Specialist paste injections 2006-08-18 17:47:19
Many therapies are injected into the body as a thick paste. Pastes have a variety of unique and useful features. They can provide structure enabling tissue scaffolding to remain open, they are a highly concentrated form ensuring delivery of high doses, they are malleable enabling them to squeeze and spread. All pastes contain, nearly by definition, only small amounts of liquid material and most of that is bound to the ingredients of the paste. Often there is little free unbound liquid. The bound water can be tightly bound or not tightly bound. Often the ionic binding sites of the solid material are not all bound to a water molecule making the paste tacky and sticky. Some pastes can dry out very quickly and hence management of the hydration is important. Making a paste up from a powder can be tricky as all the water is frequently absorbed by the first layer of powder it touches, blocking up the channels between the particles and leaving dry patches of powder, which are hard to eliminate. Impri t has been working with its clients on robust methods to hydrate powders into consistent and reproducible pastes using special sterile mixing methods. The small amount of liquid whether bound or unbound can move sufficiently to provide lubrication between particles and solids enabling the paste to move and deform. The flowability of the paste is dependent on the level of the water. Thin pastes move more easily than a thick paste. One problem with pushing pastes, especially thin pastes, through tubes such as needles is that filtering of particles from the liquid can ccur, causing blockages in the delivery or ch nging the delivered dose. Also, pastes require considerable force to be delivered. Sometimes the force is so high it is too hard to inject. Imprint has been working with its clients to overcome these issues, to ensure the right amount of paste is delivered easily to the right site in the body, even if this site is hard to find.

Paste based therapeutics 2006-08-17 13:55:18
A paste-injector has been developed for a client. It has successfully delivered a paste-based product to a specific site. The design has been proven to significantly reduce the clogging of the product and increase accuracy of the dose delivered. The designs for this product were delivered within two weeks, whilst an engineering design house had laboured for two years trying to develop a suitable product.

Specialised injection sites: the eye 2006-07-20 15:34:13
Injections into eyes As is the case with the knee, serious issues frequently occur with injections into the eye (intravitreal injections). One alarming issue is the frequency of serious adverse events when the needle scratches the cornea or hits the retina. With a skilled eye surgeon, the probability of a serious adverse event for a single injection is small, around 1-3%. This level of serious events could be regarded as acceptable for a single injection. However, a low level of serious events can have a major impact if an injection is given chronically. For example, if an injection is given once every six weeks, then the patient receives eight injections annually. Thus the probability of a serious adverse event in a year per patient would be approximately 10-20% if the serious adverse event rate is 1-3% per injection. Another way of thinking of this is that 10-20% of patients every year would have a serious adverse event, which may adversely affect their vision or even blind them.

Particulate Injections 2006-07-20 15:34:03
Imprint’s particulate injectors are still achieving delivery of higher and higher concentrations of particulates. Clients are now using the technologies to maximise the delivery of their particulate products. The latest prototypes have been shown to deliver up to 750 mg/ml of certain types of particulates. This is about 3-5 times the maximum that can be injected through a standard 21- gauge needle and syringe. Particulate injections were discussed in detail in the main feature article that appeared in IMPRINT in print, Vol 1, Issue 1.

DepotOne. 2006-07-20 15:33:56
DepotOne, Imprint’s small needle that can replace large needles, is now being incorporated into clients’ projects. The lead therapeutic products using the device are now in Phase III clinical trials. DepotOne received its 510k (FDA approval) towards the end of last year and hence is available for use in the US. Imprint expects to see a string of products using the DepotOne device being launched over the next few years. Its popularity when used in conjunction with auto-injected and pen injected products has been proven. DepotOne allows pharmaceutical and biotechnology companies the freedom to increase the viscosity of the products delivered without altering the devices at all.

Quarter-inch needle launched 2006-07-20 15:33:48
Imprint is pleased to announce the development of its quarter-inch needle, the shortest needle available. This needle length will be available in most common needle gauges including 27-, 25- and 21-gauge. The shorter length will make these needles much less threatening than longer lengths. The product is now available for testing by pharmaceutical companies.

Helping to reduce cost of goods 2006-07-20 15:33:41
Imprint has been working with a number of companies to help reduce the cost of goods of injectable therapeutics. We have been developing new techniques and devices which enable our clients to make significant savings in their overall product costs.

Breaking News: Recent projects advance 2006-07-20 15:33:34
The work arising from Imprint’s centre for expertise in complex formulations is already producing exciting results. Imprint has developed a new device Micro-H to act as a solubility enhancer for a client. The system is a unique disposable technology. It can be sold with an injectable therapeutic that can increase the solubility of their product significantly. Clients have also commissioned projects to develop alternative low-cost technologies to decrease the viscosity of injectable therapeutics. These projects are progressing well with development underway of a new technology, which can be packed with a pharmaceutical product. A paste injector has been developed for a client. It has successfully delivered a paste-based product to a specific site. The design has been proven to significantly reduce the clogging of the product and increase accuracy of the dose delivered. The designs for this product were delivered within two weeks, whilst an engineering design house had laboured for two years trying to develop a suitable product. In addition Imprint has designed and delivered a mixing system, based on a very simple concept, which could rapidly and reproducibly mix difficult combinations of products, and could be scaled-up to full production within three months. These designs now have strong patent protection and are available for other clients to use.

