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Publication numberUS3185626 A
Publication typeGrant
Publication dateMay 25, 1965
Filing dateMar 6, 1963
Priority dateMar 6, 1963
Publication numberUS 3185626 A, US 3185626A, US-A-3185626, US3185626 A, US3185626A
InventorsBaker Claude W
Original AssigneeSterling Drug Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Tablet coating method
US 3185626 A
Abstract  available in
Images(2)
Previous page
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Claims  available in
Description  (OCR text may contain errors)

United States Patent 3,185,626 TABLET CGATING METHOD Claude W. Baker, Albany, N.Y., assigner to Sterling Drug Inc, New York, N.Y., a corporation of Delaware No Drawing. Filed Mar. 6, 1963, Ser. No. 263,100

5 Claims. (Cl. 167--82) This invention relates to tablets and other individual dosage forms. More particularly the invention is concerned with an economical, time-saving process for sugar coating core tablets.

Tablet coating is an old art in which traditional methods have remained essentially unchanged although in recent years some steps have been made toward reducing the tedious and time-consuming operation. Thus, a tablet or compressed pellet is sized with a water repellent resin such as shellac or zein and the resultant tablet 0r pellet is then subcoated with several coats of a material such as gelatin or acacia along with subcoating powders designed for dusting the subcoats. The subcoating operation although time consuming and expensive has been considered necessary in order to round and shape the tablet preparatory to applying a sugar coating with or without added coloring. After further finishing and polishing there is obtained a pharmaceutically elegant tablet but the inordinate amount of time required in the application and drying of the numerous coats including subcoating, color coating and smoothing coat maks the production of such tablets quite expensive.

In comparatively recent times various film coating procedures have been introduced and these methods have materailly reduced the time required to prepare a finished tablet. However, the film coating procedures suffer from a number of disadvantages which in certain instances outweigh the time-saving advantages. For example, the filmforming materials being organic in nature require the use of organic solvents, e.g., alcohol, acetone, ether etc., which are flammable and toxic. It is therefore necessary to carry out the process in explosion-proof equipment with provision for adequate ventilation and exhaust.

Further complications to the well-known tabletting procedures are introduced when it is desired to color the tablet for purposes of distinctiveness or identification. For many years only dyes of the soluble type were used and this necessarily limited the number and range of colors that could be used. In recent times insoluble dyes or lakes have been incorporated into coloring compositions by the use of surfactants to maintain the dyes or lakes in suspension and more recently it has been found that the surfactant was unnecessary. These improvements materially reduced the operating time for coloring solids but the time-consuming subcoating of the tablets was still carried out.

According to the present invention core tablets, that is, tablets which may be sealed, sized or enteric coated but not rounded, are sugar coated in one-quarter to one-third the time required by any previously known method. Utilization of the compositions and process of the invention greatly reduces the operating time by eliminating completely subcoats and smoothing coats hitherto believed necessary.

Additionally, a color, either water-soluble or waterinsoluble, can be incorporated at any stage to give a stable, pharmaceutically elegant finished tablet for which the color is reproducible from batch to batch or operator to operator. There is no necessity for subcoating the rough core tablet or applying smoothing coats yet the finished tablet has stability upon aging, resistance to cracking during sudden temperature changes and a pleasing appearance 7O comparable with tablets made by conventional procedures.

Patented May 25, 1965 The compositions useful in the process of the invention are comprised of an adhesive aqueous suspending medium such as a gelatin solution or preferably a syrup solution and an opaque non-toxic, pharmaceutically acceptable water insoluble pigment as for example titanium dioxide, iron oxide, barium sulfate and calcium carbonate, and if desired a non-toxic dye of either the water-soluble or water-insoluble type.

The aqueous suspending medium is preferably a syrup solution, e.g., an aqueous sugar solution such as an aqueous solution of glucose, lactose, maltose or sucrose. The preferred syrup or sugar solution is a sucrose solution although other sugar derivatives such as mannitol and sorbitol can be used.

