spacer
home > pmps > winter 2010 > fantastic plastic
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Fantastic Plastic

In the current global market, prefilled syringes comprise more than two billion units per year in development and use. The rise of the prefilled syringe as the preferred container originated with an extremely successful market introduction of syringes for heparins by Sanofi and Rhone-Poulenc Rorer (Sanofi-Aventis) in Europe in the early 1980s. The prefilled syringe market has now exploded due to several factors: the growth of biopharmaceuticals, the need to eliminate overfills, precision of delivery volume, convenience of delivery, cost-effectiveness, reduction of dosage errors, or a combination of these factors (1-4).

Currently, glass dominates the prefilled syringe market. However, plastic prefilled syringes are making advances, particularly where glass has been unsuitable as a delivery system. In the last decade, pharmaceutical protein and peptide drug products have been approved for use with prefilled plastic syringes. More products using plastic prefilled syringes are currently in various phases of drug development.

COMBINATION DRUG DELIVERY SYSTEMS

Many chronic diseases, such as multiple sclerosis and rheumatoid arthritis, require home-based administration of injectable treatments. This need has spawned an increased interest in combination drug delivery systems that are safe and convenient, and that help to improve the administration process.

Pen injectors and multi-dose cartridges were created for those with frequent injection needs; however, they are limited to specific therapies such as diabetes and growth hormones, which often require weighed dosages or dose titration. While pen injectors were designed for frequent injections and for those who require variable dose capabilities, they are not ideal for chronic users of fixed-dose medications, including those suffering from dexterity issues. The need for a safe, reliable, easy-to-use, single-dose injection system was apparent.

Auto-injectors have been recognised as a convenient method for delivering drug products through an intuitive activation mechanism designed especially for patients who may have dexterity issues that affect their ability to inject a drug treatment effectively with a traditional syringe. As patients and caregivers become increasingly involved in determining the best treatment option, biopharmaceutical and pharmaceutical companies, with the help of device companies, are adapting to meet the needs of the consumer. Today’s auto-injectors represent a compelling, easy-to-use delivery solution rooted in simplicity, accuracy, durability, flexibility and quality.

TRADITIONAL SYSTEMS: PERFORMANCE ISSUES

Traditionally, auto-injector systems utilise 1ml-long glass prefilled syringes. While these systems have been successful, there are notable limitations, including autoinjector performance issues. Recent studies have shown that silicone oil, which is often used to increase lubricity in syringe systems, is often distributed nonuniformly, leaving certain areas of the prefilled syringe surface with insufficient lubrication (5). The low or inconsistent silicone oil coating can have a significant impact on the piston travel or glide forces, especially in the use of auto-injectors. In 2006, commercial lots of a drug product delivered by an auto-injector containing a glass prefilled syringe were recalled in a number of European countries because of problems with slow or incomplete delivery of the drug (6). Areas of non-uniformity may cause travel forces to increase, causing failure or incomplete injection.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Douglas Stout is the Director of Strategic Market Development for West’s Advanced Injection Systems platform. He has more than 20 years of experience in business development and marketing in the pharmaceutical industry and has spent the last 10 years focusing specifically on drug delivery. His current responsibilities include market and business development for West’s Advanced Injection Systems platform. He is also the commercial representative assisting West’s Strategic Product Development group. Douglas earned his marketing degree from Rowan University. Email: douglas.stout@westpharma.com

Vinod Vilivalam, PhD, is Director of Strategic Market and Technical Development for Daikyo Crystal Zenith’s prefillable and vial platforms, part of West’s Innovation group. His current responsibilities include market development, technical support and developing collaborative research alliances with academic and commercial institutions to develop solutions for unmet needs. Vinod earned his MS and PhD in Pharmaceutics in 1993 and 1996 from Duquesne University, Pittsburgh, and successfully completed a two-year business management programme in 1999 at The Wharton School, University of Pennsylvania. Email: vinod.vilivalam@westpharma.com

spacer
Douglas Stout
spacer
spacer
spacer
Vinod Vilivalam
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
More info >>

White Papers

Choosing the Right CMO for HPAPI Manufacturing

AMRI

Over the past few years a steady stream of contract manufacturing organizations (CMO) have added high potency active pharmaceutical ingredient (HPAPI) production capacity. The expansions give biopharma executives charged with selecting HPAPI production partners an unprecedented number of options, but all this choice creates a problem — which CMO should you pick when each is touting similar technical capabilities?
More info >>

 
Industry Events

DIA 2019 Global Annual Meeting

23-27 June 2019, San Diego Convention Center

DIA 2019 is more than just a meeting: it’s where brilliant minds come together to create solutions. Thousands of global innovators will convene to engage in discussions on today’s hottest topics in the life sciences field, propose ways to combat daily challenges, and network to create lasting connections.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement