Tergus CEO, Dr. Vijendra Nalamothu and Dr. Marc Hens of Tergus co-wrote an article that appeared recently in American Pharmaceutical Review. The article, titled Topical Drug Delivery Considerations for Biologics, outlines specific considerations for formulating proteins and peptides for topical delivery.

The article states that, according to the analyst firm Global Information, the demand for biologics and biosimilars is estimated to grow to more than $100 billion in 2015, continuing the double-digit growth rate seen in the last decade. As the industry continues to grow, alternative delivery methods are of increasing interest—particularly the topical delivery of large molecules. Formulation for any topical pharmaceutical is a top priority since the efficacy of the molecule can be affected by any misstep. Biologics also have the additional consideration of achieving the right penetration to the target.

The article goes on to say that topical delivery of any drug is a challenge because the skin, which is the largest organ in the human body, acts as a protective barrier. The compact structure and hydrophobic nature of the stratum corneum (SC) are the primary attributes supporting the barrier function of the skin. As a result, the cutaneous delivery of drugs usually requires the use of penetration enhancers or some other physical or chemical disruption of this skin layer.

The article also discusses, in detail, the considerations for penetration enhancers, factors affecting formulation, manufacturing considerations, as well as preservation and delivery. Drs. Nalamothu and Hens demonstrate their deep expertise in semi-solid dosage forms in dealing with the unique challenges of topical biologics and biosimilars.

Topical Drug Delivery Considerations for Biologics is worth a read.