`
`Page 1 of 1
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`Contact
`
`PDF version (292KB)
`PIN code is necessary
`
`PHARMACOAT® (Hypromellose*)
`
`* Instead of Hydroxypropyl Methylcellulose we changed its generic name to
`Hypromellose as from October, 2002.
`
`Film coating was developed as a sub-coating for sugar coating in the
`1950s, and film-coated tablets were introduced in the early 1970s.
`Since then, development work aimed at enhancing efficiency by
`increasing the production rate of film-coated tablets and reducing costs
`has been carried out along with efforts to increase the bioavailability of
`drugs. Film coating is now a well-established and effective technique.
`PHARMACOAT® was developed from hypromellose (also known as
`hydroxypropyl methylcellulose) in 1963, during the early days of film
`coating. It has been the subject of a continuous program of
`development and quality improvement. Film coatings of this type are
`now in widespread use throughout the world. PHARMACOAT® is
`also effective as a binder, because it does not interact with drugs and
`has high stability and non-ionic properties. In addition,
`PHARMACOAT® can be used in place of gelatin for hard capsule
`manufacturing because of its greater stability.
`
`PHARMACOAT® Water-Soluble Film Coating Agent
`(Hypromellose; USP)
`
`PHARMACOAT
`
`Grade
`603
`645
`606
`615
`
`Substitution Type
`
`2910
`
`Labeled Viscosity (mPa¥s)*
`3
`4.5
`6
`15
`
`Note: * 2 wt.% aqueous solution at 20oC according to the USP measuring method.
`PHARMACOAT® is also useful as a binder for tablets or granules.
`
`SB-4 Sugar Coating Binder
`(Hypromellose; USP)
`
`SB-4
`
`Substitution Type
`2208
`
`Labeled Viscosity (mPa¥s)*
`4
`
`Note: * 2 wt.% aqueous solution at 20oC according to the USP method.
`SB-4 is useful as a binder for sugar coating.
`
`http://www.metolose.jp/e/pharmaceutical/tc-5.shtml
`
`9/27/2016
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1012 - Page 1
`
`
`
`信越化学工業 セルロース部
`
`Page 1 of 1
`
`▲ TC-5®(hypromellose)
`< Old pharmaceutical name: hydroxypropyl methylcellulose:
`Film-coating has been developed as for the Undercoat of frosting in the 1950s, as
`then, in the early 1970s new dosage form has appeared in film-coated tablets.
`Discussed the increased productivity and cost savings since the rational prescription
`of the drug, aiming to further consider the Bioavailability of the drug and now film-
`coated golden age marks has arrived.
`TC-5® are undertaken in the film coating developed early in 1963, hypromellose
`(hydroxypropyl methylcellulose) developed as a base, and then continuous quality
`improvement. At present, Japan and grew up on the water soluble film coating
`cannot do without in the world wide.
`TC-5® , to provide features such as "no interactions with drugs" "excellent
`stability'" non-ionic"as a binder is perfect material.
`Has also been used as well in recent years, from the mad cow disease problem
`instead of gelatin capsules for pretreatment.
`
`PDF file (1.25 MB)
`Access code is
`required.
`
`TC-5® Water soluble film coating
`(Japan Pharmacopoeia hypromellose; degree of substitution type: 2910)
`
`Varieties
`
`Degree of substitution type
`
`View viscosity (mPa / s) *
`
`TC-5
`
`E
`
`M
`
`R
`
`S
`
`2910
`
`3
`
`4.5
`
`6
`
`15
`
`Note) in a 20 ° C * 2% aqueous solution viscosity (Japan pharmacopoeia).
`TC-5® is a versatile as a binder.
`
`SB-4 sugar-coating binders
`(Japan Pharmacopoeia hypromellose; degree of substitution type: 2208)
`
`Varieties
`
`View viscosity (mPa / s) *
`
`SB-4
`
`SB-4
`
`4
`
`Note) in a 20 ° C * 2% aqueous solution viscosity (Japan pharmacopoeia).
`
`METOLOSE® SM-4 granules for water soluble film coating
`(Japan Pharmacopoeia methyl cellulose)
`
`Varieties
`
`View viscosity (mPa / s) *
`
`SM-4
`
`SM-4
`
`4
`
`Note) in a 20 ° C * 2% aqueous solution viscosity (Japan pharmacopoeia).
`SM-4 the form of yours as a binder.
`
`http://65.55.252.15/proxy.ashx?h=kEddWSQmawPwNTUa2RpdmqVjUr1ZN5X8&a=http...
`
`9/27/2016
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1012 - Page 2
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