ISP PHARMA C1020 Advantia Performance

8/2/2019 ISP PHARMA C1020 Advantia Performance

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Product Guide

Advancing the Science of Coating

Pharmaceuticals

Performance

Enhancing

Technology

Advantia PerformanceCoating Systems

for Delayed (Enteric) Drug Release


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Table of Contents

Introduction. 3

ISP: A Partner for Film Coating ........................................................................................3

Development.of.Advantia.Performance.Coating.Systems..

by.Statistical.Design.of.Experiments 4

Advantia Performance 190024HA49 .............................................................................5

Color Coating Systems .....................................................................................................5

Application.of.Advantia.Performance.Coating.Systems. 6

Aspirin Tablets with Advantia Performance Coating System ...........................................6

Details of Coating Process Used ......................................................................................7

Overview of Results Obtained ..........................................................................................9

General.Coating.Guidelines.for..

Advantia.Performance.Coating.Systems. 12

Suspension Preparation Guidelines ...............................................................................12

General Coating Condition Guidelines ...........................................................................12

Sub-Coating Guidelines .................................................................................................13

Technical.Service.and.Support 14

Technical Capabilities .................................................................................................14

Regulatory.and.Safety. 14

Storage.and.Handling. 15

Getting.Started. 15

2..Advantia.Performance.Coating.Systems.


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ISP.Pharma.Technologie

IntroductionAdvantia Perormance Coating Systems are pre-blended, ready-to-use

powders based on methacrylic acid ethyl acrylate copolymer or lm coating

o pharmaceutical oral solid dosage orms (tablets, multiparticulates, two-piece

gelatin capsules, and sotgels) to produce a delayed-release (or enteric-release)

eect. Available pigmented or unpigmented, Advantia Perormance Coating

Systems are easy-to-use powders that can be readily dispersed in water and applied.

With an Advantia Perormance Coating Systems, suspension preparation is

simple. Te more traditional procedure or preparing enteric-coating suspensions

oten requires three steps. In the traditional process, the rst step is to homogenize

the plasticizer, detackier and, optionally, an antioam agent in water to orm

a suspension. Ater a suitable mixing time, this suspension is then added, with

mixing, to an acrylic polymer dispersion. Tis combined suspension is passed

through a sieve. For colored enteric-coating ormulation, a colorant must be

added using an additional processing step.

With an Advantia Perormance Coating Systems, powder is added to water(stirred in a suitable mixing tank to create a vortex) and mixed. With this process,

there are ewer processing steps involved, and ewer ingredients to inventory and

submit to quality control testing compared with a traditional system, thus saving

time and money.

ISP:.A.Partner.for.Film.Coating

Experience. As a supplier o high-quality excipients or solid dosage orms,

including Plasdone binders and Polyplasdone super disintegrants, to the

pharmaceutical, vitamin and nutritional industries or over 50 years, ISP has

developed sound expertise in ormulation o oral solid dosage orms. Tis

expertise complements our capabilities with respect to designing lm-coating

systems. ISP has over 50 sales specialists and 40 scientists dedicated to its

pharmaceutical business, working in local oces and laboratories around the

world to respond to customer needs and ensure consistent product rom

laboratory to commercial production.

Innovative. In addition to oering lm coating systems based on conventional

technology, ISP is developing innovative coating systems based on its experience

as a leading polymer research company. Te ISP technical team has core strengths

in design and development o novel unctional systems based on molecularstructure-property relationships, to provide rapid solutions to customer needs.

At ISP, our scientists are working to develop an enhanced range o lm coatings

designed to meet the evolving needs o the pharmaceutical industry. We are

committed to advancing the science o tablet lm coatings.

Worldwide. With over 70 locations worldwide, serving customers in more than

90 countries, ISP can provide the global sales and service support our customers

require rom a lm coating supplier. Our eight pharmaceutical laboratories are

staed with scientists that have experience in the ormulation o oral solid dosage

orms, design o coating ormulations, color matching, and coating applications.

ISP.Pharmaceuticals.Product.Guid


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Development.of.Advantia.Performance..

