Plume geometry is one attribute tested in bioavailability and bioequivalence studies of nasal inhalers: vaccines are being developed that can be delivered by nasal inhalers
Bioavailability (BA) and bioequivalence (BE) studies of nasal inhalers measure plume geometry to document compliance with FDA regulations. Delivery of the drug to the mucus membranes on the insides of the nostrils is essential for proper absorption. A jet-like spray will deliver the medicine to the back of the nose where it will simply trickle down the back of the throat. Too wide of a spray will result in some of the drug being sprayed on the edges of the nostril, an area that does not have the absorption capability of the mucus membranes.
Research into the viability of using nasal inhalers as a delivery system for vaccines is gaining popularity because of the ability of this system to solve some unique problems. Vaccine formulations typically require cold-chain storage and transport. This protocol is impractical when dealing with populations in geographic regions that are either remote or lack a reliable power source, countries without an established healthcare infrastructure and when responding to crisis situations. To date, the only inhalable vaccine available is the flu vaccine; however, a dry powder inhalable measles vaccine is scheduled to undergo clinical trials in 2010 in India. Dr. Robert Sievers, the leader of the team that developed this vaccine, said, “Not only might (inhalable vaccines) reduce the risk of infection from HIV, hepatitis, and other serious diseases due to unsterilized needles, they may prove more effective against disease.” Bioavailability and bioequivalence studies will ensure the identity, strength, quality, purity and potency of this and all future inhalable vaccines.
Best-in-Class Bioavailability and Bioequivalence Features:
- Performs in vitro BA studies on samples from three or more batches: a clinical batch to link in vitro performance with in vivo data, a primary stability batch and a production-scale batch.
- Uses standard of less than 5% difference between drug concentration in the test and reference product formulations.
- Validates the accuracy and precision of all in vitro tests before beginning the study.
Top Considerations Before Selecting Bioavailability and Bioequivalence Providers:
Compliance with government regulations is very important. These regulations differ from country to country and are always evolving. Make sure that your provider understands the importance of compliance and stays current with the rules and procedures.
Key Producers:
1. Rules-Based Medicine, Inc. (RBM), founded in 1998, uses Multi-Analyte Profiling (MAP) technology to help companies make their drug development programs more efficient and effective. RBM is the world's leading laboratory testing biomarkers, which are used to determine the biochemical reason that some patients respond better to a therapy. Corporate headquarters and CLIA-certified biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and its wholly owned subsidiary EDI GmbH is in Reutlingen, Germany. Through EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems which serve as a platform for ex vivo drug safety and efficacy studies. By combining EDI’s cell culture systems with its HumanMAP® biomarker testing services, RBM is able to offer customers a preview of the physiological and biochemical impact of a new drug before the human trial stage begins.
2. The Jackson Laboratory fulfills its mission statement of “discover(ing) the genetic basis for preventing, treating and curing human disease, and…enable(ing) research and education for the global biomedical community" by offering academic programs for teachers, and high school through predoctoral students, as well as offering student internships and hosting events on campuses. In addition to conducting genetic research, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Its more than 1,400 employees are work in offices in Bar Harbor, Maine and Sacramento, California.
3. Diteba Research Laboratories Inc., a contract research organization (CRO), provides a wide range of analytical and bioanalytical research and testing services, including raw material, active ingredient and finished product testing and commercial stability studies to the pharmaceutical, biopharmaceutical and nutraceutical industries. Its academic network, along with a newly built world-class pharmaceutical laboratory and a Scientific Data Management System, enable delivery of a range of R&D services. Diteba offers customers a comprehensive information infrastructure in order to guarantee Quality Assurance and Compliance with electronic signature and electronic audit trail regulations, and employs best-in-the-industry practices and methods to manage all areas of the drug development process. Diteba, founded in 2003, is a private corporation located in Toronto, Ontario.
4. GVK Biosciences Private Limited (GVK BIO) is an Indian CRO which offers process research and development, including process development, analytical development, quality, and IP management; clinical, bioavailability, and bioequivalence studies; clinical trials and data management to global Pharma and Biotech companies. They report that they have nearly 100,000 square feet of laboratory space. The company, incorporated in 2000, is based in Hyderabad, India and has a clinical pharmacology unit in Ahmadabad. GVK Biosciences Private Limited operates as a subsidiary of GVK Power and Infrastructure Ltd.
Bioavailability and Bioequivalence
Definition: A study used to compare a test product to a reference product by determining its bioavailability and bioequivalence. Bioavailability (BA) is the relative degree of absorption and the rate that the active ingredient in a drug or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of action. Bioequivalence (BE) is achieved when there is no statistical difference between the rate and extent of absorption of the active ingredient from those of a reference product which has been administered at the same molar dose under the same conditions as the active ingredient. BE involves the comparison of the BA of one product with the BA of another product.
