US3256111A - Method for coating tablets - Google Patents
Method for coating tablets Download PDFInfo
- Publication number
- US3256111A US3256111A US416101A US41610164A US3256111A US 3256111 A US3256111 A US 3256111A US 416101 A US416101 A US 416101A US 41610164 A US41610164 A US 41610164A US 3256111 A US3256111 A US 3256111A
- Authority
- US
- United States
- Prior art keywords
- coating
- tablets
- air
- hydroxypropylmethylcellulose
- gloss
- 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
Links
- 238000000576 coating method Methods 0.000 title claims description 51
- 239000011248 coating agent Substances 0.000 title claims description 45
- 238000000034 method Methods 0.000 title claims description 25
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 13
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 13
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 13
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 13
- 239000008199 coating composition Substances 0.000 claims description 12
- 239000012530 fluid Substances 0.000 claims description 8
- 239000002904 solvent Substances 0.000 claims description 7
- 238000009835 boiling Methods 0.000 claims description 6
- -1 2-HYDROXYPROPOXYL GROUPS Chemical group 0.000 claims description 5
- 239000011253 protective coating Substances 0.000 claims description 4
- 230000001681 protective effect Effects 0.000 claims description 4
- 238000005243 fluidization Methods 0.000 claims description 2
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 12
- 239000000203 mixture Substances 0.000 description 7
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 6
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 239000000725 suspension Substances 0.000 description 6
- 238000009492 tablet coating Methods 0.000 description 5
- 239000002700 tablet coating Substances 0.000 description 5
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 4
- 238000009501 film coating Methods 0.000 description 3
- 239000007888 film coating Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 239000003125 aqueous solvent Substances 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- CBOQJANXLMLOSS-UHFFFAOYSA-N ethyl vanillin Chemical compound CCOC1=CC(C=O)=CC=C1O CBOQJANXLMLOSS-UHFFFAOYSA-N 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 238000009495 sugar coating Methods 0.000 description 2
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 1
- 241000136406 Comones Species 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 230000002939 deleterious effect Effects 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 229940073505 ethyl vanillin Drugs 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 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 1
- 239000000463 material Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 239000013557 residual solvent Substances 0.000 description 1
- 229940085605 saccharin sodium Drugs 0.000 description 1
- 239000011877 solvent mixture Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005303 weighing Methods 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- 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
- A61K9/2893—Tablet coating processes
Definitions
- This invention relates to tablet coatings and to a method of obtaining a pharmaceutically-elegent tablet. More particularly, this invention relates to the glosscoating 'or shining of a previously-coated pharmaceutical tablet.
- the tablet-coating art has recently become aware of the advantages of employing the air-coating method for applying coating solutions to tablets. Among the many advantages is the elimination of the familiar coating pans and drying ovens, not to overlook the time-saving element.
- An example of such a method for air-coating tablets is described in U.S. 2,648,609.
- Another technique for applying a coating solution by the air-coating method is described in co-pending application Serial No. 11,364, now US. Patent 3,112,220, of which applicant is a joint inventor.
- a coating should have a glossy finish in order to have a pleasing appearance.
- the finished tablets are shiny due to the bufiing action which is exerted onthe table-ts by tumbling in the pan.
- an aircoating method is employed, the tablets receive no buffing action and consequently the finish on the tablet is dull and unattractive. This is true whether a plastic film-coating as described in US. 2,881,085, or a standard sugar coating, is applied to the tablets. Further, whether the tablets are coated with certain plastic films or a sugar coating, and Whether the coating is applied in the pan or by the air coating method, these coatings may be sensitive to high temperatures and humidity upon storage, and become tacky.
- a protective coating to previouslycoated tablets comprising formulating a fluid coating composition consisting essentially of hydroxypropylmethylcellulose containing 5-15 by weight of 2-hydroxypropoxyl groups and 2732% by weight of methoxyl groups and a low-boiling, non-aqueous solvent for said hydroxypropylmethylcellulose, and directing a mixture of warm air and said coating composition upwardly through a bed of said tablets to cause fiuidization of said tablets, for a period of at least minutes.
- the above method of applying the protective coating or gloss coating comprises the newer air application method wherein the bed of tablets is maintained in fluidized form and the coating composition is introduced in the form of a spray.
