Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products

Sreedhara, Alavattam; Wong, Rita; Lentz, Yvonne; Schoenhammer, Karin; Stark, Christoph

doi:10.1007/978-1-4939-2316-8_7

Cited by 9 publications

(3 citation statements)

References 14 publications

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“…The QTPP is an essential element of a QbD approach and forms the basis of design of the generic product 16,17 [20][21][22][23] . While hardness is considered as process variable and risk assessment had been discussed.…”

Section: Quality Target Product Profile (Qtpp) Element Analysis Of Drmentioning

confidence: 99%

“…The coefficients with second order term (b 11 and b 22 ) indicate the quadratic nature and b 12 is the interaction term (combining effect of independent factors). This study investigated utility of a 2-factor, 3-level factorial design and optimization process for matrix tablet prepared by direct compression method.…”

Section: Hausner's Ratiomentioning

confidence: 99%

“…The design was provided the following empirical second order equation (Full Model). Where Y was represented response, b 0 was intercept, b 1 and b 2 are the coefficient of main effects, b 12 was the coefficient for the interaction term and b 11 and b 22 were the coefficients for the second order quadratic terms. Non-significant estimated coefficients were dropped from the full model by adopting a significance test for the regression coefficient.…”

Section: Fig3: In-vitro Drug Release Profile Curve For Batch F1 To F9mentioning

confidence: 99%

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2016

IJPSR

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This study posed a challenge for the risk management to research and development projects in a highly regulated and volatile pharmaceutical industry, in which projects are extremely long, complex, costly and prone to failure. Project management in new product development, must be efficient and effective. This emphasizes the importance of risk management. Quality by design (QbD) refers to an advanced approach toward drug development. QbD is a vital part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of QbD. The purpose of this research was to discuss the pharmaceutical QbD for formulation development with a case study of Orally Disintegrating Tablet (ODT) of Donepezil Hydrochloride (DPH). The study describes elements of the QbD for DPH ODT, include: Defining quality target product profile, identifying critical quality attributes, establishing design space, control strategy. ODT of DPH was prepared by direct compression method using Crospovidone, MCC and level of polymer was optimized, factorial design was used as part of risk analysis to optimize the level of other excipients. Thus, the work facilitates the adoption and implementation of QbD for formulation development using QbD and could increase efficiencies, provide regulatory support.

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