Pharmaceutical scientists are still just beginning to understand the working mechanisms of nano-sized particles in drug delivery. For formulators, one of the key challenges has been to design particles that increase bioavailability of the drug to specific targets but still have minimal side effects to the patient. For manufacturers, processing nanomedicines requires having to rethink traditional production operations. How do the unique properties of nano-sized particles affect the means in which they are handled, blended, mixed, coated, lyophilized?
Yesterday I read about one interesting approach to the successful lyophilization of a nanodrug. Scientists at AlphaRx (Markham, Ontario), a small biopharmaceutical company, say they have lyophilized the company’s inhalable Zysolin nanomedicine (a Tobramycin compound for the adjunctive treatment of Gram-negative pneumonia). Joseph Schwarz, the company’s chief scientist has called this “a technological milestone” for the nanomedicine industry, noting that “It is well known that many FDA-approved ingredients used in nanomedicine formulations cannot be readily lyophilized.” According to the release, Schwarz identifies this difficulty as “the major obstacle” to the therapeutic development of nanomedicines. The company now plans to move on to clinical batch material manufacturing.
One of the objectives behind the US Food and Drug Administration’s science-based approach to drug manufacture is gaining better process understanding, making the link between drug quality and critical process attributes. It is of a fortunate coincidence, then, that at the same time the industry is gaining this understanding, formulators are presenting the industry with the unique challenges from nanoparticle-based products.