Application of ethylcellulose coating to hydrophilic matrices. Influence of storage conditions and type of plasticizers. Ethyl cellulose or ethylcellulose is a derivative of cellulose in which some of the hydroxyl groups on the repeating glucose units are converted into ethyl ether groups. Plasticization of cellulose ethers used in the film. Changes in film mechanical properties may ultimately influence the drug release, stability and other physicochemical properties of the coated dosage forms. Plasticizerpolymer interactions have been studied by measuring the intrinsic viscosities of both ethyl cellulose and hydroxypropyl methylcellulose in a series of dialkyl phthalates and in a series of liquid glycols respectively. Cellophane may be safely used for packaging food in accordance with the following prescribed conditions. It is generally known that organic application of ethylcellulose coating can result in stronger film compared to the aqueous system.
Received 19 august 2003, revised 11 october 2003, accepted 3 november 2003. Design, formulation and manufacture of filmcoated drug. The aim of our research was to investigate the effect of the length of the polymer chain and the concentration of triethyl citrate used as a plasticizer on the thermal stability of the film structure in the case of two ethyl cellulose films ec 10 and ec 45 used for preparing mr dosage forms. Before the film coating, preformulation studies are necessary in order to study the physicochemical and thermal properties of the free films, e. Effects of molecular weight on phase separated coatings. Hydrophilic matrix tablets are commonly used for extended release dosage forms. Film coating is a common step in tablet manufacture that can be used to. Abstract ethylcellulose has become a polymer widely used in pharmaceutical film coating, especially when it is necessary to produce a modifiedrelease dosage. The film coat, along with the tablet shape and size, defines the. December 5, 2014 the dow chemical company page 2 of 7 ethylcellulose polymers are used in a variety of pharmaceuticals, personal care products, foods, ceramics, pastes, inks, and specialty coatings.
To minimize these losses, an alternative is the creation of a physical barrier around granules. Carrageenan as a drug release modifier in ethylcellulosebased film. Its primary release mechanism is drug diffusion across a waterinsoluble membrane, explained rina chokshi, phd, project leader, controlled release technology, fmc biopolymer. The food additive ethyl cellulose may be safely used in food in accordance with the following prescribed conditions. The diltiazem hcl 50% pellets were coated using fluid bed processor with ethyl cellulose and hpmc containing coating. The film coating act a membrane that allows infusion of gi fluid and the outward diffusion of drug or the release process may. Influence of storage conditions and type of plasticizers on ethylcellulose and acrylate films formed from aqueous dispersions.
Several recent studies focused on improvement strategies to enhance the quality of bionanocomposite coating film materials. The influence of sheath solvent s flow rate on the quality of electrospun ethyl cellulose nanofibers. Further, it is employed as a binder, filler, plastic coating and diluents of color. Ethyl cellulose is often employed in the form of a hot melt for strippable coatings. Us2281445a us317969a us31796940a us2281445a us 2281445 a us2281445 a us 2281445a us 317969 a us317969 a us 317969a us 31796940 a us31796940 a us 31796940a us 2281445 a us2281445 a us 2281445a authority us united states prior art keywords ethyl cellulose solvent films film resistant prior art date 19400208 legal status the legal status is an assumption and is not a. Nitrate film was used for xray photography for some time, where its hazardous nature was most acute, thus in 1933, became disused for such purposes, along with its uses for motionpicture films in 1951, when it was replaced by cellulose acetate film commonly known as safety film. Biobased nanocomposite coating films have been used in numerous recent applications with different aspects because of environmental factors and their biodegradability properties.
They have very low tolerance for hydrocarbons and limited compatibility with. Ethyl cellulose polymer has been used as a coating material for oral sustainedrelease dosage forms since 1985 1. Pectinethylcellulose film coating formulations for. Rapid aqueous ethyl cellulose pseudo latex wurster fluid. Multiparticulate ec coating times are typically further lengthened by slow spray rates necessary to prevent the problem of particle adhesion.
