STARCH 1500®
`
`P A R T I A L L Y P R E G E L A T I N I Z E D M A I Z E S T A R C H
`
`Flexibility for performance
`
`C
`
`O
`
`L
`
`O
`
`R
`
`C
`
`O
`
`N
`
`®
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 001
`
`

`

`DIRECT COMPACTION
`
`Starch 1500 performs key functions in
`direct compaction formulations as a binder,
`disintegrant, flow-aid and self-lubricant.
`It also promotes formulation f lexibility
`by complementing and enhancing the
`functionality of other excipients.
`
`B I N D E R
`
`As a dr y binder, it compresses well,
`predominately deforming plastically. Starch
`1500 can be used with other excipients,
`such as microcrystalline cellulose, lactose,
`and dicalcium phosphate, to produce
`tablets with excellent hardness and low
`friability at compaction forces typically
`used in tableting operations.
`
`D I S I N T E G R A N T
`
`Starch 1500 performs the actions of two
`disintegrants; maize starch and free amylose
`in dry processes. In some applications, 2%
`to 10% of Starch 1500 provides disintegrant
`action as effective as super disintegrants,
`greatly reducing costs. (See Figure 1)
`
`Figure 1
`
`DISINTEGRATION PROFILE FOR HYDROCHLOROTHIAZIDE TABLETS, 50 MG **
`
`DISINTEGRATIONTIME(MINUTES)
`
`The combination of maize starch and
`free amylose has a positive impact on
`drug dissolution. Supporting the tablet
`disintegration data in Figure 1, the
`resulting drug dissolution data
`in
`Figure 2 compares Starch 1500 with
`more costly disintegrants.
`
`STARCH 1500 ®
`PARTIALLY PREGELATINIZED MAIZE STARCH
`T H E S U P E R I O R M U LT I F U N C T I O N A L E X C I P I E N T F O R
`
`S O L I D D O S A G E D E V E L O P M E N T
`
`Starch 1500 is a unique pharmaceutical excipient combining
`
`several properties in a single product. Only Starch 1500
`
`performs the multiple functions of a binder, disintegrant,
`
`flow-aid and self-lubricant. It is extremely versatile, being
`
`effective in a variety of processing methods for solid oral
`
`dosage forms. Starch 1500 also exhibits synergy, enhancing
`
`the functionality of other commonly used excipients
`
`in formulations.
`
`MULTIFUNCTIONAL
`Provides a unique range of functions:
`
`• Binder
`• Disintegrant
`• Flow-Aid
`• Lubricant
`
`VERSATILE
`Flexible performance in a variety of applications:
`
`DIRECT
`COMPACTION
`
`WET
`GRANULATION
`
`CAPSULE PLUG
`FORMATION
`
`Binder
`Disintegrant
`Flow-Aid
`Lubricant
`
`X
`X
`X
`X
`
`X
`X
`X*
`X*
`
`X
`X
`X
`X
`
`* In the extra granular phase
`
`COST-EFFECTIVE
`Cuts process and material costs by reducing or eliminating:
`
`• Excess binders
`• Superdisintegrants
`• Additional lubricants and glidants
`• Manufacturing steps
`
`MANUFACTURED FOR THE PHARMACEUTICAL INDUSTRY
`• Manufactured in modern cGMP facilities dedicated solely
`to the production of pharmaceutical excipients
`
`INDUSTRY LEADING TECHNICAL EXPERTISE
`• Worldwide manufacturing, distribution and technical
`service facilities
`
`• Formulation and application development support
`
`• Global regulatory assistance
`
`• Innovative new product development
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 002
`
`

