Pharmaceutical Technology Europe - July 2012 - (Page 6)

Optimising Drug Delivery for Modern Biologics For many of today’s biologic drugs, formulation and delivery options can present multiple dilemmas when determining product attributes, frequency of dosing, dose volume, number of treatments and delivery mechanism. However, there are opportunities to improve the patient experience through formulation and delivery device technologies. In an ideal world, patients with chronic conditions could take a single pill once a year or undergo a onetime noninvasive treatment that is administered without the need for a hospital or doctor visit. Unfortunately, treatment regimens for many of today’s most prevalent chronic conditions require multiple, repeated doses of drug at frequent and regular intervals. volume and reduce dosing frequency, and using higher-volume systems. Potential solutions would be to increase the dose concentration to fit within the classic 1 mL volume limitation or to expand the dose to a larger volume. Concentration has been the choice for many products to date because dosages have increased in the cases of products like BristolMyers Squibb’s Orencia, although the 1 mL paradigm has not been broken. In fact, some recently introduced self-injected products, such as UCB’s Cimzia, have concentrations of up to 200 mg/mL. Second, if the injection is rapid and the volume is too large, there is potential for the product to leak back from the injection site, reducing the bioavailability relative to the total dose. Lastly, a larger volume of product may require a larger device for self-delivery and, potentially, a longer injection time, neither of which is likely to be desirable, especially in a crowded therapeutic class. A potential solution is the development and use of systems that administer the dose into the subcutaneous space more slowly. Due to the longer duration of injection, the device or system may need to be temporarily attached to the body at an appropriate injection site; thus, the current industry interest in patchinjection technologies. Technologies that allow for delivery of higher drug product doses may be applicable to certain emerging needs for mAb products. For instance, the potential to coformulate (i.e., containing more than one mAb product in a single dose), may be a significant area of investigation to create next-generation therapeutic options. A major limitation for some solutions is viscosity, which can be significantly higher than would be expected for a normal mAb solution. The ability to deliver such products in higher volumes may increase the attractiveness of pursuing combination drug products. PTE Opportunities for improvement There are opportunities, however, to improve the patient experience using formulation and delivery device technologies. Treatment regimens can be optimised, for example, by formulating drugs to higher concentrations to reduce dosing frequency, using higher-volume delivery systems to deliver a larger An extended version of this article is available at: PharmTech.com/Burgess Bart E. Burgess is manager of business development, selfinjection systems, at West Pharmaceutical Services. 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 Getty Images/Maria Toutoudaki http://www.PharmTech.com/Burgess 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