- the method comprises the forming of a columnar bed of tablets to be coated wherein the bed is preferably greater in height than it is in the horizontal cross-sectional dimension.
- An air stream is directed upwardly through a portion of this bed with sufficient force to move the tablets in that portion upwardly, thus forming a fluidized spout of tablets.
- the spout extends above the top of the bed with the tablets falling therefrom back onto the top of the bed.
- the tablets move downwardly.
- the cellulose coating material is atomized and introduced into the upwardly moving stream of air.
- the atomized cellulose fluid is deposited on the tablets in the upwardly moving spout with the deposited liquid being dried by the air.
- the temperature of this air is preferably between 30 and C. to provide for fast evaporation of the low-boiling solvent used in the coating composition
- the low-boiling non-aqueous solvent referred to above is preferably a solvent or solvent mixture which has a boiling point below about 80 C., e.g. ethanol, methanol, methylene chloride, chloroform, benzene, ethyl acetate, and mixtures thereof.
- the coating solution should contain between 10 and 50 grams of the hydroxypropyhnethylcellulose per liter, amount of fluid coating solution employed should be between 0.1 and 0.5 liter per kilogram of tablets.
- Typical coated tablets A batch of 3 kg. of vitamin tablets weighing an average of 0.603 gram is placed in the coating chamber of an air-suspension tablet-coating apparatus with a coating chamber diameter of 15 cm. Air of 60 C. is pressed into this chamber at 4.2-4.7 mfi/min. The air-nozzle has an orifice of 1.75 mm. diameter; the coating composition is introduced into the upwardly moving stream of air through a nozzle of 0.7 mm. diameter whereby it is atomized and deposited on the tablets.
- the coating solution has the following composition:
- the coating operation is completed when all the coating suspension is exhausted, or within about 15 minutes.
- a short drying cycle follows, to strip residual solvent from the coating chamber.
- the tablets are now covered by a plastic, colored, hard film-coating but have a dull appearance objectionable to many consumers.
- Gloss c0ating.-The -dull, coated tablets are, without removal from the coating chamber of the above aircoater, coated with the clear typical gloss-coating solution shown above. Air of 60 C. is introduced into the coating chamber at about 4.5 mP/min. and after about 10 minutes the tablets are elegant, shiny and, due to their gloss, easier to swallow than the dull precoated tablets. Appropriate digestion studies show that there is no measurable time difference between the distintegration times of the dull-coated and of the shiny glosscoated tablets.
- the gloss-coating of the present invention adheres to precoated tablets regardless of the components in the precoating film; whether the initial film contains hydroxypropylmethylcellulose as the main film-forming comon ent or as a minor component, or whether hydroxypropylmethylcellulose is totally absent in the initial fi-lm, the gloss-coating composition applied by the present method forms a shiny, protective and non-peeling film over the initial coating.
- the hydroxypropylmethylcellulose usedinthe present process has, among others, the advantages of being soluble in organic solvents and in water.
- the water-solubility is of importance for the rapid disintegration of the tablet in the bodys digestive liquids, and the solubility in organic liquids makes the formulation of a glosscoating solution very simple: the protective film dries rapidly onto the tablets, and the gloss-coating operation takes only a very short time. Further, due to the high solubility of the hydroxypropylmethylcellulose in the body fluids, rapid excretion from the patients body is achieved.
- the gloss-coating film provides the tablets so finished with a protective layer that improves the stability of the tablets against moisture and high temperatures, even though the gloss-coating film needs to be no thicker than about microns.
- the film so applied is non-brittle and completely transparent so that color identifications or other insignia pressed onto the tablet sunface are plainly visible.
- a further advantage of the present process is its applicability in an apparatus that is frequently used for the initial coating operation. However, care should be taken that the initial coating is completely dried before the gloss coating of the present process is applied.
- the film-coating composition of the present process can be applied without ever requiring the removal of the tablets from the coating apparatus.
- the gloss coating so applied not only has esthetic value but also serves as a seal to protect the colored coating from deleterious storage conditions without measurably influencing the disintegration time of the tablet.
