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Pharmaceutical Manufacturing and Packing Sourcer
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The dynamics of the pharmaceutical market are rapidly evolving, due to
catalysts such as unmet medical needs, the introduction of new drugs
and a keen focus on healthcare costs, including the ever-increasing
generics market.Other drivers changing this marketplace include
evolving regulatory standards, the expanding emerging market sector,
the need to prolong market shares of drugs coming off patent in the
near future through the use of differentiation and life cycle
management strategies, and more emphasis on patient compliance and
convenience. In this article existing device technologies will be
reviewed and we will look at how all the above factors are currently
driving emerging device technologies in these drug delivery areas.
Nasal Drug Delivery
Pharmaceutical metered nasal spray pumps have been around for more than
40 years and are the drug delivery device of choice for ailments such
as nasal congestion and allergic rhinitis, which between them have more
than 350 million sufferers worldwide. Recent pressure from regulatory
authorities, including the distribution of guidance documents, have
focused on the chemistry, manufacturing and control (CMC) aspects of
these products, looking to measure and control some of their critical
quality attributes such as dosing and spray performance (1). In
response to this, device manufacturers are developing a new generation
of nasal spray pumps with improved performance and robustness to meet
these requirements.
An example of this is CPS drug delivery technology.This type of pump
incorporates technical advances such as pre-compression – which leads
to more consistent dosing due to decreased dependence on patient
actuation forces – as well as spring loaded tip-seals that give a much
longer and stable spray phase. In a conventional system, only 30 to 40
per cent of a dose is delivered during the fully developed phase,
compared with over 80 per cent when using CPS (see Figures 1 and
2).Technical advances like this have also led to optimised droplet size
distribution.
A unique property of CPS is that there are no metal contact parts in
the fluid or drug product path. CPS can also provide life cycle
management opportunities; it can be used with preservative-free
formulations – as this pump meets microbial challenge testing – and can
consistently deliver a non-preserved drug product throughout its
lifespan. Opportunities in emerging markets where low cost, ease and
simplicity of use are essential have seen nasal spray systems
introduced for treatments of diseases such as influenza using
disposable nasal unit dose systems – for example,Nasovac from the Serum
Institute of India (2). Nasal sprays are also gaining market share in
the breakthrough pain management arena with recent launches of
Fentanyl-based products such as Instanyl from Nycomed and PecFent from
Archimedes Pharma in Europe.
Devices for pulmonary aerosol delivery, such as pressurised metered
dose inhalers (pMDIs), DPIs and nebulisers first appeared in the
marketplace more than 50 years ago, and more than 600 million devices
are manufactured every year. DPIs are gaining market share, in
particular for asthma and chronic obstructive pulmonary disease (COPD)
medications, as well as more recently with anti-viral drugs.Numerous
innovations have emerged in the DPI area including patient convenient
multi-dose devices, which contain 30 or 60 doses, and incorporate a
dose counter and/or other dose delivery signals or feedback, such as
visual, auditory and safety features to avoid double dosing. One such
device is the Prohaler DPI (see Figure 3), which was developed with
extensive user focused design studies, ensuring that the product is
easy to teach, intuitive, easy to use and portable; indeed, it
incorporates many of the features mentioned above. In addition, the
inhaler has been tested extensively in the clinic with asthmatic and
COPD patients in order to optimise key performance characteristics such
as breath triggering levels, air flow and powder delivery performance.
Ophthalmic Delivery
According to the World Health Organization, about 314 million people
worldwide suffer from impaired vision, and 45 million are fully blind
(3). Increasing numbers of people are at risk of age-related visual
impairment as the global population grows and demographics shift
towards a higher proportion of older people, even in developing
countries. For chronic treatment, multi-dose containers would be the
preferred, most cost-effective option. Few options are available for
ophthalmic use, and most of the current packaging concepts require
preservatives in the formulation stage to guarantee microbial stability
and sterility.The major, preservative-free alternative established on
the market is single-dose blow-fill-seal containers.
An adaptation of an approach that is well established for
preservative-free nasal spray systems – a mechanical seal technology
combined with sterile filtration of the venting air – provides a highly
effective delivery system. A springloaded tip-seal keeps the system
closed until a defined pressure is reached during actuation.The
formulation is then forced through the orifice.When the pressure drops
as a result, the tip seal immediately closes the orifice by an outward
motion, which prevents any backflow of contaminated liquid or
particles. For the venting air, a sterile filter (0.2μm nominal pore
size) is used to stop microorganisms from entering.As some ophthalmic
formulations have compatibility issues with metal, the design of the
ophthalmic system features a metal-free fluid path.
One device that has emerged from the development process is the
ophthalmic squeeze dispenser (OSD).The OSD is actuated by squeezing a
modified 10ml low-density polyethylene (LDPE) bottle and the device can
easily be adapted for a reasonable range of viscosities which allow the
delivery of a consistent drop size (see Figure 4).
This new generation of multi-dose ophthalmic devices, with all their
advantages, can provide the cutting edge for the life cycle management
of established products,with low investments in filling technology.
Encouraging Compliance
With the current difficulties in the world economy and the subsequent
pressure on healthcare costs worldwide, more companies are looking into
patient compliance as a means of reducing the burden on the healthcare
system. Lack of compliance – that is, not taking the right dose of the
right medication at the right time for the prescribed duration of a
treatment – has significant cost implications if medication is wasted,
or the patient requires additional treatment due to poor compliance,
and at worst can actually be harmful to patients (4). In order to
address this issue, products are being developed by the industry to aid
compliance, two examples of which are side actuation nasal spray
technology and a family of electronic devices specifically aimed at
improving patient compliance (see Figure 5). Aspects such as
ergonomics, handling comfort and ease of actuation were the main
drivers in development, and feedback from the end users confirmed
improvements in all these areas.
Another potentially powerful addition to the patient compliance area is
the use of electronic devices such as e-counters, elockout systems and
data monitoring.To address compliance needs, a platform of edevice
technologies is also in development which can be incorporated as part
of the drug delivery system.Such devices can help patients to count
their doses and, consequently, to see how many doses remain before they
need to refill their prescriptions. In addition, electronics can allow
self-dosing of treatments such as breakthrough pain medication, without
direct healthcare professional supervision,and can protect the patient
with lockout systems that would prevent accidental overdosing or
diversion with potentially potent controlled substances.All these
developments offer excellent opportunities to enhance patient
compliance and can eventually be part of integrated electronic
healthcare provider systems, which could become standard in the future.
Conclusion
There are many new and innovative developments emerging in the nasal,
pulmonary and ophthalmic drug device delivery areas, all aiming to meet
the evolving needs of these markets, such as stricter regulatory
standards and life cycle management.The patients themselves should also
benefit from some these innovations as they also contribute to patient
compliance and will bring significant benefits to users, and help
manage healthcare costs in an ever-evolving world.
References
1. Guidance for Industry, Nasal Spray and Inhalation Solution,
Suspension and Spray Drug Products Chemistry, Manufacturing and
Controls Documentation, US Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(CDER), July 2002
2. www.seruminstitute.com
3. WHO Fact Sheet No 282, Visual impairment and blindness, May 2009
4. WHO Adherence to long term therapies, Evidence for action, 2003 report
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