Quality by Design: Concept to Applications

Author(s): Suryakanta Swain*, Rabinarayan Parhi, Bikash Ranjan Jena, Sitty Manohar Babu

Journal Name: Current Drug Discovery Technologies

Volume 16 , Issue 3 , 2019

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Graphical Abstract:


Abstract:

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA).

Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components.

Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized.

Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

Keywords: Critical quality attributes, high-throughput screening, process analytical technology, genotoxic impurities, design of experiment, antidiabetic drugs.

[1]
Lawrence XY, Gregory A, Mansoor AK, et al. Understanding Pharmaceutical Quality by Design. AAPS J 2014; 16(4): 771-83.
[2]
U.S. Food and Drug Administration. Guidance for Industry, Q8(2) Pharmaceutical development. 2009; 1-25.
[3]
Bhambure R, Kumar K, Rathore AS. High-throughput process development for biopharmaceutical drug substances. Trends Biotechnol 2011; 29(3): 127-35.
[4]
Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J. Pharmaceutical product development: A quality by design approach. Int J Pharm Investig 2016; 6: 129-38.
[5]
Rathore AS. A roadmap for implementation of Quality by Design (QbD) for biotechnology products. Trends Biotechnol 2009; 27(9): 546-53.
[6]
Van HP, Harms J, Wang X, Rathore AS. Case Study on Definition of Process Design Space for a Microbial Fermentation Step In: Rathore AS, Mhatre R, Eds Quality by Design for Biopharmaceuticals: Principles and Case Studies, John Wiley & Sons, Inc, Hoboken, NJ, USA 2009.
[7]
Kozlowski S, Swann P. Considerations for Biotechnology Product Quality by Design In: Rathore AS, Mhatre R, Eds Quality by Design for Biopharmaceuticals: Principles and Case Studies, John Wiley & Sons, Inc, Hoboken, NJ, USA
[8]
U.S. Department of Health and Human Services, Food and Drug Administration. 2004, Guidance for Industry, PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Available from. http://www.fda.gov/down-loads/ Drugs/GuidanceCompliance Regulatory Information/ Guidances/ucm070305.pdf (Accessed on: 15-6-2017).
[9]
Rathore AS, Winkle H. Quality by Design for pharmaceuticals: regulatory perspective and approach. Nat Biotechnol 2009; 27(1): 26-34.
[10]
Rege K, Pepsin M, Falcon B, Steele L, Heng M. High-throughput process development for recombinant protein purification. Biotechnol Bioeng 2006; 93(4): 618-30.
[11]
Low D, Rhona OL, Narahari SP. Future of antibody purification. J Chromatogr B 2007; 848(1): 48-63.
[12]
Beckley KN, Tangir A, Gijs WK, et al. Design strategies for integrated protein purification processes: Challenges, progress and outlook. J Chem Technol Biotechnol 2008; 83(2): 124-32.
[13]
Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009; 27(1): 26-34.
[14]
U.S. Food and Drug Administration. Guidance for Industry, Q8 Pharmaceutical development. 2006; 1-9.
[15]
U.S. Food and Drug Administration. Guidance for Industry, Q8 (R2) Pharmaceutical development. 2009; 1-25.
[16]
Lipsanen T, Antikainen O, Raikkonen H, Airaksinen S, Yliruusi J. Novel description of a design space for fluidised bed granulation. Int J Pharm 2007; 345(1-2): 101-7.
[17]
Nail S, Searles J. Elements of quality by design in development and scale-up of freeze parenterals. Biopharm Int 2008; 21(1): 44-52.
[18]
Snyder LR, Glajch JL. Computer-assisted method development for high performance liquid chromatography. Elsevier Science Ltd, Amsterdam. J Chromatogr Library 1990; 485: 607-15.
[19]
Horvath CS, Melander W, Molnar I, Molnar P. Enhancement of retention by ion-pair formation in liquid chromatography with nonpolar stationary phases (Solvo phobic theory of reversed phase chromatography, Part III). Anal Chem 1977; (49): 2295-305.
[20]
