Pharmaceutical Technology Europe - July 2012 - (Page 2)

Extended Release Injectables Angie Drakulich is editorial director of Pharmaceutical Technology. The industry has seen growth in extended-release (ER) injectables in recent years. These complex, long-term delivery products aim to reduce the number of injections a patient needs; for example, moving from once-a-day to once-a-month or less frequently. ER injectables can also ease patient compliance and relapse. One dominant type of an ER injectable product is polymer-based. This type includes microspheres, implants and gels. These systems rely on diffusion through a polymer, as well as erosion of that polymer to control release of the API. Another type involves conjugating a releasable chemical moiety to the active drug, thereby making a prodrug that is less soluble for slow uptake, or is slower to clear from the body. Another type would be insoluble salts. Extended-release injectables are considered to be complex dosage forms by the regulatory authorities. These products bring key challenges to the manufacturing process, including sterility assurance, the number of unit operations required, as well as comparability and control strategy concerns. Pharmaceutical Technology Europe spoke to experts engaged in the development and manufacture of ER injectables to dig deeper into these challenges and to offer potential solutions. Participating in the article are: Paul Herbert, vice-president of process development at Alkermes; Andrew J. Thiel, PhD, an associate research fellow, and David M. Loffredo, PhD, a director, both in Pharmaceutical Research and Development at Hospira; Mary Stickelmeyer, a research fellow with Eli Lilly and Company; and Arthur J. Tipton, PhD, head of Birmingham Laboratories within Evonik’s Healthcare Pharma Polymers product line. Sterilisation ER injectables cannot be terminally sterilised. Why is this the case, and what types of sterilisation should be used instead? (Herbert, Alkermes): The challenge with terminal sterilisation is that the physical and chemical stability of the materials used in ER injectables, drug and polymers, do not generally withstand the temperatures required to effect terminal sterilisation. Terminal sterilisation utilises high temperatures or radiation to make the product sterile. These conditions are likely to affect the API, creating some level of impurities. For polymer-based ER injectables, these high temperatures would melt the polymer and radiation would 2 ER injectable challenges 9 Column crunch 5 GMP deficiencies 11 Top Tech 6 Biologics drug delivery 12 Staff 7 News bites www.pharmtech.com Gett Get Get t mage /Yam da Taro Gett y Images /Yamada Taro et ages Y age Yam d Taro g o http://www.pharmtech.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - July 2012

Pharmaceutical Technology Europe - July 2012
Contents
Meeting Manufacturing Challenges Tied to Extended-Release Injectables
EMA and MHRA Provide Insight into Increasing GMP Deficiencies
Optimising Drug Delivery for Modern Biologics
News Bites
Column Crunch: Parallel Trade; Procurement Changes; Highpotency Manufacturing; and Sustainable Biotech
Top Technologies

Pharmaceutical Technology Europe - July 2012