Unit Dosing from a Bottle - Healthcare Compliance Packaging Council

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A Canon Communications LLC Custom Publication September 2007
Unit Dosing
from a
Bottle

Rx Packaging 101
Video Released
Afive-minute video titled, “Rx Packaging 101,”
has been produced by HCPC Executive
Director Peter Mayberry. It can be viewed at
www.unitdose.org. “We made this video,”
Mayberry explains, “as an educational tool to compare
the way many medicines are distributed by manufacturers
and dispensed to consumers in the United States versus
the way the exact same drugs are distributed and dispensed
throughout most of the rest of the world.”
Using actual examples of bulk bottles, pharmacy vials,
EU-style blisters, and several unit-dose formats that have
been recent recipients of the HCPC’s Compliance Package
of the Year Awards, the video explains the benefits of
manufacturers’ original packaging over bulk distribution
methods. Noted in the video, for instance, is the fact
that bulk distribution requires pharmacy repackaging and
that bulk distribution makes it somewhat easier for
unscrupulous characters to introduce counterfeit
products or expired drugs with those that are still good.
The video also notes that repackaging in the pharmacy
compromises the efficacy assurances achieved through
FDA stability-testing requirements.
Numerous benefits of unit-dose formats as manufacturers’
original packaging are underscored in the video
as well. “We placed special emphasis on the fact that unitdose
formats assure U.S. consumers that their medicines
come out of the package in the exact same condition
they were when the manufacturer put them in the package,”
Mayberry said. “I think this is an important point
that may be lost by many consumers.” Other benefits of
unit dosing cited in the video include the following:
■ The ability to ship FDA-approved literature for
patients with each container of drug product.
■ The ability to print bar codes on each package that
can be scanned in the pharmacy.
■ The fact that compliance-prompting features can be
incorporated to help consumers take their
medications properly.
Referring to video-sharing Internet sites such as
YouTube and GoogleVideo, Mayberry said, “We have this
whole new medium for inexpensively educating vast
numbers of people, so how could we not put something
like this together?” As the saying goes, a picture is worth
a thousand words. And with a complex subject like
worldwide pharmaceutical packaging practices, a video
may be worth millions of words.
To view the video, please go to www.unitdose.org and click on the
link to “Rx Packaging 101.” The HCPC welcomes viewer comments and
other input after they have had a chance to watch the new video.

September 2007 Unit Dose Alert, Volume 4, Issue 3
On the Cover
The NextBottle from One World Design and Manufacturing Group
A new design allows users to dispense one dose at a time
from a bottle.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Views
Bulletin from the Board
A letter from George Burke,
HCPC’s Chairman of the Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
The NextBottle from One World Design
and Manufacturing Group. Photo By:
Daniel Guzman
Unit Dose Alert is a quarterly, copyrightprotected
publication of the Healthcare
Compliance Packaging Council. Material
in this publication may not be reprinted,
or otherwise used, with out the express
written permission of the HCPC. For
more information on the HCPC or any
material contained in Unit Dose Alert,
please contact our headquarters at 131
E. Broad St., Ste. 206, Falls Church, VA
22046. Telephone: 703/538-4030; fax:
703/538-6305; www.unitdose.org.
Unit Dose Alert is produced by
Canon Communications LLC and
distributed with Pharmaceutical &
Medical Packaging News. The opinions
expressed within are solely those of the
HCPC and/or its members and are
not those of Canon Communications
or Pharmaceutical & Medical Packaging
News. ©2007 by the Healthcare
Compliance Packaging Council. All
rights reserved. Reproduction in whole
or part without written permission is
prohibited.
Director’s Chair
A letter from Peter G. Mayberry,
Executive Director,
Healthcare Compliance Packaging
Council . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Member’s Corner
Körber Medipak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
News
Industry News
A look at developments in
pharmaceutical compliance
packaging ............................7
Member News
Updates on HCPC
members ................................9
“There is, in fact, solid research demonstrating
that unit-dose formats with complianceprompting
features increase refill rates and
improve health outcomes. It would seem
intuitive, therefore, that Rx manufacturers
would turn to these packaging formats now as
a means of boosting profits.”
Sections
Staff Page
Who’s who in the HCPC ......4
Calendar of Events
Where to travel ..................17
Membership Form
Join the HCPC! ................19
September 2007 • www.unitdose.org • Unit Dose Alert 3

2007–2008 Board of Directors
Mr. George Burke
Chairman of the Board
President
Sharp Corp.
7451 Keebler Way
Allentown, PA 18106
Mr. Hubert Keil
Vice Chairman of the Board
Managing Director and CEO
Uhlmann Packaging Systems
44 Indian Lane E.
Towaco, NJ 07082-1032
Mr. Walter Berghahn
Treasurer
Vice President, Packaging Technology
American Health Packaging
14 Palomino Rd.
Gilford, NH 03249
Mr. Rick Knight
Global Business Manager
Honeywell Healthcare Specialty Films
101 Columbia Rd.
Morristown, NJ 07962
Mr. William Sharpless
Global Market Director
Pharma, Medical, Cosmetic,
and Retail Packaging
Alcoa Flexible Packaging
6603 West Broad St.
Richmond, VA 23230
Mr. Shawn Reilley
Executive Vice President
Anderson Packaging
4545 Assembly Dr.
Rockford, IL 61109
Mr. Renard Jackson
Executive Vice President, Sales and Marketing
Catalent Pharma Solutions
3001 Red Lion Rd.
Philadelphia, PA 19114
Executive Staff
Peter G. Mayberry
Executive Director
Kathleen Hemming
Associate Director & Editor,
Unit Dose Alert Magazine
Headquarters Office
Healthcare Compliance Packaging Council
131 E. Broad St., Ste. 206
Falls Church, VA 22046
Phone 703/538-4030
Fax 703/538-6305
www.unitdose.org
Sponsorships and Publication
Canon Communications LLC
11444 West Olympic Blvd.
Ste. 900
Los Angeles, CA 90064
Sponsorships: Patricia Spinner,
973/808-1250
4 Unit Dose Alert • www.unitdose.org • September 2007

Bulletin from the Board
From Baltimore to New Brunswick
George Burke
Chairman of the Board
President
Sharp Corp.
Rotating between
regulatory and
pharmaceutical
manufacturing
perspectives will
serve our audience,
so we have elected
to bring our event
to manufacturing’s
backyard,
New Jersey.
Departing from our long tradition
of hosting our major
educational event in the
Philadelphia area, the Healthcare
Compliance Packaging Council
took the Annual National Symposium
on Patient Compliance
from Philly to Baltimore this year.
And while we found that doing
so had virtually no impact on
attendance, positively or negatively,
we have decided to take our
show on the road once again.
In 2007, we were able to
attract the same number of
attendees to Baltimore. We successfully
drew a number of
speakers in the regulatory community,
given their proximity
to the venue. It was successful
for us all. The program was
strong, and those in attendance
benefited from the educational
offerings and informational
briefings.
So one would think that
moving from one successful
venue to another would be
enough to satisfy us for the next
six years? Not a chance!
The HCPC’s 2008 Annual
National Symposium will be
held May 13–14 in New
Brunswick, NJ, at the Hyatt
Regency Hotel. We have had
much luck with Hyatt properties
in the past, having held
six consecutive events at the
Hyatt Regency Penn’s Landing
in Philadelphia.
Because the HCPC is committed
to presenting the most
relevant and stimulating discussion
on the most important
topics of interest to the pharmaceutical
compliance packaging
industry, the Board determined
that rotating between
regulatory and pharmaceutical
manufacturing perspectives
would serve our audience well.
That being the case, the New
Jersey location for our 2008
event will be easily accessible
for many of our colleagues
in the pharmaceutical manufacturing
and packaging industry.
We have elected to
bring our event to manufacturing’s
backyard.
From now until May 2008,
we will be shaping our program.
We welcome suggestions
from our readers for topics and
speakers of interest to the unitdose
packaging community.
Each year, thorough research
and thoughtful coordination is
an integral part of the creation
of our annual educational program.
Your thoughts and input
will be incorporated into our
2008 Symposium. Feel free to
contact the HCPC staff at
703/538-4030 or post your suggestions
on the 2008 Symposium
Web page at www.unit
dose.org/symposium. htm.
September 2007 • www.unitdose.org • Unit Dose Alert 5

Director’s Chair
Compliance NOW
Peter G. Mayberry
Executive Director
Healthcare Compliance
Packaging Council
Manufacturers can
improve their return
on investment by
adopting better
packaging. These
investments will pay
off, year after year,
for the entire life
span of the product.
Several interesting items
landed on my desk over
the past few weeks—all of
them related to the global
problem of pharmaceutical
noncompliance (i.e., patients’
not taking their medications
properly. An article titled “Prescription
for Trouble” from the
July 8 edition of New Jersey’s
Star-Ledger newspaper, for
instance, references a 2006
study that found that pharmaceutical
manufacturers lose $25
billion to $70 billion annually
because of noncompliance. Yes,
that is billion, and, yes, that is
every year!
Even more interesting is the
author’s premise that such losses
can no longer be ignored
considering the state of new
drug development. Specifically,
reporter Jeff May writes,
“Research pipelines are not as
productive as they once were,
so drugmakers need to maximize
their investments in a drug
until the patent expires.” Just
getting consumers to take their
medications properly is one
way to maximize these investments,
the author notes, and
even suggests unit dosing as a
means to this end. “Simpler
strategies [for improving compliance]
can have big payoffs
too,” he writes. “In Europe,
drugs are sold in blister packs
that allow patients to see
instantly whether they have
missed a day.”
There is solid research
demonstrating that unit-dose
formats with complianceprompting
features increase
refill rates and improve health
outcomes. It would seem intuitive,
therefore, that Rx manufacturers
would turn to these
packaging formats now as a
means of boosting profits. So
why aren’t pharmaceutical manufacturers
distributing more Rx
drugs in these formats?
One answer is that people
who follow compliance issues
seem to be interested only in
solving the problem entirely. In
other words, they want to swallow
the entire elephant instead
of taking bites out of it here and
there. This seems readily apparent,
for instance, in another
report that crossed my desk this
summer from the National
Council on Patient Information
and Education (NCPIE) titled
“Enhancing Prescription Medicine
Adherence: A National
Action Plan.” At the heart of
this report is a set of 10 recommendations,
not one of which is
even remotely practical.
How realistic is it to advocate
that we solve the noncompliance
problem, for instance,
by creating “a public/private
partnership to mount a unified
national education campaign to
make patient adherence a
national health priority,” or
that we “immediately implement
professional training and
increase the funding for professional
education on patient
medication adherence”? Yet
these are two of the recommendations
offered by NCPIE.
continued on page 17
6 Unit Dose Alert • www.unitdose.org • September 2007

