scholarly journals Applications of Statistical Tools for Optimization and Development of Smart Drug Delivery System

2021 ◽  
Author(s):  
Pankaj Sharma
Keyword(s):  
Dosage Form ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Quality Attributes ◽  
Critical Material ◽  
Statistical Tools ◽  
Pharmaceutical Dosage Form ◽  
Critical Quality Attributes ◽  
Critical Material Attributes ◽  
Form Development

In the novel dosage form development, quality is the key criterion in pharmaceutical industry. The quality by design tools used for development of the quality products with tight specification and rigid process. The specifications of statistical tools are essentially based upon critical process parameters (CPPs), critical material attributes (CMAs), and critical quality attributes (CQAs) for the development of quality products. The application of quality by design in pharmaceutical dosage form development is systematic, requiring multivariate experiments employing process analytical technology (PAT) and other experiments to recognize critical quality attributes depend upon risk assessments (RAs). The quality by design is a modern technique to stabilize the quality of pharmaceutical dosage form. The elements of quality by design such as process analytical techniques, risk assessment, and design of experiment support for assurance of the strategy control for every dosage form with a choice of regular monitoring and enhancement for a quality dosage form. This chapter represents the concepts and applications of the most common screening of designs/experiments, comparative experiments, response surface methodology, and regression analysis. The data collected from the dosage form designing during laboratory experiments, provide the substructure for pivotal or pilot scale development. Statistical tools help not only in understanding and identifying CMAs and CPPs in product designing, but also in comprehension of the role and relationship between these in attaining a target quality. Although, the implementation of statistical approaches in the development of dosage form is strongly recommended.

Quality by Design in Pharmaceutical Formulation

2019 ◽  
pp. 221-239
Author(s):  
Sundaramurthy Vivekanandan
Keyword(s):  
Quality By Design ◽  
Drug Product ◽  
Quality Attributes ◽  
Pharmaceutical Products ◽  
Design Approach ◽  
Critical Quality Attributes ◽  
Quality Product ◽  
Product Profile ◽  
Critical Material Attributes ◽  
Quality By Design Approach

Quality by design (QbD) is a systematic, scientific, risk-based approach to product development and manufacturing process to consistently deliver the quality product. In this chapter, application, benefits, opportunities, regulatory requirements involved in quality by design of pharmaceutical products are discussed. In quality by design approach, during development, the developer defines quality target product profile (QTPP) and identifies critical quality attributes (CQA). Critical process parameters (CPP) of unit operations which impacts critical quality attributes need to be identified to understand the impact of critical material attributes (CMA) on quality attributes of the drug product. Quality by design approach is defined in ICH guidelines Q8 – Pharmaceutical Development, Q9 – Quality Risk Management, Q10 – Pharmaceutical Quality System. This chapter describes the implementation of new concepts in quality by design like design of experiments to achieve design space, control strategy to consistently manufacture quality product throughout the product lifecycle.

scholarly journals Explicating the Applications of Quality by Design Tools in Optimization of Microparticles and Nanotechnology Based Drug Delivery Systems

2021 ◽  
Vol 12 (4) ◽  
pp. 4317-4336
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Delivery Systems ◽  
Design Parameters ◽  
Sampling Errors ◽  
Critical Material ◽  
Assessment Design ◽  
Critical Material Attributes

Quality by design (QbD) can also contribute to design, manufacturing, and producing highly finished goods. To better explain the manufacturing processes, the FDA focused QbD in the healthcare industry, based on a comprehensive understanding of how technology and design parameters affect the quality of the manufactured product. Various elements of QbD are critical quality attributes (CQA); critical material attributes (CMAs), and critical process parameters (CPPs). The tools generally applied in QbD are risk assessment, design of experiments, and process analytical technology. The various benefits of the QbD model are preventing sampling errors and variability in research studies, less experimentation, and enhanced productivity. Since the microparticles and nanotechnology-based formulations need complex experimentation and an extremely time-consuming process, the application of QbD tools in such investigations can intelligently conclude the research processes. This review article provides a brief outline of the fundamentals, elements, and tools of QbD. Furthermore, the recently published applications of QbD in the optimization of microparticles and nanotechnology-based drug delivery systems have been discussed in this review.

