METHOCEL Cellulose Ethers
`
`Technical Handbook
`
`
`
`OVERSIZE
`TP
`1180
`. C6
`M3
`1991
`
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`

`

`OVERSIZE
`TP
`1180
`.C6
`M3
`1991
`
`
`
`Institute ofPaper Science and Technology
`575 14th Street, NW.
`Atlanta, Georgia 30318
`
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`

`Table of contents
`
`Page
`
`An introduction to METHOCEL cellulose ethers ................................................. .. 2
`
`Applications for METHOCEL cellulose ethers ..................................................... .. 6
`
`Regulated uses ..................................................................................................... .. 10
`
`How to prepare solutions of METHOCEL ................................
`
`........................ .. 12
`
`Four dispersion techniques, step-by—step ............................................................. .. 16
`
`Properties of METHOCEL powders ................................................................... n 18
`
`Properties of solutions of METHOCEL .............................................................. .. 19
`
`Thermal gelation in aqueous media ..................................................................... .. 27
`
`Properties of films of METHOCEL ...............
`
`................................................... .. 31
`
`Analytical methods .............................................................................................. ..33
`
`Handling considerations ...................................................................................... .. 35
`
`
`
`fgéi‘éfsme
`
`economy
`
`1
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`{0&ng
`
`An introduction to
`
`METHOCEL cellulose ethers
`
`
`
`METHOCEL* cellulose ethers are wa—
`
`ter—soluble polymers derived from cel-
`lulose, the most abundant polymer in
`nature. For over 50 years these versa-
`tile products have played an important
`role in foods, cosmetics, pharmaceuti—
`cals, latex paints, construction prod-
`ucts, ceramics, and a host of other ap—
`plications.
`METHOCEL products are
`used as thickeners, binders, film form—
`ers, and water retention agents. They
`also function as suspension aids, sur—
`factants, lubricants, protective col-
`loids, and emulsifiers. In addition, so-
`lutions of METHOCEL thermally gel,
`a unique property that plays a key role
`in a surprising variety of applications.
`You won't find this valuable combina-
`
`tion of properties in any other water—
`soluble polymer. Table 1 provides an
`overview of these physical. chemical.
`and performance properties.
`
`Multifunctionality and efficiency
`improve formulation economy
`
`The fact that so many useful properties
`are simultaneously present and often
`act in combination can be a significant
`economic advantage.
`In many appli-
`cations. two. three. or more ingredients
`would be required to do the same job
`performed by a single METHOCEL
`product.
`In addition. METHOCEL
`cellulose ethers are highly efficient.
`often yielding optimum performance
`at lower concentrations than required
`with other water-soluble polymers.
`
`Range of product choices gives you
`the formulating versatility you need
`
`The broad range of METHOCEL
`products available is certainly one rea-
`son they've been used successfully in
`so many different applications. There
`are two different chemical types and
`each is available in different grades,
`physical forms, and viscosities. By
`choosing a specific METHOCEL
`product it's possible to obtain the opti—
`mum degree of thickening, binding,
`
`Call tollfree,
`1-800-258-2436. Askfor
`Extension 26/METHOCEL
`
`[Q
`
`*Trademark of The Dow Chemical Company
`
`moisture retention, and other properties
`desired in a given formulation.
`
`Two different chemical types
`
`METHOCEL cellulose ether products
`are available in two basic types: Meth-
`ylcellulose and hydroxypropyl meth—
`ylcellulose. Both are made by the re—
`action of wood or cotton cellulose fi-
`bers with chemical reactants in the
`
`presence of caustic soda. The fibrous
`reaction product is purified and ground
`to a fine, uniform powder.
`Methylcellulose is made using
`methyl chloride. These are
`METHOCEL A brand products. Hy—
`droxypropyl methylcellulose products
`are made using propylene oxide and
`methyl chloride. These are
`METHOCEL E, F, J, and K brand
`products. There are also special-grade
`METHOCEL products available that
`have been formulated to meet the re—
`
`quirements of specific industries.
