C@@H](O)C(=O)[C@@H]1C DSEKYWAQQVUQTP-XEWMWGOFSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 239000004166 Lanolin Substances 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- 229930006000 Sucrose Natural products 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
- 238000003915 air pollution Methods 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 239000004922 lacquer Substances 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 235000019388 lanolin Nutrition 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
Classifications
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Fodder In General (AREA)
Description
Es ist bekannt, Preßlinge ζ. Β. für Arzneimittel durch Überziehen mit polymeren Substanzen wie Schellack gegen Feuchtigkeit zu schützen [vgl. W. A. Ritschel: Die Tablette, Editor Cantor KG, Aulendorf (1966) Seite 365].It is known to ζ pellets. Β. for drugs by coating with polymeric substances such as shellac to protect against moisture [cf. W. A. Ritschel: Die Tablette, Editor Cantor KG, Aulendorf (1966) page 365].
Diese polymeren Substanzen werden in Wasser oder Organischen Lösungsmitteln auf die Preßlinge aufgetragen. Die Verwendung von Wasser als Lösungsmittel ist yedoch in den meisten Fällen nicht möglich, weil ^entweder die Preßlinge zu leicht wasserlöslich sind oder :_das Wasser nur unter Bedingungen entfernt werden ikann, unter denen sich die Preßlinge verändern. Auch die Verwendung organischer Lösungsmittel bringt Nachteile mit sich, da zur Vermeidung toxischer Rückstände in der Arzneizubereitung häufig eine thermische Nachbehandlung der Überzüge erforderlich ist und weil durch das Entfernen der organischen Lösungsmittel mit der Abluft eine Luftverschmutzung eintritt, die — besonders in dicht besiedelten Gebieten — zu einer Beschränkung auf geringe Produktionsmengen führen kann. Die Brennbarkeit und Toxizität der Lösungsmittel erfordert zudem eine Reihe kostspieliger Vorsichtsmaßnahmen zum Schutz des Personals und der Produktionsanlagen.These polymeric substances are applied to the compacts in water or organic solvents. However, in most cases it is not possible to use water as a solvent, because ^ either the compacts are too easily soluble in water or: _the water can only be removed under certain conditions ikann, under which the compacts change. The use of organic solvents also brings Disadvantages with it, since to avoid toxic residues in the drug preparation often a thermal post-treatment of the coatings is required and because of the removal of the organic Solvents with the exhaust air an air pollution occurs, which - especially in densely populated areas - can lead to a restriction to small production quantities. The flammability and toxicity of the Solvents also require a number of costly precautions to protect personnel and the Production facilities.
Der Erfindung liegt die Aufgabe zugrunde, Preßlinge so gegen Feuchtigkeit zu isolieren, daß diese Nachteile nicht auftreten.The invention is based on the object of isolating compacts from moisture in such a way that these disadvantages do not occur.
Diese Aufgabe wird erfindungsgemäß dadurch gelöst, daß man die Preßlinge zuerst direkt und ohne
Verwendung eines Lösungsmittels mit einer Schicht aus Wachs und einem öligen Medium überzieht und
anschließend die weiteren Überzüge in bekannter Weise aufbringt.
Das Überziehen der Preßlinge mit dem Wachs und dem öligen Medium kann in den üblichen Einrichtungen
zum Überziehen von Preßlingen, z. B. Dragierkesseln, in bekannter Weise erfolgen.According to the invention, this object is achieved by first coating the compacts directly and without the use of a solvent with a layer of wax and an oily medium and then applying the further coatings in a known manner.
The coating of the compacts with the wax and the oily medium can be carried out in the usual devices for coating compacts, e.g. B. coating pans, carried out in a known manner.
Als Wachse [vgl. Römpp: Chemie-Lexikon, 6. Aufl. (1966) Seite 7042 f] kommen insbesondere Ceresin,As waxes [cf. Römpp: Chemie-Lexikon, 6th edition (1966) page 7042 f] come in particular ceresin,
ίο Wollwachs, Paraffine, hydriertes Rizinusöl in Frage.ίο wool wax, paraffins, hydrogenated castor oil in question.
Geeignete ölige Medien sind z.B. natürliche oderSuitable oily media are, for example, natural or
synthetische öle wie acetylierte Monoglyceride und flüssige Gemische aus gesättigten Triglyceriden.synthetic oils such as acetylated monoglycerides and liquid mixtures of saturated triglycerides.
Überzogene Tabletten, die aus den nach dem neuenCoated tablets from the after the new
Verfahren isolierten Preßlingen hergestellt sind, zeigen eine sehr gute Widerstandsfähigkeit gegen Feuchtigkeit. Ein besonderer Vorteil des neuen Verfahrens besieht darin, daß die übrigen galenischen Eigenschaften (Härte, Zerfallzeit u.a.) der überzogenen Tabletten praktischProcess insulated compacts are produced, show a very good resistance to moisture. A particular advantage of the new process is that the other galenic properties (hardness, Disintegration time, etc.) of the coated tablets is practical
■io' nicht verändert werden. ■ io ' cannot be changed.
