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Aqueous Emulsion Coating for Pharmaceutical Dosage Form

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Aqueous Emulsion Coating for Pharmaceutical Dosage Form Europaisches Patentamt 0 347 024 3> European Patent Office J) Publication number: Dffice europeen des brevets 3) EUROPEAN PATENT APPLICATION © Application number: 89303290.4 © Int. CI.4: A61K 9/32 , A61K 9/36 , A61K 9/22 © Date of filing: 04.04.89 The title of the invention has been amended © Applicant: ALZA CORPORATION (Guidelines for Examination in the EPO, A-lll, 950 Page Mill Road P.O. Box 10950 7.3). Palo Alto California 94303-0802(US) © Inventor: Wong, Patrick S.-L. © Priority: 21.04.88 US 184478 2030 Cornell Street Palo Alto California 94306(US) © Date of publication of application: Inventor: Theeuwes, Felix 20.12.89 Bulletin 89/51 1634 Fallen Leaf Lane Los Altos California 94022(US) © Designated Contracting States: AT BE CH DE ES FR GB GR IT LI LU NL SE © Representative: Evans, David Charles et al F.J. CLEVELAND & COMPANY 40-43, Chancery Lane London, WC2A UQ(GB) © Aqueous emulsion coating for pharmaceutical dosage form. © A dosage form is disclosed comprising a cured emulsion coat that surrounds a drug. The emulsion comprises a lower alkyl acrylate-lower alkyl methacrylate copolymer and ethyl cellulose. The emulsion optionally comprises a hydrophilic poly- mer. eg < CM CO CL LU Xerox Copy Centre 1 EP 0 347 024 A2 2 AQUEOUS EMULSION FOR PHARMACEUTICAL DOSAGE FORM This invention pertains to a pharmaceutical final dosage form. dosage form comprising an aqueous emulsion coat It will be appreciated by those skilled in the and to an aqueous emulsion coat. drug dispensing art that if a coating is provided that is substantially free of organic solvents when coat- 5 ing drugs, drug granules, drug powders, drug dis- BACKGROUND OF THE INVENTION pensers, and the like, such a coating would have an immediate positive value and, concomitantly, represent an advancement in the drug coating art. In Remington's Pharmaceutical Sciences, 14th Likewise, it will be appreciated by those versed in Ed., p 1681. (1970), it is reported that pill coating w the dispensing art that if a coating that is applied has been a pharmaceutically accepted technique from a non-organic solvent, and the coated delivery for well over ten centuries. For instance, Rhazes device possesses the thermodynamic ability to de- (850-932 A. D.) in the ninth century used a mu- liver a beneficial drug at a controlled rate, such a cilage for coating pills, and Avicenna (980-1037 A. delivery device would have a practical application D.) is credited with the introduction of silver and 15 in the field of human and veterinary medicine. gold pill coatings into medicine. At one time the coating of pills with finely powdered talcum, called pearl coating, was very popular. The gelatin coating OBJECTS OF THE INVENTION of pills was introduced by Garot in 1838. The first sugar coated pills in the United States were im- 20 ported from France in about 1842. The first sugar In view of the above presentation it is an imme- coated pills manufactured in the United States was diate object of this invention to provide a novel and in 1856 by Warner, a Philadelphia pharmacist. The useful coating composition for dosage forms, which coating of pills with tolu was done in about 1860 coating composition overcomes the disadvantages and twenty-four years later Unna introduced the 25 associated with the prior art. enteric coated pill. Another object of this invention is to provide a Various pharmaceutical articles of manufacture new coating composition comprising pharmaceuti- have been coated by the drug dispensing art. For cally acceptable ingredients, and which coating example, tablets were coated to provide a more composition is innocuous and useful for manufac- attractive dosage form, to protect the drug content 30 turing dosage forms. from moisture and to enhance its taste. Then too, Another object of this invention is to provide a tablets were provided with a coat for releasing a non-toxic coating composition that is substantially drug by enteric dissolution in the intestine of a free of organic solvents, and which coating com- warm-blooded animal. Recently, in 1972, Theeuwes position is useful for making dosage forms by and Higuchi coated osmotic dosage forms with a 35 standard manufacturing techniques. semipermeable rate controlling wall for delivering a Another object of this invention is to provide a drug at a known rate per unit time. aqueous based coating composition, which com- While the above-mentioned dosage forms are position is relatively uncomplicated, is capable of useful in the management of health and disease application without difficulty, and has a relatively serious disadvantages are associated with them. 40 low cost. That is, usually organic solvents are used for ap- Another object of the invention is to provide an plying the coating to the drug and serious, unwan- aqueous polymeric coating composition that exhib- ted drawbacks accompany the use of organic sol- its