`
`Premium grades
`for food and drug applications
`
`METHOCEL Premium products have
`long been used by the food and drug
`industries. Both methylcellulose and
`hydroxypropyl methylcellulose are rec—
`ognized as acceptable food additives
`by the U.S. Food and Drug Admini-
`stration (FDA) and are listed in the
`Food Chemicals Codex and the Inter-
`national Codex Alimentarius. Both are
`included in the United States Pharma-
`
`copoeia (USP XXI). Methylcellulose
`is considered Generally Recognized As
`Safe (GRAS) by the FDA.
`
`Standard grades r
`for other applications
`
`Standard grade METHOCEL products
`have the same performance properties
`as Premium grades. The major differ—
`ence is that Standard grades can have
`slightly higher levels of impurities.
`Standard grades are not approved for
`use in foods, although some Standard
`grade products may be used as compo—
`. nents of containers coming in contact
`with food (indirect food additive).
`
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`—>
`
`General properties common to the
`whole family of METHOCEL cellu—
`lose ether products are listed in
`this table. Individual METHOCEL
`
`products exhibit these properties to
`varying degrees, and may have ad-
`ditional properties desirable in
`specific applications. Detailed in-
`formation on the performance
`properties of METHOCEL prod-
`ucts can be found on pages 18-32.
`
`
`
`Table 1: General properties of METHOCEL cellulose ethers
`
`Water solubility. METHOCEL cellulose ethers dissolve in water with no sharp solubil—
`ity limit. Surface-treated and granular METHOCEL products can be added directly to
`water systems. This feature provides exceptional handling flexibility and control of solu-
`bilization rate. While untreated METHOCEL powders are soluble in cold water, they must
`first be thoroughly dispersed in the water to prevent lumping. Dispersion techniques are
`described on pages 12-17.
`
`Organic solubility. Certain types and grades of METHOCEL are also soluble in binary
`organic and organic solvent/water systems, providing a unique combination of organic
`solubility and water solubility.
`
`No ionic charge. METHOCEL cellulose ethers are non-ionic and will not complex with
`metallic salts or other ionic species to form insoluble precipitates.
`
`Thermal gelation. Aqueous solutions of METHOCEL products gel when heated above
`a particular temperature, providing controllable quick-set properties. Unlike gels formed
`by protein thickeners, the gels go back into solution upon cooling.
`
`Surface activity. METHOCEL products exhibit surfactancy in aqueous solutions to pro—
`vide emulsification, protective colloid action, and phase stabilization. Surface tensions
`range from 42 to 56 dynes per cm.
`
`Metabolic inertness. Used as food and drug additives, METHOCEL products do not
`add calories to the diet.
`
`Enzyme resistance. Enzyme resistant METHOCEL products provide excellent viscos-
`ity stability during long—term storage.
`
`LOW taste and odor. Important in food and pharmaceutical applications.
`
`pH stability. Stable over a pH range of 3.0-1 1.0.
`
`Water retention. METHOCEL cellulose ethers are highly efficient water retention
`agents. This is valuable in food products, ceramics, and many other applications.
`
`Thickening. METHOCEL cellulose ethers thicken both aqueous and non-aqueous
`systems. The viscosity is related to the specific METHOCEL product molecular weight,
`chemical type, and concentration.
`
`Film formation. METHOCEL products form clear, tough, flexible films that are excel-
`lent barriers to oils and greases. In food applications, this property is often utilized to
`retain moisture and prevent oil absorption during cooking.
`
`Binding. Used as high performance binders for pigments, tobacco products, structured
`foods, pharmaceutical products, and ceramics.
`
`Lubrication. Used to reduce friction in rubber, portland cement, and ceramic extrusions.
`Also used to improve pumpability of slurries such as stucco. In food applications, lubricity
`aids in extrusion and other forming processes.
`
`Suspending. Used to control settling of solid particles (e.g., herbs and spices in salad
`dressings, solids in ceramic slips, and antacid suspensions).
`
`Colloidal action. Used to prevent droplets from coalescing or agglomerating.
`
`Emulsificatiou. METHOCEL cellulose ethers stabilize emulsions by reducing surface
`and interfacial tension and by thickening the aqueous phase.