Coating.Systems.by.Statistical.Design..

of.ExperimentsIn the development o Advantia Perormance Coating Systems, ISP used a

statistical design o experiments (D.o.E.) approach to understand the impact

o component levels on the perormance o an enteric coating system to provide

consistent, reproducible enteric release proles. Using the data generated and

the predictive capabilities o the D.o.E. sotware, ISP can identiy the optimum

ormulation, and its perormance attributes, best suited or each customers

application. For example, the data acilitate the selection o enteric lm coating

ormulations with a broad range o potential attributes, such as:

Fastest drug release in buer, pH 6.8

Most eective gastric resistance at lowest weight gain

Most suitable or enteric coating o intagliated tablets

Te last o these points oten presents a challenge or enteric lm coating since the

coating deposited within the intagliation is likely to be much thinner, and possess

a less suitable coating structure, so that maintaining eective gastric resistance is

compromised. ISP scientists have studied enteric-coated intagliated tablets, using

erahertz analysis technology. In Figure 1, erahertz analysis o two intagliated

tablets is shown, indicating that the enteric lm is signicantly thinner within the

intagliation and at the edges.

Figure.1.Coating thickness assessed using Terahertz technology indicates potential or

compromising integrity o enteric lm coating on an intagliated tablet.


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Advantia.Performance.190024HA49.

Advantia Perormance 190024HA49, a white coating ormulation, has been

selected as our standard concept sample and is intended to be a starting

point ormulation. In cases where additional perormance attributes are

required, ISP scientists utilize the D.o.E. sotware in combination with

responses generated rom the design o experiment, to produce a coating

ormulation more suitable or a given application.

Color.Coating.Systems

When a colored tablet is required, a colored Advantia Perormance coating

can be ormulated to meet your individual color needs, limited only by specic

color regulations. ISP maintains strict color control to ensure lot-to-lot

consistency. ypical colored examples are shown in Figure 2.

Alternatively, tablets can be enteric-coated with a white Advantia

Perormance Coating System and subsequently overcoated with a

colored Advantia Prime Coating System (cellulosic lm-coating system).For a colored product, please contact your local ISP sales oce or account

representative.

Figure.2.Advantia Perormance Coating Systems can be pigmented to reduce the

number o processing steps.


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Application.of.Advantia..

Performance.Coating.Systems.Advantia Perormance Coating Systems have been used or a broad range o

applications requiring a delayed-release coating, including the coating o tablets,

capsules (sotgels) and multiparticulates. Examples o active pharmaceutical

ingredients (APIs) that ISP scientists have worked on with Advantia PerormanceCoating Systems are shown in able 1.

Table.1.APIs that have been the subject o coating projects with Advantia Perormance

While each coating application may have specic requirements (in terms o type

o process and specic process conditions used), a project involving the enteric

coating o 325-mg aspirin tablets serves as an example o the application

o Advantia Perormance Coating Systems.

Aspirin.Tablets.with.Advantia .Performance.Coating.System

Te primary objective was to produce enteric-coated aspirin (325-mg) tablets that

met all o the requirements o the U.S. Pharmacopeia (USP) in terms o enteric

perormance, while meeting the critical objectives imposed by accelerated stabilitytesting, especially with respect to levels o ree salicylic acid ormed ater such

testing or three months at 40C, 75% RH.

Class Product.Examples

NSAIDS/Analgesics

Dicloenac sodium

Ketoproen

Indomethacin

Para-amino-salicylic acid

Aspirin

Proton Pump Inhibitors

Omeprazole

Pantoprazole

Lansoprazole

Rabeprazole

Laxatives Bisacodyl

Bisacodyl + docusate sodium

Anti-epileptics Sodium valproate

Enzymes Pancreatin


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Table.3.Process conditions used or application o Advantia Perormance enteric coating to

325-mg aspirin tablets

At the conclusion o the coating trials, enteric-coated aspirin tablets were

evaluated or:

Gastric resistance, where 100 tablets were exposed or two hours in 0.1N

HCl solution, ater which the number o ailures was determined (ailures

in this case consisted o tablets that either disintegrated or had sotened

and become swollen).