Industry News
FDA Seeks Input on
Unit-of-Use Packaging
for Antidepressant Drugs
To ensure that a MedGuide accompanies every prescription of
antidepressant medication, FDA strongly recommends the use of
unit-of-use packaging. But is it happening?
FDA convened a public hearing
from June 12–13 in
Washington, DC, to solicit
input on its MedGuide program.
One topic that emerged
several times during the twoday
hearing was the agency’s
2005 recommendation that
unit-of-use packaging be used
as a means of ensuring that
MedGuides are dispensed with
all prescriptions for antidepressant
drugs. As Unit Dose
Alert readers may recall,
MedGuides are leaflets that
FDA requires manufacturers to
distribute with products that
the agency determines pose a
particular risk to consumers if
not taken properly.
MedGuides follow a specified
format, are written in language
that most consumers can
understand, and must be
approved by FDA. Until recently,
however, FDA applied
MedGuide requirements on a
product-by-product basis. Only
a handful of drugs had to be dispensed
with one of these documents.
But in early 2005, FDA
issued a requirement that all
antidepressant drugs be shipped
with MedGuides by their manufacturers
to warn about the
risk of suicidal thoughts and/or
September 2007 • www.unitdose.org • Unit Dose Alert 7

Industry News
behaviors amongst adolescents
and young adults who have been
prescribed these drugs. This was
the first time that the Agency had
required a MedGuide for an
entire class of drug product.
Moreover, to ensure that a
MedGuide accompanied every
prescription of antidepressant
medication dispensed at the
pharmacy, FDA strongly recommended
that manufacturers
adopt unit-of-use packaging for
these medicines.
The distinguishing characteristic
of unit-of-use packaging
is that products shipped in these
formats are not supposed to be
repackaged in the pharmacy.
Unit-dose formats are a subset
of unit of use, but bottles and
other multidose containers also
fall into the unit-of-use category
so long as they are not intended
for repackaging prior to being
dispensed.
This differs from most drugs
in the United States that are
shipped by the manufacturer in a
bulk container and have to be
transferred from big bottles into
little bottles by pharmacy personnel
when prescriptions are
filled. If a MedGuide is required,
manufacturers typically ship
enough copies so that one can be
dispensed with each prescription
filled from the bulk bottle.
According to the pharmacy
industry, this has been historically
problematic, however,
because MedGuides can become
separated from the bulk container
through any number of
circumstances.
Since 2005, FDA has expanded
its requirements to other
classes of drug products—most
notably prescription nonsteroi -
dal anti-inflammatory drugs
(NSAIDs) and certain products
used to treat pediatric attention
deficit disorders—but the agency
has not yet included the recommendation
that unit-of-use formats
be used to comply with
these requirements.
The first witness to testify
MedGuides are leaflets that FDA
requires manufacturers to distribute
with products that the agency
determines pose a particular risk to
consumers if not taken properly.
during the hearing was Congressman
Michael Ferguson
(R–NJ), who spoke of complaints
he had received from
constituents in his district who
were not given MedGuides when
they filled prescriptions for antidepressants.
Specifically, Rep.
Ferguson told the assembly that
“if even one parent failed to
receive the required Medication
Guide, and I say this as a father
of four young children, that parent,
through no fault of their
own, cannot make a fully
informed decision about
whether antidepressant medications
are appropriate for their
child. And the consequences of a
less than fully informed decision
could be dangerous.”
And when a panel of pharmaceutical
representatives testified
on June 13, FDA officials asked
about unit-of-use formats several
times. Robert Temple, MD,
director of FDA’s Office of Medical
Policy, posed this question to
Catherine Melfi of Eli Lilly and
Co.: “Because we’ve been aware
of the difficulties of getting people
to recognize that there’s a
MedGuide that needs to be handed
out with medicines… [my
office has] …strongly encouraged
people to develop unit-of-use
packages when there’s a
MedGuide [requirement]. Sometimes
when a drug is about to be
approved, we usually gain
acceptance of that approach. But
if it’s after the fact, we encounter
considerable resistance. Where
are you on this?”
Melfi replied, saying, “That’s
a tough one for me to answer on
behalf of Lilly.” She went on to
say that insurance companies
sometimes will only reimburse
for a specific number of doses. If
the unit-of-use package contains
a number of doses that differs
from what is approved for reimbursement,
it presents problems
for pharmacy personnel. In such
cases, she said, pharmacists are
“…opening up another one of
those unit-of-use [packages],
dumping out four pills, and I
don’t know what they do with
the MedGuide in that case.”
This problem was solved years
ago in Europe, of course, when
pharmaceutical manufacturers
adopted a 10-count standard for
most medications and, as a senior
FDA official explained several
years ago, “…it didn’t take
long for European doctors to
learn how to write scrips in
counts of ten.”
Copies of the transcripts
from both days of this hearing
are available via the Internet at
www.fda.gov/cder/meeting/
medication_guides_200706.
htm. As this article went to press,
the HCPC was preparing a formal
comment to FDA’s docket
on this issue.
8 Unit Dose Alert • www.unitdose.org • September 2007

