Design Engineers Help Patients Get Protein Drugs into the Body

Greystone Associates Analyzes the Rapid Growth of Biological Combination Products

[ClickPress, Wed Sep 12 2007] In recent years, the number of protein-based pharmaceuticals reaching the marketplace has increased exponentially. The clinical application of these drugs is limited by a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs have until recently been marketed almost exclusively for parenteral administration.

A limitation of the parenteral route for delivery of peptides and proteins is the extremely short half-lives of these drugs – in the order of a few minutes. This demands repeated administration, which is inconvenient to the patient. For this reason, non-parenteral routes of administration are being pursued, most notably inhalation (Exubera). Another approach is to incorporate controlled release parenteral formulations, where a single injection may release the drug over several weeks or longer.

These combination products, where the drug and device are clinically tested and approved as a single product entity, are becoming one of the fastest new drug categories. Combination drug delivery products are growing at an annual rate of fourteen percent across all technology segments, and will total $38 Billion in 2008. The growth of combination products is having a significant effect on the way drugs and devices are developed. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies. The new devices – a group that includes pen injectors and dry powder inhalers - are typically patient-friendly, easing compliance concerns, which have a non-negligible effect on drug formulations and delivery decisions, and are becoming a significant factor in the prescribing decisions of many physicians.

More information is available at

http://www.greystoneassociates.org/Protein_Delivery.htm


About Greystone

Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

Contact:

Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org Source: Greystone Associates

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