Advances in Formulation and Manufacturing Strategies for the Delivery of Therapeutic Proteins and Peptides in Orally Disintegrating Dosage Forms

Therapeutic proteins and peptides (TPPs) are increasingly favoured above small drug molecules due to their high specificity to the site of action and reduced adverse effects resulting in increased use of these agents for medical treatments and therapies. Consequently, there is a need to formulate TPPs in dosage forms that are accessible and suitable for a wide range of patient groups as the use of TPPs becomes increasingly prevalent in healthcare settings worldwide. Orally disintegrating dosage forms (ODDF) are formulations that can ensure easy-to-administer medication to a wider patient population including paediatrics, geriatrics and people in low-resource countries.

Highlights

Cheaper production costs and extended life of TPPs in ODDFs leads to ease of transport and storage

TPPs in ODDFs are age-appropriate dosage forms increasing compliance in paediatrics and elderly

Co-administration of TPPs with excipients such as SNAC enhances absorption across mucosa

Buccal and sublingual delivery of TPP-loaded ODDFs increases bioavailability of products

There are many challenges involved in developing suitable pharmaceutical strategies to protect TPPs during formulation and manufacturing, as well as storage, and maintenance of a cold-chain during transportation. This review will discuss advances being made in the research and development of pharmaceutical and manufacturing strategies used to incorporate various TPPs into ODDF systems.

Download the full review article as PDF here: Advances in Formulation and Manufacturing Strategies for the Delivery of Therapeutic Proteins and Peptides in Orally Disintegrating Dosage Forms

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This very detailed and interesting review paper mentions several excipients and techniques like: HPMC, chitosan, amino acids, PLGA, PVA, Povidones, Hisorad, Ludiflash, Electrospinning, mini tablets, Hot melt extrusion, ODT

Shazia Bashir, Rawan Fitaihi, Hend E. Abdelhakim, Advances in Formulation and Manufacturing Strategies for the Delivery of Therapeutic Proteins and Peptides in Orally Disintegrating Dosage Forms, European Journal of Pharmaceutical Sciences, 2023, 106374, ISSN 0928-0987, https://doi.org/10.1016/j.ejps.2023.106374.