Member News
Cortegra Appoints Struhar
as VP of Finance and Control
James A. Struhar has been
named vice president of
finance and control at Cortegra,
a leading provider of packaging
solutions for the pharmaceutical
industry.
“James is coming to Cortegra
at an exciting and important
point in our history,” remarks
Victor Dixon, Cortegra’s President.
“His financial management
and leadership skills will be a
tremendous advantage as the
company executes its long-term
growth strategy. Struhar’s 20-plus
years of experience with manufacturing
firms makes him an
important addition to our management
team.”
Mr. Struhar is a certified public
accountant and joins Cortegra
from Outsourcing Services
Group, where he was vice president
of finance operations. He
had held that position since 1999
in various capacities in the financial
department. He holds a BBA
in accounting from Pace University
and an MBA from Long
Island University.
Cortegra, a subsidiary of
Menasha Corp., has more than
30 years’ printing experience
focusing exclusively on the pharmaceutical
industry. The company
is one of the recognized leaders
in providing packaging and labeling
services for pharmaceutical
and related industries. Its products
include labels, inserts and
outserts, folding cartons, booklets,
and extended-content labels.
Contact Cortegra at 973/808-
8000 or visit the company online
at www.cortegra.com.
Uhlmann Aquires Germany-based Koch
Maschinenbau GmbH
The Uhlmann Group has purchased
Koch Maschinenbau GmbH. Founded in
1969 and headquartered in Germany,
the company is a respected manufacturer
of specialty machines for packaging
solutions. Its products range from standard
blister manufacturing and sealing
machines to complex packaging systems
with automatic product feeding and endof-line
packaging features. With this
acquisition, these machines will now be
available to North American companies
through Koch Packaging Systems LP,
which has been established at the
Uhlmann Packaging Systems headquarters
in Towaco, NJ.
“We are very proud to announce our
acquisition of Koch Maschinenbau
GmbH and most pleased to introduce
Koch Packaging Systems LP to the United
States and Canada,” says Hubert Keil,
Uhlmann Managing Director and CEO.
“Their machines for packaging solutions,
in particular their machines for manufacturing
large blisters, will be a huge asset to
the Uhlmann machine line.”
Contact Hubert Keil at Uhlmann for
further details at 973/402-8855.
September 2007 • www.unitdose.org • Unit Dose Alert 9

Member News
SolVin Planning to Increase Production
of PVdC; Potential Asian Plant Location
In response to growing
demand for PVdC, SolVin has
announced that it plans to build
a second production facility with
an annual output of 10,000 tn.
An Asian location is currently
being considered, and Solvay’s
site in Map Tha Put in Thailand
is a possibility.
SolVin, a joint venture
between Solvay and BASF, currently
serves PVdC latex clients
out of its production unit in
Tavaux, France. A decision
regarding the new location will
be confirmed later this year.
“The unique properties of
polyvinylidene chloride latex,
which SolVin markets under the
Diofan brand name, make it the
preferred choice of the food and
pharma industry to match the
highest barrier requirements,”
states Vincenzo Morici, General
Manager of the Specialty
Polymers Strategic Business
Unit for Solvay.
“SolVin intends to uphold its
commercial and technological
leadership as well as its global
reputation of excellence for this
class of products. We will be in a
position to continue serving our
clients’ expansion, while feeding
Solvay’s strategy of sustainable
and profitable growth in the
Specialty Polymers business,”
Morici adds.
Contact Kirk Paisley at
740/587-7169 or by e-mail at
kirk.paisley@solvay.com for
more information.
Klöckner Pentaplast Wins Prestigious Febrafarma
2007 Quality Award
Brazilian Pharmaceutical
Industry Federation presented
Klöckner Pentaplast of Brazil
with the distinguished 2007
Febrafarma Quality Award during
the opening ceremonies of the
recent FCE Pharma trade show
in Sa ~ o Paulo, Brazil. The Quality
Award is voted on by the federation’s
membership, which
consists of 267 pharmaceutical
manufacturers and industry associates,
both domestic and foreign
companies operating in Brazil.
This year, Klöckner Pentaplast
won in the “Plastics to
Film” category. “We are delighted
to accept this award and are
honored to be recognized by
Febrafarma as a committed
partner of the Brazilian pharmaceutical
industry,” says
Michael Tubridy, President and
COO of Klöckner Pentaplast/Americas.
Our recently
announced coating and laminating
capacity investment in
Brazil will enable us to continue
to support our customers’
growing demand for locally
produced, high-quality barrier
films and to further enhance
new product development capabilities
in the market.”
Klöckner Pentaplast Group
is the world’s leading producer
of films for pharmaceutical,
medical device, food, electronics,
and general-purpose thermoform
packaging, as well as
printing and specialty applications.
Founded in 1965 in
Montabaur, Germany, Klöck -
ner Pentaplast has grown from
its initial facility to 20 current
production operations in 11
countries.
Contact Nancy Ryan, Manager
of Global Communications,
at 540/832-1427 for more information,
or visit the company
online at www.kpfilms.com.
10 Unit Dose Alert • www.unitdose.org • September 2007