- the method of applying a protective glossy coating to previously coated and dried tablets comprising the steps of (formulating a fluid coating composition consisting essentially of hydroxypropylmethylcellulose containing 5-15 by weight of Z-hydroxypropoxyl groups and 27-32% by weight of methoxyl groups as the sole film-forming component, and a nonaqueous solvent for said hydroxypropylmethylcellulose, said solvent having a boiling point below about 80 C.,
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- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Preparation (AREA)
Description
United States Patent Office 3,256,111 Patented June 14, 1966 3,256,111 METHOD FOR COATING TABLETS Robert E. Singiser, Guruee, IlL, assignor to Abbott Laboratories, North Chicago, 111., a corporation of Illinois No Drawing. Continuation of application Ser. No. 32,516, May 31, 1960. This application Dec. 4, 1964, Ser. No. 416,101
5 Claims. (Cl. 117-85) This is a continuation of application Serial No. 32,516 filed on May 31,- 1960, now abandoned.
This invention relates to tablet coatings and to a method of obtaining a pharmaceutically-elegent tablet. More particularly, this invention relates to the glosscoating 'or shining of a previously-coated pharmaceutical tablet.
The tablet-coating art has recently become aware of the advantages of employing the air-coating method for applying coating solutions to tablets. Among the many advantages is the elimination of the familiar coating pans and drying ovens, not to overlook the time-saving element. An example of such a method for air-coating tablets is described in U.S. 2,648,609. Another technique for applying a coating solution by the air-coating method is described in co-pending application Serial No. 11,364, now US. Patent 3,112,220, of which applicant is a joint inventor.
It is well-recognized in the tablet-coating art that a coating should have a glossy finish in order to have a pleasing appearance. When the pan-coating method is employed for coating, the finished tablets are shiny due to the bufiing action which is exerted onthe table-ts by tumbling in the pan. On the other hand, when an aircoating method is employed, the tablets receive no buffing action and consequently the finish on the tablet is dull and unattractive. This is true whether a plastic film-coating as described in US. 2,881,085, or a standard sugar coating, is applied to the tablets. Further, whether the tablets are coated with certain plastic films or a sugar coating, and Whether the coating is applied in the pan or by the air coating method, these coatings may be sensitive to high temperatures and humidity upon storage, and become tacky.
It is therefore an object of the present invention to provide gloss on a precoated tablet by the air-type coating method. It is another object of this invention to provide a tablet coating which provides improved hightemperature and moisture resistance. It is a further object of this invention to provide elegant pharmaceutical tablets with a gloss coating which does not prolong the disintegration time of the tablet.
These and other objects are accomplished. by the method of applying a protective coating to previouslycoated tablets comprising formulating a fluid coating composition consisting essentially of hydroxypropylmethylcellulose containing 5-15 by weight of 2-hydroxypropoxyl groups and 2732% by weight of methoxyl groups and a low-boiling, non-aqueous solvent for said hydroxypropylmethylcellulose, and directing a mixture of warm air and said coating composition upwardly through a bed of said tablets to cause fiuidization of said tablets, for a period of at least minutes. The above method of applying the protective coating or gloss coating comprises the newer air application method wherein the bed of tablets is maintained in fluidized form and the coating composition is introduced in the form of a spray.
Briefly stated, the method comprises the forming of a columnar bed of tablets to be coated wherein the bed is preferably greater in height than it is in the horizontal cross-sectional dimension. An air stream is directed upwardly through a portion of this bed with sufficient force to move the tablets in that portion upwardly, thus forming a fluidized spout of tablets. The spout extends above the top of the bed with the tablets falling therefrom back onto the top of the bed. In the parts of the bed adjacent the spout, the tablets move downwardly. The cellulose coating material is atomized and introduced into the upwardly moving stream of air. The atomized cellulose fluid is deposited on the tablets in the upwardly moving spout with the deposited liquid being dried by the air.
In the above definition of the process, reference is made to the use of warm air. The temperature of this air is preferably between 30 and C. to provide for fast evaporation of the low-boiling solvent used in the coating composition, The low-boiling non-aqueous solvent referred to above is preferably a solvent or solvent mixture which has a boiling point below about 80 C., e.g. ethanol, methanol, methylene chloride, chloroform, benzene, ethyl acetate, and mixtures thereof. The coating solution should contain between 10 and 50 grams of the hydroxypropyhnethylcellulose per liter, amount of fluid coating solution employed should be between 0.1 and 0.5 liter per kilogram of tablets.
