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Abstract
There is no single-component excipient fulfills all the requisite performance to allow an active pharmaceutical ingredient to be formulated into a specific dosage form. Co-processed excipient has received much more attention in the formulation development of various dosage forms, specially for tablet preparation by direct compression method. The objective of this review is to discuss the emergence of co-processed excipients as a current and future trend of excipient technology in pharmaceutical manufacturing. Co-processing is a novel concept of combining two or more excipients that possess specific advantages that cannot be achieved using a physical admixture of the same combination of excipients. This review article discusses the advantages of co-processing, the need of co-processed excipient, general steps in developing co-processed excipient, limitation of co-processed excipient, technologies used in developing co-processing excipients, co-processed excipients in the literature, marketed products and future trends. With advantages offered by the upcoming newer combination of excipients and newer methods of co-processing, co-processed excipients are for sure going to gain attraction both from academia and pharmaceutical industry. Furthermore, it opens the opportunity for development and use of single multifunctional excipient rather than multiple excipients in the formulation.
Highlights
In the past 10 y, the focus of both academia and pharmaceutical industry has been shifted from developing new active pharmaceutical ingredient (API) to formulation technology [1]
Pharmaceutical excipients are defined as the substances other than the API which has been appropriately evaluated for safety and are intentionally included in a drug delivery system [2]
It is generally agreed by the formulation scientist that there is no single-component excipient fulfills all the requisite performance to allow an active pharmaceutical ingredient to be formulated into a specific dosage form [5]
Summary
In the past 10 y, the focus of both academia and pharmaceutical industry has been shifted from developing new active pharmaceutical ingredient (API) to formulation technology [1]. The study concluded that co-processed excipient of microcrystalline and spray dried lactose at 90:10 % w/w was the optimum formulation which showed good compressibility and fast disintegration. Added advantage Low degree of hydroscopicity, good flowability, tablet hardness independent of machine speed High compressibility, good mouth feel, better tableting at low cost Directly compressible grade Better flow, reduced sensitivity to wet granulation, better hardness of tablet, reduced friability Less grittiness and minimal chalkiness High compressibility, excellent taste masking, free flow, superior content uniformity, controlled particle size distribution Capable of formulating high dose, small tablets with poorly flowable active ingredients Good flowability due to spray drying, the acceptable crushing force due to lactose content and rapid disintegration depending on Reference 85. It opens the opportunity for development and use of single multifunctional excipients rather than multiple excipients in formulation [103]
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