Gastric juice uptake, where, again using 100 tablets exposed to 0.1N HCl

solution or two hours, the weight o tablets was determined (ater careully

drying the surace o each tablet beore weighing).

Drug release in gastric juice, ater two hours, using the USP apparatus 2

and 0.1N HCl solution as the dissolution medium.

Dissolution in phosphate buer, pH 6.8, again using USP apparatus 2.

In addition, samples o enteric-coated tablets were packaged into HDPE bottles,

with desiccant packs and subsequently oil sealed, and then set up or stabilitytesting under accelerated conditions or three months at 40C and 75 %RH. At the

conclusion o the testing period, tablet samples were subjected to analysis or:

Drug release in gastric juice, ater two hours, using the USP apparatus 2

and 0.1N HCl solution as the dissolution medium.

Dissolution in phosphate buer, pH 6.8, again using USP apparatus 2.

Free salicylic acid content.


Process.Parameter Process.Setting

Quantity o tablets used (kg) 7.5 (previously sub-coated)

Enteric-coating suspension Advantia Perormance (sprayed at 20% w/w solids)

Process air fow 200 cm/340 m3h-1

Atomizing air pressure (bar) 1.7

Pattern air pressure (bar) 2.8

Pan speed (rpm) 15.0

Trial.A Trial.B

Spray rate (g min-1) 25 30

Inlet temperature (

C) 50 60

Exhaust temperature (C) 40 45

Tablet bed temperature (C) 41 45


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Overview.of.Results.Obtained

Te results obtained or 325-mg aspirin tablets, enteric-coated as described earlier,

are shown in able 4.

Table.4.Enteric test and stability results obtained or 325-mg aspirin tablets coated with

Advantia Perormance Coating System

Test.Condition Results.Obtained

Initial

Trial.A Trial.B

Acid uptake (%, mean or 100 tablets

ater 2 hours exposure)5.5 3.8

Gastric ailures (% or 100 tablets ater

2 hours exposure at 100 rpm)5.0* 3.0*

Dissolution in 0.1N HCl solution (% ater2 hours exposure)

0.61** 1.86**

Dissolution in phosphate buer, pH=6,8

(% ater 90 minutes at 100 rpm)100*** 100***

After.3.Months.at.40 C,.75.%RH

Dissolution in 0.1N HCl solution (% ater

2 hours exposure at 100 rpm)1.43** 2.64**

Dissolution in phosphate buer, pH=6,8

(% ater 90 minutes at 100 rpm)100*** 100***

Free salicylic acid (%) 0.09**** 0.06****

* No tablets disintegrated, and the only ailures observed were tablets with a slight

sotening o the coating

** USP limit nmt 10%

*** USP Q value > 80%

**** USP limit nmt 3.0%


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A representative sample o the enteric-coated aspirin tablets is shown in Figure 3.

Figure.3.Enteric-coated aspirin tablets (325-mg) with Advantia Perormance Coating System

As can be seen, all samples o aspirin tablets that had been enteric-coated with

an Advantia Perormance Coating System easily met the pre-requisites o the USP

monograph or delayed-release aspirin tablets.


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In terms o gastric resistance, urther improvements could be obtained, i required,

by adjusting the levels o enteric coating applied. ypical enteric dissolution results

to be obtained by doing so are shown in Figure 4.

Figure.4. Infuence o amount o Advantia Perormance Coating System applied on drug release

rom enteric-coated tablets

Note: First two hours o test were conducted in 0.1N HCl, ater which the medium was changed

to buer, pH=6.8.

ISP.Pharmaceuticals.Product.Guide

6% Weight Gain

12% Weight Gain

10% Weight Gain

16% Weight Gain

8% Weight Gain

14% Weight Gain

0

20

40

60

80

100

120

0 30 60 90 120 125 130 135 140 145 150

Time (min)

%D

rugReleased


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General.Coating.Guidelines.for..

