US3331696A - Dragee coating composition - Google Patents

Dragee coating composition Download PDF

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Publication number
US3331696A
US3331696A US252275A US25227563A US3331696A US 3331696 A US3331696 A US 3331696A US 252275 A US252275 A US 252275A US 25227563 A US25227563 A US 25227563A US 3331696 A US3331696 A US 3331696A
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United States
Prior art keywords
coating
drages
sugar
suspension
coating composition
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 - Lifetime
Application number
US252275A
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English (en)
Inventor
Rieckmann Peter
Schalk Heinz
Theel Eckhard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from DEB65598A external-priority patent/DE1184459B/de
Application filed by Individual filed Critical Individual
Priority to US331638A priority Critical patent/US3395213A/en
Application granted granted Critical
Publication of US3331696A publication Critical patent/US3331696A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/343—Products for covering, coating, finishing, decorating
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/02—Apparatus specially adapted for manufacture or treatment of sweetmeats or confectionery; Accessories therefor
    • A23G3/20—Apparatus for coating or filling sweetmeats or confectionery
    • A23G3/26—Apparatus for coating by tumbling with a liquid or powder, spraying device-associated, drum, rotating pan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005—Coating of tablets or the like
    • 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
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)

Definitions

  • the present invention relates to a process for the manufacture of drages and to an apparatus therefor. In one aspect it relates to an automatic process for rapidly manufacturing pharmaceutically acceptable drages.
  • Drage represents one of the most wide-spread forms in which drugs are administered, and Y that the administration of drugs in this form is growing in popularity.
  • Drage preparations are characterized by the advantages that they are easy to ingest and eliminate the bad taste which is characteristic of so many drugs.
  • the drage is a particularly important vehicle for use in connection with drugs which are sensitive to light, air, and moisture.
  • special coatings can be applied so that the drage will not dissolve until it reaches the intestines, resulting in excellent tolerability and permitting the oral administration of drugs not possible in the absence of such coatings.
  • the manufacture of drages suitable for commercial utilization involves many diiculties. As heretofore carried out, it is a manual art requiring much practice, skill, and experience.
  • the pill or center coming from the tablet forming machine has first applied thereto where necessary, isolation coatings which act to protect the pharmaceutical substances from external influences.
  • the pill or center is then coated with a sugar syrup of a certain composition and thereafter with mixtures of talc, chalk and like solid fillers. This process has to be repeated several times in order to apply to the pill as quickly as possible sufficient material to produce on the drage edges which are rounded.
  • the surface of the pill so obtained is not smooth and has to be smoothed out in further steps, using therefor both sugar Syrups and powdered sugar.
  • the smoothing step is followed by coloring steps, whereby a uniformly colored drage is achieved only following the application of many coats of colored sugar syrup. Finally the drages are waxed or glazed. Between each of the individual steps in the process, the drages are taken from the coating treatment kettle and dried in large drying machines or ovens so that the moisture necessary in connection with the coating applications cannot penetrate through the covering and damage the drugs forming the center or core.
  • Another object of the invention is to provide a method for the manufacture of drages which are of a purity, surface smoothness, taste, and color which makes their use convenient and inexpensive without any disagreeableness to the patient who has to take repeated doses of the pharmaceutical contained in the drage.
  • Still another object of the invention is to provide a substantially automatic method for the manufacture of drages.
  • Still another object ofthe invention is to provide a rapid method for the manufacture of drages.
  • Still a further object of the invention is to provide an apparatus for the manufacture of drages which are of a purity, surface smoothness, taste, and color suitable for commercial use.
  • Still a further object of the invention is to provide coating suspensions for coating drages, containing polyethylene glycol in addition to sugar and filler materials in aqueous suspension.
  • FIG. 1 is a schematic illustration of one preferred embodiment of the apparatus of the invention
  • FIG. 2 isa schematic illustration of another preferred embodiment of the apparatus of the invention.
  • FIG. 3 is a diagrammatic representation of the wiring of an embodiment of the apparatus shown in FIG. 2,
  • FIG. 4 is a schematic illustration of another preferred embodiment of an apparatus of the invention showing in particular the use of a hand dryer as a source for heated air, and
  • FIG. 5 is a diagrammatic representation of the wiring of the embodiment of FIG. 4.
  • each coating which is applied is a relatively thin coating, is dried immediately and consequently no penetration of moisture into the center during the coating process takes place. Since smooth coatings are formed from the start, the total or over-all coating can also be much thinner than usual.
  • the coatings in accordance with the invention amount to approximately up to 1%. times the weight of the center where formerly the coatings Vamounted to about twice the weight of the center.
  • the coating suspensions of the invention per se are novel and can be produced very simply without heat merely by stirring the components together and homogenizing the resultant suspension, for example in a corundum disk mill or the like;
  • Table l which follows, illustrative examples of a number of coating suspensions according to the present invention are set out. It is possible in accordance with the invention to add coloring material from the start of the process if desi-red, thus achieving a uniform coloration of the drages.
  • the invention makes possible for the first time the possibility in a single operation to applythe coating suspension onto the pill center and to dry the same thereon.
  • the need for handwork is eliminated other than that which is required for adjusting the equipment at the beginning and at the end of the process.
  • the requirement for experienced technicians to carry out the process is eliminated.
  • drying ovens are no longer required whereby the frequent transporting of the drages from the kettle Vto the drying oven and back which represents a serious disadvantage of the coating'processes as conventionally practiced is eliminated.