Significance of In-Vitro and In-Vivo Correlation in Drug Delivery System

2018 ◽  
Vol 4 (4) ◽  
pp. 523-531
Author(s):  
Hina Mumtaz ◽  
Muhammad Asim Farooq ◽  
Zainab Batool ◽  
Anam Ahsan ◽  
Ashikujaman Syed
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparations ◽  
Pharmacokinetic Profile ◽  
In Vitro Dissolution ◽  
Time Saving ◽  
Pharmaceutical Dosage Form ◽  
Short Period ◽  
Form Development

The main purpose of development pharmaceutical dosage form is to find out the in vivo and in vitro behavior of dosage form. This challenge is overcome by implementation of in-vivo and in-vitro correlation. Application of this technique is economical and time saving in dosage form development. It shortens the period of development dosage form as well as improves product quality. IVIVC reduce the experimental study on human because IVIVC involves the in vivo relevant media utilization in vitro specifications. The key goal of IVIVC is to serve as alternate for in vivo bioavailability studies and serve as justification for bio waivers. IVIVC follows the specifications and relevant quality control parameters that lead to improvement in pharmaceutical dosage form development in short period of time. Recently in-vivo in-vitro correlation (IVIVC) has found application to predict the pharmacokinetic behaviour of pharmaceutical preparations. It has emerged as a reliable tool to find the mode of absorption of several dosage forms. It is used to correlate the in-vitro dissolution with in vivo pharmacokinetic profile. IVIVC made use to predict the bioavailability of the drug of particular dosage form. IVIVC is satisfactory for the therapeutic release profile specifications of the formulation. IVIVC model has capability to predict plasma drug concentration from in vitro dissolution media.

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Biologicals ◽  
2016 ◽  
Vol 44 (5) ◽  
pp. 291-305 ◽  
Author(s):  
Nadja Alt ◽  
Taylor Y. Zhang ◽  
Paul Motchnik ◽  
Ron Taticek ◽  
Valerie Quarmby ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Quality By Design ◽  
Design Principles ◽  
Quality Attributes ◽  
Critical Quality Attributes

Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

2018 ◽  
Vol 14 (3) ◽  
pp. 129-134
Author(s):  
Alisha Desai ◽  
Jayanta Kumar Maji ◽  
Kanhoba Walavalkar ◽  
Priti J Mehta
Keyword(s):  
Quality By Design ◽  
Review Process ◽  
Critical Material ◽  
Technical Requirements ◽  
The Us ◽  
Product Profile ◽  
United States Food ◽  
Critical Material Attributes ◽  
States Food ◽  
Us Fda

Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submission process. It is a question–answer format applied to Quality Overall Summary section of the submission. The format includes putting up questions under every section, so the applicant can submit precise and accurate data for approval of the respective application. The QbR format can be applied to NDA, ANDA, and Type II DMF applications. The companion document available with Manual of Policy and Procedures 5015.10 (MaPP 5015.10) allows the reviewer to inspect the critical information in the data provided. It encourages applicants to encompass Quality by Design (QbD) in their development process. QbR gives a structure through which the data collected by applying QbD can be presented. For effective application of QbR format, the submission should be backed with thorough scientific knowledge, risk assessment data, and data integrity. The questions asked compel the applicant to provide justification for the various decisions made in the development phase. Also, questions regarding quality target product profile, critical quality attributes, critical material attributes, critical process parameters and design of experiment are covered under the QbR format. MaPP 5015.10 finalized by US FDA in 2014 clarifies the concept of QbR. There is MicroQbR available which includes questions confirming the sterility of the product. QbR is a step towards speeding up the review process with an intention to motivate the applicants to implement QbD to the project.

scholarly journals Development and Validation of a Ultra Flow Liquid Chromatography Method for the Assay of Boceprevir Using a Quality-by-Design Approach

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 3023-3032
Author(s):  
Manish Majumder ◽  
Ramesh B ◽  
Minaketan Tripathy
Keyword(s):  
Risk Assessment ◽  
Flow Rate ◽  
Mobile Phase ◽  
Quality By Design ◽  
Quality Attributes ◽  
Assay Method ◽  
Chromatography Method ◽  
Critical Quality Attributes ◽  
Critical Method ◽  
Quality By Design Approach

Quality by design guided. The assay method of Boceprevir is developed in accordance with ICH Q8(R2) guideline with due validation. .In this process, the Target analytical profile (TAP) of the drug was set and critical method parameters (CMP) were investigated by systematic risk assessment experimentation to control critical Quality Attributes (CQA). In this, A Cause Effect Risk Assessment Matrix with Control-Noise-Experiment (CNX) is used for identifying the high-risk variables i.e Percentage of Organic Modifier (% methanol), pH of the Buffer and flow rate of the mobile phase. The surface response methodology was applied to optimize the critical method parameters (CMP) as well as Critical Quality Attributes (CQA) to find out the Design space of the method. The Optimum assay method condition was mobile phase Acetate Buffer (50mM) pH 5.4: Methanol (11:89), Flow rate: 0.9 ml/min, Lambda Max: 207. The separation was achieved in the Eclip Plus C-18 column (250 × 4.6 mm, 5μm) at ambient temperature. The retention time of Boceprevir was found to be 4.2 min. The method evaluation was performed according to the (Q2R1) ICH guideline.

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