Advantia.Performance.Coating.Systems

Suspension.Preparation.Guidelines

It is recommended to use Advantia Perormance Coating Systems at 20% solids

in water. Te maximum solids level will depend on the particular spray gun, pump

and coating equipment used.

Te suspension is prepared in a one-step process that involves:

Adding the required quantity o water into a suitable mixing vessel and

centering the propeller stirrer in the mixing vessel as close to the bottom

as possible.

Setting the mixer to the astest possible speed that maintains a vortex without

drawing air into the water.

Adding the Advantia Perormance powder to the vortex as quickly as possible,

avoiding fotation o the powder and increasing the mixer speed as necessary

to maintain the vortex.

Maintaining mixer speed to ensure a reasonably vigorous mixing o the

suspension throughout the 60-minute reconstitution period.

At the end o the reconstitution period, the suspension should ideally be passed

through a 60-mesh screen to remove any undispersed material.

Advantia Perormance Coating System suspensions should be gently mixed during

the coating process in order to prevent sedimentation o suspended ingredients

and thus a change in the respective ratios o critical ingredients in the coating

ormulation.

General.Coating.Condition.GuidelinesTe suggested coating conditions or application o Advantia Perormance Coating

System rom an aqueous coating suspension with solids content o ~20% on tablets

are provided in able 5. As the methacrylic polymers have a lower glass transition

temperature (g) than hydroxypropylmethyl cellulose (HPMC), lower inlet, exhaust

and bed temperatures are recommended compared with those conditions used or

a typical cellulosic lm-coating process.


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Table.5 General coating conditions or application o aqueous coating suspension o Advantia

Perormance Coating System using a 19 ully perorated pan tted with a Schlick ABC spray

gun and loaded with 7-8kg o tablets.

Sub-Coating.Guidelines

While application o a sub-coat to the surace o the dosage orm being coated is

not a pre-requisite or using Advantia Perormance coatings, this practice is oten

benecial since it:

Minimizes surace abrasion o the core prior to application o the enteric

coating, thus ensuring a more reproducible result in terms o drug release.

Minimizes the potential or interaction between the core and the enteric

coating, especially when such interaction may compromise the unctionality

o the enteric coating (as is potentially the case when the core contains alkaline

materials) or may aect the stability o the API should it be sensitive to the

inherent acidity o the enteric-coating polymer.

ISP typically recommends Advantia Prime 199989HA09 (able 6). However, a wide

range o cellulosic-based lm-coating ormulations can be used as a sub-coating,

depending on the tablet core and local regulations. Please consult your local ISP

sales oce or account representative.

Table.6 Prior to application o an Advantia Perormance enteric-release coating,

Advantia Prime 199989HA09 should be applied as a sub-coating.

Product.Name Color

Suggested.

Suspension.

Solids.(%)

Suggested.

Weight.Gain.

(%)*

Advantia Prime 199989HA09 Clear 10-12 1.5-3.0

* Depending on the size, shape and surace characteristics o the core (tablets, capsules

or multiparticulates).

Parameter Settings

Inlet temperature (oC) 50-60

Tablet bed temperature (oC) 36-42

Exhaust temperature (oC) 38-44

Spray rate (g min-1) 22-32

Air Flow 175-225 cm/297-382 m3 h1

Atomizing air pressure (bar) 2.2-2.5

Pattern air pressure (bar) 2.4-2.8

Pan speed (rpm) 12-18


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Technical.Service.and.SupportISP is committed to providing service and support to customers globally during

the development process through ull-scale commercial production. At ISP, we

have eight technical centers dedicated to supporting our customers and their

eorts with respect to pharmaceutical oral solid dosage orms with our excipients

and lm coating systems. Each laboratory is ully equipped and staed with

pharmaceutical scientists who have experience in pharmaceutical ormulation

and lm-coating technology.

