Formulation Development and Quality Assurance of Sustained Release Tablets of Atenolol: A QbD Approach
Mr. Kanhaiyalal Prakash. Patil
, Dr Rakesh K. Jutav , Ms. Yusmeen Ghori
Keywords Atenolol, extended-release tablets, Quality by Design (QbD), Design of Experiments (DoE), Critical Quality Attributes (CQA), Quality Target Product Profile (QTPP), RP-HPLC, validation of analytical methods, pharmaceutical formulation, drug release
ABSTRACT
This study applies a Quality by Design (QbD) methodology to formulate and assess sustained release tablets of atenolol. By focusing on process control, risk assessment, and product knowledge, QbD offers a methodical and scientific foundation for pharmaceutical development. Critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs) were found in this study along with the establishment of the Quality Target Product Profile (QTPP).
This project develops and evaluates atenolol sustained release tablets using a Quality by Design (QbD) approach. QbD provides a systematic and scientific basis for pharmaceutical development by emphasizing process control, risk assessment, and product understanding. This research established the Quality Target Product Profile (QTPP) and identified critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs).
The enhanced formulation exhibited regulated and prolonged drug release for a longer duration, enhancing therapeutic effectiveness and patient adherence. Validation outcomes affirmed the dependability and strength of the established analytical method. In summary, the research emphasizes that the QbD method is a powerful instrument for creating high-quality pharmaceutical formulations with decreased variability and improved performance
"Formulation Development and Quality Assurance of Sustained Release Tablets of Atenolol: A QbD Approach", JETNR - JOURNAL OF EMERGING TRENDS AND NOVEL RESEARCH (www.JETNR.org), ISSN:2984-9276, Vol.4, Issue 4, page no.667-711, April-2026, Available :https://rjpn.org/JETNR/papers/JETNRTH00014.pdf
Volume 4
Issue 4,
April-2026
Pages : 667-711
Paper Reg. ID: JETNR_233447
Published Paper Id: JETNRTH00014
Downloads: 00086
Research Area: Pharmacy All
Country: Nandurbar, Maharashtra, India
ISSN: 2984-9276 | IMPACT FACTOR: 9.87 Calculated By Google Scholar | ESTD YEAR: 2023
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.87 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: RJPN (IJPublication) Janvi Wave