  • a further considerable advantage ofthe instant process is that the time required for production of a batch of drages amounts to only about one day.
  • Example 1 8 kilograms of drage centers of 6 mm. diameter (weight of centers 8O mg., number of centers 100,000) are introduced into a kettle having a 60 cm. diameter provided with a powerful exhaust system.
  • the spraying system is adjusted so that about ml., of the coating suspension are sprayed onto the centers within a period of 25 seconds in each of the coating steps.
  • the centers are circulated, i.e. rotated for 1.5 minutes following the spraying without any external interference so that thek suspension can be uniformly distributed on the surface of the drages.
  • the batch is then dried with a current of -hot air for 2 minutes. These three steps are repeated until 8.5 kg. of suspension Vhave been applied.
  • the coating suspension employed is-one in accordance with the invention containing polyethylene glycol in addition to sugar and solid llers.
  • the drages which have had smooth coatings Vfrom the 4start of the procedure are now Vready for Waxing.
  • the total production time ⁇ amounts to aboutYV 6.5 to 7 hours and no supervision of any kind is required in this period.
  • the drages After the coating has been completed, the drages have a weight of Ing.V
  • the coating dissolves in the Erweka disintegration tester in about 4 minutes which is comparable with a very good candy coating as formed by the process as used hitherto.
  • Example 2-5 The process of Example 1 was repeated, the data and results of these coating operations as carried out in accordance with the process of the invention are set out in Table 2 which follows:
  • the apparatus according to the invention which is particularly suitable for carrying out the fully automatic coating process consists of three separate systems:
  • a spray gun 13 such as is conventionally used for spray painting is used for spraying the coating suspension.
  • the advantage of using a spray gun of this type is based on the fact that it is provided with a proportioning valve so that different amounts of coating suspension can be applied at a constant time setting.
  • a possible disadvantage, however, is that compressed air is required to be used therewith resulting in the formation of mists which are removed from the system through an exhaust line and representing suspension not deposited on the drages.
  • FIG. 3 The wiring diagram showing the relationship of the timer mechanisms 17 to the remaining apparatus of FIG. 2 is shown in FIG. 3.
  • the coating suspension maintained under pressure in vessel 21 is either fed to the spray nozzle 25 or is carried back through an over-pressure valve 26 into the supply vessel 21.
  • the coating suspension of the invention generally is not inclined to settle out, it has nevertheless proven advantageous to avoid any possible formation of sediment by agitating the suspension. Under the circulation produced by the gear pump, of course, no other agitating system is required.
  • the electrical control of the spray gun is carried out by means of a solenoid 23 which actuates the trigger resulting in spraying. If a. gear pump and spray nozzle are used, the control is carried out by means of commercially available magnetic three-way valves.
  • a hair dryer as shown in the embodiment of FIGS. 2 and 3, for example, can be used as a hot air source for small kettles. Even for large kettles, the output of a standard hand dryer is adequate (see FIGS. 4 and 5 Of course, any other hot air source can be used for drying as long as it provides the assurance that the temperature and rate of ow of the air are constant.
  • the timing regulation for the apparatus described above is carried out in a known manner utilizing the conventionally available electrical timers. These contain, for example, revolving cams which open and close the necessary contacts. It has proven advantageous, however, to be able to adjust accurately the spraying time, the inactive period, and the drying time, and this is done by means of three-time switching mechanisms. When separate switching mechanisms are used, the running time can be adjusted during operation which is not directly possible in the case of cam-operated timers.
  • the apparatus described above can, if desired, be combined into a very practical readily movable unit as has been shown in FIG. 1.
  • the apparatus is connected With single-phase or three-phase current source by means of a single cable. If the hot air unit is not built in, a control line is required for the hot air in-feed.
  • carbowax designates the trade name of a gnoup of non-volatile, solid, polyethylene glycols, soluble in both water and aromatic hydrocarbons and which are manufactured by Carbide and Carbon Chemical Company, a Division of Union Carbide and Carbon Corporation of New York City, New York.
  • Carbowaxes are supplied in various grades, the grades being designated by numerals as shown in the specification. Increasing grade numbers indicate increasing molecular weights.
  • the drying of the drages is effected by means of hot air of -120 C., preferably.
  • the drying may be effected also at lower temperatures, whereby the duration of that step will last longer, naturally.
  • the time ranges for each of the steps of the coating process according to the present invention depend on the size of the kettle as well as that of the drage centers, of the humidity of the atmosphere and the like conditions.
  • the ⁇ spraying step has a duration of 5-50 sec., the pause 10-100 sec. and the drying step 50-200 sec.
  • the apparatus for effecting the manufacture of the drage according to the present invention is composed of a number of parts known per se. However, as special 7 arrangement of those components-as shown in the accompanying drawings-is necessary to guarantee an absolutely perfect coating process. Y
  • a drage coating composition for coating pill centers consisting essentially of an aqueous sugar solution containing 40-50 weight percent of sugar, 1-10 weight percent of polyethylene glycol and 10-20 weight percent of an inert solid ller wherein said solid filler is a member selected from the group consisting of starch, gurnarabic, chalk, Vkaolin, talc, titanium oxide, alkaline metal phosphates and mixtures thereof.
  • said solid filler is a member selected from the group consisting of starch, gurnarabic, chalk, Vkaolin, talc, titanium oxide, alkaline metal phosphates and mixtures thereof.
  • a coating composition according to claim 1 additionally containing a colorant.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Preparation (AREA)
  • Paints Or Removers (AREA)
  • Electrostatic Spraying Apparatus (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Application Of Or Painting With Fluid Materials (AREA)
US252275A 1962-01-20 1963-01-16 Dragee coating composition Expired - Lifetime US3331696A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US331638A US3395213A (en) 1963-01-16 1963-12-05 Sugar- and polyethylene glycol-coated dragees, nonsticking together, or to dragee-making kettles