`
`3
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`Figure 1: Typical chemical structures of METHOCEL products
`
`
`
`|L
`
`I I I I
`
`CH2
`H
`eHchCHa
`OH
`
`|
`CHgCH CH2
`I
`(I)
`CH3
`
`H
`
`I
`l
`J n-2
`
`o
`I
`CH3
`
`Viscosity grades
`from 3 to 100.000 mPa-s
`
`METHOCEL cellulose ether products
`are available in various Viscosity
`grades, ranging from 3 to 100,000
`mPa-s**. Since the viscosity of a so-
`lution depends on the concentration of
`METHOCEL, this wide range of prod-
`uct viscosities allows you to obtain the
`Viscosity you want in a formulation
`while using a concentration that gives
`the desired level of other performance
`properties.
`**N0te: mPa-s (millipascal-sec«
`onds) is equivalent to CF (centipoise). All
`solution yiscosities are measured with Ub-
`
`belohde riscometers at a 2 percent concen—
`tration in water at 20 °C (68 0F t.
`
`Available as powders,
`surface-treated powders,
`and in granular form
`
`For further formulating versatility,
`METHOCEL products are available in
`three different forms: Powder, sur-
`face—treated powder, and granular. The
`form influences the techniques used in
`making solutions. Untreated powders
`are soluble in cold water but must be
`
`thoroughly dispersed before they begin
`to dissolve. Surface-treated powders
`and granular products can be added
`directly to water systems.
`Techniques commonly used in
`preparing solutions with different
`physical forms of METHOCEL prod-
`ucts are summarized on pages 12—17 of
`this handbook.
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`._>
`Methylcellulose
`METHOCEL A brand products
`
`_}
`Hydroxypropyl Methylcellulose
`METHOCEL E. METHOCEL F_.
`METHOCEL J, & METHOCEL K'
`brand products
`
`All METHOCEL cellulose ether
`
`products have the polymeric back-
`bone of cellulose, a natural carbo—
`hydrate that contains a basic re—
`peating structure of anhydroglu—
`cose units. During the manufac-
`ture of cellulose ethers. cellulose
`fibers are treated with caustic solu-
`tion which in turn is treated with
`
`methyl chloride. yielding the
`methyl ether of cellulose.
`For hydrosypropyl meth-
`ylcellulose products, propylene ox-
`ide is used in addition to methyl
`chloride to obtain hydroxypropyl
`substitution on the anhydroglucose
`units. This substituent group.
`—0CH_,CH(0H)CH3, contains a
`secondary hydroayl on the number
`two carbon and may also be con-
`sidered to form a propylene glycol
`ether of cellulose. These products
`possess ranting ratios of hy-
`draq‘propyl and methyl substitu-
`tion. a factor which influences or-
`ganic solubility and the thermal ge-
`lation temperature of aqueous so-
`lutions.
`
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`__)
`Example A:
`METHOCEL A4C Premium is the
`
`designation for a premium grade
`methylcellulose product having a
`viscosity of 400 mPa-s.
`
`Example B:
`METHOCEL JSMS is a standard
`
`grade, hydroxypropyl methylcellu-
`lose product with a viscosity of
`5,000 mPa-s, which has been sur—
`face—treatedfor easy dispersion.
`
`Note: There are also a number of
`special purpose METHOCEL
`products developedfor cosmetics,
`pharmaceuticals, ceramics. and
`other applications which have dif-
`ferent systems of nomenclature
`(e.g. METHOCEL 40-Series prod-
`ucts, a family of special surface-
`treated products for cosmetic for-
`mulations).
`
`
`
`
`
`Key to product nomenclature for
`METHOCEL products
`
`METHOCEL is a trademark of The
`
`Dow Chemical Company for a line of
`cellulose ether products. In identify-
`ing many individual METHOCEL
`products, an initial letter identifies the
`type of cellulose ether. "A" identifies
`methylcellulose products. "E", "F",
`"J", and "K" identify different hy—
`droxypropyl methylcellulose products.
`The number that follows iden-
`
`tifies the viscosity in millipascal—sec-
`onds (mPa-s) of that product measured
`at 2% concentration in water at 20°C.
`
`The letter "C" is frequently used to
`represent 100, and the letter "M" is
`used to represent 1000 in designating
`viscosity.
`Several different suffixes are
`
`also used to identify special products.
