Dan Stendahl, research analyst at Frost and Sullivan, comments on the market for microencapsulated pharmaceuticals and concludes that what you can't see can heal you
Microencapsulation solves problems.
Detergents, agrochemicals, foods and printing inks, generally in particles from 1 to 1000 microns, can be protected from the environment until a product or person benefits from their release.
In the pharmaceutical industry, microencapsulation is a way of packaging active ingredients, often to enable drug delivery to the patient. Microencapsulation may facilitate delivery via drug stabilisation and drug solubilisation.
Stabilisation captures active ingredients before natural degradation or expiration, while solubilisation transforms them to a state that can be absorbed by the body.
How it works.
For readily soluble pharmaceuticals, microencapsulation may still improve their effectiveness. Controlled release, extended release, and targeted or site-specific delivery technologies can enhance the precision and duration of individual treatments.
The rate of release can be controlled by coating microparticles individually, forming tiny 'reservoirs', or by entrapment within a gel or solid matrix.
Encapsulated pharmaceuticals can then be administered orally, injected, inhaled, etc, in parts of the body where pH or rates of diffusion are understood.
Most microencapsulated products owe their functionality to the degradation of these reservoirs or matrices in response to physiological stimuli in the body.
While the structural difference between a reservoir and a matrix is rather simple, many microencapsulation solutions use them in combination, or use both micro and nanoparticle sizes. Salvona offers a dermal patch, which uses a multi-component delivery mechanism.
Upon contact with the skin, the patch degrades to expose a nanoencapsulated drug, which is then absorbed during the second phase of delivery.
Lupron Depot.
An example of a widely successful injectable microencapsulated technology is Tap Pharmaceutical's Lupron Depot, which is used to treat prostate cancer, endometriosis, and precocious puberty.
The synthetic polylactide polymer encapsulated drug was the first approved by the FDA for parenteral sustained release in 1989.
The drug was approved for four-month injections in 1997 and now has a market size in excess of $800 million.
Tap, a joint venture between Abbott Laboratories of the United States and Takeda Chemical Industries of Japan, promotes the drug as an alternative to surgical castration for suppressing testosterone production in those that suffer from prostate cancer.
Who makes it happen.
Unlike for other stages of drug formulation, most microparticle expertise rests not in the hands of monolithic pharmaceutical corporations, but rather in small R and D companies that specialise in these tiny packages.
After developing a new drug, innovator companies will often partner with one or more microparticle or drug delivery experts in parallel to most quickly find a way to bring the drug through feasibility testing and to market.
Companies specialising in microencapsulation may offer a wide array of solutions, like Particle and Coatings Technologies, Southwest Research Institute, and Eurand, or focus on a particular technology, like BioSante's calcium phosphate delivery platform.
Who derives benefit.
Trends driving microencapsulation formulation and utilisation in pharmaceuticals focus primarily on improving convenience for patients and healthcare providers.
In the case of Lupron Depot, required injections have graduated from 12 times a year to three.
The benefit lies not only in fewer invasive procedures, but also in reduced costs and time spent in clinical visits.
Similarly, oral tablets can be reformulated to include a combination of drugs or to release more quickly or slowly. BioSante is conducting clinical trials to deliver insulin via oral and inhalation delivery routes instead of intravenously, making the treatment less painful and creating less waste. Conventional oncology drugs are toxic and present significant side effects.
Improving the precision of targeting systems and extending the half-lives of medicines would require less drug volume to achieve the same or even better results, maximising the benefit of treatment while minimising the associated risks.
Who foots the bill.
Joint ventures and development contracts are structured on a case-by-case basis.
Still, microparticle research companies have several options at their disposal when financing the development of their platforms.
In addition to funding by big pharma or venture capital, contract research organisations may independently supplement revenue streams by manufacturing lines of consumer products.
Though not as profitable as a blockbuster pharmaceutical, over-the-counter consumer products for hair, skin, and dental care are not mired in the same red tape as prescription drugs, do not require extensive feasibility studies and expensive clinical trials, and can thus generate a steady revenue stream relatively quickly.
Through greater self-sufficiency, a research organisation is poised for more ownership in its experience and autonomy in negotiating the licensing of its technologies.
An example of this business model is BioSante, which remains confident in prospects for its calcium phosphate platform.
However, the company has mitigated the risk of one single product line by developing a topical gel hormone replacement therapy, which it plans to use to drive larger projects.
Acceptance.
The likelihood of microencapsulation acceptance is not in question; microparticle release already plays a prominent role in drug delivery, a trend that will only increase within the medium term.
However, considering how many drug delivery startups have emerged since the late 1990s, there will probably be fewer long-term opportunities than companies scrambling for a foothold in the market.
Close relationships with big pharma and high calibre capital will undoubtedly be key, especially in the eventuality of market consolidation.
For those partnering with generics, which remain a nascent application, success will be most likely judged by the ability to quickly match or add value to drugs scheduled to lose patent protection within the next 10 to 15 years.
For over-the-counter applications, affordability for consumers will be an equally important driver in bringing new technologies from inception to market.
Key to advantageous positioning in each of the three segments will be the ability to convince potential partners of the value added by proprietary solutions, as well as the superiority of this value over competitors.