To better understand the method of the present in vention, reference is made to the following example which is meant as an illustration only.
Typical gloss-coating s0luti0n.-To a mixture of equal parts of methylene chloride and ethanol is added 20 grams of hydroxypropylmethylcellulose with agitation. After a clear solution is formed, additional methylene chloride/ethanol (1:1) is added to produce a total volume of one liter, and the mixture is thoroughly stirred.
Typical coated tablets.A batch of 3 kg. of vitamin tablets weighing an average of 0.603 gram is placed in the coating chamber of an air-suspension tablet-coating apparatus with a coating chamber diameter of 15 cm. Air of 60 C. is pressed into this chamber at 4.2-4.7 mfi/min. The air-nozzle has an orifice of 1.75 mm. diameter; the coating composition is introduced into the upwardly moving stream of air through a nozzle of 0.7 mm. diameter whereby it is atomized and deposited on the tablets. The coating solution has the following composition:
, Grams Hydroxypropylmethylcellulose of '50 c.p.s. 40.0 Yellow D & C Lake #5. 60.0 Titanium dioxide 40.0 Saccharin sodium 2.0 Ethyl vanillin 8.0 Castor oil 2.5
Methylene chloride/ethanol 1:1, q.s. to 2 liters.
The coating operation is completed when all the coating suspension is exhausted, or within about 15 minutes.
A short drying cycle follows, to strip residual solvent from the coating chamber. The tablets are now covered by a plastic, colored, hard film-coating but have a dull appearance objectionable to many consumers.
Gloss c0ating.-The -dull, coated tablets are, without removal from the coating chamber of the above aircoater, coated with the clear typical gloss-coating solution shown above. Air of 60 C. is introduced into the coating chamber at about 4.5 mP/min. and after about 10 minutes the tablets are elegant, shiny and, due to their gloss, easier to swallow than the dull precoated tablets. Appropriate digestion studies show that there is no measurable time difference between the distintegration times of the dull-coated and of the shiny glosscoated tablets.
Substantially the same results are obtained when the solvent system in the typical gloss-coating solution is replaced by chloroform/ethanol, benzene, ethyl acetate, or methanol. Also, by replacing the precoating formula and the given above with other standard coating solutions or suspensions, the same beneficial effect is obtained with the gloss-coating of the present invention.
It is particularly interesting and noteworthy that the gloss-coating of the present invention adheres to precoated tablets regardless of the components in the precoating film; whether the initial film contains hydroxypropylmethylcellulose as the main film-forming comon ent or as a minor component, or whether hydroxypropylmethylcellulose is totally absent in the initial fi-lm, the gloss-coating composition applied by the present method forms a shiny, protective and non-peeling film over the initial coating.
The hydroxypropylmethylcellulose usedinthe present process has, among others, the advantages of being soluble in organic solvents and in water. The water-solubility is of importance for the rapid disintegration of the tablet in the bodys digestive liquids, and the solubility in organic liquids makes the formulation of a glosscoating solution very simple: the protective film dries rapidly onto the tablets, and the gloss-coating operation takes only a very short time. Further, due to the high solubility of the hydroxypropylmethylcellulose in the body fluids, rapid excretion from the patients body is achieved.
The gloss-coating film provides the tablets so finished with a protective layer that improves the stability of the tablets against moisture and high temperatures, even though the gloss-coating film needs to be no thicker than about microns. The film so applied is non-brittle and completely transparent so that color identifications or other insignia pressed onto the tablet sunface are plainly visible. A further advantage of the present process is its applicability in an apparatus that is frequently used for the initial coating operation. However, care should be taken that the initial coating is completely dried before the gloss coating of the present process is applied. It is thus possible to use the air-suspension method for coating pharmaceutical tablets with any desired film suspension or solution, and after the tablets are dried in the same coating chamber by the supply of dry warm air the film-coating composition of the present process can be applied without ever requiring the removal of the tablets from the coating apparatus. The gloss coating so applied not only has esthetic value but also serves as a seal to protect the colored coating from deleterious storage conditions without measurably influencing the disintegration time of the tablet.