These polymers are used alone or in combinations to provide optimal results. The uncoated and ethylcellulose coated matrix tablets were. Coating barriers comprising ethyl cellulose fisons. A strategy to modulate drug release profile and reduce drug release variability. Ethyl cellulose is the waterinsoluble cellulose ether used most commonly in film coating for pharmaceutical purposes rowe, 1984. The plasticizerethyl cellulose solution was then added to nonaqueous pectin solution and stirred for another 30 minuets using magnetic stirrer to produce coating formulation containing 1. The properties of ethyl cellulose sustained release products, including film coated tablets 7, microspheres 8,9, microcapsules 10 and matrix tablets.
Understanding curing of ethylcellulose film coating and in vitro in. Ethyl cellulose ec is a waterinsoluble cellulose derivative commonly used for such coatings, but its permeability for most drugs is low1. It is also used as a filmformer in coatings, hotmelt adhesives and transfer inks. Controlledrelease film coatings based on ethylcellulose. The applications of cnts have lately been transformed for their use in controlled drug delivery through the oral route. Dasbach the dow chemical company, midland, michigan 48674, usa introduction ethylcellulose ec is a waterinsoluble polymer, which has been used successfully for coating applications in drug delivery with. Physicomechanical analysis of free ethylcellulose films. The adhesive formulation provided above can be used for manufacturing coatings and heat sealing compounds for food packaging, soap wraps, shelf paper and label coatings. Design, formulation and manufacture of filmcoated drug products. The extent of these changes is influenced by several factors such as the amount of plasticizers added, type of plasticizers used, film forming conditions, film storage temperature and humidity. The ec viscosity level depends on the level of ethoxy used. The principal uses for ethyl is cellulose injection mouldings are in those applications where good impact strength at low temperatures is required, such as refrigerator bases and flip lids and icecrusher parts. In the present work urea granules were coated with polyhydroxybutyrate and ethyl cellulose in various conditions in the presence of emulsifiers.
A quantitative relationship was established that could be used to quantify the extent of coalescence in ec curing to a reasonable accuracy. In all experiments, barrier coatings were applied to nonpareils 30 35 mesh which had been coated with diphenhydramine hcl using a minifluid bed coater. Tri ethyl citrate tec and dibutyl sebacate dbs were the plasticizers used while hydroxypropyl methyl cellulose hpmc was used as the poreformer. Nitrocellulose xray film ignition was the cause of the. Water insoluble film forming agents used to create a barrier to drug release include various cellulose derivatives and polymethacrylates. Eudragit rsrl,27 starch acetate,28 ethyl cellulose29 and eudragit.
Ethyl cellulose general information, process, products. Before film coating, preformulation studies are necessary in order to study the physicochemical and thermal properties of free films, e. Functional film coats can also be used as a part of the products stabilisation strategy and to modify or delay drug release. Combinations of pectin and ethylcellulose, in the form of an aqueous dispersion, were used as coating formulations. A novel spray method for producing ethyl cellulose ec and hydroxypropyl cellulose hpc freefilms was developed. Cellulose for coating, cellulose for coating suppliers and. Studies were conducted to determine the mechanism of drug release from pellets coated with an ethylcellulosebased pseudolatex widely accepted for use as a sustained release coating for. Film formation can be achieved by applying the polymer from an or ganic solution l3, from a coating emulsion or from an. The number of ethyl groups can vary depending on the manufacturer. Understanding tablet coating process lfa tablet presses. Ethylcellulose is used as the primary film former and as a modifier for waxes, glycerides, and other cellulosic resins. Film coating technology is now a days very important in the field of pharmacy particularly in formulation development. In the last 25 years tablet coating has undergone several fundamental changes. Many polymeric film coats applied onto a dosage form have been reported to undergo changes in mechanical properties upon storage.
A wide variety of cellulose for coating options are available to you, such as coating auxiliary agents, petroleum additives, and electronics chemicals. Because of its high glass transition temper corresponding author. Review of bionanocomposite coating films and their. Plasticization of cellulose ethers used in the film coating of tablets. In order to modify the release profile through ec coatings a watersoluble component, such as hydroxypropyl cellulose hpc, can be added to. Ethyl cellulose ec polymer was characterized for its property before. Advantia prime coating systems are available pigmented or unpigmented and are based on existing pharmaceuticallyacceptable polymers, for example hydroxypropylmethyl cellulose hpmc, hydroxyproypyl cellulose hpc and ethyl cellulose ec. This invention relates generally to coatings and more specifically to improved extended release coating barriers comprising a filmforming polymer and a plasticizer which. Tough films with good resistance to marring and weathering are possible through combinations of cellulose acetate butyrate resins with thermoplastic acrylic resins. Ethyl cellulose is used as a food additive and as an emulsifier. Effect of manufacturing conditions and polymer ratio on.