`"P" is sometimes used to identify
`METHOCEL Premium grade prod-
`ucts. "LV" refers to special "Low Vis—
`cosity" products. "G" identifies
`"Granular" products. The letter "S"
`identifies "Surface-treated" products.
`
`How to get started
`formulating with METHOCEL
`
`To completely evaluate how
`METHOCEL cellulose ethers can im-
`
`prove quality, performance, and econ—
`omy in your formulations, you'll want
`to try them in your own lab. Whether
`you are developing an entirely new
`product or are working to improve an
`existing one, chances are you'll find a
`METHOCEL product that's ideally
`suited to your needs.
`
`Free samples
`and literature available
`
`Sample quantities of METHOCEL
`products are available free of charge
`for your developmental work. You
`can obtain samples by calling your lo-
`cal Dow sales office or by calling our
`toll-free number, 1-800-258-2436.
`Literature covering the use of
`METHOCEL products in many of the
`applications listed on pages 6-9 of this
`handbook is also available on request.
`
`Just call l-800-258-2436, tell us what
`types of formulations or products you
`are working on, and we'll send you all
`the current literature that applies.
`
`Our Technical Service
`
`and Development staff can help
`
`Talking with someone on our Techni-
`cal Service and Development (TS&D)
`staff can save you a great deal of for-
`mulation time. In certain applications,
`a blend of METHOCEL products may
`give best results, and the details may
`have already been worked out by
`someone in our lab. We have technical
`
`personnel who specialize in foods, ce-
`ramics, paints, cosmetics, pharmaceuti-
`cals, construction products, and other
`specific uses for METHOCEL prod—
`ucts. By taking advantage of their ex—
`perience with METHOCEL, you'll get
`a head start with your formulation and
`be certain of getting the most out of
`these versatile products.
`
`Call 1-800-258-2436. Ask for
`extension 26/METHOCEL
`
`Again, if you would like samples, ad-
`ditional literature, or technical assis—
`tance, don't hesitate to call. Call your
`local Dow sales office listed on the
`back cover of this brochure, or use the
`toll—free number. Call today. The
`sooner you get started formulating with
`METHOCEL, the sooner you'll start
`seeing improved performance and
`economy in your products.
`
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`
`
`
`Applications for METHOCEL cellulose ethers
`
`Adhesives
`
`Agricultural Chemicals
`
`Carpet backsizing compounds —~
`METHOCEL imparts excellent foam—
`ing characteristics or "pan froth" to
`backsizing compounds. This helps
`keep the adhesive in the glue line in-
`stead of soaking into the backing ma-
`terials. Also, due to thermal gelation,
`adhesives set quickly and dry faster at
`elevated temperatures.
`
`Leather processing adhesives — Used
`to paste hides to smooth porcelain or
`glass surfaces in leather drying proc-
`esses. Due to water retention effi-
`
`ciency and thermal gelation.
`METHOCEL proves much more ef-
`fective than starch based pastes.
`
`Plywood laminating adhesives — Used
`to control viscosities in glues for ply—
`wood manufacture. Thermal gelation
`and thickening properties keep the ad-
`hesive from soaking into the wood.
`
`Cigar and cigarette adhesives — Safe
`and efficient. METHOCEL products
`have long been used as binders for re»
`constituted tobacco sheets and as adhe—
`
`sives for cigar and cigarette manufac-
`ture.
`
`Wallpaper pastes — Used as the pri-
`mary adhesive in dry mixes.
`METHOCEL provides the wet tack
`required to hold a variety of paper
`types on the wall, yet has excellent slip
`properties so patterns can easily be
`matched. In premixed pastes,
`METHOCEL is used to control viscos—
`
`ity and improve wet tack. Pastes made
`with METHOCEL cellulose ethers are
`
`easily cleaned up with water and don't
`provide a source of nourishment for
`insects.
`
`Latex adhesives — METHOCEL is
`
`used as a thickener in a variety of latex
`adhesives (e.g.. adhesives used in shoe
`manufacturing). Fast drying speeds
`and high wet tack strength due to ther—
`mal gelation are key benefits in many
`of these applications.
