A New Approach - TPMA

A New Approach Predictive Packaging Optimization Solutions Through Science

Thai Pharmaceutical Manufacturers Association (TPMA)

Bangkok 28 October 2016 Guy Calcagno

Business Director, Pharmaceutical Films, Asia

Kevin J. Carter

Global Business Development Manager, Pharmaceutical Films Division

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Packaging Trends

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Key trends for Packaging in Asia

• Rising labour income and health projects will lead to higher drug use per

capita, most of them in climate zones 3 and 4

• Change in nutritional habits will accelerate the number of obese people

• Critical pollution levels lead to higher incidence of cancer /pulmonary diseases

• Lower priced, affordable drugs for a higher number of population. Major

playground for domestic/regional pharma companies

• Better informed patients (Internet), access and “care about health/quality of life” attitude

Increase of spending power

Increase in lifestyle

diseases

Continued Generics growth

Strong growth in OTC

• Transfer to and capacity increase in Asia Region to cope with the growth (e.g. AZ, BHC, E. Merck, MSD, Pfizer, Roche, Sanofi)

• The «Golden Egg» for the Healthcare Industry, globally. World population of

65+ increases by 200 million within 10 years

Western Pharma companies going East

Ageing population

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Ageing population is a fact

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Consumption of Pharma Blister Packs is increasing in all regions

Source: Allied Development Corp. 2014

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Consumption of Pharma Blister Packs by Geographic Region (billion units)


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Global Forming Web Consumption by Structure


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Installed Base of Blister Packaging Equipment (number of machines)


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Asia Consumption of Pharma Blister Packs by End-use (billion units)


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Predictive Packaging Optimization Solutions

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Predictive Packaging Optimization Solutions Throughout the Product Lifecycle

Objective is to maximize value and efficiency of customers’ packaging design & operations, with capability to expand to a global scope

Technical & Educational

Services

ASAP shelf life

modeling software and

ASAP laboratory-based

studies provide fast-

paced simulation of drug

stability to reduce

guesswork and risk of

failure

In-house CNC

machine and Uhlmann

blister line allow for

rapid creation of

sample tooling and

blister packages for

customers

Blister simulation

software uses finite

element analysis to

optimize barrier

properties

and form, as well as

tool design

Consulting/support in

initial material selection

for new drugs, off-

patent drugs by

generics producers,

cold-form to

thermoform switch-

outs, etc.

On site technical

support

Resin to Blister

educational program

to support

engineering, quality

and operations onsite

or at the kp i.center

Value engineering

analysis to maximize

efficiency of

packaging operations

Prototyping

Material Selection

Blister

Design

Fast-track Drug Stability

Modeling

ASAP : Accelerated Stability Assessment Program

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ASAP Accelerated Stability Modeling Software and Lab Testing

Material Selection


Modeling

Blister

Design Prototyping


Services

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ASAP Accelerated Stability Modeling Software and Lab Testing

INPUTS

• Product formulation, type, dose, size, packaging preferences, planned regions of release

OUTPUTS

• Stability profile of drug across multiple climate zones from highly accelerated conditions using FreeThink Technologies’ ASAP modeling software and lab services

• Recommended kp film types to confidently achieve shelf life requirements

• Customer can now proceed to blister design and sampling, knowing their product’s actual requirements

Material Selection


Modeling

Blister

Design Prototyping


Services

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Stability Assessment Platform

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• The leading technology for accurate determination of package design and material

combinations through scientific analytical processes for successful stability packaging under

ICH Stability Guidelines

• Drug product characterization

• Cavity and blister design

• Material identification

What

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• Speed to market

• The stability assessment process takes approximately 8 weeks

• Reduces actual stability requirements

• By identifying the correct packaging needs based on the product characteristics, less

materials will be used in actual stability packaging for accelerated and long-term

• Develop packaging strategies

• Eliminate stability failures and over-packaging

• Identifies materials required for all ICH climate zone conditions

Why

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• Stability assessment process

• Perform laboratory conditioning on dosage form and evaluate using existing stability

methods

• Laboratory conditioning and ASAP modeling to determine MVTR requirement

• Design and optimize thermoformed blister cavities for each dosage

• BlisterPro modeling to identify materials to align with ASAP MVTR

• Option to perform total cost and capacity modeling study for global packaging demand

• Work with OEM and site operations to determine packaging equipment limitations

How

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• Stability Assessment Platform can identify multiple packaging strategies

• Traditional strategy: One material all Zones with 2 year dating

• Product and package modeling for accelerated and all ICH zones for 2 years

• Lifecycle management 1: One material all Zones with 3 year dating

• Product and package modeling to for accelerated and all ICH zones for 3 years

• Lifecycle management 2: Zone specific packaging

• Identify specific materials for individual climate zones for 2 or 3 years

Results

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Multiple Design Analysis Capabilities and Applications