Member News
Nosco Joins the HCPC as a Full Corporate Member
Nosco, a high-quality printed packaging supplier,
has recently joined the Healthcare Compliance
Packaging Council as a Full Corporate Member.
Nosco’s products include folding cartons,
blister cards, compliance packaging, printed literature,
pressure-sensitive labels, combination packaging,
and multiple-panel labels.
The company profile outlines its primary focus
to help its customers prevent counterfeiting and
diversion, reduce cost and complexity, launch drugs
worldwide, enhance brand image, and comply with
industry regulations.
Nosco also offers branded strategic service initiatives
for RFID package integration, solutions
engineering, on-demand solutions, and security
protection.
Joe Tenhagen, Nosco’s Vice President of Marketing,
will serve as the company’s representative to the
HCPC and may be reached at jtenhagen@nosco.com
or by phone at 513/573-7194.
Cortegra Gains ISO 9001 Certification
for all Facilities
Cortegra is proud to announce that it is been awarded ISO 9001 certification
for its facilities in Fairfield, NJ; Evansville, IN; and Raleigh,
NC. A company that has been audited by the International Organization
for Standardization and is awarded ISO 9001 certification has
undergone a rigorous review and audit process and has been found to
apply business practices consistent with quality products and services.
Cortegra President, Victor Dixon, remarks, “Cortegra has always
had an unshakable commitment to quality products and services
because in the pharmaceutical industry, the stakes are very high.
Pharmaceutical companies must be certain that the businesses they
partner with are as dedicated to excellence as they are. Now, in
addition to offering our pharmaceutical clients CGMP compliance,
we have proven that we share the same dedication by offering the
added assurance of ISO certification.”
To earn the ISO 9001 certification, Cortegra had to meet the following
requirements:
• Having a set of procedures that cover all key processes in the
business demonstrating “Plan Quality In.”
• Monitoring manufacturing processes to ensure that they are producing
quality products.
• Maintaining accurate and complete records.
• Checking outgoing products for defects, with appropriate corrective
action when necessary.
• Regularly reviewing individual processes and the quality system
itself for effectiveness.
• Facilitating continual improvement.
For further information on Cortegra and its products and ser -
vices, call 973/808-8000 or visit its Web site at www.cortegra.com.
September 2007 • www.unitdose.org • Unit Dose Alert 11

Member News
Uhlmann Packaging Systems Expands
Tool Shop Capabilities
By adding more than $3 million
in capital machinery investments
in the last few years,
Uhlmann Packaging Systems
continues to expand its tool-shop
capabilities to offer service and
value in providing tooling,
upgrades, and rebuilds for
Uhlmann blister machines, cartoners,
and feeders. Precision,
OEM-crafted tooling can be
delivered by Uhlmann within
seven weeks, which is the shortest
lead time in the industry. This
lead time represents a reduction
of more than 50% from five
years ago, and Uhlmann projects
to cut it by another 20% in the
next year.
“With a total of three Deckel
Maho machining centers,
Uhlmann’s Tool Shop features
the most advanced equipment in
the world,” says Hubert Keil,
Uhlmann Managing Director
and CEO. “These machines are
at the center of an aggressive and
continuing modernization and
improvement plan that allows
Uhlmann to react as quickly as
possible to customer needs and
requests, helping them to keep
pace with the increasing demands
and challenges of the pharmaceutical
market.”
This equipment affords
Uhlmann the distinct manufacturing
advantages that allow for
12 Unit Dose Alert • www.unitdose.org • September 2007