`

`Figure 2
`
`Figure 3
`
`Figure 4
`
`DISSOLUTION PROFILE FOR HYDROCHLOROTHIAZIDE TABLETS, 50 MG**
`
`EJECTION FORCE VALUES FOR HYDROCHLOROTHIAZIDE TABLETS
`
`CONCENTRATION DEPENDENT VISCOSITY PROFILES
`
`VISCOSITY(CP)
`
`EJECTIONFORCE(KN)
`
`% RELEASED
`
`TIME (MIN)
`
`COMPACTION FORCE (KN)
`
`% SOLIDS
`
`** Tablets were formulated with 25%
`hydrochlorothazide, 0.25% magnesium
`stearate, and equal parts lactose and
`dicalcium phosphate. Equal portions of
`the lactose and dicalcium phosphate
`were substituted with 2% or 10%
`Starch 1500.
`
`Hydrochlorothiazide 25%, excipient
`74.75% , 0.25% magnesium stearate
`as lubricant
`
`Traditional starch paste at 85°C
`compared to Starch 1500 and a
`fully pregelatinized starch prepared
`in cold water
`
`F L O W - A I D
`
`Starch 1500 provides excellent f low
`properties, demanded by today’s high-speed
`tableting and capsule filling equipment;
`ensuring that manufacturers can produce
`tablets and capsules with consistent
`uniform weight and drug content.
`
`S E L F L U B R I C A N T
`
`The high inherent lubricity of Starch
`1500 enables the formulator to lower the
`levels of traditional lubricants, such
`as magnesium stearate. For example,
`magnesium stearate added in high levels,
`or when over-blended, can slow dissolution
`and cause problems with compaction
`(soft tablets) and film coating (poor film
`adhesion). Therefore, Starch 1500 enables
`lubricant levels and their potential problems
`to be reduced or eliminated. (See Figure 3)
`
`WET GRANULATION
`
`In wet granulation applications, Starch
`1500 exhibits dual functionality as both
`binder and disintegrant as a result of
`partial cold water solubility. Starch 1500
`allows process flexibility:
`it can be
`dry-blended with other ingredients
`before adding water, or a portion can
`be dispersed in cold water. A slurry of
`Starch 1500 in cold water provides
`effective binding properties at higher
`solids and lower viscosity than traditional
`starch pastes, which must be heated
`and prepared at lower concentrations.
`(See Figure 4) Processing costs are
`reduced by eliminating the time and
`expense of preparing traditional binder
`solutions.
`In addition, granulations
`using Starch 1500 as a binder give
`excellent tablet hardness and fast
`disintegration.
`
`In fluid bed granulations, Starch 1500
`alone can be used as both binder
`a n d d i s i n t e g r a n t . F o r ex a m p l e ,
`capsule-shaped acetaminophen tablets,
`500mg, of excellent hardness and
`friability values of less than 0.19%
`were produced through the simple
`formulation of 85% acetaminophen and
`15% Starch 1500 used as the wet
`granulation binder. In this formulation,
`Starch 1500 functioned as an exceptional
`disintegrant with disintegration time
`less than 1 minute. Dissolution was
`excellent. Test results showed 80% drug
`release within 5 minutes.
`In addition,
`the low viscosity of Starch 1500 in cold
`water allowed higher binder content
`solutions and faster spray times, resulting
`in reduced process times.
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 003
`
`

`

`CAPSULE PLUG FORMATION
`
`Starch 1500, as a f low-aid, improves
`uniformity of capsule fill. As a binder,
`Starch 1500 facilitates plug formation in
`dosator-type equipment and reduces
`powder fallout when the plug is
`transferred. The inherent lubricity of
`Starch 1500 means a lower force to
`eject material into the capsule shell
`(compared to other excipients) and
`leads to reduced wear on dosator-type
`equipment.
`
`C O L O R C O N
`
`S U P P L I E R
`
`O F
`
`C H O I C E
`
`Colorcon has a firm commitment to providing products and
`
`services for high quality coating systems and formulated
`
`products along with technical support dedicated to meeting
`
`STARCH 1500
`PRODUCT RANGE
`
`customers’ needs. In addition, a focus on market issues
`
`and technology development has earned Colorcon an
`
`Colorcon has made Starch 1500 even
`more versatile by developing a line of
`products for optimal performance
`applicable to a variety of formulations.
`The Starch 1500 product range is produced
`exclusively for the pharmaceutical
`industr y under cGMP guidelines.
`Starch 1500 products are designed to
`meet regulator y needs worldwide.
`Specific products conform to the
`USP/NF, Ph.Eur, and JPE compendial
`monographs.A firm
`
`international reputation in the pharmaceutical industry as
`
`the supplier of choice.
`
`Colorcon’s worldwide network of technical service laboratories
`
`and experts bring solutions to our customers when and
`
`where they are needed. These resources serve all aspects
`
`of customer projects including; formulation development,
`
`application development, scale-up support and regulatory
`
`information. We understand the impact of speed to
`
`market in the competitive fast paced pharmaceutical
`
`industry and support our customers in the production
`
`of highly effective formulations in reduced time frames.
`
`Take advantage of our experience, technology and
`
`creativity; enhance your position in the marketplace.
`
`Make Colorcon your partner, your supplier of choice.
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 004
`
`

