Case Studies – Pharmaceuticals, Medical and Medical Devices


PHARMACEUTICAL


Reckitt Benckiser: How to assess an innovative Gaviscon powder

Testing a new dissolving granule formulation

Reckitt Benckiser are leaders in heartburn and indigestion relief, committed to finding solutions for disruptive heartburn and indigestion.

The challenge

Gaviscon Direct Powder (GDP) is a novel formulation design in the form of individual doses of quick dissolving granules without the need for water. The product offers convenience and ease of use with rapid melting in the mouth which may provide important benefits regarding patient compliance in the treatment of symptoms of reflux. Comprehensive testing is required to prove the efficacy of this product, as with any other pharmaceutical formulation.

The research

Reckitt Benckiser performed research using their Texture Analyser to investigate the physical properties of the alginate raft created when Gaviscon is consumed.

The outcome

In vitro raft strength testing confirmed that despite the novel product formulation GDP was able to form an alginate raft which met the conditions stipulated by the British Pharmacopoeia. The in vivo gamma scintigraphy study in healthy volunteers further confirmed raft formation above the meal in the stomach and that GDP emptied after the meal. The raft formation and gastric retention profile were noninferior to the established Liquid Gaviscon.


The University of Witwatersrand: Measuring the compressibility of intraocular devices

Inserting a contact lens

With a collaborative approach, the Division of Ophthalmology at the University of Witwatersrand aims to foster skills and produce a well-rounded ophthalmic team that offers a comprehensive world class service, with a strong focus on academic excellence and innovative research.

The challenge

For AIDS patients, retinitis (contracted from the cytomegalovirus) is among the most common opportunistic infections, which if left untreated inevitably results in blindness. To replace intravitreal therapy, which is highly invasive, among the most promising developments are intraocular implants/devices designed to deliver drugs with precision directly to the required areas offering several advantages to alternative therapies. However, such devices are extremely complicated to manufacture, are prohibitively expensive and (as they are not biodegradable) at the point of removal may increase the risk of wound leaking.

The research

As a result, researchers developed a small implantable doughnut-shaped minitablet that erodes in the body. Their TA.XTplus Texture Analyser was used to characterise the compressibility of the polymers used in making the device using a ball probe indentation of the tablet to obtain its Brinell hardness number. The low compression forces of the polymer material chosen deemed it suitable for the device with regard to wear on major tableting equipment such as punches and dies.

The outcome

The Texture Analyser was successfully used in selecting a polymer for use in an ocular implant by this research team.


How to measure the mechanical properties of temporary scaffolds

Surgical staff in operating theatre

The Indian National Institute of Technology is a university globally trusted for technical excellence where learning and research integrate to sustain society and industry.

The challenge

Tissue engineering is a promising technology for treating tissue defects or replacing nonfunctional tissues/organs. It relies upon a temporary scaffold that is basically an artificial structure which provides the support for 3D tissue formation or organogenesis. Ideally, scaffolds should be able to accommodate human cells, orchestrate their growth and differentiation leading to tissue regeneration and ultimately make it feasible for implantation. Since ligament injury is most common and ligament-alone grafts are not so successful to replace the injured ligaments, the researchers are experimenting with the construction of a composite scaffold which can guide the stem cells to differentiate into fibrocartilage that bridges the bone-ligament interface, i.e. enthesis.

The research

Scientists used their Texture Analyser for the publication ‘Fabrication of silk-based composite scaffold for bone-ligament-bone graft using aqueous polymeric dispersion technique’. Tensile tests were carried out on temporary scaffolds that provide support for 3D tissue formation.

The outcome

Silk-based multi-compartmental scaffolds were found to be suitable for enthesis tissue engineering due to their porosity and matching mechanical properties.


MEDICAL


Measuring tablet dispersion with Aprecia Pharmaceuticals

Tablet on tongue

Aprecia is the global leader in commercial-scale 3D printing for pharmaceutical manufacturing technology. They are committed to creating new solutions for unmet healthcare needs by developing pharma-ready innovations and complementary technology platforms that enable patient-centric products and help take medicine to its fullest potential.

The challenge

Aprecia Pharmaceuticals announced some exciting news in March 2016 for people who take Levetiracetem, a medication that helps prevent seizures. Levetiracetem comes in a large pill format that can be difficult for many adults and children to swallow. Doctors have long been aware of what happens if the experience of taking the medication is unpleasant. It’s common in these cases that patients will often skip, forgot, or avoid taking their medication. Aprecia has developed a method called ZipDose that uses to 3D printing to manufacture Levetiracetem. The 3D printed tablets deliver a highly efficient dose and dissolve instantly with a sip of water.

The research

The TA.XTplus Texture Analyser was used to test and analyse the tablet’s dispersion time in aqueous fluid.

The outcome

The drug’s new form is expected to greatly improve the experience of patients who take the medicine.


Northwestern University: How to measure the mechanical strength of nanocomposite sponges

Nanocomposite samples

The Northwestern University Feinberg School of Medicine invites students, faculty and staff to be part of a forward-thinking institution committed to improving human health through education and discovery.

The challenge

The field of orthopedic tissue engineering is quickly expanding with the development of novel materials and strategies designed for rapid bone regeneration. While autologous bone grafts continue to be the standard of care, drawbacks include donor-site morbidity and short tissue supplies.