`
`Dispersing agents ~ Used as a sus—
`pending and dispersing aid for wettable
`pesticide and fertilizer powders. Pro-
`vides high wet tack and adhesion to
`waxy plant surfaces. Chemically inert
`and nonionic, METHOCEL cellulose
`ether is compatible with a wide range
`of active ingredients.
`
`Spray adherents — Spray adherents or
`"seed stickers” made with
`
`METHOCEL effectively bind pesti—
`cides, innoculants, and nutrients to
`seeds. METHOCEL products feature
`low plant toxicity and won't harm ger-
`minating plants.
`
`Ceramics Processing
`
`Tape casting — Provides better flow
`and leveling, and more uniform thick-
`nesses. Low sodium residues provide
`purity necessary for electronic items.
`Thermal gelation reduces binder mi—
`gration and surface faults.
`
`Extrusion forming — Used as a tempo—
`rary binder and processing aid.
`METHOCEL cellulose ether allows
`
`precise control of rheology in ceramic
`mixes. permitting broader operating
`ranges. Lubricity reduces energy con-
`sumption and die wear, promotes
`smoother surfaces. Thermal gelation
`permits extrusion of extremely deli—
`cate. thin walled shapes without sag-
`ging or deformation.
`
`Dry and isostatic pressing —
`METHOCEL provides optimum grain
`lubrication for tighter, more uniform
`packing. The results are more predict—
`able green densities, less shrinkage
`during firing, and higher fired
`strengths.
`
`Glazes/porcelain enamel — Improves
`control of viscosity and rheology. In
`addition, METHOCEL cellulose ethers
`fire out completely in the kiln.
`
`Injection molding — Provides higher
`' green densities and better green
`strength.
`
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`a T
`
`he seemingly diverse products
`and processes listed here all have
`one thing in common; all benefit
`significantly from remarkably
`small concentrations of
`METHOCEL cellulose ethers. In
`
`most cases. the major benefits are
`improved physical properties. but
`in many applications there are im-
`provements in processing efiiciency
`and overall economy as well.
`For more detailed infor-
`mation on any of these applica-
`tions. contact your local Dow sales
`ofi‘ice or call us toll-free at I -800—
`258—2436.
`
`Call tollfree,
`1-800-258-2436. Askfor
`Extension 26/METHOCEL
`
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`
`
`High temperature coatings/refractory
`mixes and mortars — Improves work-
`ability and application properties.
`Low ionic salt residues won't lower
`
`melting points. Can permit a reduction
`in use of low melting point plasticiz-
`ers.
`
`Chemical Specialties
`
`Wall and ceiling textures — Imparts
`pumpability, adhesion, workability;
`and water retention in wall and ceiling
`texturizing products.
`
`Cement plaster and stucco —
`METHOCEL cellulose ether provides
`water retention for proper curing, im—
`proved workability, and pumpability.
`
`Resins — METHOCEL is used to con-
`
`Foods
`
`trol rheology and as a colloidal stabi—
`lizer in a variety of epoxy, fiberglass,
`and urea—formaldehyde resins.
`METHOCEL provides ideal flow and
`leveling characteristics, plus quick set
`properties due to thermal gelation.
`
`Rubber — Used as mold-release agents,
`stabilizers, and thickeners in rubber
`latexes, METHOCEL cellulose ethers
`contribute to more uniform drying and
`less pinholing.
`
`PVC suspension polymerization —
`Used in PVC polymerization as a pri—
`mary and secondary suspension agent.
`Provides excellent particle size con—
`trol, good porosity for improved plasti—
`cizer absorption, low reactor scaling,
`and high bulk densities.
`
`Construction Products
`
`Dry wall tape joint compounds — Used
`to impart workability, shrink and
`crack resistance, slip, and adhesion in
`tape joint compounds. Water retention
`properties increase open times and
`help maintain a wet edge.
`
`Tile mortars — METHOCEL provides
`water retention and workability to
`portland cement based ceramic tile
`mortars. Also improves adhesion, re-
`duces skinning, and increases open
`time.
`
`Masonry mortars — Used as a perform-
`ance additive in masonry mortars,
`METHOCEL extends board life and
`
`improves workability. METHOCEL
`also contributes to air entrainment, of—
`ten reducing the need for other addi—
`tives for this purpose.