Member News
tool manufacturing with short
delivery times and accuracies
down to two ten-thousandths of
an inch. The two Deckel DMC
8U machines and the Deckel
DMC 60U feature the following
technologies:
• Five-axis machining for re -
duced production times and
enhanced quality.
• A six-station programmable
palette pool for automatic
loading, unloading, and multiple
tool manufacturing.
• A 180-tool in-machine storage
system that allows for
quick changeover with dedicated
dimensions and preset
specifications.
• Lights-out operation for
extended, unmanned shift
capabilities.
In addition to the tool-shop
deliverables, Uhlmann also
offers a new tablet lay-down
device developed in-house, an
ever-expanding $2 million
inventory of spare and wear
parts, and the newest Uhlmann
B-1880 Blister Machine, reportedly
the world’s fastest, for onsite
testing, operator training,
and live demonstrations.
Uhlmann has its U.S. headquarters
in Towaco, NJ, and
products include blister
machines, cartoning systems,
line-monitoring and control
systems, and downstream
packaging machinery.
Contact Hubert Keil at
973/402-8855 for additional
information.
New Unit-Dose
Launches
Announced by
American Health
Packaging
American Health Packaging
(AHP) recently launched
11 more products in its growing
unit-dose line. They include
the following:
• Primidone tablets in 50-mg
and 250-mg strengths (ABrated
to Mysoline).
• Zolpidem Tartrate tablets in
5-mg and 10-mg strengths
(AB-rated to Ambien).
• Minoxidil 2.5-mg and 20-
mg tablets (AB-rated to
Loniten).
• Lithium Carbonate ER 450-
mg tablets (AB-rated to
Eskalith ER).
• Propranolol ER 60-mg,
80-mg, 120-mg, and 160-
mg capsules (AB-rated to
Inderal LA).
American Health Packaging
is the only supplier of Primidone
tablets to the market in
unit-dose packaging—another
first for the company.
All AHP unit-dose items are
bar coded to the dose level to
support bedside scanning.
More unit-dose launches are
expected this year. For more
information, contact Sid
McFadden, AHP Marketing
Manager at 614/492-8177, ext.
309, or e-mail smcfadden@
amerisourcebergen.com.
September 2007 • www.unitdose.org • Unit Dose Alert 13

Member’s Corner
Körber Medipak: Three Packaging
Specialists Under One Roof
Advances in drug
delivery as well as
trends toward
small lot sizes and
quantities are driving
demand for a
responsive packaging
technology partner.
P
ackaging has become a
critical factor in the production
and marketing of
drugs and medicines. Packaging
has to meet stringent demands
to maintain medicine stability.
It must guarantee the patient
simple yet safe handling to
ensure the desired success of
the treatment, and, in the over
the counter (OTC) sector, for
example, it must promote sales
through designs aimed at specific
target groups. In addition,
today’s pharmaceutical industry,
like other branches of industry,
is specifically analyzing the
efficiency of its production
processes and seeking to fulfill
the potential for optimization.
As a result, the entire packaging
sector has increased
enormously in importance.
Packaging systems—from
the packaging material right
through to the packaging
lines—are available as a solution,
producing secure, low-cost
packaging for medicines combined
with maximum patient
convenience.
Pharmaceutical companies
can benefit greatly if, for broad
areas of their packaging
processes, they rely on only one
partner that can provide comprehensive
solutions from the
pack material to the corresponding
systems. The Körber Medipak
Group, with its member
companies Dividella AG (Grabs,
Switzerland), Rondo AG (Basel,
Switzerland; and Norristown,
PA), and MediSeal GmbH
(Schloss Holte, Germany), is
just such a specialist in single-
MediSeal CP600-P3000 blister line features vacuum suction arms that
transfer the blisters into two tracks directly from the fast-cycle punch.
14 Unit Dose Alert • www.unitdose.org • September 2007

Member’s Corner
source solutions.
Körber Medipak is the fourth
and youngest pillar of Körber
AG, which, with 9300 employees
in 2006, achieved annual sales of
approximately 1.5 billion euros.
Thirty independent companies
and numerous sales and service
companies operate under the
umbrella of the management
holding company.
The Körber Medipak Group
can provide the pharmaceutical
industry with an optimal portfolio
of services for the entire liquids
and solids packaging sector.
The range of services includes
concepts and solutions extending
from packaging development
through supply of appropriate
materials to complete machinery
and systems applications.
Rondo’s core competency lies
in the development and manufacture
of standard and special
paperboard packs for the pharmaceutical
and cosmetic industry.
Dividella develops and manufactures
machines for fully automated
packaging of ampules, injection
bottles, carpules, complete
syringes, and cylindrical items. Its
machines also package other
products that are difficult to
stack, such as tablet blisters,
patches, transdermals, or plastic
ampule strips in combination
packs in two different pack variants:
top-loading cartons and
wallets or box-wallets. Medi -
Seal’s know-how lies in dosing
and packaging solids, powders,
and paste products. For such
applications, the company develops
and manufactures blister
machines and stand-alone and
integrated cartoning machines as
well as flat sachet machines.
Körber Medipak considers
itself to be an integrated systems
supplier for packaging solutions
Major advances are being made
with drug-delivery systems, which
not only provide the packaging for
the drug but also enable its
medical application.
The Körber Medipak system concept: pack development, pack materials,
and packaging machines—all from a single source
in the pharma sector. The company
sees two future challenges
in particular for pharmaceutical
companies. Major advances
are being made with drugdelivery
systems, which not
only provide the packaging for
the drug but also enable its
medical application. For these
products, it is important to
ensure optimal design of appropriate
secondary packaging, in
relation to the packaging process
and patient handling.
Big changes are also taking
place in terms of the quantities
that are being produced and have
to be packed. Although the key feature
of pharma production used to
be high output rates per machine
or per line, there is currently a
trend toward small lot sizes and
very small quantities. There are
many reasons for such development:
active ingredients are often
tailored to specific groups of
patients, and different regulatory
requirements are often instituted
for packaging or patient information
in different countries.
Körber Medipak is in a position
to provide its customers
quickly with customized solutions
thanks to the development
of new packs by Rondo and the
construction of modular, multiple-purpose
systems by Dividella
and MediSeal. The decisive
advantage for pharma companies
lies in the universality of the
packaging systems offered by
September 2007 • www.unitdose.org • Unit Dose Alert 15

