In recent years TTP has developed over 30 significant drug delivery devices and contributed to the development of many more. Our expertise includes: pulmonary and parenteral devices; the delivery of liquids, powders and tablets; mechanical devices, electronic devices and novel mechanisms; eye and nasal delivery.
Whether because there are close competitors for the same indication or because the remaining patent life is short, few drugs are sufficiently differentiated to command a sustainable price premium. With payers increasingly linking payment to patient outcomes, progressive pharma companies know that they need to look beyond simple drug delivery to a patient’s overall disease management and quality of life. Not only does this include technical aspects such as adherence, compliance, and monitoring, but softer issues such as influencing patient motivation will also be critical.
The next generation of drug delivery solutions will draw on expertise in sensing, communication, medical electronics, and even psychology, as well as prerequisites such as robust product definition, human factors, and mechanical engineering. This requires a development partner with the same breadth of skills and experience.
Pharmaceutical companies seek to create drugs with a unique therapeutic effect, but they also require devices that enable their drugs to take effect.
Another way for a device to deliver on the commercial front is by responding to user wants or needs, and when AstraZeneca saw a gap in the market for a device with an easy to use dose counter, we were their clear choice of development partner.
A problem, common to many inhalation devices, is the inability of the user to tell how much drug remains. Typically, this is judged by the user shaking the device to guess what is left — hard to do given the relative weights of the drug and the device, and inaccurate.
Making the most of our expertise from developing over 30 inhalation devices, we created a high-reliability counter that provides a non-linear motion of a dial on a colour display, enabling a clear dose count from 120 down to 0. The colour display alerts patients to the number of doses remaining in their inhaler, providing both patient value and significant market differentiation.
Meeting the robust versus low-cost challenge, TTP has designed a quarter of the world’s inhalation devices.
TTP was able to draw on its engineering and medical device development expertise to design a mechanism that is both robust (failure rates of 1 in a million) and whose cost is compatible with that of a “throw-away” device.
Hovione came to TTP with a clear brief and a device requirement matched to a single formulation for the Japanese market.
In order to meet tight commercial timelines driven by the Japanese government’s flu pandemic fears, we needed a project plan that went from concept generation to first moulded prototypes in less than two months.
TTP assembled a small dedicated team to leverage core knowledge of design and manufacturing principles to take on the challenge.
Our response was TwinCaps®: a two-component, single dose, dry powder inhaler for systemic delivery.
Focusing on one design concept, and by means of early and repeated prototyping coupled with a concurrent engineering approach, TTP was able to meet the incredibly short product launch deadlines.
Launched by Daiichi Sankyo, Japan’s second largest pharmaceutical company, TwinCaps® outsold Relenza and Tamiflu within the first six months and is the world’s best-selling, disposable inhaler.
Taking Clinical Designs’ original concept for the valve, TTP initially demonstrated a successful manufacturing solution for the technology. We then developed a full pMDI device around this valve and took this design through to pilot production. The result is a 6-part breath-actuated inhaler (BAI) instead of a more typical 14- or 15-part BAI.
The device has a low fire point for easy actuation, and a very low step change in pressure drop. This gives a nice 'feel', increasing patient acceptability as does its small size and ease of use (open – inhale – close). It also achieves excellent in-vitro equivalence.
The K-Haler is a unique pressurised metered-dose inhaler (pMDI) which uses an innovative kink valve to create a breath-actuated delivery mechanism. Breath-actuated devices are typically expensive and complex with many components. The novel kink valve in our design enabled a much simpler design and lowered the cost to manufacture.
Hopefully these case studies have shown you just a little of what a collaboration with TTP can achieve, from the creation of powerful and ground-breaking new products and solutions, through to their development and manufacture.
We believe it’s a uniquely visionary approach to Drug Delivery that can help our partners harness – and commercialise – the power of a great idea.
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