Abstract

IMPACT OF FORMULATION INGREDIENTS ON QUALITY OF THE PARENTERAL PRODUCTS

Shah Neel Virendrakumar*, Solanki Himanshu, Prajapati Vipul, Jani Girish, Solanki Sarvangi

ABSTRACT

Excipients are the integral part of pharmaceutical products development to achieve desired product profile. This review discusses the role of such excipients as well as the impact of formulation ingredient on quality of the parenteral product. The role of excipients such as bulking agents, buffering agents, tonicity modifiers, antimicrobial agents, surfactants and co-solvents as well as their impact on the quality of the products has also been discussed. Development of parenteral preparations typically requires specific consideration on the type and quality of excipients used. Excipients play a critical role in the creation of medicines, helping to preserve the efficacy, safety and stability of active pharmaceutical ingredients and ensuring that they delivered their promised benefits to patients. A careful choice of excipients is crucial for the development of effective and innovative pharmaceuticals. In spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. To deliver parenteral drugs to the final consumer, with intact product quality has remained a prime concern for every parenteral drug manufacturer.

Keywords: Parenterals, Excipients, Formulation development, Quality.