Drug Delivery Companies
SkyePharma (www.skyepharma.com) uses drug delivery technologies to improve the dosing characteristics of pharmaceutical products that are deemed safe and effective. In December, the FDA approved SkyePharma’s Foradil® Certihaler™ (formoterol fumarate inhalation powder) for the treatment of asthma. The product, co-developed by SkyePharma and Novartis, is approved in 27 countries.
“By reformulation, SkyePharma can often improve the therapeutic effect, minimize side effects, and render dosing more convenient for the patient,” said the company’s CEO, Frank Condella, who added that the company is focusing on oral and inhalation drug delivery, primarily in the areas of asthma and chronic obstructive pulmonary disease. The company is also working on timed-release tablets and solubilization technology that is designed to overcome the low bioavailability of many promising drug leads, as well as IDD® drug delivery systems, which consist of a micrometer- to sub-micrometer-sized, water-insoluble drug core stabilized with phospholipids with or Matrixx Initiatives (www.matrixxinc.com) develops “novel and proprietary drug delivery systems to give consumers better ways to get better,” stated Carl Johnson, president and CEO. Zicam, the company’s wholly owned subsidiary, offers Zicam® and Nasal Comfort branded products for a range of common afflictions. These offerings include Zicam Cold Remedy with a portable unit dose delivery, homeopathic allergy/sinus products that help people build up a natural resistance, cough-relief products in spray and meltable tablet form that eliminate chewing and drinking water, and multi-symptom cold and flu relief products in predose spoon form to mix with a beverage.
The Nasal Comfort line has a level of sodium chloride in the solution greater than that found in the nasal membranes. As a result, the cells of the nasal membrane diffuse fluid that, in effect, reduces the swelling of the membrane, allowing for BioSphere Medical (www.biospheremed.com) offers minimally invasive diagnostic and therapeutic applications based on bioengineered microsphere technology. The spherical co-polymer formulation enables highly targeted vascular delivery for treatment of benign uterine fibroids through occlusion of the blood supply and malignant primary liver cancer, explained Richard Faleschini, president and CEO.
Using a minimally invasive transcatheter procedure called uterine fibroid embolization, Embosphere® microspheres are injected into uterine arteries, blocking blood flow to the fibroid, thus shrinking it over time. The drug is effective for large and multiple fibroids, thereby reducing the need for hysterectomies, Faleschini said. Hepasphere™ expanding microspheres treat liver cancer by absorbing contrast media and saline solutions and selectively bonding with positively charged material through an ionic interaction process. The company also makes Quadrasphere expanding microspheres, which are used to treat hypervascularized tumors and peripheral arteriovenous malformations.
Halozyme Therapeutics (www.halozyme.com) produces recombinant human enzymes for drug delivery, palliative care, oncology, and infertility, explained David Ramsay, CFO. The company’s portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. Enhanze, Halozyme’s drug delivery technology, temporarily degrades hyaluronic acid (HA), a space-filling, gel-like substance that is a major component of tissues throughout the body, facilitating the penetration and diffusion of other drugs that are injected subcutaneously, intramuscularly, or intravenously.
Halozyme’s recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase®, a recombinant human hyaluronidase for cumulus removal in the in vitro fertilization process and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs.
SCOLR Pharma (www.scolr.com) offers a suite of patented CDT® controlled-delivery technologies applicable to modified oral dosage forms, each focusing on specific barriers to optimize drug administration, according to Daniel O. Wilds, president and CEO. “The common rationale underpinning all these systems is the ability to dissociate or modify the site, duration, and magnitude of drug action from the inherent physical limitations and chemical properties of the drug molecule itself,” he explained.
SCOLR’s self-correcting matrix delivery systems use the basic ionic interaction between polymers and additives to preferentially hydrate and influence peripheral hardening of the gel matrices with a progressive shift in gel formation toward the central core, thus controlling erosion and dissolution. The release rate from these systems is not adversely affected by ionic strength, tablet hardness, pH, hydrodynamics, and other physiological parameters.
Preliminary results from pilot bioavailability testing of SCOLR’s refined 24-hour CDT-based ondansetron tablets indicated that the formulation enables a once-daily, sustained-release tablet that prevents chemotherapy- and radiation-related nausea and vomiting.