The research

Researchers developed a novel nanocomposite sponge composed of poly(1,8-octanediol-co-citrate) (POC) and the bioactive ceramic β-tricalcium phosphate (TCP). used their TA.XTplus Texture Analyser to publish ‘Advanced Nanocomposites for bone regeneration’. The Texture Analyser was used to assess the mechanical strength of a novel nanocomposite sponge using repeat compression tests.

The outcome

The researchers showed that these nanocomposite sponges could be used as a depot for bone-producing (osteogenic) growth factors and supported the use of this sponge for future bone tissue engineering efforts.


Tensile strength of cartilage grafts: ETH Zurich

Tensile test on TA.HDplus

The Institute of Pharmaceutical Sciences at the Swiss Federal Institute of Technology Zurich is devoted to cutting-edge research at the interface of life and pharmaceutical sciences with the aim to develop concepts, targets, and prototypes for tomorrow's diagnostics and therapeutics.

The challenge

Bioprinting is an emerging technology for the fabrication of patient-specific, anatomically complex tissues and organs. A novel bioink for printing cartilage grafts was developed based on two unmodified FDA-compliant polysaccharides, gellan and alginate, combined with the clinical product BioCartilage (cartilage extracellular matrix particles).

The research

Researchers at ETH Zürich published a paper of their work entitled 'Bioprinting Complex Cartilaginous Structures with Clinically Compliant Biomaterials' that employed their TA.XTplus Texture Analyser to perform tensile tests on dumbbell shaped samples of bioprinted cartilage grafts, finding them to be strong and ductile. This enabled the development of patient-specific cartilage grafts with good mechanical and biological properties.

The outcome

The versatile method can be used with any type of tissue particles to create tissue-specific and bioactive scaffolds.


MEDICAL DEVICES


Measuring the Biomechanics of Sternum Closures at the University of Missouri-Columbia

Rib cage illustration

Researchers at the University of Missouri-Columbia focus on lifesaving discoveries that address the most prevalent health problems. The school is nationally ranked in such areas as family and community medicine, primary care, pharmacology and physiology, and health management and informatics.

The challenge

Poor healing of median sternotomy can significantly increase morbidity, mortality, and hospital costs. Effective union requires reliable sternal fixation. Although wire has proven the most reliable and widely used sternotomy closure material, no experimental studies had compared a large variety of wiring techniques in a human model.

The research

Researchers developed an easily reproducible experimental model using cadaveric human sterna and compared several wiring methods to assess closure strength and stability. They employed their Texture Analyser to carry out a study on the biomechanics of sternum closures after a sternotomy. Fifty-three fresh adult human cadaveric sternal plates with adjacent ribs were fixed with specially designed spiked stainless steel clamps and attached to a TA.HDplus Texture Analyser. The Texture Analyser was used to assess stiffness and displacement using perpendicular repetitive variable force loads of 800 Newtons cycling at a rate of 0.5mm/s. A range of closures were assessed.

The outcome

This new way of sternotomy closure testing was found to be reliable, inexpensive, and easily reproducible and distinguished the suitable closures from the unsuitable.


Queen’s University Belfast: Cyclical compressive strength of intravaginal rings

Nurse holding red ribbon

The School of Medicine, Dentistry and Biomedical Sciences at Queen’s University Belfast is addressing key global challenges in healthcare by making scientific breakthroughs in mechanisms of disease, translating these to innovative therapeutics and preventive interventions to improve patient outcomes.

The challenge

The mechanical properties of an IVR must ensure optimal vaginal compatibility and user acceptability. If the mechanical strength is too low, the ring could either be expulsed from the vagina or be prone to rupture. If the mechanical strength is too high, the inflexibility of the device could cause irritation or ulceration of the vaginal tissue.

The research

Researchers, and experts at physical characterisation at Queen’s University Belfast, have been using their TA.XTplus extensively for many years in both pharmaceutical and medical device applications. More recently they used their Texture Analyser to study the cyclical compressive strength of a range of formulations for intravaginal rings for HIV microbicide delivery. Additionally, the mechanical characteristics of the rings before and after release were tested to look at the influence of the presence of active drugs on their mechanical characteristics.

The outcome

The Texture Analyser was successfully used for mechanical analysis of these samples.


Leo Pharma and their Research into Microneedle mechanical strength measurement

Microneedle test piece

Leo Pharma are an independent, research-based pharmaceutical company. They support public policies that promote the discovery of innovative medicines and better accessibility to those who need them.

The challenge

Microneedles are micron-scale structures designed to pierce the stratum corneum and permit delivery of an active ingredient transdermally or to the epidermis and dermis. Microneedle (MN) technology offers an efficient and minimally invasive and painless drug delivery method compared to conventional transdermal patches and intravenous injections. Microneedle arrays have been prepared from many diverse materials such as silicon, stainless steel and biodegradable polymers. To prevent the microneedles from breaking on insertion into the skin, the mechanical strength of the microneedles should be such that the force required to fracture the microneedle is significantly greater than the force required to insert the microneedle into the skin.

The research

Leo Pharma used their TA.XTplus Texture Analyser in the patent application of their microneedle patch.

The outcome

Generally, the force required to insert a microneedle patch into the skin and have it penetrate past the stratum corneum is in the range of 0.4-8N, for instance 2-7N, such as 5N, per patch containing 25 microneedles per cm2. The failure force of the microneedle can be assessed as either a fracture force or the force required to compress the microneedle by a defined length. These forces can be easily determined using a texture analyser performing a compression test.



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