The compositions useful in carrying out the improved process can, if desired, contain coloring materials which are any of the non-toxic dyes, lakes and pigments which have been certified for use in the food, drug and cosmetic industries. For example, water-soluble dyes as illustrated by PD & C Yellow No. 5, water-insoluble dyes and lakes as illustrated by .D & C Green No. 5 and pigments as illustrated by yellow, brown, red and black iron oxides, titanium dioxide and barium sulfate are suitable as colorants.

The method of coating core tablets in accordance with the invention comprises forming the syrup or sugar solution in which is suspended the opacifying material by the use of suitable mixing equipment. The suspension is then added to core tablets in a rotating coating pan and the appropriate number of coats applied with air drying after each coat. At any stage colors of the type described above can be added if desired by adding the appropiate color to the syrup and applying the number of coats necessary to give the desired coloring.

The following examples will further illustrate the invention, without however limiting the latter thereto.

Example 1 Coating suspensions incorporating various dyes were prepared as follows:

(A) Grams FD & C Yellow No. 5 0.20

Titanium dioxide, N.F. 7.20

Sucrose (as 70% syrup) 360.00

PD 8.: C Blue No. 1 0.07

Titanium dioxide, N.F. 7.20

Sucrose (as 70% syrup) 360.00

PD & C Yellow No. 6 0.22

Titanium dioxide, N.F. 7.20

Sucrose (as 70% syrup) 360.00

FD & C Red No. 4 0.25

Titanium dioxide, N.F. 7.20

Sucrose (as 70% syrup) 360.00

Mapico Black 0.72

Titanium dioxide, N.F. 7.20

Sucrose (as 70% syrup)- 360.00

Mapico Black 0.36

Brown iron oxide 7.20

Sucrose (as 70% syrup) 360.00

The dyes and pigments were suspended in the syrup and thoroughly mixed. Each of the coloring compositions was added to sized unrounded placebo tablets in a rotating pan until the tablets were evenly covered. The result- Example 2 Grams Titanium dioxide, NF. 14.0 Sucrose (as 70% syrup) 800.0

The above suspension was applied to a run of sized, unrounded oxypertine tablets rotating in a coating pan. A total of 40 mg. per tablet of the coating composition Was applied in about two and one-half hours to give a white sugar coated tablet equal in quality to oxypertine tablets coated in the conventional in five hours.

Example 3 Kilograms Brown iron oxide 0.232

Vanillin 0.004 Sucrose (as 70% syrup) 9.200

A suspension of the above ingredients was applied to a run of size, unrounded pancreatin-containing digestant tablets sold under the trademark Doxegest rotating in a coating pan. Application of the coating composition required about two and one-half hours and the resultant brown tablet was comparable to subcoated Doxegest tablets and required about one-third the time.

Example 4 Grams Titanium dioxide, NF. 2.80 FD & C Yellow No. 5 .062

Sucrost (as 70% syrup) 250.00

A suspension of the above ingredients was applied to a run of sized, unrounded cold tablets containing phenylephrine sold under the trademark Neosynephrine, acetyl p-aminophenol and vitamin C rotating in a coating pan. A total of 125 mg. per tablet was applied in about two and one-half hours. The yellow tablet thus obtained was equal in quality to sized, unrounded cold tablets coated in the conventional manner in six hours.

I claim:

1. .A method of coating tablets which comprises repeatedly adding portions of an aqueous suspending medium containing a non-toxic pharmaceutically acceptable pigment to sized, unround tablets rotating in a coating pan.

2. The method of claim 1 in which the pigment is selected from the group consisting of titanium dioxide, calicum carbonate, barium sulfate and iron oxide.

3. The method of claim 1 in which the aqueous suspending medium is a syrup solution.

4. The method of claim 1 in which a member of the group consisting of water-soluble and water-insoluble dyes is incorporated in the aqueous suspending medium.

5. The method according to claim 1 in which the aqueous suspending medium comprises a sucrose solution containing titanium dioxide and a colorant, and

.drying the finished tablets.