`
`Bakery products — Thermal gelation
`aids in gas retention during baking, in-
`creasing baked volumes and improving
`texture. METHOCEL also provides a
`more moist texture, increased shelf
`life, improved emulsification of bat—
`ters, and better freeze/thaw stability.
`
`Pie and pastry fillings — Thermal gela—
`tion reduces boilover during baking,
`inhibits moisture migration from fill-
`ings to crusts during freezing.
`METHOCEL also improves freeze/
`thaw stability.
`
`Frozen desserts — Modified ice crystal
`size gives smoother texture, improved
`emulsion stability. Increased air en—
`trainment improves overrun.
`
`Whipped toppings — Improved whip-
`ping properties for better body and ap-
`pearance. Improved emulsion stability
`prevents syneresis and extends open
`times. Inhibits phase separation in fro-
`zen toppings, even through repeated
`freeze/thaw cycles.
`
`Structured and extruded foods — Low
`concentrations of METHOCEL give
`optimum binding strength in matrix
`systems. Due to moisture retention
`and oil insolubility properties, fried
`foods are more moist, less greasy.
`Thermal gelation gives increased con-
`trol over texture and "bite". Increased
`
`lubricity aids in processing.
`
`Frying batters — In addition to forming
`an oil insoluble barrier to block oil
`
`absorption and moisture loss during
`frying, METHOCEL Premium food
`
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`
`
`
`gums improve adhesion of batters to
`meat and vegetable substrates. As a
`result, blow-off of batters is reduced
`and the life of frying oil is extended.
`
`Salad dressings and sauces —— Better
`stability for oil—in-water emulsions
`extends shelf life. Solids stay in sus-
`pension longer and control over body
`and pouring characteristics is im-
`proved.
`
`Gelled Fuels
`
`Fuel thickeners — METHOCEL cellu-
`lose ethers are used as thickeners for
`
`gelled alcohol used in charcoal light—
`ers, restaurant candles, and canned fuel
`products.
`
`Household Products
`
`Cleaners and detergents — Provides
`viscosity control, cling, foaming, soil
`antiredeposition, and emulsion stabili-
`zation to household cleaners and deter—
`
`gents.
`
`Paints
`
`Latex paints — Used as a thickener in
`latex paints. Provides high enzyme
`resistance which helps stabilize viscos—
`ity. Film forming properties contrib—
`ute to better paint film quality with
`fewer pinholes. The product uniform-
`ity offered by METHOCEL cellulose
`ethers can mean lower quality control
`costs and more predictable perform—
`ance for paints.
`
`Paint Removers
`
`Scrape-015‘ and flush-ofipaint remov—
`ers — The unique combination of or—
`ganic and water solubility offered by
`METHOCEL products makes them
`ideal thickeners for scrape—off and
`flush—off paint removers. They pro-
`vide the thickening and cling needed
`to retain the paint remover on vertical
`or inclined surfaces, yet permit the sof—
`tened paint to be rinsed off easily with
`water.
`
`Paper Products
`
`Greaseproof coatings, release coat-
`ings, and surface sizings — Grease and
`oil barrier properties in conjunction
`with film forming abilities make
`METHOCEL valuable in a variety of
`paper coatings and sizings. The high
`film tensile strength and good elonga—
`tion properties offered by
`METHOCEL play key roles in these
`applications.
`
`Personal Care Products
`
`Shampoos - METHOCEL cellulose
`ether is widely used as a thickener in
`shampoos. Since the thickener per—
`formance of METHOCEL doesn't de—
`
`pend on a high surfactant level, it's the
`thickener of choice for shampoos de-
`signed for dry and normal hair.
`METHOCEL also helps stabilize
`foams, so shampoos have better lather
`characteristics.
`
`Creams and lotions - METHOCEL
`
`can contribute film forming and secon-
`daly thickening properties which im-
`prove afterfeel and other sensory char—
`acteristics in creams and lotions.
`
`Pharmaceuticals
`
`Tablet coatings — METHOCEL cellu-
`lose ethers form strong films with good
`adhesion. They provide a taste mask-
`ing film and act as excellent barriers
`for water sensitive drugs or compo-
`nents. Coatings of METHOCEL also
`increase compressive strength and re—
`duce friability.