It combines the proven performance of a cellulose acetate polymer with the coating and technical excellence of colorcon. Effect of manufacturing conditions and polymer ratio on the permeability and film annica jarke this thesis considers the effect of manufacturing conditions and polymer ratio on water permeability and morphology of freefilms. Ec ethyl cellulose ec ethyl cellulose has to be used in combination with other water soluble additives such as the hpmc as it is completely insoluble in water and gastric juices. Cellulose acetate is used as a film base in photography, as a component in some coatings, and as a frame material for eyeglasses. Pdf mechanism of release from pellets coated with an. For example, cnts are now used in tablet coating, along with hydrogels such as ethyl cellulose, cellulose acetate, and hydroxypropyl methylcellulose hpmc, for achieving the desired sustained release profile of drug delivery.
Ethyl cellulose being used in sustained release coatings is commonly applied at high weight gains resulting in lengthy coating runs. Ethyl cellulose adhesives age fairly well, but discolor in sunlight. Ethylcellulose is used in pharmaceutical technology as a coating agent. In the process of film coating, a thin stable polymer film coat is created on the surface of a solid dosage form, such as tablets, capsules, pellets or crystals.
About 10 g of this solution was cast into a glass petri dish casting area 100. Use of polyhydroxybutyrate and ethyl cellulose for coating. In addition to this, it is used in lacquers and plastic toughing. Ethyl cellulose organic solutions are often used for both hydrophobic film coating 10, and controlled release coating of solid dosage forms 11. Thermal study of ethyl cellulose coating films used for modified. Cellulose esters are also used as film formers in nail polish formulations. Methyl cellulose wikimili, the best wikipedia reader. Film coating process of tablets in pharma manufacturing. Minimal weight gain 23% as opposed to 6080 % for sugar coating coat is less likely to affect disintegration. This study has demonstrated that aqueous ec coating of multi. Evaluation of physical properties of plasticized ethyl. Film coating techniques can be effectively used either to sustain the release extended release0r delay the release enteric coating of drug. Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Surelease is aqueous polymeric dispersion of ethyl cellulose used for sustained release film coating.
Effects of plasticizers, additives, and solvents karen a. The great number of polymers available for coating ensure different dissolution profiles. Ong department of pharmacy, faculty of science, national university of singapore, singapore. Product safety assessment ethocel ethylcellulose polymers. Most colourants used in film coating are available in. Ethyl cellulose ec is a nontoxic, stable, compressible, inert, hydrophobic polymer that has been widely used to prepare pharmaceutical dosage forms. The situation is most concerning for drugs with narrow therapeutic windows, eg. Ethyl cellulose is used as a food additive as an emulsifier. Ethyl cellulose coatings are used to modify the release of a drug, 6 78 to mask an unpleasant taste, or to improve the stability. Thereafter, ethyl cellulose7cps was added into it with continuous stirring for approximately 30 mins. Opadry ca is the first onestep semipermeable membrane designed to ensure consistent release from osmotic pump tablets. While hydroxypropyl cellulose hpc and hydroxypropyl methyl cellulose hpmc are watersoluble and can be applied as aqueous solutions, 1,2,3,4 commercial.
Thermal study of ethyl cellulose coating films used for. Ethylcellulose is used in pharmaceutical industry as a coating agent, flavoring fixative, tablet binder and filler, film former, and as a viscosityincreasing agent. Coatings chemicals eastman cellulose acetate butyrate cab5311 cab5311 is a cellulose ester with a higher butyryl level than cab381 type esters. Film coating is a method widely used for the development of solid dosage forms. Many modifications were advocated to improve the basic process. It is prepared from wood pulp or cotton by treatment with alkali and ethylation of the alkali cellulose with ethyl chloride. The purpose of the study was to investigate the potential of pectin, ethylcellulose combinations as a practical film coating for colonic delivery. E325 eastman cellulose esters for formulated products.