Member’s Corner
Körber Medipak. Together with
the customer’s own experts,
Rondo’s specialists develop
product-matched packaging that
fulfills all requirements in terms
of official regulations and
patient handling, as well as special
requirements such as suitability
for people with restricted
motor function, child safety, or
protection from counterfeiting.
Design requirements against
a background of product marketing
are also taken into
account during development. All
the development stages take into
consideration subsequent optimal
machine suitability in the
production process using
Dividella or MediSeal systems.
In the case of production lines
on which Dividella and MediSeal
machines are used together, close
cooperation within the associated
companies also ensures reliable
production without any
interface problems. For example,
there are systems in operation
in which MediSeal
thermoformers and
Dividella syringe feeders
are being used, or in
which sachet machines
are combined with
downstream top-load
cartoners, with the carton blanks
being supplied by Rondo.
Overall, Körber Medipak’s
comprehensive packaging concepts
offer maximum reliability
All the development stages take
into consideration subsequent
optimal machine suitability in the
production process using Dividella
or MediSeal systems.
and flexibility—packaging and
machines are optimally matched,
guaranteeing the ultimate in production
reliability.
Like Körber AG, Körber
Medipak, too, is active worldwide,
maintaining sales and
service companies in
the United States,
France, the United
Kingdom, China,
and parts of Asia.
Despite all the dovetailing
under the umbrella of the Körber
Medipak Group and the
resulting synergy effects, the
three companies also continue
to act independently in their
respective markets. Each company
has know-how, accumulated
over decades, in clearly
delimited areas of pharma
packaging. The manageable
company structures guarantee
a practical, customer-orientated
approach to the development
and implementation of
innovative packaging solutions.
Together, they provide their customers
with comprehensive solutions
from a single source, extending
from pack development
through choice of the necessary
materials to packaging lines, in
conjunction with the guarantee
that the pack and the system will
work in perfect harmony.
New packaging concepts
can be implemented
optimally with Dividella’s
NeoTop machines.
16 Unit Dose Alert • www.unitdose.org • September 2007

Calendar
Upcoming Events
For information on these events, please contact the HCPC at 703/538-4030.
September
HCPC Board of Directors Meeting
September 11
Uhlmann Packaging Systems LP
Towaco, NJ
Annual Contracting and Outsourcing
Conference & Exhibition
Contract Pharma
September 18–19
Hyatt Regency New Brunswick
New Brunswick, NJ
www.contractpharma.com
October
Pack Expo Las Vegas
Packaging Machinery Manufacturers Institute
October 15–17
Las Vegas Convention Center
Las Vegas
www.packexpo.com
March 2008
Interphex
March 26–28, 2008
Philadelphia Convention Center
Philadelphia
www.interphex.com
May
Annual National Symposium on Patient
Compliance
May 13–14, 2008
Hyatt Regency New Brunswick
New Brunswick, NJ
www.unitdose.org/symposium.htm
September
Showcase 2008
Date to be determined
Honeywell’s Larry Bossidy Learning Center
Morristown, NJ
November
HCPC Full Membership Meeting
November 13
Tremont Grand Hotel
Baltimore
continued from page 6
Director’s Chair
A far more practical approach to reducing noncompliance
is to convince Rx manufacturers that
they can improve their return on investment by
adopting better packaging and that these investments
will pay off, year after year, for the entire life
span of the product. Make no mistake, better packaging
cannot eliminate the noncompliance problem.
However, if manufacturers realize that innovative
packaging can help them recover some of the
billions of dollars they are losing each year, it could
be a proverbial “win-win-win” for industry, consumers,
and the overall economy.
September 2007 • www.unitdose.org • Unit Dose Alert 17