`
`Granulation — Used at low concentra-
`
`tions as binders in the granulation
`process, METHOCEL produces hard
`tablets with low friability, yet won't
`negatively affect tablet disintegration.
`METHOCEL allows the reduction of
`
`compression force, an important factor
`in extending the life of tooling and
`equipment.
`
`Mylan v. Qualicaps, |PR2017-00203
`QUALICAPS EX. 2035 - 10/40
`
`Call tollfree,
`1-800-258-2436. Ask for
`Extension 26/METHOCEL
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2035 - 10/40
`
`

`

`Controlled release — METHOCEL cel-
`lulose ether can be used for controlled
`
`Textiles
`
`Textile printing pastes —— Used as emul—
`sion stabilizers in textile printing
`pastes, METHOCEL cellulose ethers
`help keep inks from wicking into fab-
`rics.
`
`Fabric sizings — METHOCEL helps
`hold fibers together, strengthening fab-
`rics during manufacturing processes.
`The lubricity of METHOCEL helps out
`friction, permitting faster equipment
`speeds.
`
`Temporary adhesives — Excellent wet
`tack and quick set properties make
`METHOCEL an ideal temporary fabric
`adhesive.
`
`release pharmaceuticals using two dif-
`ferent methods: 1) METHOCEL can
`be used in a hydrophilic matrix tablet
`or capsule as described in a separate
`bulletin on sustained release.
`
`2) METHOCEL is also used in diffu-
`sion control films comprised of
`METHOCEL cellulose ethers and
`
`ETHOCEL* ethylcellulose resins.
`The water soluble METHOCEL dis-
`
`solves out of the film, leaving the wa-
`ter insoluble ETHOCEL ethylcellu-
`lose. Drug diffusion and film porosity
`are controlled by the amount of
`METHOCEL used.
`
`Water soluble thermoplastics —
`METHOCEL cellulose ethers can be
`
`heated and mixed with a plasticizer for
`extrusion or molding into a wide range
`of physical forms. This process is
`used to produce single unit matrix tab—
`lets, multi—particulate delivery such as
`extruded beads or chips, implants,
`transdermal patches, suppositories, or
`liquid-filled hard shell capsules.
`
`Liquid preparations — METHOCEL
`products are used in oral and topical
`liquid pharmaceuticals because they
`are excellent thickeners, improve
`emulsion stability, suspend solids, lu-
`bricate, and retain moisture. The pro—
`tective colloid action and emulsifying
`properties of METHOCEL also benefit
`many liquid formulations.
`
`*Trademark of The Dow Chemical Company
`
`
`
`Mylan v. Qualicaps, |PR2017-00203
`QUALICAPS EX. 2035 - 11/40
`
`9
`
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`
`

`

`Regulated uses
`
`Pesticide Use
`
`Under 4OCFR 180.1001, certain inert
`ingredients used in pesticide formula-
`tions are exempt from the require-
`ments of a tolerance. Methylcellulose
`and hydroxypropyl methylcellulose
`may be used in formulations applied to
`growing crops or raw agricultural
`commodities after harvest, and meth-
`ylcellulose may be used in formula-
`tions applied to animals. Both Stan—
`dard and Premium grade METHOCEL
`cellulose ether products are appropri-
`ate.
`
`Pharmaceuticals
`
`Premium grades of METHOCEL A,
`METHOCEL E. METHOCEL F, and
`METHOCEL K products are used for
`pharmaceutical and topical applica—
`tions. Methylcellulose and hy-
`droxypropyl methylcellulose are listed
`in USP XXI. In addition, methylcellu-
`lose (METHOCEL A products) is
`Generally Recognized As Safe
`(GRAS) by the Food and Drug Ad—
`ministration.
`
`To support new drug applica-
`tions, master files for these products
`are on file at the Bureau of Drugs of
`the Food and Drug Administration.
