Tablets Capsules

TC0321

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10 March/April 2021 Tablets & Capsules Jeffrey E. Browne and David Fulper Catalent Oral dosage form delivery options for lipid-based formulations dosage form L This article discusses the increasing use of lipid-based for- mulations for delivering challenging active pharmaceutical ingredients and describes the factors formulators must consider when selecting whether to use hard-shell capsules or softgels to deliver such formulations. ipid-based drug delivery systems have found widespread acceptance for the development of drug products containing active pharmaceutical ingredients (APIs) that pose devel- opment challenges for formulators. This is evidenced by the significant numbers of FDA-approved drug products that have been formulated using lipid-based formulations (LBFs) when a bio-enhancing technology is required [1]. Poor bioavailability often results from an API's limited aqueous solubility and/or membrane permeability and can lead to target exposure levels not being achieved and/or a greater risk of intra- and inter-subject absorption variabil- ity (food effects). Formulators can overcome many API challenges by using LBFs, especially as the formulation can include a wide range of excipients to improve solubility and absorption, and importantly, to make bioavailability more consistent. Excipients can also be used to improve membrane permeability—another cause of poor bioavail- ability. LBFs can also be beneficial for products with low API doses where ensuring content uniformity proves dif- ficult. The use of LBFs is widely recognized by regulatory authorities, and there is an established selection of orally safe excipients that are inactive ingredients (IIGs) or gen- erally recognized as safe (GRAS).

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