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Soft, chewable gelatin matrices represents an excellent alternative to traditional oral administration forms (tablets, soft and hard capsules) for pharma-and nutraceuticals; especially for the pediatric and geriatric segments as well as for those suffering from dysphagia. As of today, chewable delivery units, most commonly produced using gelatin, are a very popular formulation design for vitamin and dietary supplements. Bioactive components can be present in such formulations as lipids in O/W emulsions, as dispersed particulate matter or dissolved in the aqueous phase or in the lipid phase in the case of O/W emulsions. Challenges do however exist: many of the bioactive ingredients give a distinct taste, are vulnerable to degradation or may influence the gelling properties of gelatin. This is highlighted by many of the current chewable multivitamins only containing a small fraction of the whole array of vitamins/minerals included in traditional tablets and soft gels. Pharmaceuticals have many of the same issues, coupled with stricter regulatory demands in regards to quality, stability and bioavailability compared to nutraceuticals, making formulation of pharmaceutical chewables potentially even more challenging. However, many of these challenges may be solved through innovative formulation design. By adjusting pH or using buffer systems, by adding taste masking or stability enhancing excipients or by using encapsulation techniques, even the more challenging active ingredients may potentially be incorporated into gelatin-based chewables.

The results suggest that easy-to-swallow and well taste-masked soft chewable tablet formulations with extended shelf life are within reach for several active pharmaceutical ingredients (APIs).

A challenge with formulating water-in-oil-in-water (W/O/W) emulsions is the uncontrolled release of encapsulated compound prior to application. Pharmaceuticals and nutraceuticals usually have amphipathic nature, which may contribute to leakage of the active ingredient. In the present study, cyclodextrins (CyDs) were used to impart a change in the relative polarity and size of a model compound (ibuprofen) by the formation of inclusion complexes. Various inclusion complexes (2-hydroxypropyl (HP)-β-CyD-, α-CyD-and -CyD-ibuprofen) were prepared and presented within W/O/W emulsions and the initial and long-term encapsulation efficiency was investigated. HP-β-CyD-ibuprofen provided the highest retention of ibuprofen in comparison to a W/O/W emulsion with unassociated ibuprofen confined within the inner water phase, with a 4 fold increase in the encapsulation efficiency. An improved, although lower encapsulation efficiency was obtained for the inclusion complex -CyD-ibuprofen in comparison to HP-β-CyD-ibuprofen, while α-CyDibuprofen had similar encapsulation efficiency as unassociated ibuprofen. The lower encapsulation efficiency of ibuprofen in combination with α-CyD and γ-CyD was attributed to a lower association constant for the γ-CyD-ibuprofen inclusion complex and the ability of α-CyD to form inclusion complexes with fatty acids. For the W/O/W emulsion prepared with HP--CyD-ibuprofen, the highest retention of ibuprofen was obtained at hyper-and iso-osmotic conditions and by using an excess molar ratio of CyD in comparison to ibuprofen. In the last part of the study it was suggested that the chemical modification of the HP--CyD molecule did not influence the encapsulation of ibuprofen, as similar encapsulation efficiency was obtained for an inclusion complex prepared with mono-1-glucose--CyD.