Encapsulation of Anabolic Peptide in Lipid Nano Vesicles for Osteoporosis

Background: Screening of critical variables, including formulation and process variables, in the development of various dosage forms facilitates the identification of the most influencing parameters, which modulate the responses, thereby helping in building the strong quality target product profile. Objective: The objective of the present work was to screen out the most influential and critical variables for the development of an anabolic peptide encapsulated lipid nanovesicles (PTH-LNVs). Methods: PTH-LNVs were prepared by the ethanol injection method. Taguchi standard orthogonal array L8 design was employed to assess the effect of formulation and processing variables on different response variables. Independent variables considered were drug concentration, lipid concentration, cholesterol concentration, stirring rate, and rate of injection, whereas dependent variables studied were particle size, PDI, zeta potential, % entrapment efficiency, and % drug loading. Particle size, PDI, and zeta potential were evaluated by a zeta sizer. Drug loading efficiency and % entrapment efficiency were determined by HPLC analysis. Results: The ethanol injection method was employed to formulate PTH-LNVs using Taguchi standard orthogonal array L8 design. From the half-normal plot and Pareto ranking analysis, it was found that drug, lipid, and cholesterol concentration have a significant effect on responses of formulation and are hence considered critical variables during the formulation development. Conclusion: The presented work demonstrates the feasibility of Taguchi orthogonal array design in the screening of potential independent factors in the development of peptide encapsulated nanoformulations.