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEB65598A DE1184459B (de) 1962-01-20 1962-01-20 Dragierverfahren
DEB75309A DE1247547B (de) 1962-01-20 1962-01-20 Dragiervorrichtung

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US3331696A true US3331696A (en) 1967-07-18

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US252275A Expired - Lifetime US3331696A (en) 1962-01-20 1963-01-16 Dragee coating composition
US605648A Expired - Lifetime US3381659A (en) 1962-01-20 1966-12-29 Dragee preparation and apparatus therefor

Family Applications After (1)

Application Number Title Priority Date Filing Date
US605648A Expired - Lifetime US3381659A (en) 1962-01-20 1966-12-29 Dragee preparation and apparatus therefor

Country Status (9)

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US (2) US3331696A (zh)
BE (1) BE627268A (zh)
CH (1) CH441624A (zh)
DE (1) DE1247547B (zh)
FI (1) FI40403B (zh)
GB (3) GB968442A (zh)
LU (1) LU43021A1 (zh)
NL (3) NL134927C (zh)
SE (1) SE325996B (zh)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3420931A (en) * 1964-04-23 1969-01-07 Merck Ag E Pharmaceutical dragee
US3456050A (en) * 1965-01-13 1969-07-15 Boehringer & Soehne Gmbh Dragee preparation
US3480468A (en) * 1965-02-12 1969-11-25 Farmaceutici Italia Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating
US3511914A (en) * 1967-01-31 1970-05-12 Schering Corp Throat lozenge vehicle
US5286748A (en) * 1981-01-05 1994-02-15 Eby Iii George A General method of shortening the duration of common colds by application of medicaments to tissues of oral cavity
US20020044970A1 (en) * 2000-08-31 2002-04-18 Toshio Takeuchi Monolayer sugar-coated tablet and process for preparation thereof