9800 Ascorbinsäure-Preßlinge, bestehend aus je ; !50 mg Ascorbinsäure, 200 mg Lactose, 5 mg Maisstärke $5 ,und 1,25 mg Magnesiumstearat, werden in einem Dragierkessel mit 50 g einer Mischung aus durch Destillation gereinigten acetylierten Monoglyceriden besprüht und mit 2,5 g fein gepulvertem hydriertem Rizinusöl bestreut. Anschließend läßt man den Kessel jo mit den Preßlingen 5 Minuten rotieren. Danach werden ' die Kerne mit einer Suspension aus 1,0% Carboxymethylcellulose, 1,0% Polyvinylpyrrolidon, 50,0% Sacccharose, 1,0% fein disperse Kieselsäure, 6.8% Talkum, 2,5% Calciumcarbonat, 2,0% Gummi Arabikum, 6,0% Farblack und 29,7% Wasser überzogen.9800 ascorbic acid pellets, each consisting of; ! 50 mg of ascorbic acid, 200 mg of lactose, 5 mg of corn starch $ 5, and 1.25 mg of magnesium stearate are sprayed in a coating pan with 50 g of a mixture of acetylated monoglycerides purified by distillation and sprinkled with 2.5 g of finely powdered hydrogenated castor oil. The kettle is then allowed to rotate with the compacts for 5 minutes. Then 'the cores with a suspension of 1.0% carboxymethyl cellulose, 1.0% polyvinylpyrrolidone, 50.0% sucrose, 1.0% finely dispersed silica, 6.8% talc, 2.5% calcium carbonate, 2.0% rubber Arabica, 6.0% colored lacquer and 29.7% water coated.
Die gemäß dem Beispiel erhaltenen Dragees wurden mit solchen gleicher Zusammensetzung, jedoch ohne Isolierschicht, verglichen. Nach einer Lagerzeit von 4 Wochen bei 400C betrug der Ascorbinsäuregehalt in den erfindungsgemäß überzogenen Dragees 99,3%, während er bei den anderen auf 93,2% abgesunken war. Die Zerfallzeit im Magensaft blieb bei den zuerst genannten Dragees konstant bei 2—3 Minuten, während sie bei den anderen auf 4—6 Minuten zunahm.The coated tablets obtained according to the example were compared with those of the same composition, but without an insulating layer. After a storage time of 4 weeks at 40 ° C., the ascorbic acid content in the coated tablets according to the invention was 99.3%, while in the others it had dropped to 93.2%. The disintegration time in the gastric juice remained constant at 2-3 minutes in the case of the first-mentioned coated tablets, while in the case of the others it increased to 4-6 minutes.
Claims (1)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19762614020 DE2614020C2 (en) | 1976-04-01 | 1976-04-01 | Method for isolating pellets |
| JP3658977A JPS52143219A (en) | 1976-04-01 | 1977-03-31 | Prepara tion of tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19762614020 DE2614020C2 (en) | 1976-04-01 | 1976-04-01 | Method for isolating pellets |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE2614020A1 DE2614020A1 (en) | 1977-10-20 |
| DE2614020C2 true DE2614020C2 (en) | 1984-01-26 |
Family
ID=5974160
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE19762614020 Expired DE2614020C2 (en) | 1976-04-01 | 1976-04-01 | Method for isolating pellets |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JPS52143219A (en) |
| DE (1) | DE2614020C2 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61242633A (en) * | 1985-04-18 | 1986-10-28 | Nippon Sanso Kk | Surface processing method for retarding reaction or dissolution for water of material allowing to react with water or dissolving in water |
| AU2083595A (en) * | 1994-04-06 | 1995-10-30 | Takeda Chemical Industries Ltd. | Solid vitamin c preparation and a method of producing the same |
| US6660302B1 (en) * | 2000-09-06 | 2003-12-09 | Chr. Hansen, Inc. | Dry-powder film coating composition and method of preparation |
| GB2407498B (en) * | 2003-10-30 | 2008-06-11 | Cipla Ltd | Oral formulations for 5-HT receptor agonists with reduced degradation of active ingredient |
-
1976
- 1976-04-01 DE DE19762614020 patent/DE2614020C2/en not_active Expired
-
1977
- 1977-03-31 JP JP3658977A patent/JPS52143219A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| NICHTS-ERMITTELT |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS52143219A (en) | 1977-11-29 |
| DE2614020A1 (en) | 1977-10-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8110 | Request for examination paragraph 44 | ||
| D2 | Grant after examination | ||
| 8364 | No opposition during term of opposition | ||
| 8339 | Ceased/non-payment of the annual fee |