As pharmaceutical companies seek to leverage the cost advantages of global market reach by streamlining product processes, rationalizing supply chains and accommodating changes in
drug formulations, the packaging is becoming an increasingly important issue.
Over the past 40 years, blister packaging has become an
industry standard because it offers flexibility in design while
delivering high productivity and quality outcomes for oral
Underlying this adoption is the universally accepted benefit inherent in the unit dose concept, which provides visual
and haptical evidence of the number of doses taken, making
it easy for patients to follow their therapy. It is a comfortable and a familiar means of taking medication – and is one
of the main reasons why the majority of marketed medicines
have been presented as tablets and capsules over many decades.
However, change is underway. Looking at companies’ drug
development pipelines, it appears that both the absolute
number and the percentage of oral solids in those pipelines
versus other dosage forms is declining. At the same time,
the number of oral solid drugs requiring high to ultra-high
barrier protection to maintain stability and achieve shelf life
targets is growing substantially as a result of new formulations and the desire to market and distribute drug products
on a world-wide basis.
This structural change presents opportunities but not
without significant challenges in designing and utilizing effective packaging capable of accommodating the extremes
of temperature and humidity. It is now self-evident that
the barrier protection offered by primary packaging developed for use in moderate climatic zones does not provide a
global solution – particularly when a growing list of Active
Pharmaceutical Ingredients (APIs) are sensitive to moisture,
oxygen and even light and less soluble than in the past.
This trend is all the more apparent because of the growth
of the pharmaceutical industry in emerging markets. Countries
such as Brazil and India, which require packaging to meet the
necessary criteria for hot climates, namely ICH Zones 4 and
4b, as well as many other parts of South America, Africa, and
Southeast Asia, have prompted the development of the film in-
Leveraging a global packaging strategy can help
manufacturers and patients
The need for ultra-high barrier protection is rising as more
innovative formulations come to market.
novations. These include Honeywell’s Aclar® UltRx 6000 film –
an effective solution in protecting moisture-sensitive medicines
whatever the climatic conditions.
THE PACKAGING IMPERATIVE
The need for ultra-high barrier protection is on the rise
as a result of the pharmaceutical industry’s innovations in
the domain of formulations (oral dissolve technologies, extended release technologies and combination treatments).
The use of a growing number of poorly soluble drug substances presents a challenge in arriving at a viable formulation, often involving reducing drug particle size down to
submicron level to enhance dissolution rate.
With this trend towards the decrease in drug particle
size, the overall surface of all drug particles in the dosage is
greatly enhanced; therefore if the drug molecule exhibits a
moisture or oxygen-sensitive chemical group, the likelihood
for chemical degradation is increased.
Commercially, for pharmaceutical companies, these more
moisture-sensitive dosages require packaging technology
that enables the successful delivery of the drug therapy to
any climatic region through a single solution. High barrier
film supports this global strategy by enabling longer prod-
Advantages of a Global