Monk KE, Rieger HJ, Molnar I. Expanding the term “Design Space” in high performance liquid chromatography. J Pharm Biomed 2011; (56): 874-9.
[21]
Musters J, Leendert VB, Kellenbach E. Applying QbD principles to develop a Generic UHPLC method which facilitates continual improvement and innovation throughout the product lifecycle for a commercial API. American Chemical Society. Org Process Res Dev 2013; 17(1): 87-96.
[22]
David A, Cyrus A, Patrick JF, et al. Application of quality by design elements for the development and optimization of an analytical method for protamine sulphate. J Pharm Biomed Anal 2012; 25: 61-7.
[23]
Karmarkar S, Yang X, Garber R, Szajkovics A, Koberda M. Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance. J Pharm Biomed Anal 2014; 100: 167-74.
[24]
Szabolcs F, Jeno F, Imre M, Katalin G. Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2nm particles and design space computer modelling. J Chromatogr A 2009; 1216: 7816-23.
[25]
Schmidt AH, Molnár I. Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations. J Pharm Biomed Anal 2013; 78-79: 65-74.
[26]
Bousses C, Ferey L, Vedrines E, Gaudin K. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products. J Pharm Biomed Anal 2015; 115: 114-22.
[27]
Rathore AS. A roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol 2009; 27(9): 546-53.
[28]
Mingjiang S, David Q. Liu Al-SK. A systematic method development statergy for determination of pharmaceutical genotoxic impurities. Org Process Res Dev 2010; 14(4): 977-85.
[29]
Havele M, Dhaneshwar S. Development and validation of a HPLC method for the determination of metformin hydrochloride, gliclazide and piogliglitazone hydrochloride in multicomponent. Webmed Central Pharmaceut Sci 2010; 1(10)WMC0010
[30]
Jain D, Jain S, Jain D, Amin M. Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and glimepiride by RP-HPLC in tablet formulation. J Chromatogr Sci 2008; (46): 501-4.
[31]
Monks K, Molnar I, Rieger HJ. Quality by design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. J Chromatogr A 2012; (1232): 218-30.
[32]
Food and Drug Administration. Guidance for industry, Q8 (R1) Pharmaceutical Development 2009; Nov, Available from. http://www.fda.gov/downloads/Drugs/./Guidances/ucm073507.pdf
[33]
ICH. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q8 Pharmaceutical Development 2005; Available from. http://www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q10/Concept_papers/Q10_Concept_Paper.pdf (Accessed on: 20-7-2017).
[34]
Kan S, Lu J, Liu J, Wang J, Zhao Y. A quality by design (QbD) case study on enteric coated pellets: Screening of critical variables and establishment of design space at laboratory scale. Asian J Pharm Sci 2014; 9: 268-78.
[35]
Porfire A, Muntean DM, Rus L, Sylvester B, Tomuta I. A quality by design approach for the development of lyophilized liposomes with simvastatin. Saudi Pharm J 2017; 25: 981-92.
[36]
Seely RJ, Haury J, Rathore AS, Sofer G. Process Validation in Manufacturing of Biopharmaceuticals 3rd Ed Taylor & Francis: Boca Raton, FL 2005; pp. 13-50.
[37]
Uhlenbrock L, Sixt M, Strube J. Quality-by-Design (QbD) process evaluation for phytopharmaceuticals on the example of 10-deacetylbaccatin III from yew. Resource-Efficient Technol 2017; 3: 137-43.
[38]
ICH. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q6, A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 1999; Available from. http://www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf (Accessed on: 20-4-2017).
[39]
ICH. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 1999; Available from. http://www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
[40]
Food and Drug Administration. Guidance for industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. 2004; Available from. http://www.fda.gov/downloads/Drugs/./Guidances/ucm070305.pdf