On The Cover
One Dose at a Time from a Bottle?
One World introduces the NextBottle as an
alternative to amber pharmacy-dispensed vials.
Encouraging pharmaceutical
compliance with a bottle
is possible thanks to the
latest revolutionary design from
One World Design and Manufacturing
Group. The NextBottle is
the first bottle to dispense one
dose at a time while indicating the
day and time to better ensure
patient compliance in taking medication.
According to Marty
Mason, One World’s Director of
Marketing and Package Solutions,
“Better compliance leads to better
health outcomes, resulting in a
win-win-win proposition for
patients, pharmaceutical companies,
and healthcare providers.”
Featured on our cover this
issue, the NextBottle is a reclosable
package that provides the
same child-resistant, senior-friendly
attributes of a traditional medicine
bottle, eliminating the risk
of testing failure toward the end
of product development and market
launch.
Once opened, the interior of
the bottle features a dial across
the top that allows dispensing of
one dosage only per day via a dial
mechanism outlining the days of
the week. (The dial can be manually
advanced to expel dosages for
subsequent days.)
Benefits outlined by One
World for its latest design include
its distinctive shape that provides
a large billboard space for
pharmacy labels and the ability
to be stacked, minimizing storage
space. Branding opportunity
via differentiation is also
expanded with this unique design.
Additionally, the NextBottle can
be run on existing packaging
equipment installed at most pharmaceutical
companies. Durability
of the high-density polyethylene
material allows for improved
portability.
The NextBottle is focused on
providing an alternative to the
typical amber-colored plastic bottles
in which the vast majority of
prescription drugs are dispensed
at the pharmacy. This package
encourages patient compliance,
which the traditional bottle cannot,
while providing child resistance
with a conventional push
and turn cap as well as being easy
for adults to open.
One World Design and Manufacturing
Group, based in Warren,
NJ, design and manufacture
highly innovative pharmaceutical
packaging aimed at improving
patient compliance while providing
enhanced branding
opportunities. For further
information, contact Marty
Mason, at 908/769-1234, ext.
150, or by e-mail at mmason@
oneworlddmg.com.
The NextBottle dispenses one dose with the turn of a dial.
PHOTO BY: DANIEL GUZMAN
18 Unit Dose Alert • www.unitdose.org • September 2007

Corporate Membership Application
Join the HCPC Today
Full Membership in the Healthcare Compliance
Packaging Council is available to the following
types of businesses:
■ Commercial manufacture and sale of plastic
film, plastic sheet, or paperboard used in unitof-use
strip and blister packaging for pharmaceutical
and other medical and diagnostic
applications in the United States.
■ Commercial manufacture and sale of metallic
film or sheeting materials used in such packaging
in the United States.
■ Manufacture and sale of equipment used in
the fabrication of such packaging.
■ Converting, printing, or laminating of materials
for such packaging.
■ Contract packaging operations that use such
packaging.
Non-Voting Membership is available to any company
that would qualify for full membership but
has annual sales of less than $10 million in unitdose
blister materials, and voluntarily elects to surrender
its voting rights and board membership.
Associate Membership is available to any business
or individual that is not eligible for full membership,
but supports the goals of the Council. Associate
members may not vote or serve on the Board
of Directors.
Trade Association, Testing Company, Educational
Institution and Consultant Memberships are available
to those interested organizations or individuals.
Annual Dues Structure
Full Membership — $6,000
Non-Voting Membership — $3,000
Associate Membership — $3,000
Trade Association/Testing Company — $1,000
Educational Institution — $500
Consultant — $500
Please Complete All Sections
I. Company Profile
Company Name ____________________________
Street Address/P.O. Box ______________________
City _________________ State ____ Zip________
Contact Name/Title ________________________
Tel. (____) __________________________________
Fax (____) __________________________________
E-Mail Address ____________________________
Web Site Address (if applicable)
__________________________________________
II. Membership Class:
____ Full
____ Non-Voting
____ Associate
____ Trade Association or Test Company
____ Educational Institution
____ Consultant
III. Business Category (check one or more):
____ Plastic Film/Sheet or Paperboard
Manufacturer
____ Metallic Film or Sheeting Manufacturer
____ Blister Packaging Machinery Manufacturer
____ Converter, Printer, Laminator of Blister
Packaging
____ Contract Packaging Operation
____ Trade Association
____ Testing Company
____ Educational Institution
____ Consultant
____ Other (Please Specify)
IV. Payment Address
Please enclose check payable to the Healthcare
Compliance Packaging Council, and mail to:
Peter G. Mayberry
Executive Director
Healthcare Compliance Packaging Council
131 E. Broad St., Ste. 206
Falls Church, VA 22046
Telephone (703) 538-4030
Non-Voting Members ONLY must sign the following certification:
As the designated representative to the Healthcare Compliance
Packaging Council, I ________________________ (your name)
certify that my company _________________________ (company
name) has annual sales of less than $10 million in blister packaging
materials, and that we have elected to join the Healthcare Compliance
Packaging Council on a non-voting basis.
Signature: ________________________________
September 2007 • www.unitdose.org • Unit Dose Alert 19

would like to thank our sponsors for their support.
pharm a p ackaging r esearc h