Mannitol and MCC were some of the excipients investigated to elucidate the pros and cons of their use in children solid formulations. In addition, excipient-excipient and excipient-drug interactions were studied on the nano-scale to unveil scientific information on materials behaviour in the solid state to reduce the risk of interactions during downstream operations. In our laboratory, functionality of excipients used in solid dosage forms for children were studied using novel methodologies that enhance our understanding of the composition of excipients on the nano and micro-scale. Research groups have already started compiling information on excipient functionality in an electronic database 7. It is also critical that analytical testing of co-processed excipients is performed to confirm no chemical change during processing 2. Other additional materials may include flavours or colourants to enhance the aesthetic properties of the dosage form.Īccordingly, some of these excipients require further characterisation of their composition to fully understand the functionality and physico-chemical / mechanical properties to support quality by design (QbD) to formulation development 6,7. This in turn can provide the desirable target product profile of the orally disintegrating tablet (ODT) or the child-friendly dosage form.Įssentially, most of the ready-to-use excipients contain at least one polyol (sugar alcohol) such as mannitol or sorbitol alongside excipients which enhance swelling and disintegration of the tablet in few seconds 5. These products could simplify the formulation development process and reduce the associated technical challenges as the mixtures contain optimised amounts of diluent, disintegrant and binder.
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Some examples of these are Ludiflash, Pharmaburst and F-Melt, which are usually a mixture of two or more excipients with contrasting functionalities to achieve desirable ready-to-use excipient blends 4.
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There has been a considerable amount of mixed or co-processed excipients (not new chemical entities) introduced to the market for the development of fast disintegrating or dissolving dosage forms for children. The new excipients developed for paediatric formulations sometimes belong to more than one functional group (multifunctional) and hence, pose additional burden on the manufacturer to demonstrate their precise role during regulatory submissions.
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Technical considerations for excipient development in paediatric formulationsĮxcipients are subdivided into multiple functional classes dependant on their composition and the role they undertake in the final dosage form 3.