A Breath of Life

June 15, 2016

A Breath of Life

Background of a Killer

Every three minutes a new mother somewhere in the world dies after giving birth from excessive blood loss. In what is universally celebrated as a joyous event, childbirth is too often marred by postpartum hemorrhaging (PPH) that claims the lives of some 140,000 women each year. 1 As the leading cause of death in new mothers, PPH accounts for roughly 6% of maternal deaths annually. Throughout the developing world, however, that number rises to more than 30%. 2

Why the huge disparity? The lack of a modern infrastructure and medical resources are largely to blame. With little or no access to medical facilities, drugs, or even electricity for an estimated 1.2 billion people around the globe, many women are unable to receive proper obstetric care. 3 That means they likely do not receive a lifesaving injection of oxytocin, a hormone, shortly after giving birth to stop excessive bleeding. The reason why is infuriating simple. In its present form, oxytocin requires refrigeration. A recent sampling of oxytocin ampoules in Uganda, for instance, found that up to 74% of the oxytocin ampoules suffered from temperature-induced degradation. In other instances, including home births and poorly equipped hospitals in developing countries, the lack of skilled caregivers and even syringes also come into play, especially for a drug that is not easy to inject into muscle tissue. 4

Eureka Moments

For Michelle MacIntosh, a pharmaceutical research scientist at the Monash Institute of Pharmaceutical Sciences (MIPS) and Senior Lecturer at Monash University in Australia, her passion for solving the oxytocin problem started with the University's 2007 purchase of a PerkinElmer analytical instrument along with a letter from a young Botswanan graduate student. Still in use today, the instrument helped launch Prof. McIntosh's incredible journey to where she and her team now stand on the very brink of seeing their research become a reality that will soon hopefully eliminate PPH deaths around the world. As for the graduate student's letter?

"She expressed an interest in learning more about pharmacokinetics, bioequivalence, and analytical techniques," remembers McIntosh, a recognized expert in all three areas. So when she discussed possible research projects with her colleagues for the student, Dr. Richard Prankerd, an expert in creating a dry powder for inhalation, mentioned the challenge of converting oxytocin into an inhaled formulation. If successful, it would eliminate the need for refrigeration, syringes, needles, and even skilled medical care. Oxytocin could become a self-administered aerosol in a disposable inhaler. 5

Building a World-class Lab

Since that day, McIntosh and her research team have made giant strides in developing oxytocin as a self-administered, dry aerosol to expectant mothers. They are the recipients of several prestigious global awards and innovation grants, including support from the Bill & Melinda Gates Foundation. Throughout their research, the team has relied on a suite of PerkinElmer instruments to advance not only their oxytocin project, but also other research areas that have earned the Monash Institute of Pharmaceutical Science (MIPS) its well-deserved reputation as a global leader in innovation and medical research.

Amid all of the kudos and international attention being showered on MIPS and McIntosh's groundbreaking research into spray-dried delivery of pharmaceuticals, she and her team have never lost their appreciation for the hard work, science, and state-of-the-art instrumentation that helped earn them international recognition.

"We use PerkinElmer's DSC 8500 [Differential Scanning Calorimetry] to determine the glass transition temperature of oxytocin formulations," Dr. McIntosh says. The glass temperature (Tg) region is where a polymer transitions from a hard, glassy material to a soft, rubbery one.

Among several other PerkinElmer® instruments used regularly by McIntosh's lab on the oxytocin project is what she describes as the "hybridized configuration" of the PerkinElmer Frontier™ IR/FIR Spectrometer, Clarus® 680 GC, and AxION® iQT™ GC/MS/MS. "This configuration helps us determine whether the formulation ingredients evaporate or sublime on heating," she says.

Commenting on PerkinElmer's SpotlightTM 400 FT-IR Imaging System, Dr. McIntosh notes that "it is allowing us to understand the uniformity of the ingredients in a spray-dried formulation," while the Janus® Integrator platform, "is being used to aliquot large numbers of samples from pharmacokinetic studies for oxytocin content," McIntosh says, adding that the PerkinElmer connection to the oxytocin project is a longstanding one.

Today, several other companies including pharmaceutical giant GlaxoSmithKline are ready to help develop and distribute the new PPH treatment once it makes its way successfully through research studies that began last year. 6 So far, the research shows that the prototype spray is as effective as traditional oxytocin. In the interim, McIntosh continues to follow a simple driving force "to share our knowledge to help people all around the world," she says. "The privilege of working on a project like this is what really motivates me and makes it easy to come to come to work every day."

The PerkinElmer instruments mentioned are for research use only.  Not for use in diagnostic procedures.

References

  1. John R Smith, MD; Chief Editor: Ronald M Ramus, MD, et. al., "Postpartum Hemorrhage," Medscape.
  2. Fawole B, Awolude OA, Adeniji AO, Onafowokan O. "WHO Recommendations For The Prevention Of Postpartum Haemorrhage: RHL Guideline," (last revised: 1 May 2010). The WHO Reproductive Health Library; Geneva: World Health Organization.
  3. The World Energy Outlook, WEO Electricity Access Database, 2015.
  4. Michelle McIntosh, "Tackling Postpartum Haemorrhage," Monash University, 2013.
  5. Kashyap Patel, "Tackling Postpartum Haemorrhage," Monash University, Monash Institute of Pharmaceutical Sciences, 2013.
  6. GSK, "Innovation And Collaboration With Monash University," GlaxoSmithKline Press Release, 2016.

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