A young start-up company is gearing up to challenge the likes of Pfizer by developing a new insulin product, based on its novel nano-based intranasal delivery technology.
NanoDerma, a young Israeli company specialising in advanced transdermal and intradermal formulations, has recently been directing its expertise towards an intranasal insulin product amid growing interest in alternative insulin delivery techniques that avoid the traditional needle-based approach.
Although nasal drug delivery systems have been around for a while, there have been limitations in the technique due to low delivery payload, poor reproducibility and mucosal irritation.
NanoDerma has developed a drug delivery platform based on microemulsion technology that appears to combat these issues and make it a viable option for insulin delivery for treatment of diabetes.
The system is made up of water, oil, surfactant/s and co-surfactant, and is based on nano-droplets of 10-50nm that form a viscous, semi-solid or homogenous liquid gel in the nostril.
The system can incorporate "almost any lipophilic and hydrophilic compound as well as large molecules," says the company, and also offers other advantages with no chemical penetration/absorption enhancers, no alcohol and no other irritating constituents.
"The NanoEmulsion technology has been shown to successfully delvier various drugs through the skin a higher rates and extents relative to the existing corresponding products in the market," says Amnon Sintov, NanoDermo vice president of R&D.
"[It] offers complete incorporation and solubility of large amounts of almost any drug and biopharmaceutical."
With non-injected delivery of large molecules such as insulin having been NanoDerma's main objective over the last year, the company has high hopes for its intranasal insulin formulation. Already having completed pharmacokinetic and pharmacodynamic studies in rabbits, results for the new formulation are looking very promising:
"We have finalised bioavailability studies in rabbits (diabetic models), which showed the nasal spray application of NanoEmulsion including insulin resulted in a shorter time to reach peak plasma level of insulin than subcutaneous injection," Dr Haim Levy, NanoDerma CEO told in-PharmaTechnologist.com.
While the average absolute bioavailability of the intranasal formulation is about 43 per cent of injected insulin, this still compares favourably with Pfizer's inhalable formulation, Exubera, which only manages around 10 per cent.
Also, due to the high pay load possible with the company's drug delivery technology, there is no need to apply more than 100 microlitres to achieve the required hypoglycaemic effect, a volume unlikely to cause any irritation in users and therefore aid compliance.
The NanoEmulsion formulation also resulted in plasma glucose levels similar to injectable administrations, and although insulin was quickly eliminated from the plasma after one hour, the hypoglycaemic effect lasted "much longer" after the nasal administration, said Levy.
"The non-injectable insulin market is facing a renaissance," said Levy "[and] insulin manufacturers are constantly seeking added value for their product." To this end, NanoDerma has already initiated talks with potential partners in Europe and East Asia for the development of its intranasal insulin product.
NanoDerma isn't the only company taking the nasal route to break into the insulin delivery market. Bentley Pharmaceuticals for example, currently has a recombinant intranasal insulin spray for postprandial hyperglycemia in Phase II trials in the US, although unlike the NanoDerma product it contains a physiological absorption enhancer.
US firm Nastech is also in the process of developing a nasal insulin product for type I diabetes, and in December reported positive results from a Phase I trial when compared with Exubera inhalable powder and injectable insulin.