DRUG DELIVERY
Delivery systems for new vaccine and drug dosage forms
This article reviews some of the latest improvements in delivery systems for administering new treatments for diseases such as cancer, malaria and pulmonary hypertension.
Drug delivery device specialist Aptar Pharma and INSYS have jointly developed a customised sublingual unit-dose spray (UDS) device for the delivery of SUBSYS™, a new dosage form for managing breakthrough cancer pain. SUBSYS™ (fentanyl) sublingual spray is indicated for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant adult patients who are already routinely taking other opioid pain medicines for cancer pain. Breakthrough cancer pain is often defined as a temporary flare in pain that can be quite severe. These flares occur in the context of background pain that is otherwise usually well- controlled with opioids. Until now, fentanyl has been available in many dosage forms including nasal, sublingual dissolving tablets and oral transmucosal. INSYS’s SUBSYS™ is the first unit-dose sublingual spray for fentanyl.
Aptar Pharma’s UDS is designed to offer ready-to-use convenience compared with traditional multi-dose spray pumps which need to be primed prior to first use and sometimes re-primed when used infrequently.
Adjuvant for malaria DNA vaccine candidate
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life- threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, Vical has a number of strategic partnerships with pharmaceutical and biotechnology companies that provide the company with
opportunities to expand its product pipeline. The company recently announced that researchers at Ehime University in Japan and their collaborators have developed a - formulated DNA vaccine candidate formulated with the company’s Vaxfectin® adjuvant with the potential to prevent transmission of malaria. Results of the initial testing demonstrate that the malaria parasite life cycle was interrupted in mosquitoes fed with malaria-infected human red blood cells incubated with serum from vaccinated mice. Vical provided the DNA vaccine plasmid backbone and the adjuvant used in the research.
“ Vical develops biopharmaceuticals
based on its patented DNA delivery technologies ”
The transmission-blocking DNA vaccine candidate, formulated with Vical’s Vaxfectin® adjuvant, expresses the Plasmodium vivax malaria parasite protein Pvs230, which is present in both human and mosquito stages of the parasite’s life cycle. Anti-Pvs230 antibodies
generated by vaccinated mice recognised the Pvs230 protein and interrupted the parasite’s development in mosquitoes. The amino acid sequence of Pvs230 protein is also highly conserved among multiple field isolates of P. vivax, increasing the potential for a single vaccine to provide broad protection. The mouse-generated Pvs230 antibodies, incubated with P. vivax-infected human red blood cells and then fed to mosquitoes, statistically reduced the number of parasites and the infection rate in mosquitoes. A Vaxfectin®-formulated malaria vaccine therefore has the potential to interfere with the transmission of P. vivax to humans through mosquitoes. This novel transmission-blocking approach may thereby protect the broader population from widespread malaria outbreaks. Further study of the vaccine candidate has been proposed.
FDA clears expanded delivery system compatibility
The FDA’s Center for Devices and Radiological Health (CDRH) has granted 510(k) clearance for compatibility of Ikaria,
Inc’s INOMAX drug delivery systems with three additional respiratory care devices. The INOMAX DS and the INOMAX DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems, and other respiratory care devices.
The INOMAX DS and INOMAX DSIR are proprietary drug delivery systems that deliver INOMAX (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation, and treats HRF in this fragile newborn population. The FDA’s clearance of these additional respiratory care devices for use with the INOMAX DS and INOMAX DSIR makes Ikaria’s INOMAX drug delivery systems fully compatible with the most commonly used invasive mechanical ventilation methods and non-invasive respiratory strategies in neonatal intensive care units (NICUs), including continuous positive airway pressure (CPAP) and nasal cannulae. The INOMAX drug delivery systems are now compatible with the Fisher & Paykel Healthcare Bubble CPAP System and the Hamilton-C2 and Hamilton- G5 ventilators.
The INOMAX DS and INOMAX DSIR drug delivery systems are part of a comprehensive offering known as the INOMAX therapy package. In addition to the use of Ikaria’s proprietary, FDA-cleared drug delivery systems, the INOMAX therapy package includes INOMAX (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on- site hospital training, customer service, and all related disposable items.
Further information For further information visit the following websites:
www.aptar.com www.insysrx.com www.vical.com
www.inomax.com March/April 2012 sp2 Inter-Active 43
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