Advanced International Journal for Research

E-ISSN: 3048-7641   •   Impact Factor: 9.11

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Volume 6 Issue 6
November-December 2025

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Formulation Development Studies

Author(s) Mr. Sujit Annappa Waghmare, Ms. Hema Suresh Chougule, Ms. Rupali kudlik Ghute
Country India
Abstract Formulation development plays a critical role in transforming an active pharmaceutical ingredient (API) into a safe, effective, and patient friendly dosage form. The present work focuses on the systematic design, optimization, and evaluation of a pharmaceutical formulatio aimed at improving the stability, bioavailability, and therapeutic performance of the selected drug. Pre-formulation studies were conducted to assess physicochemical properties, compatibility with excipients, and critical material attributes influencing product performance. Various prototype formulations were developed using a Quality by Design (QbD) approach, and key process parameter were optimized to achieve the desired critical quality attributes. The optimized formulation was evaluated for physicochemical characteristics, drug release behavior, stability, and overall product performance in accordance with regulatory guidelines. Results
demonstrated that the finalized formulation meets all predefined quality standards and offers improved therapeutic efficacy compared t conventional preparations. This study highlights the importance of systematic formulation development in ensuring product quality an enhancing patient outcomes.
Keywords Pre-Formulation, NDDS
Field Medical / Pharmacy
Published In Volume 6, Issue 6, November-December 2025
Published On 2025-12-05
DOI https://doi.org/10.63363/aijfr.2025.v06i06.2187
Short DOI https://doi.org/hbdsvc
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E-ISSN 3048-7641
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