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Pharmaceutical Manufacturing and Packing Sourcer

First Class Delivery

For several years we have been seeing an exciting expansion of transdermal drug delivery capabilities, presenting the pharmaceutical industry with an opportunity to meet the needs of healthcare providers, patients and regulatory bodies with an efficient and user-friendly technology. A key force in the demand for new transdermal technologies is the growth of the biopharmaceutical market.The traditional syringe delivery method

for these drugs is well-established, but room exists for improvement in delivery efficiency and for increased patient comfort.Microneedle delivery provides companies with a number of advantages in the administration of biopharmaceuticals. Reformulating these drugs for transdermal delivery offers the possibility of longer action, greater and/or faster onset of action, and fewer side effects. For example, research has shown that many vaccines may produce a more robust immune response when delivered intradermally compared to traditional injection, and the immune response can also be faster. In addition, a more efficient delivery system can help make an expensive drug easier to access for a greater number of people.

Transdermal delivery allows the drug to be released in a predictable manner and is significantly more comfortable for patients, which creates the possibility of improved patient compliance.The microneedle technology minimises the risk of inadvertent needle pricks and also gives patients the ability to selfadminister medications, which can be an important differentiator for a product in terms of pharmacoeconomics (see Figure 1).Transdermal technologies can also play an important role in life cycle management for a drug. A firm with an existing product can reformulate it for this delivery route and differentiate it from generic substitution, extending its life and maximising its value.

Microneedle Technology

A number of new transdermal technologies are currently in development at several companies. Some of the best offerings in this area include both a solid and hollow Microstructured Transdermal System (sMTS and hMTS) respectively.These technologies use biocompatible, polymeric microneedles to bypass the barrier properties of the stratum corneum.As noted above, this method of delivery allows pharmaceutical companies to administer previously undeliverable molecules, including vaccines, proteins and peptides to the dermal/epidermal layers of the skin.

One sMTS microneedle patch is composed of 300 to 1,500 solid microneedles that are 250 to 700 μm tall.The microneedles are coated with a therapeutic agent, and the device can deliver a dose up to 0.03 mg.The hMTS microneedle system utilises a somewhat different method of delivery, with the therapeutic agent contained in a reservoir attached to the hollow microneedle patch.The patch provides a diffuse area for intradermal infusion, with 18 structures configured across a 1 cm2 array.

The microneedles on the hMTS are 900 μm tall, and function on the patch as mini-hypodermic needles (see Figure 2). Slight pressure releases the agent through the microneedles. When applied to the skin, the microneedles penetrate the stratum corneum and epidermis to reach the dermis,well above the nerve endings that could cause a patient discomfort. The hMTS system is designed with an adhesive that allows the device to be worn on average from five to 20 minutes, and it is capable of delivering a liquid dose up to 2 ml. Research has also demonstrated delivery of 1 ml in as little as 90 seconds.The reservoir on the hMTS is compatible with existing injectable formulations and filling processes.Tests have demonstrated that administration of model drug compounds with these devices sometimes produces pharmacokinetic (PK) profiles and bioavailability results that are comparable to an injection.

Both the sMTS and hMTS devices are simple and non-intimidating some of the primary virtues of transdermal devices (see Figure 3). But these active devices offer more capabilities than traditional transdermal patches, bringing new levels of efficiency and versatility to the category. With these additional delivery methods, transdermal delivery can now compete with syringe injections in many realms.



The Challenges of Microneedle Manufacturing

As interest grows in this area of delivery, pharmaceutical firms must align themselves with manufacturing partners that can effectively meet their needs.While many pharmaceutical companies have the expertise and equipment to manufacture commonly used tablets and capsules, microneedle manufacturing presents a number of new challenges. Infrastructure, equipment and knowledge are required to manufacture these devices, and the microreplication technology involved is highly specialised.Developing a relationship with a microneedle manufacturing partner allows pharmaceutical firms to utilise facilities dedicated to manufacturing microneedle product lines.

A significant amount of customisation may be involved in adapting a drug for microneedle delivery, adding to the demands placed on manufacturers. Pharmaceutical companies will require guidance from manufacturing partners to determine if their candidate molecules are suitable for active transdermal delivery, and manufacturers will need to provide expertise to develop an optimised formulation.Microneedle manufacturers should also be prepared to provide assistance with navigating regulatory requirements as firms look to expand into new territories with their formulations.

To bring microneedle technologies to market, pharmaceutical firms will need to align with manufacturing partners capable of providing a wide range of services and expertise.Manufacturing partners must offer reliable product delivery, expert supply chain management and facilities that are compliant with current good manufacturing practice (cGMP). In addition, manufacturers must be capable of large-scale production for clinical trials and product commercialisation.To succeed, these devices will have to be produced by the millions in a precise and economical fashion.

An additional challenge for firms looking to develop a new product is controlling costs, and the degree of sophistication of the manufacturing partner can play a critical role in this area. One very effective way of controlling costs is by reducing a new drugs time to market. Pharmaceutical firms should seek out manufacturing partners that can provide the necessary chemistry, manufacturing and controls system data package for regulatory bodies to facilitate fast approval.



Promising Applications

As the biopharmaceutical market continues to grow, so too will the demand for needle-free injection systems. Furthermore, public health and homeland security officials have emphasised the need to effectively and efficiently vaccinate large populations in the face of viral pandemics or security threats. An MTS system presents an excellent way of meeting these challenges.

Transdermal delivery can also play an important role as healthcare efforts improve in emerging markets. Microneedle systems have been developed for several molecules in a manner that reduces the need for cold storage, which enables much simpler distribution and access to the drug. This gives pharmaceutical firms the opportunity to provide faster and less expensive distribution.

As outlined here, the microneedle platform offers the efficiency, versatility, and speed of delivery of a syringe injection, combined with the comfort and convenience of a transdermal patch.This combination of benefits offers pharmaceutical companies a number of important opportunities. Firms can utilise this technology to differentiate an existing drug and extend its life, or move into the emerging biopharmaceutical market with a novel and efficient delivery for a new molecule.

To move products into the commercial realm, microneedle manufacturers may be called on to provide analytical work and regulatory assistance, as well as help in planning and execution for these new technologies work that goes far beyond the scope of simple manufacturing.The sophisticated design of these new devices will require firms and manufacturers to work in a collaborative manner to successfully introduce a product. However, the potential for the technology is such that this investment is likely to be well rewarded in the marketplace.


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Tom Martin is the Business Manager of 3Ms Microstructured Transdermal Systems (MTS) business, which includes several products currently under development that utilise 3Ms novel microstructured technology. Tom joined 3M in 1981 after earning his Bachelor of Science in Biomedical Engineering from the University of Iowa. During his 29 years at 3M, Tom has held leadership roles in multiple 3M divisions and in multiple functions. Prior to joining DDSD Tom had worked in various healthcare groups in 3M Medical, 3M ESPE, and 3M Purification, Inc. He has held positions in process engineering, product development, laboratory and manufacturing management, Six Sigma, as well as business development. Email: twmartin1@mmm.com
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