Abstract

In the domain of pharmaceutical formulation, the selection of excipients for semisolid dosage forms stands as a pivotal aspect, influencing the product’s efficacy, stability, and patient acceptability. Therefore the formulation of semi-solid dosage forms demands meticulous consideration of excipient selection to achieve desired product characteristics and therapeutic outcomes. This comprehensive review embarks into the multifaceted landscape of excipient selection in semi-solid formulations, elucidating key features and  considerations critical for formulation development. An excipient interacts with the drug in the dosage form and/or provides a matrix that affects critical quality attributes of the drug, including solubility, stability and bioavailability. Through a systematic exploration, various excipients including gelling agents, emulsifiers, viscosity modifiers, and preservatives are examined for their roles in imparting desired rheological properties, stability, skin compatibility, and drug release kinetics. Limited understanding of excipient functionality can compromise product quality and process control. “Safety and efficacy”: Excipients can be associated with adverse events, either by direct action or by developing undesirable adducts. Additionally, advancements in excipient technology, regulatory considerations, and strategies for excipient compatibility assessment are discussed. By synthesizing insights from current literature and industry practices, this review serves as a valuable resource for formulation scientists, researchers, and regulatory  authorities engaged in the development and optimization of semi-solid dosage forms.

Keywords: Creams, Excipients, Gels, Ointments, Pastes, Semi solids