Critical analysis and future challenges. Approaches that combine the traditional advantages of capsules with both permeation enhancers and protease-inhibiting or enzyme-mitigating compounds are among the most commonly explored oral delivery strategies. These approaches often use biologics that are approved through injectable routes, likely in an effort to expedite approval. Of the current studies, the majority are focused on diabetes treatment, as non-invasive insulin delivery has long been one of the active targets in the field of drug delivery. One common theme between oral biologic trials and preclinical work is the use of traditional dosage forms for formulation packaging. The advantages of this are twofold: the established protective benefits of capsules can be used to encapsulate these newer technologies, and patients are familiar with this dosage form. Examples of approved, orally delivered peptides exist; however, many of these examples still have formulation challenges. For example, Minirin, the orally administered version of desmopressin acetate, is a peptide that has low manufacturing costs and high potency168. As such, modifications to the peptide structure were sufficient to enable a bioavailability of 0.16%, which is not high enough for most biologics but were sufficient for Minirin. Taltirelin, another approved, orally available biologic, is a highly stable peptide that requires limited formulation to achieve therapeutic levels of bioavailability168. Other examples of approved peptides for oral delivery, such as cyclosporin A and antimicrobial biologics, have been reviewed elsewhere168. Another approach, which builds on the recent interest in the microbiome and clinically used bacteria-based therapeutics128, utilizes genetically engineered bacteria to deliver biologics. The clinical applications of these approaches have been for local delivery and have been reviewed elsewhere169; however, it may be possible to leverage genetically engineered bacteria to secrete drugs, enzyme inhibitors or absorption enhancers to facilitate systemic absorption. Living drug factories may provide benefits that non-living systems cannot, such as their capacity to establish permanent or semi-permanent colonization or their natural ability to navigate the mucus and interact with intestinal cells.
Handbook On Injectable Drugs Ebook 54
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