`Permission to open the master file can
`be obtained by writing:
`
`The Dow Chemical Company
`Product Safety & Compliance
`2030 Dow Center
`
`Midland, MI 486 74
`
`Note! The Dow Chemical
`
`Company advises against the use of
`METHOCEL cellulose ether products
`in any form in the preparation of par-
`enteral or intravenous injections. be-
`cause the material is not readily me—
`tabolized. Significant injury to the
`kidney may result from impurities in
`the blood stream, especially if the
`methylcellulose had not been properly
`dissolved.
`
`
`
`
`
`A bibliography of pharmaceu—
`tical and medical references is avail—
`able from:
`
`The Dow Chemical Company
`Chemicals and Performance
`Products Department
`2020 Dow Center
`
`Midland, MI 48674
`
`Foods
`
`The properties of METHOCEL Pre-
`mium cellulose ethers have long been
`used in the food industry. Methylcel-
`lulose is approved as a multiple pur—
`pose GRAS food substance according
`to 21CFR 182.1480. It is also allowed
`
`for use in meat products according to
`9CFR 318.7 and 9CFR 381.147.
`
`Hydroxypropyl methylcellu—
`lose is approved for direct food use by
`the FDA according to 21CFR-‘
`172.874** It is also approved by the
`USDA as an emulsifying agent, binder,
`thickener, and stabilizer and is listed in
`the Standards and Labeling Policy
`Book published by the USDA. Be-
`cause METHOCEL products are ap-
`proved for direct food use, they can be
`used as packaging components and in
`indirect applications for food use. Pre-
`mium grade METHOCEL products
`meet the specifications of the United
`States Pharmacopeia (USP) and the
`Food Chemicals Codex (FCC). Pre-
`mium grade METHOCEL products are
`also available which meet the Euro—
`
`pean Pharmacopeia (EP) and the Japa—
`nese Pharmacopeia (JP).
`
`***METHOCEL J products are not
`cleared under this regulation.
`
`Mylan v. Qualicaps, |PR2017-00203
`QUALICAPS EX. 2035 - 12/40
`
`Call tollfree,
`1-800-258-2436. Ask for
`Extension 26/METHOCEL
`
`10
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2035 - 12/40
`
`

`

`
`
`When labeling these food in-
`gredients, one can take advantage of
`either their proper chemical names or
`their common or usual names. There-
`
`fore one could use "methylcellulose"
`or "modified vegetable gum" for
`METHOCEL A products. For
`METHOCEL E, F, or K products, one
`could use "hydroxypropyl methylcellu-
`lose" or "carbohydrate gum".
`METHOCEL products are also certi-
`fied as kosher for year round and Pass—
`over use by the Union of Orthodox
`Jewish Congregations of America.
`METHOCEL Premium prod-
`ucts are approved for use in the Euro—
`pean Economic Community (EEC)
`and have E number status. The EEC
`
`allows methylcellulose (E461) and hy~
`droxypropyl methylcellulose (E464)
`for broad food use. However, the
`regulations for specific food ingredi—
`ents vary from country to country.
`Please contact us for the status of spe-
`cific applications.
`
`EPA/TSCA compliance
`
`in compliance with EPA regulations,
`all Dow sales items subject to the re-
`porting requirements have been re—
`ported to the Administrator of the
`Environmental Protection Agency for
`inclusion in the inventory of existing
`commercial chemical substances under
`
`Section 8 (b) (l i) of the Toxic Sub-
`stances Control Act PL94—469 (15
`USC 2601 et seg.). Where the product
`consists of a mixture, we will assure
`that the individual chemicals were re—
`
`ported. The Chemical Abstracts Serv-
`ices Registry No. (CAS) is 9004—67-5
`for methylcellulose and 9904—65-3 for
`hydroxypropyl methylcellulose.
`
`Mylan v. Qualicaps, |PR2017-00203
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`
`11
`
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`

`

`
`
`
`
`How to prepare solutions of METHOCEL
`
`METHOCEL cellulose ether products
`are carbohydrate polymers which dis—
`solve in cold water (and in some in-
`stances in certain organic solvents.) by
`swelling and subsequent hydration.
`There is no sharp solubility limit such
`as occurs in the dissolution of ionizing
`salts. The concentration of
`
`METHOCEL in solution is usually
`limited by the viscosity that a manu-
`facturer is equipped to handle. It also
`depends on the Viscos