|
 |
| home > epc > autumn 2004 > understanding the challenges and opportunities in nasal drug delivery |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
Nasal drug delivery has proven to be an attractive means of delivering medications such as antihistamines (Astelin® from MedPointe), corticosteroids (Flonase® and Rhinocort Aqua® from GlaxoSmithKline and AstraZeneca, respectively), and decongestants (Afrin® from Schering Plough). The nasal cavity area is also effective at absorbing pain management medications (Migranal® and Imitrex® from Xcel Pharmaceuticals and GlaxoSmithKline, respectively), and vaccines (FluMist® from MedImmune). Additionally, researchers are actively investigating the use of the olfactory region of the nose for penetrating the brain-blood barrier to treat central nervous system (CNS) disorders such as Alzheimer's and Parkinson's diseases, stroke, brain tumours and erectile dysfunction (PT-141 from Palatin Technologies) with fewer side effects than ingested or injected methods (1). This article will focus on some of the challenges facing nasal drug delivery including: development, formulation, testing and regulatory approval.
Product Development
Nasal drug delivery and development typically begins by identifying a target indication and drug combination. Depending on the nature of the product being considered, the process can start from scratch with an original drug for a new indication, the reformulation/repackaging of any existing drug(s) with known pharmacological performance into a nasal spray, or with the creation of a generic equivalent of an existing product. Starting from scratch is clearly the most costly and time-consuming approach, and is usually only undertaken by major pharmaceutical organisations with the required resources to see the product through to market. Reformulation/repackaging is becoming more common today because therapeutic compounds (in other words particular molecules, proteins or peptides) are being developed at a rapid pace, with the end target being multiple delivery pathways (for example nasal, oral and pulmonary).
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
|
 |
News and Press Releases |
 |
Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
|
 |
