MODERN APPROACHES TO OPTIMIZING THE MIXING AND TECHNOLOGICAL PROCESSING OF PHARMACEUTICAL POWDER BLENDS BASED ON THE QUALITY BY DESIGN (QbD) CONCEPT

Received: 12 September 2026

Accepted: 16 October 2026

Published online: 30 October 2026

UDC: 615.453.2:615.014

DOI: 10.53511/pharmkaz.2026.5.9

Article type: Review Article

 

MODERN APPROACHES TO OPTIMIZING THE MIXING AND TECHNOLOGICAL PROCESSING OF PHARMACEUTICAL POWDER BLENDS BASED ON THE QUALITY BY DESIGN (QbD) CONCEPT

 

Serikbayeva E.A. ¹, Zhakipbekov K.S. ¹, Mukanova A.B. ¹,

Umurzakhova G.Zh. ², SyrmanovaG.B. ³

¹NJSC «Asfendiyarov Kazakh National Medical University», Almaty, Republic of Kazakhstan

²South Kazakhstan Medical Academy, Shymkent city, Republic of Kazakhstan

³Auezov South Kazakhstan University, Shymkent city, Republic of Kazakhstan

 

Introduction. The manufacturing of powder dosage forms requires control of the physicochemical and technological characteristics of starting materials, as well as blending, transfer, and dosing parameters. The Quality by Design (QbD) concept provides a scientific and risk-based framework for evaluating factors affecting pharmaceutical product quality.

Objective. To critically analyze modern approaches to optimizing the mixing and technological processing of pharmaceutical powder blends based on the Quality by Design (QbD) concept, to systematize potential relationships between critical material attributes (CMAs), critical process parameters (CPPs), and critical quality attributes (CQAs) of the finished product, and to propose a structured algorithm for preliminary technological risk assessment and experimental optimization planning.

Materials and Methods. This review-based analytical study examined scientific publications addressing QbD, quality risk management, experimental design, and process analytical technologies in powder dosage form manufacturing. The methodological framework was based on ICH Q8(R2), ICH Q9(R1), ICH Q10, ICH Q13, and ICH Q14. Comparative analysis, classification, and synthesis of scientific evidence were applied.

Results. Potentially significant material attributes, process parameters, and quality attributes of powder dosage forms were systematized. A conceptual CMA–CPP–CQA matrix was proposed to describe potential mechanisms of influence and approaches to their experimental evaluation. A structured QbD-based algorithm integrating risk identification, experimental planning, and control strategy development was developed.

Discussion

Comparison of the published studies demonstrated that the effects of material attributes and process parameters on powder blend quality depend on formulation composition, equipment characteristics, manufacturing conditions, and analytical methods. Relationships established for individual formulations cannot be directly extrapolated to other manufacturing systems. The proposed CMA–CPP–CQA matrix and QbD algorithm provide a structured framework for identifying potential risks and prioritizing experimental verification. However, their applicability requires validation under formulation-specific and process-specific conditions.

Conclusions. The proposed matrix and algorithm may serve as a methodological framework for planning studies aimed at optimizing powder dosage form manufacturing. Their practical applicability requires experimental verification for a specific formulation, dosage form, and manufacturing equipment.

Keywords: Quality by Design, powder dosage forms, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters, Quality Risk Management, Design of Experiments, Process Analytical Technology.

количество просмотров / 👁 61