Others may practice the invention in any of the numerous ways which will be suggested to one skilled in the art by the present disclosure. All such practice of the invention is considered to be a part hereof, provided it falls within the scope of the appended claims.
I claim:
1. The method of applying a protective glossy coating to previously coated and dried tablets comprising the steps of (formulating a fluid coating composition consisting essentially of hydroxypropylmethylcellulose containing 5-15 by weight of Z-hydroxypropoxyl groups and 27-32% by weight of methoxyl groups as the sole film-forming component, and a nonaqueous solvent for said hydroxypropylmethylcellulose, said solvent having a boiling point below about 80 C.,
directing a stream of air of a temperature between 30 and 80 C. upwardly through a bed of said coated tablets to cause fluidization of said tablets, and introducing said fluid coating composition into said stream o-r' warm air for a period of at least 10' minutes to form a protective coating.
2. The process of claim 1 wherein the coating solution contains between 10 and grams of hydroxypropylmethylcellulose per liter of coating solution.
3. The process of claim 1 wherein said fluid coating composition is applied in the amount of between 0.1 and 0.5 liter per kilogram of tablets.
4. The process of claim 1 wherein said warm air has a temperature between 30 and C. when entering the bed of said coated tablets.
5. The process of claim 1 wherein said coating composition is applied to the fluidized bed of tablets for a period between 10 and minutes.
References Cited by the Examiner UNITED STATES PATENTS 2,648,609 8/1953 Wurster 99l66 2,816,062 12/1957 Doerr 167--82 2,887,440 5/1959 Greiminer 167-82 2,986,475 5/1961 Mesnard et al. 117100 3,015,609 1/1962 Sanders 117-12 3,043,747 7/1962 Long 1 106-197 3,112,220 11/1963 Heiser, et al 11824 OTHER REFERENCES Wurster; Air-Suspension Technique of Coating Drug Particles, Journal of the American Pharmaceutical Association, vol. 48, No. 8 451-454.
WILLIAM D. MARTIN, Primary Examiner.
S. W. ROTHSTEIN, Assistant Examiner.
Claims (1)
1. THE METHOD OF APPLYING A PROTECTIVE GLOSSY COATING TO PREVIOUSLY COATED AND DRIED TABLETS COMPRISING THE STEPS OF FORMULATING A FLUID COATING COMPOSITION CONSISTING ESSENTIALLY OF HYDROXYPROPYLMETHYLCELLULOSE CONTAINING 5-15% BY WEIGHT O 2-HYDROXYPROPOXYL GROUPS AND 27-32% BY WEIGHT OF METHOXYL GROUPS AS THE SOLE FILM-FORMING COMPONENT, AND A NONAQUEOUS SOLVENT FOR SAID HYDROXYPROPYLMETHYLCELLULOSE, SAID SOLVENT HAVING A BOILING POINT BELOW ABOUT 80*C., DIRECTING A STREAM OF AIR OF A TEMPERATURE BETWEEN 30 AND 80*C. UPWARDLY THROUGH A BED OF SAID COATED TABLETS TO CAUSE FLUIDIZATION OF SAID TABLETS, AND INTRODUCING SAID FLUID COATING COMPOSITION INTO SAID STREAM OF WARM AIR FOR A PERIOD OF AT LEAST 10 MINUTES TO FORM A PROTECTIVE COATING.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US416101A US3256111A (en) | 1964-12-04 | 1964-12-04 | Method for coating tablets |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US416101A US3256111A (en) | 1964-12-04 | 1964-12-04 | Method for coating tablets |
Publications (1)
Publication Number | Publication Date |
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US3256111A true US3256111A (en) | 1966-06-14 |
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ID=23648531
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Application Number | Title | Priority Date | Filing Date |
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US416101A Expired - Lifetime US3256111A (en) | 1964-12-04 | 1964-12-04 | Method for coating tablets |
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Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3383236A (en) * | 1964-04-17 | 1968-05-14 | Merck & Co Inc | Continuous pharmaceutical film coating process |
US3455714A (en) * | 1964-09-01 | 1969-07-15 | Hercules Inc | Cellulose derivatives of improved dispersibility and process |
US3475187A (en) * | 1967-06-13 | 1969-10-28 | Rex Lab Inc | Edible indelible ink for pharmaceutical pellets |
US3539380A (en) * | 1968-01-08 | 1970-11-10 | Upjohn Co | Methylcellulose and polyalkylene glycol coating of solid medicinal dosage forms |
US3656997A (en) * | 1969-05-14 | 1972-04-18 | Sanol Arznei Schwarz Gmbh | Coated gelatin capsules and process for producing same |
US3751277A (en) * | 1971-03-24 | 1973-08-07 | Dow Chemical Co | Tablet coating process and composition |
US3900583A (en) * | 1971-08-10 | 1975-08-19 | American Home Prod | Contoured belt coating method |
US4001390A (en) * | 1974-04-04 | 1977-01-04 | Shin-Etsu Chemical Co., Ltd. | Method of coating pharmaceutical solid dosage forms |
US4017647A (en) * | 1974-06-11 | 1977-04-12 | Shin-Etsu Chemical Company Limited | Method for providing enteric coatings on solid dosage forms |
US4140756A (en) * | 1976-06-10 | 1979-02-20 | Mead Johnson & Company | Film-coated matrix core tablet |
US4302440A (en) * | 1980-07-31 | 1981-11-24 | Sterling Drug Inc. | Easily-swallowed, powder-free and gastric-disintegrable aspirin tablet thinly-coated with hydroxypropyl methylcellulose and aqueous spray-coating preparation thereof |
US4421738A (en) * | 1979-07-31 | 1983-12-20 | Eisai Co., Ltd. | Sugar-coated tablet containing fat-soluble pharmaceutical material |
US4508702A (en) * | 1982-06-14 | 1985-04-02 | Key Pharmaceuticals, Inc. | Sustained release aspirin |
US4555399A (en) * | 1983-11-18 | 1985-11-26 | Key Pharmaceuticals, Inc. | Aspirin tablet |
US4614545A (en) * | 1985-08-15 | 1986-09-30 | The Dow Chemical Company | Hydroxypropyl methyl cellulose thickening agents for organic liquids |
US4716042A (en) * | 1986-06-16 | 1987-12-29 | American Home Products Corporation | Stabilized coated aspirin tablets |
EP0298768A2 (en) * | 1987-07-09 | 1989-01-11 | The Wellcome Foundation Limited | Flavoured film-coated tablet |
US4816259A (en) * | 1987-02-12 | 1989-03-28 | Chase Chemical Company, L.P. | Process for coating gelatin capsules |
US4897270A (en) * | 1985-09-30 | 1990-01-30 | Glaxo Group Limited | Pharmaceutical compositions |
US5098715A (en) * | 1990-12-20 | 1992-03-24 | Burroughs Wellcome Co. | Flavored film-coated tablet |
US5194464A (en) * | 1988-09-27 | 1993-03-16 | Takeda Chemical Industries, Ltd. | Enteric film and preparatoin thereof |
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US2648609A (en) * | 1949-01-21 | 1953-08-11 | Wisconsin Alumni Res Found | Method of applying coatings to edible tablets or the like |
US2816062A (en) * | 1954-05-27 | 1957-12-10 | Univ Illinois | Hydroxyethyl cellulose tablet coating |
US2887440A (en) * | 1957-08-12 | 1959-05-19 | Dow Chemical Co | Enteric coating |
US2986475A (en) * | 1958-11-05 | 1961-05-30 | Smith Kline French Lab | Apparatus and method for coating discrete solids |
US3015609A (en) * | 1960-07-29 | 1962-01-02 | Jr Roy Y Sanders | Marked pharmaceutical tablet and method of marking the same |
US3043747A (en) * | 1958-10-22 | 1962-07-10 | Upjohn Co | Tablets coated with carboxymethylcellulose shellac composition |
US3112220A (en) * | 1960-02-26 | 1963-11-26 | Abbott Lab | Method and apparatus for coating particles |