[41]
OPS Process Analytical Technology– (PAT) Initiative. Available from. http://www.fda.gov/AboutFDA/CentersOffices/CDER ucm088828.htm (Accessed on: 10-3-2017).
[42]
I.C.H. Harmonized Tripartite Guideline. Quality. Risk Management Q9 2005; 1-9.
[43]
Schweitzer M, Pohl M, Hanna-Brown M. Implications and opportunities of applying QbD principles to analytical measurements. Pharm Technol 2010; 34(2): 52-9.
[44]
Djuris J, Djuric Z. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. Int J Pharm 2017; 533(2): 346-56.
[45]
Frederick GV, Alireza SK. Quality by design approach: Regulatory need. J Pharm Sci 2011; 10(2): 797.
[46]
Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arab J Chem 2017; 10: S3412-25.
[47]
Weiyong L, Henrik TR. Strategy for developing and optimizing liquid chromatography methods in pharmaceutical development using computer-assisted screening and Plackett-Burman experimental design. J Chromatogr A 2003; 1016: 165-80.
[48]
Terzic J, Popović I, Stajić A, Tumpa A, Jančić-Stojanović B. Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. J Pharm Biomed Anal 2016; 125: 385-93.
[49]
Karmarkar S, Garber R, Genchanok Y, George S, Yang X, Hammond R. Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities. J Chromatogr Sci 2011; 49(6): 439-46.
[50]
Badawy SIF, Lin J, Gokhale M, et al. Quality by design development of brivanib alaninate tablets: Degradant and moisture control strategy. Int J Pharm 2014; 469(1): 111-20.
[51]
Krishna MV, Dash RN, Reddy BJ, Venugopal P, Sandeep P, Madhavi G. Quality by Design (QbD) approach to develop HPLC method for eberconazole nitrate: Application to hydrolytic, thermal, oxidative and photolytic degradation kinetics. J Saudi Chem Soc 2016; 20: S313-22.
[52]
Yi-Hui L, Yi-Hsin Y, Shou-Mei W. Experimental design and capillary electrophoresis for simultaneous analysis of arbutin, kojic acid and hydroquinone in cosmetics. J Pharm Biomed Anal 2007; 44: 279-82.
[53]
Peng T, Huang Y, Mei L, et al. Study progression in application of process analytical technologies on film coating. Asian J Pharm Sci 2015; 10: 176-85.
[55]
Lee MJ, Park CR, Kim AY, et al. Dynamic calibration for the inline NIR monitoring of film thickness of pharmaceutical tablets processed in a fluid-bed coater. J Pharm Sci 2010; 99: 325-35.
[56]
Lianming W, Frederick GV. A review of recent advances in mass spectrometric methods for gas-phase chiral analysis of pharmaceutical and biological compounds. J Pharm Biomed Anal 2012; 69: 133-47.
[57]
Miroslav ZM, Valentina DM, Predrag SS, Radosav MP, Dragan MM. Coulometric–potentiometric determination of the autoprotolysis constant and the relative acidity scale of water. J Serb Chem Soc 2010; 75: 1583.
[58]
Huang J, Goolcharran C, Ghosh K. A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods. Eur J Pharm Biopharm 2011; 78(1): 141-50.
[59]
Pawar J, Tayade A, Gangurde A, Moravkar K, Amin P. Solubility and dissolution enhancement of efavirenz hot melt extruded amorphous solid dispersions using combination of polymeric blends: A QbD approach. Eur J Pharm Sci 2016; 88: 37-49.
[60]
Phil B, Phil N, Marion C, Duncan T, Keith T. The application of quality by design to analytical methods Pharma Technol 2007; 31(10).
[61]
Blackburn TD. An Introduction to QbD (Quality by Design) and Implications for Technical Professionals. 2011;. ISPE CASA Annual Technology Show.
[62]
Cole G, Hogan JE, Aulton ME. Pharmaceutical coating technology. Abingdon, UK: Taylor and Francis 1995.
[63]
Trivedi B. Quality by design (Qbd) in pharmaceuticals. Int J Pharm Pharm Sci 2012; 4: 17-29.


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Article Details

VOLUME: 16
ISSUE: 3
Year: 2019
Page: [240 - 250]
Pages: 11
DOI: 10.2174/1570163815666180308142016
Price: $65

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