To Formulate A Hyperlipidemia Dry Powder for Oral Solution Consisting of Cholestyramine Resin (without sucrose)

Abstract

The pharmaceutical industry has played a crucial role in improving patient health, but the rising costs of medications have led to concerns about sustainability. Governments worldwide are implementing measures to contain healthcare spending, with a focus on curbing pharmaceutical expenses Dosage forms, especially for oral administration, are vital in drug delivery. Among them, dry powder for oral suspension stands out as a favorable option. This formulation consists of an active pharmaceutical ingredient (API) and excipients in powder form. Dry suspensions offer advantages such as accuracy, uniformity, oral administration, stability, patient acceptability, and cost-effectiveness. They are particularly suitable for populations like pediatrics and geriatrics who may have difficulty swallowing tablets. The formulation of dry powder for oral suspension involves selecting appropriate suspending agents, sweeteners, wetting agents, buffers, preservatives, flavors, and colorants. The choice of these ingredients is crucial for improving powder flow, preventing caking, and enhancing patient acceptance. The inclusion of sweeteners like sucrose helps mask the bitter taste of drugs, while wetting agents aid in the dispersion of hydrophobic drugs. This study delves into the reformulation of cholestyramine resin for oral suspension, focusing on physicochemical properties affecting drug performance. The API undergoes thorough physical characterization, identification, and assay, ensuring compliance with quality standards. The formulation development involves selecting the optimal method (powder blends), optimizing the formula, and addressing factors like pH, sedimentation behavior, and flavor to match the innovator product. Evaluation of the optimized formulation includes pH determination, powder flow characteristics, sieve analysis, sedimentation pattern observation, viscosity determination, assay, and in vitro bile acid binding studies. The results indicate the optimized formulation's stability, comparable hygroscopic nature to the API, and bioequivalence in bile acid binding with the innovator product.In conclusion, the study provides insights into the formulation and optimization of dry powder for oral suspension, showcasing the importance of selecting suitable ingredients and ensuring bioequivalence. The optimized cholestyramine resin formulation presents a stable and viable alternative for patient use.

Keywords: cholesterol-lowering dry powder, oral suspension, cholestyramine resin, bioequivalence in bile acid binding