Technical.Capabilities

As a supplier o high-perormance Plasdone binders and Polyplasdone super

disintegrants, ISP has core capabilities in tablet ormulation, including orally

disintegrating tablets, and tablet process technology, involving wet granulation,

direct compression and roller compaction. We routinely evaluate tablet

perormance, including tablet strength, riability, compaction proles, and

dissolution characteristics. We employ a compaction simulator in our Wayne, NJ

R&D laboratory to study the undamentals o compaction and assist customers in

ormulation development, excipient selection and scale-up.

o support our Advantia Coating Systems, ISP has a broad range o tools available

or characterizing and assessing the properties o lm coatings and lm-coated

products, including those suitable or determining:

Film mechanical properties

Film adhesion

Opacity o applied coatings

Film surace qualities, including gloss and coating roughness

Coating uniormity, structure and density

Coating permeability

Rheological characteristics o coating liquids

Coated product stability

Color matching

Dissolution characteristics

Regulatory.and.SafetyAdvantia Perormance 190024HA49 contains ingredients acceptable or use on

pharmaceutical products sold in North America, the European Union and Japan.

Te polymer in Advantia Perormance 190024HA49 is produced rom dispersions

that comply with the United States Pharmacopeia/National Formulary (USP/NF)

designation or Methacrylic Acid Copolymer Dispersion and JPE monograph or

Methacrylic Acid Copolymer LD. Te polymer conorms to Ph.Eur 5.7 Methacrylic

Acid Ethyl Acrylate Copolymer 1:1 (ype B)


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Advantia Prime 199989HA09 contains ingredients acceptable or use on

pharmaceutical products sold in North America, the European Union and Japan.

ISP maintains ype IV Drug Master Files (DMFs) with the United States Food

and Drug Administration (FDA) or Advantia Prime and Advantia Perormance

products (able 8).

Table.8.To support regulatory lings o drug products with U.S. FDA, ISP supports DMFs orAdvantia Coating Systems

Please consult your local ISP sales oce or inormation concerning the suitability

or use on pharmaceutical products to be sold in other regions. ISP recognizes

the importance o providing leadership in health, saety and regulatory product

oversight as a undamental part o our business. As a leading global specialtychemical company operating in over 90 countries, ISP has experience in addressing

local and global regulatory concerns.

Storage.and.HandlingAll Advantia Coating Systems should be stored in a cool, dry place out o direct

sunlight. Te containers should be tightly closed when not in use.

Te retest intervals or Advantia Perormance Coating Systems are shown in

able 9.

Table.9.Retest intervals or Advantia Perormance Coating Systems

Te retest interval or Advantia Prime 199989HA09 is 24 months.

Getting.Startedo get started, contact your local ISP sales oce to discuss your requirements

or lm coatings or visit us at www.ispcorp.com.

Product.Family Type.IV.DMF.Number

Advantia Prime 20851

Advantia Perormance 21613

Product.Family Color Retest.Interval

Advantia Perormance Clear and White 24 months

Advantia Perormance Color 12 months


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GLOBAL LOCATIONS FOR SALES & CUSTOMER SERVICE

WORLD HEADQUARTERS

INTERNATIONAL SPECIALTY PRODUCTS

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The inormation contained in this brochure and the various products described are intended or use only by persons having technical skill and at their own discretion and risk ater they have perormed

necessary technical investigations, tests and evaluations o the product s and their uses. While the inormation herein is believed to be reliable, we do not guarantee its acc uracy and a purchaser must make its own

determination o a products suitability or purchasers use, or the pr otection o the environment, and or the health and saety o its employees and the purchasers o it s products. Neither ISP nor it s afliates shall

be responsible or the use o this inormation, or o any pr oduct, method, ormulation, or apparatus described in this brochure. Nothing herein waives any o ISPs or i ts afliates conditions o sale, and WE MAKE NO

WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILIT Y OR FITNESS OF A NY PRODUCT FOR A PARTICULA R USE OR PURPOSE. We also make no warranty against inringement o any patents by reason o purchasers

use o any inormation, product, method or apparatus described in this brochure.

Trademark registration applied or Registered trademark o the ISP group International Specialty Products. 2008 Designed & Printed in USA.

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Product Code: PHAR_C1020 07/2008

Documents

ISP PHARMA C1020 Advantia Performance