`

`UNIQUE MANUFACTURING PROCESS
`
`Starch 1500 is a partially pregelatinized maize starch manufactured exclusively for
`
`the pharmaceutical industry in dedicated cGMP facilities. The process involves a
`
`physical modification of the starch (no chemical additives or surfactants are used),
`
`resulting in the combined benefits of the soluble and insoluble functionality of
`
`Starch 1500.
`
`Maize starch is composed of two polymers, amylose and amylopectin which are
`
`tightly bound in a specific spherocrystalline structure. Through partial pregela-
`
`tinization, the bond between a portion of the two polymers is broken, providing
`
`Starch 1500 with its unique properties. The process results in partial solubility,
`
`increased particle size, improved flow properties and compactability.
`
`AMYLOPECTIN
`
`AMYLOSE
`
`Amylopectin has a branched-chain molecular
`structure, which makes it readily soluble
`in cold water. Amylopectin functions as a
`binder in wet granulation processes.
`
`Amylose has a straight-chain molecular
`structure, which exhibits a very strong
`intermolecular bonding capability. Amylose
`swells significantly when wetted, giving it
`excellent disintegrating characteristics.
`
`STARCH NF
`
`STARCH 1500®
`
`ONE EXCIPIENT, MULTIPLE FUNCTIONS
`
`Colorcon’s unique manufacturing process results in the most effective
`
`functional balance for Starch 1500, providing good cold water binding
`
`and granulation properties, yet retaining effective tablet disintegrant
`
`properties. The physical structure of Starch 1500 also imparts good
`
`compactability, flow and lubrication capabilities.
`
`These multifunctional properties can be utilized in a variety of applications,
`
`including direct compaction, wet granulation, fluid bed granulation and
`
`capsule plug formation. The distinct benefits of Starch 1500 can bring
`
`significant process flexibility to solid dosage forms.
`
`SEM photo of Starch 1500 shows individual starch grains along with aggregates bonded to the hydrolyzed starch.
`Starch 1500 has better flow characteristics than Starch NF and has much higher compactability. Photos shown at
`10 microns.
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 005
`
`

`

`STARCH 1500®
`
`P A R T I A L L Y P R E G E L A T I N I Z E D M A I Z E S T A R C H
`
`I Multifunctional for formulation versatility
`
`I Flexibility for performance in a variety of applications
`
`I Manufactured exclusively for the pharmaceutical industry
`
`I Meets global regulatory requirements
`
`WORLD HEADQUARTERS
`COLORCON
`415 Moyer Blvd., P.O. Box 24, West Point, PA 19486-0024
`Tel: 215-699-7733 Fax: 215-661-2605
`
`LOCATIONS
`
`TELEPHONE
`
`FACSIMILE
`
`UNITED STATES
`Santa Ana, California
`Indianapolis, Indiana
`Humacao, Puerto Rico
`
`EUROPE
`Dartford, Kent, England
`Bougival, France
`Idstein, Germany
`Gallarate, Italy
`Budapest, Hungary
`Barcelona, Spain
`
`ASIA/PACIFIC
`Singapore
`Shanghai, China
`Mumbai, India
`Tokyo, Japan
`
`LATIN AMERICA
`Buenos Aires, Argentina
`Bogota, Colombia
`Santa Fe, Mexico
`Caracas, Venezuela
`
`714-549-0631
`317-545-6211
`787-852-3815
`
`714-549-4921
`317-545-6218
`787-852-0030
`
`44-1322-293000
`33-1-3082-1582
`49-6126-9961-0
`39-0331-776932
`36-1-200-8000
`34-9-3589-3756
`
`44-1322-627200
`33-1-3082-7879
`49-6126-9961-11
`39-0331-776831
`36-1-200-8010
`34-9-3589-3792
`
`65-438-0318
`86-21-6489-2222
`91-22-868-2537
`81-3-5248-0581
`
`65-438-0178
`86-21-6489-2223
`91-22-868-4518
`81-3-5248-0547
`
`54-11-4552-1565
`571-418-1202
`525-292-1611
`58-2-442-4819
`
`54-11-4552-5158
`571-418-1190
`525-292-1750
`58-2-442-6340
`
`VISIT COLORCON ONLINE AT www.colorcon.com
`
`The information contained herein, to the best of our knowledge, is true and
`accurate. Any recommendations or suggestions are made without warranty or
`guarantee, since the conditions of use are beyond our control. Any information
`contained herein is intended as a recommendation for use of our products so as
`not to infringe on any patent.
`
`Starch 1500® is a trademark of BPSI.
`©1999 Colorcon
`
`EX/STAR/PB1199
`
`Colorcon’s globally available product line for the pharmaceutical
`industry includes:
`
`Complete Film Coating Systems
`Opadry®
`Opadry® II
`Opadry® AMB
`
`Modified Release Products
`Sureteric® Aqueous Enteric Coating System
`Surelease® Aqueous Ethylcellulose Dispersion
`
`Monogramming Inks
`Opacode®
`Opacode® WB
`
`Excipients
`Starch 1500® Partially Pregelatinized Maize Starch
`
`Additional Products
`Opaspray® Color Coating Dispersion
`Opatint® Food Coloring System
`Opaseal® Sealant Coating Product
`Opaglos® Tablet Core Sealant Product
`Opalux® Color Coating Product
`
`FD&C and D&C Aluminium Lakes
`
`Pigment Blends
`
`Member of the Berwind Pharmaceutical Group
`
`Par Pharm., Inc.
`Exhibit 1025
`Page 006
`
`