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Pharmaceutical Manufacturing and Packing Sourcer

Advancing Reconstitution

The use of freeze-dried - lyophilised - drugs is growing because many newly bioengineered medicines are unstable in liquid form. Lyophilised drugs are reconstituted shortly before dosing by adding a liquid diluent. Conventional reconstitution is a complex, multi-step process, requiring a high level of digital dexterity, and may require aseptic techniques. Recent innovations in reconstitution methods and drug packaging promise to alleviate many of the safety and treatment compliance issues previously encountered in the home setting. This article focuses on trends in the administration of lyophilised drugs (particularly in at-home patient environments), an evaluation of traditional as well as new, cutting-edge reconstitution systems and their benefits to both patients and pharmaceutical manufacturers.

Lyophilisation

Many new drugs, especially bioengineered products such as interferons, oncology therapies, vaccines, growth hormones and plasma derivatives, prove highly unstable in liquid form. Lyophilisation, or freeze-drying, is a technique that enables manufacturers to safely store and preserve the stability of a drug product, some that may have a shelf-life as short as two hours if stored in a liquid form. Lyophilisation uses a combination of vacuum and freezing processes to remove water from the product.


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By Paul Norton, Program Director for Clip'n'Ject, and Graham Reynolds, Director of Marketing, Europe, at West Pharmaceutical Services, Inc

Paul H Norton PE is Program Director for Clip'n'Ject at West Pharmaceutical Services in Pennsylvania, USA. Mr Norton joined the company in 1986. He holds a BME (Bachelor of Mechanical Engineering) from the University of Delaware and a MM (Master of Management) from Penn. State University. Mr Norton has been actively involved in the field of stopper introduction into barrier isolators. He has also acted as Project Manager for ready-to-sterilise products manufactured in the United States, including the installation of a USPP/WFI water system, class 100 cleanroom and a pharmaceutical stopper washing machine.

Graham Reynolds is Director of Marketing for Europe at West Pharmaceutical Services in the UK. Mr Reynolds joined the company in 1980 as a Technical Support Analyst before taking a position as an Account Manager in 1987. He has held several positions in sales including Sales Manager and Director of Business Development before moving into his current role in 2001. Between August 1999 and September 2001 Mr Reynolds led a team responsible for the successful market launch of Clip'n'Ject.

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Paul H Norton
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Graham Reynolds
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