References Cited by the Examiner UNITED STATES PATENTS 9/62 Ralf 16782 9/64 Jeffries 16782

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3054724 *May 12, 1960Sep 18, 1962Smith Kline French LabColoring discrete solids and compositions therefor
US3149038 *Sep 5, 1961Sep 15, 1964Dow Chemical CoThin film coating for tablets and the like and method of coating
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3361631 *Sep 30, 1963Jan 2, 1968Sandoz AgMethod of sugar coating pharmaceutical tablets
US3421920 *May 25, 1965Jan 14, 1969Ciba Geigy CorpTablet coating containing a linear poly-1,3-beta-glucoside
US4146653 *Aug 10, 1977Mar 27, 1979J. Pfrimmer & Co.Coating with a melt of xylitol and sorbitol
US4421738 *Mar 18, 1982Dec 20, 1983Eisai Co., Ltd.Sugar-coated tablet containing fat-soluble pharmaceutical material
US4423086 *Oct 16, 1980Dec 27, 1983Roquette FreresConfectionary and pharmaceutical products
US4693750 *Feb 21, 1986Sep 15, 1987Meggle Milchindustrie Gmbh & Co. Kg.Lactose, cellulose
US4820524 *Feb 20, 1987Apr 11, 1989Mcneilab, Inc.Gelatin coated caplets and process for making same
US4867983 *Dec 4, 1987Sep 19, 1989Mcneilab, Inc.Method for double dipping gelating coated caplets
US4965089 *Apr 10, 1989Oct 23, 1990Sauter Manufacturing Corp.High speed dipping
US4966771 *May 5, 1988Oct 30, 1990Mcneilab, Inc.Dipping and drying first one end and then the other to provide a smooth coating easy to swallow; tamper-proof
US4990358 *Mar 21, 1989Feb 5, 1991Mcneilab, Inc.Method for double dipping gelatin coated caplets
US5198227 *Jan 22, 1990Mar 30, 1993Mcneil-Ppc, Inc.Dual subcoated simulated capsule medicament
US5296233 *Dec 11, 1992Mar 22, 1994Mcneil-Ppc, Inc.Dual subcoated simulated capsule-like medicament
US5314537 *May 5, 1988May 24, 1994Mcneilab, Inc.Gelatin coated caplets and process for making same
US5512314 *Nov 28, 1994Apr 30, 1996Warner-Jenkinson CompanyContaining immobilizing metal salt to keep dye from migrating; smooth, uniform coating
US5658589 *Oct 31, 1991Aug 19, 1997Mcneil-Ppc, Inc.Subcoated simulated capsule-like medicament
US5770225 *Jun 5, 1995Jun 23, 1998Mcneil-Ppc, Inc.Compressing, applying subcoating of castor oil andhydroxypropylmethylcellulose, dipping in gelatinous solution
US5916592 *Feb 18, 1997Jun 29, 1999Mcneil-Ppc, Inc.Subcoated simulated capsule-like medicament
US6080426 *Jan 11, 1996Jun 27, 2000Warner-Lamberg CompanyProcess for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US6113945 *Feb 26, 1996Sep 5, 2000L. Perrigo CompanyCores with covering envelopes and colors
US6120801 *Apr 15, 1999Sep 19, 2000Mcneil-Ppc, Inc.Smooth, uniform and bubble free outer coating appearance to caplets
US6214380Sep 3, 1999Apr 10, 2001Mcneil-Ppc, Inc.Subcoated simulated capsule-like medicament
US6245350Apr 5, 1996Jun 12, 2001Warner-Lambert CompanyProcess for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US6326026Jan 14, 2000Dec 4, 2001Mcneil-Ppc, Inc.Caplet core containing a drug with peripheral edge surface that is bowed in shape; caplet coated with a gelatinous material; optional subcoating of a polymer, e.g. hydroxypropyl methyl cellulose
US7087242Oct 3, 2001Aug 8, 2006Mcneil-Ppc, Inc.Subcoated simulated capsule-like medicament
US7404708Dec 7, 2004Jul 29, 2008Mcneil-Ppc, Inc.System and process for providing at least one opening in dosage forms