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3658030A (en) * 1968-06-21 1972-04-25 Schaper & Brummer Kg Apparatus for coating discrete articles
FR2574659B1 (fr) * 1984-12-19 1987-01-02 Boiron Lab Sa Chaine de fabrication pour des medicaments homeopathiques, notamment pour l'impregnation des granules ou globules
JPS63199801A (ja) * 1987-02-12 1988-08-18 Chisso Corp 強磁性金属粉末の安定化処理装置
US5288500A (en) * 1987-03-13 1994-02-22 Benzon Pharma A/S Oral composition containing particles comprising an active substance
DK130287D0 (da) * 1987-03-13 1987-03-13 Benzon As Alfred Oralt praeparat
US5397054A (en) * 1992-08-26 1995-03-14 Dolmar Gmbh Pressure jet cleaning appliance

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US632014A (en) * 1899-03-09 1899-08-29 Simon Hackelberg Composition for protecting panes of glass.
US751981A (en) * 1904-02-09 Process of preserving wood
US2217020A (en) * 1938-04-01 1940-10-08 Peters Mach Co Depositing machine
US2472650A (en) * 1947-04-11 1949-06-07 Harvey P Curlee Confection making machine
US2540253A (en) * 1949-02-08 1951-02-06 Merck & Co Inc Granulation process
US2991226A (en) * 1958-02-03 1961-07-04 Frosst & Co Charles E Long-acting wax-like talc pillage of penicillin
US3030273A (en) * 1959-09-02 1962-04-17 Abbott Lab Plastic tablet coating
US3073748A (en) * 1960-11-28 1963-01-15 Tanabe Seiyaku Co Coated medicaments

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2551329A (en) * 1946-08-15 1951-05-01 Technicolor Motion Picture Film treating apparatus
LU31452A1 (zh) * 1951-05-29
US2652805A (en) * 1951-06-26 1953-09-22 Smith Kline French Lab Apparatus for coating tablets, pills, or other small objects
US2810606A (en) * 1956-08-30 1957-10-22 Herbert S Taylor Liquid fertilizer calibrating device
US3101040A (en) * 1957-07-15 1963-08-20 Ralston Purina Co Apparatus for manufacturing stable pelleted foods
US3095326A (en) * 1960-02-19 1963-06-25 Gen Foods Corp Batch-type apparatus for tumble coating discrete particles
NL282752A (zh) * 1961-09-10

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US751981A (en) * 1904-02-09 Process of preserving wood
US632014A (en) * 1899-03-09 1899-08-29 Simon Hackelberg Composition for protecting panes of glass.
US2217020A (en) * 1938-04-01 1940-10-08 Peters Mach Co Depositing machine
US2472650A (en) * 1947-04-11 1949-06-07 Harvey P Curlee Confection making machine
US2540253A (en) * 1949-02-08 1951-02-06 Merck & Co Inc Granulation process
US2991226A (en) * 1958-02-03 1961-07-04 Frosst & Co Charles E Long-acting wax-like talc pillage of penicillin
US3030273A (en) * 1959-09-02 1962-04-17 Abbott Lab Plastic tablet coating
US3073748A (en) * 1960-11-28 1963-01-15 Tanabe Seiyaku Co Coated medicaments

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3420931A (en) * 1964-04-23 1969-01-07 Merck Ag E Pharmaceutical dragee
US3456050A (en) * 1965-01-13 1969-07-15 Boehringer & Soehne Gmbh Dragee preparation
US3480468A (en) * 1965-02-12 1969-11-25 Farmaceutici Italia Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating
US3511914A (en) * 1967-01-31 1970-05-12 Schering Corp Throat lozenge vehicle
US5286748A (en) * 1981-01-05 1994-02-15 Eby Iii George A General method of shortening the duration of common colds by application of medicaments to tissues of oral cavity
US20020044970A1 (en) * 2000-08-31 2002-04-18 Toshio Takeuchi Monolayer sugar-coated tablet and process for preparation thereof
US6994872B2 (en) * 2000-08-31 2006-02-07 Teikoku Hormone Mfg. Co., Ltd. Monolayer sugar-coated tablet and process for preparation thereof

Also Published As

Publication number Publication date
DE1247547B (de) 1967-08-17
GB968441A (en) 1964-09-02
CH441624A (de) 1967-08-15
GB968442A (en) 1964-09-02
FI40403B (zh) 1968-09-30
SE325996B (zh) 1970-07-13
NL6617044A (zh) 1967-09-25
NL287846A (zh)
NL121874C (zh)
GB968443A (en) 1964-09-02
NL134927C (zh) 1967-09-25
LU43021A1 (zh) 1963-03-15
US3381659A (en) 1968-05-07
BE627268A (zh)

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