Packaging Design

MVTR Comparisons of Different Designs

Evaluation of New Pack Design

Design of New Packaging

Comparison of New & Existing Film Properties

Evaluation of Multi-capsule Designs

Evaluation of Multi-capsule Designs

• Comparison of design options for multi-capsule doses

• Optimization of blister geometry and card density

• Shelf life extension options without changing film type

CLOSE

Comparison of New & Existing Film Properties

• Thermoformability and MVTR comparisons

• Expert advice on switching production issues

• Determination of most economical solution to meet requirements

CLOSE

Design of New Packaging

• Optimize blister shape and barrier material

• 3D modeling of blisters and molds

• Ability to produce physical samples to test design suitability

CLOSE

Evaluation of New Pack Design

• Determination of thermoformability of existing designs

• Optimization steps to improve efficiency

• Check for under- or over-packaging

CLOSE

MVTR Comparisons of Different Designs

• BlisterPro® Fine Element Analysis (FEA) software accurately predicts MVTR for different film types

• Effects of blister geometry on permeability

• Influence of capsule density and film types on MVTR

CLOSE


Modeling

Blister

Design

Material Selection

Prototyping Technical & Educational

Services

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INPUTS

• Dosage, size, form of drug; stability/permeability from ASAP study; required geometry, packaging format, etc.

OUTPUTS

• Optimized design for blister cavity and card; CAD model of thermoforming tools

• Finite element analysis of blister cavity to precisely determine barrier level

• Simulations and expertise in thermoforming best practices allow optimal design to be recommended


Modeling

Blister

Design

Material Selection


Services

Packaging Design

21 21


Modeling

Blister

Design

Material Selection


Services

Packaging Design

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Data Driven Material Selection for Product


Modeling

Blister

Design

Material Selection


Services

Material Selection

• ASAP permeation threshold analysis considered for multiple climate zones

• Cost structure, operational and utilization metrics analyzed in total cost modeling

Zone IVb test conditions of 30°C/75%RH simulated at 2 and 3 years

Years Degradant

Threshold

MVTR

Material

recommendation

Cavity

MVTR

3 Total Imp 0.0113 PA400 0.0086

2 Total Imp 0.0300 PA200 0.0223

Zone II test conditions of 25°C/60%RH simulated at 3 years

Years Degradant

Threshold

MVTR

Material

recommendation

Cavity

MVTR

3 Total Imp >3.0 PH M570/01 or P250/40 0.1741

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Packaging Portfolio Analysis - Current packaging cost estimation

• Total cost of current packaging (single/double)

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Packaging Portfolio Analysis - Thermoformed packaging options

• 10ct single and double configurations

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Packaging Portfolio Analysis - Packaging Capacity Overview

• Thermoformed packaging capacity review

Production hours

Total Annual

Production Doses/hour

Capacity increase

(doses)

New annual

capacity

Current packaging 8,694 271,405,834 31,218 0 271,405,834

Thermoform (existing) 6,421 271,405,834 42,268 96,076,228 367,482,062

Thermoform (new line) 3,864 271,405,834 70,240 339,257,293 610,663,127

Thermoform w/12ct (new line) 3,658 271,405,834 74,195 373,646,741 645,052,575

Annual Capacity estimation

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Design & Productivity

Optimization

The Case Problem

• James is currently packaging a drug in

both a pouch and a desiccant, because

he knows it needs to be well protected

from humidity

• He wants to find a way to eliminate the

need for these to improve productivity,

cost and yield, without sacrificing shelf

life stability

The Approach

• It is agreed that an ASAP lab study

from FreeThink Technologies would be

a necessary first step to understand

the drug’s needs and moisture uptake

behavior

• The requirements predicted from the

ASAP study were then used in a

Blister simulation analysis to

determine the optimal film and blister

cavity design to deliver that level of

protection

Permeability Recommendation and Modeling Prediction

-0.5

0

0.5

1

1.5

2

2.5

0 10 20 30 40 50 60 70 80

Ch

an

ge

In

Ma

ss

(%

) -

Re

f

Sample RH (%)

DVS Isotherm Plot

© Surface Measurement Systems Ltd UK 1996-2013DVS - The Sorption Solution

-0.5

0

0.5

1

1.5

2

2.5

0 10 20 30 40 50 60 70

Ch

an

ge

In

Ma

ss

(%

) -

Re

f

Sample RH (%)

DVS Isotherm Plot

Cycle 1 Sorp Cycle 1 Desorp

© Surface Measurement Systems Ltd UK 1996-2013DVS - The Sorption Solution

(0.013)

Conclusion

• James being able to remove the pouch and desiccant

from his production, resulting in a 44% increase in

productivity and a 23% decrease in materials used

• James realized he’s not in it alone – technology and

teamwork can eliminate many of the resource-

wasting trials inherent in packaging design

• Getting products to market quicker with greater

confidence in shelf life stability is a win-win, making

your first choice the right choice, every time

Thank you

A New Approach - TPMA

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