US7416738Mar 21, 2003Aug 26, 2008Mcneil-Ppc, Inc.Pharmaceutical pills comprising drugs such as non-steroidal antiinflammatory agents, and cores surrounded by shells, having apertures for timed or sustained drug delivery
US7429619Aug 2, 2002Sep 30, 2008Mcneil Consumer HealthcarePolyacrylic film forming compositions
US7530804Dec 7, 2004May 12, 2009Mcneil-Ppc, Inc.System and process for providing at least one opening in dosage forms
US7635490Mar 21, 2003Dec 22, 2009Mcneil-Ppc, Inc.Modified release dosage form
US7785650Jun 27, 2007Aug 31, 2010Mcneil-Ppc, Inc.Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising hydroxypropylmethyl cellulose and xanthan gum, carrageenan, and mixtures thereof, or hydroxypropylmethyl cellulose and castor oil or maltodextrin
US7838026Oct 28, 2003Nov 23, 2010Mcneil-Ppc, Inc.Burst-release polymer composition and dosage forms comprising the same
US7879354Jan 13, 2004Feb 1, 2011Mcneil-Ppc, Inc.tablet core having two ends; includes gelatinous coatings over both and do not meet and form a circumferential gap or band through which the subcoating is visible
US7955652Nov 29, 2007Jun 7, 2011Mcneil-Ppc, Inc.Tablet with patterned exterior coating films; multicolor layout
US7968120Sep 28, 2002Jun 28, 2011Mcneil-Ppc, Inc.Modified release dosage forms
US7972624Feb 24, 2009Jul 5, 2011Shun-Por LiMethod of manufacturing modified release dosage forms
US8067029Jul 23, 2004Nov 29, 2011Mcneil-Ppc, Inc.Rapidly disintegrating gelatinous coated tablets
US8114328Aug 4, 2004Feb 14, 2012Mcneil-Ppc, Inc.Method of coating a dosage form comprising a first medicant
US8282957Jun 24, 2009Oct 9, 2012Mcneil-Ppc, Inc.Coated particles containing pharmaceutically active agents
US8309118Jun 21, 2002Nov 13, 2012Mcneil-Ppc, Inc.Mixture containing carrageenan, hydrocolloids; multilayer coatings
US8357395Dec 17, 2008Jan 22, 2013Mcneil-Ppc, Inc.Manufacture of tablet
US8383632Sep 3, 2009Feb 26, 2013Mcneil-Ppc, Inc.Method for making cetirizine tablets
US8394415Nov 20, 2007Mar 12, 2013Mcneil-Ppc, IncModified release analgesic suspensions
US8545887Sep 28, 2002Oct 1, 2013Mcneil-Ppc, Inc.Modified release dosage forms
US8652517 *Sep 22, 2005Feb 18, 2014Sandoz GmbhCoating of tablet cores
US8673190Dec 7, 2011Mar 18, 2014Mcneil-Ppc, Inc.Method for manufacturing dosage forms
US8673352Apr 15, 2005Mar 18, 2014Mcneil-Ppc, Inc.Modified release dosage form
US8722089Feb 17, 2009May 13, 2014Mcneil-Ppc, Inc.Dip coated compositions containing a starch having a high amylose content
US8771716Jan 31, 2013Jul 8, 2014Mcneil-Ppc, Inc.Modified release analgesic suspensions
US8815290Dec 16, 2010Aug 26, 2014Mcneil-Ppc, Inc.Rapidly disintegrating gelatinous coated tablets
EP1602363A1Jun 2, 2005Dec 7, 2005McNeil-PPC, Inc.Immediate release dosage form comprising shell having openings therein
EP2255795A1Mar 21, 2003Dec 1, 2010McNeil-PPC, Inc.Immediate release dosage form comprising shell having openings therein
WO1981001100A1 *Oct 16, 1980Apr 30, 1981G BussiereProcess for hard coating with sorbitol and products obtained thereby
WO2001037816A2 *Nov 21, 2000May 31, 2001Biochemie GmbhCoating of tablet cores
WO2004028508A1Mar 21, 2003Apr 8, 2004Mcneil Ppc IncModified release dosage forms with two cores and an opening
Classifications
U.S. Classification427/2.2, 424/479
International ClassificationA61K9/28
Cooperative ClassificationA61K9/28
European ClassificationA61K9/28