• M.R BHALEKAR
• SONALI BHARMAL

Abstract : The pharmaceutical quality by design (QbD) and describe how it can be used to ensure pharmaceutical quality .Quality cannot be tested into products but quality should be built in by design.The objective of the present study was to design and develop a formulation for immediate release tablet of propranolol hydrochloride using quality by design principles. The potentially high-risk formulation and process variables. Risk assessment technique was used to determine Critical quality attributes (CQA) and which studies were necessary to achieve product and process understanding to develop a control strategy. Risk assessments done The development of Generic Propranolol Hydrochloride , 10 mg. Brand Ciplar Tablet, 10 mg is summarized in this research. The immediate release (IR) tablet indicated for the relief of moderate to severe physiological symptoms. We used Quality by Design (QbD) to develop Propranolol Hydrochloride IR tablets. The quality target product profile (QTPP) of IR tablet were identified risk assessment was carried out by prior Knowledge and experience to define the critically of factors based on their impact by Ishikawa fishbone diagram. A 2^3 full factorial design (FFD) was employed to study the effect of critical factors on various attributes of the IR tablet.

Keywords: Propranolol hydrochloride IR tablet , Quality by Design , Risk assessments , full factorial design.

"FORMULATION AND DEVELOPMENT OF PROPRANOLOL HCl IMMEDIATE RELEASE TABLET THROUGH QUALITY BY DESIGN (QbD) APPROACH", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 6, page no.540-560, June 2019, Available :http://www.jetir.org/papers/JETIR1906O77.pdf

"FORMULATION AND DEVELOPMENT OF PROPRANOLOL HCl IMMEDIATE RELEASE TABLET THROUGH QUALITY BY DESIGN (QbD) APPROACH", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 6, page no. pp540-560, June 2019, Available at : http://www.jetir.org/papers/JETIR1906O77.pdf