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US2648609A (en) * | 1949-01-21 | 1953-08-11 | Wisconsin Alumni Res Found | Method of applying coatings to edible tablets or the like |
US2816062A (en) * | 1954-05-27 | 1957-12-10 | Univ Illinois | Hydroxyethyl cellulose tablet coating |
US2887440A (en) * | 1957-08-12 | 1959-05-19 | Dow Chemical Co | Enteric coating |
US3043747A (en) * | 1958-10-22 | 1962-07-10 | Upjohn Co | Tablets coated with carboxymethylcellulose shellac composition |
US2986475A (en) * | 1958-11-05 | 1961-05-30 | Smith Kline French Lab | Apparatus and method for coating discrete solids |
US3112220A (en) * | 1960-02-26 | 1963-11-26 | Abbott Lab | Method and apparatus for coating particles |
US3015609A (en) * | 1960-07-29 | 1962-01-02 | Jr Roy Y Sanders | Marked pharmaceutical tablet and method of marking the same |
Cited By (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3383236A (en) * | 1964-04-17 | 1968-05-14 | Merck & Co Inc | Continuous pharmaceutical film coating process |
US3455714A (en) * | 1964-09-01 | 1969-07-15 | Hercules Inc | Cellulose derivatives of improved dispersibility and process |
US3475187A (en) * | 1967-06-13 | 1969-10-28 | Rex Lab Inc | Edible indelible ink for pharmaceutical pellets |
US3539380A (en) * | 1968-01-08 | 1970-11-10 | Upjohn Co | Methylcellulose and polyalkylene glycol coating of solid medicinal dosage forms |
US3656997A (en) * | 1969-05-14 | 1972-04-18 | Sanol Arznei Schwarz Gmbh | Coated gelatin capsules and process for producing same |
US3751277A (en) * | 1971-03-24 | 1973-08-07 | Dow Chemical Co | Tablet coating process and composition |
US3900583A (en) * | 1971-08-10 | 1975-08-19 | American Home Prod | Contoured belt coating method |
US4001390A (en) * | 1974-04-04 | 1977-01-04 | Shin-Etsu Chemical Co., Ltd. | Method of coating pharmaceutical solid dosage forms |
US4017647A (en) * | 1974-06-11 | 1977-04-12 | Shin-Etsu Chemical Company Limited | Method for providing enteric coatings on solid dosage forms |
US4140756A (en) * | 1976-06-10 | 1979-02-20 | Mead Johnson & Company | Film-coated matrix core tablet |
US4421738A (en) * | 1979-07-31 | 1983-12-20 | Eisai Co., Ltd. | Sugar-coated tablet containing fat-soluble pharmaceutical material |
US4302440A (en) * | 1980-07-31 | 1981-11-24 | Sterling Drug Inc. | Easily-swallowed, powder-free and gastric-disintegrable aspirin tablet thinly-coated with hydroxypropyl methylcellulose and aqueous spray-coating preparation thereof |
US4508702A (en) * | 1982-06-14 | 1985-04-02 | Key Pharmaceuticals, Inc. | Sustained release aspirin |
US4555399A (en) * | 1983-11-18 | 1985-11-26 | Key Pharmaceuticals, Inc. | Aspirin tablet |
US4614545A (en) * | 1985-08-15 | 1986-09-30 | The Dow Chemical Company | Hydroxypropyl methyl cellulose thickening agents for organic liquids |
US4897270A (en) * | 1985-09-30 | 1990-01-30 | Glaxo Group Limited | Pharmaceutical compositions |
US4716042A (en) * | 1986-06-16 | 1987-12-29 | American Home Products Corporation | Stabilized coated aspirin tablets |
US4816259A (en) * | 1987-02-12 | 1989-03-28 | Chase Chemical Company, L.P. | Process for coating gelatin capsules |
EP0298768A2 (en) * | 1987-07-09 | 1989-01-11 | The Wellcome Foundation Limited | Flavoured film-coated tablet |
EP0298768A3 (en) * | 1987-07-09 | 1990-02-07 | The Wellcome Foundation Limited | Flavoured film-coated tablet |
US5194464A (en) * | 1988-09-27 | 1993-03-16 | Takeda Chemical Industries, Ltd. | Enteric film and preparatoin thereof |
US5098715A (en) * | 1990-12-20 | 1992-03-24 | Burroughs Wellcome Co. | Flavored film-coated tablet |
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