Abstract

LYOPHILIZATION UNVEILED: ADVANCING SUSPENSION FORMULATION WITH CUTTING-EDGE TECHNIQUES AND INNOVATIONS

Dr. Rajesh Vooturi*, Suresh Kumar Joshi, Vrushab Pipada, Dileep J. Babu Bikkina and Subhash Zade

ABSTRACT

Overview of parenteral suspensions as a specialized drug delivery form for poorly soluble or insoluble drug, emphasizing their formulation in non aqueous and aqueous solvents. Traditional manufacturing methods involve gamma sterilization, which will challenges for thermolabile drugs. Lyophilization techniques as an alternative of utilizing organic solvents that are subsequently removed during lyophilization to ensure sterility and stability. Factors impacting lyophilization include solvent selection and process parameters like drying temperature and pressure. Recent innovations focus on formulation strategies, process developments like advancements in excipient use, controlled nucleation. Future directions highlight automation, personalized medicine, sustainability and advanced excipient development, promising enhanced safety and efficacy in pharmaceutical applications.

Keywords: Novel excipients, QbD, controlled ice nuceation, PAT, particle dispersion, Gamma sterilization.