Customised device design improves injections 2006-07-20 15:33:26
Injecting complex formulations (such as particulates, highly viscous products and gels), and paste-based formulations is difficult. This is especially so if the injection is to uncommon sites such as the knee, the bone, the knuckle and the eye. Skill and extra care are needed to guarantee safety whilst ensuring the injections are performed accurately and reproducibly. Current injection devices were designed to deliver saline-based or near-saline based materials into the subcutaneous or intramuscular tissue. It is therefore not surprising that the current devices are frequently poor at delivering a complex formulation. Also these existing devices have been often found poor at injecting therapies in to specialised areas. Examples of the difficulties found injecting formulations into specialised areas can be found in the item on Specialised Injection Sites. They illustrate the unrecognised and definitely under-appreciated problem of the injection device limiting the performance of an injectable therapy. The device can limit the amount of therapeutic product delivered, be the cause of adverse events, and reduce the accuracy of placement of the product, amongst other issues. In summary, the device can be the unexpected cause of a problematic injectable product. It is often the case that a specialist device specifically designed to deliver a therapy to a sensitive area will reduce or eliminate many of these issues. Unfortunately, suitable off-the-shelf specialist devices for these sensitive areas are often unavailable. In addition, the real problem to solve is often not obvious and needs careful consideration. This is particularly the case for the delivery of complex, viscous, particulate and unusual therapies. Imprint has been using its expertise in the delivery of complex formulations to help clients to develop bespoke delivery devices. They maximise the safety and accuracy of injecting non-standard formulations into subcutaneous tissue and injecting standard and non-standard therapies into specialist areas. Although the potential gains are significant, bespoke delivery devices are often not even considered as a viable option because there is a perception that it will be more expensive and risky. This can be a misconception with apparent savings from ignoring the bespoke device option being exposed down the line as a false economy. “It is almost always cheaper and less risky to wrap a partly customised device around an existing formulation than to spend time altering the formulation to make it go through an existing device,” comments Imprint’s Business Development Director, Kevin Maynard. “Devices are very precisely defined and have very predictable performances. Developing a new formulation and its multiple interactions including activity, toxicity, solubility and stability is not as well defined as a device and hence is usually a far less predictable and more risky path.” Having a customised device: • should dramatically improve the performance and safety of a product. • should improve accuracy of delivery • can always enable delivery of a more optimised formulation • will reduce delays due to lengthy reformulations • can dramatically reduce costs as it is much cheaper to alter a device than to alter a formulation The advances that such a device can give a therapeutic are often so formidable that frequently the product’s competitive position is greatly strengthened. The skills required to develop a device to deliver complex injectable formulations to specialised areas are fairly rare. Even the minimum requirement for success in this field – a unique combination of knowledge and experience of engineering formulation sciences, clinical science and regulatory affairs – is difficult to find. Analysis of fluid flow of complex formulations is perhaps one of the most difficult engineering disciplines. Combining this area of knowledge with the equally difficult area of formulation science creates a highly complex skill-set. When this is overlaid with the need for in-depth knowledge of biology/anatomy, clinical sciences and the complex regulatory issues surrounding drug device combinations, it is not surprising there are few groups with the necessary all-round expertise to deliver successful results. Imprint is uniquely dedicated to this area. By focusing on difficult-to-inject therapies, Imprint provides clients with unrivalled expertise and knowledge. Thus the company can solve, demonstrate, and implement solutions faster with substantially reduced cost and risk. Indeed, Imprint solves many problems that other suppliers cannot.

DepotOne receives 510k clearance 2006-07-20 15:33:15
Imprint Pharmaceuticals is pleased to announce that DepotOne, its lead product has received a 510k clearance from the US FDA. This clearance means that the DepotOne needle can now be used in the clinic in America. Imprint is supplying the product to companeis for use in clinical trials. DepotOne is a 'small' needle with the fluidics of a large needle. It enables formulators over come the challenge of delivering difficult-to-inject drugs without resorting to an unacceptably large needle.

DepotOne receives CE Mark 2005-11-15 10:27:25
Imprint Pharmaceutical is pleased to announce that its DepotOne needle technology has received its CE Mark. The CE mark means that DepotOne needles are now available for sale in Europe. The DepotOne needle is designed to deliver highly viscous materials without resorting to an unacceptably large needle. Formulation scientists have been delighted by the extra fluid capacity provided by the DepotOne needle. This extra fluidic capacity enables formulation scientists to deliver larger doses and move beyond the current limits of injectable formulations. DepotOne enables the delivery of larger doses and can become the cornerstone for development of longer-acting therapies and higher blood concentrations. Marketers are fully aware of the significant perceptual damage that large needles can cause to the reputation of an injectable therapeutic product. They are planning to use DepotOne to reduce the impact of the large needle issue so the positive aspects of their product can be highlighted.

Launch of newest version of DepotOne needle 2004-08-16 10:41:08
Imprint announces the launch of the latest version of its DepotOne needle. The needle is a 23 gauge DepotOne needle with the fluidic capacity of an 18 gauge standard needle. This is Imprint's largest capacity DepotOne needle to date. The needle is a clear advance on current technology, providing doctors with a much more acceptable route to inject extremely viscous liquids. Fluids with a viscosity in excess of 3000 centipoise can now be easily injected with a very patient-acceptable 23 gauge SQ or IM needle.