long term stability and is resistant to sedimenta- vents. For example, organic solvents generally are tion in a fluid environment of use. toxic to living tissue and they must be substantially 45 Another object of this invention is to provide an pulled from the dosage form to avoid a hazard to aqueous coating composition that is useful for the dosage form's recipient. Another serious manufacturing a drug delivery device possessing drawback with the use of organic solvents is that drug release rate controlling properties. they are flammable thereby possibly providing the Another object of this invention is to provide a danger of fire during the manufacturing process. so drug delivery device that can be manufactured by Also, organic solvents present an environmental conventional manufacturing procedures into various problem and the use of such solvents requires sizes, shapes and designs that comprise an im- complicated recovery systems to avoid contaminat- provement in the dispensing art characterized by ing the environment. The recovery systems are coating the device with a non-toxic, aqueous coat expensive to operate and adds to the cost of the that surrounds a drug. 2 3 EP 0 347 024 A2 1 Another object of this invention is to provide an dosage form is illustrated in Figure 1. In Figure 1 a aqueous-solvent coating composition that is non- dosage form 10 comprises a powdered drug 11, :lammable. is not an environmental hazard during generally exhibiting a powder size that passes ermuiation and when applied to a drug core. through a sieve having an opening from 0.074 mm Another object of this invention is to provide a 5 to 0.250 mm, surrounded by a coating composition Drocess for applying an aqueous coating onto a 12. Coating composition 12 comprises an aqueous jrug core thereby providing an orally administrable emulsion of ethylacrylatemethyl methacrylate and jrug dosage form an aqueous latex of ethylcellulose. Coating com- Other objects, features and advantages of this position 12 optionally comprises a hydrophilic poly- nvention will be more apparent to those versed in 70 mer such as polyvinyl alcohol, and the like. tie drug dispensing art from the following detailed In Figure 2 another embodiment of dosage specification taken in conjunction with the drawings form 10 is seen in opened view. In Figure 2 dosage and the accompanying claims. form 10 comprises granules 13 of drug. The drug granules generally exhibit a granule size that 15 passes through a sieve having an opening from BRIEF DESCRIPTION OF THE DRAWINGS greater than 0.250 mm to 9.50 mm. Drug granules 13 are surrounded by aqueous applied coating composition 14. Coating composition 14, in a pres- In the drawing figures, which are not drawn to ently preferred embodiment, comprises an aque- scale but are set forth to illustrate various embodi- 20 ous emulsion of an acrylate-methacrylate polymer ments of the invention, the drawing figures are as exhibiting a glass transition temperature of about follows: 10° C, an aqueous latex that is partially miscible Figure 1 is an opened view depicting a pow- with the aqueous emulsion of the acrylate and dered drug coated with the coating composition which latex imports mechanical stability to the ac- provided by this invention; 25 rylate emulsion, and an optional hydrophilic poly- Figure 2 is an opened view illustrating gran- mer that regulates the water permeability of the ules of a beneficial drug coated with the aqueous- aqueous acrylate-latex composition. The wall, or carrier based composition provided by this inven- the membrane composition, is formed by coales- tion. cence of the latex particles that are intermingled Figure 3 is a view of an osmotic device 30 with the water soluble polymer during a low tem- designed and shaped for orally administering a perature curing cycle, in a presently preferred em- dosage amount of a drug to the gastrointestinal bodiment at least one com ponent of the ingre- tract of a warm-blooded animal; dients comprising the blended emulsion exhibits a Figure 4 is an opened view of the osmotic glass transition temperature lower than the curing device of Figure 3 depicting the wall of the osmotic 35 temperature so that coalescence occurs during the device comprising a wall-forming coating composi- drying period. tion provided by the invention; In Figure 3 another embodiment of dosage Figure 5 is a view of the osmotic device of form 10 is illustrated manufactured as an osmotic Figure 3 in opened section illustrating the osmotic drug delivery device 10. In Figure 3 osmotic dos- device comprising another embodiment of the wall- 40 age form 10 comprises a body 15 comprising a forming coating composition provided by the inven- wall 16 that surrounds and forms an internal com- tion; partment, not seen in Figure 3. Osmotic dosage form 10 comprises at least one passageway 17 for In the drawings and in the specification like connecting the interior of dosage form 10 with the parts in related figures are identified by like num- 45 exterior of osmotic dosage form 10.
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