NDLI: Optimization of the Manufacturing Process for Oral Formulations Using Multivariate Statistical Methods

Content Provider	Springer Nature Link
Author	rioka, Tadashi Kikuchi, Shingo Onuki, Yoshiri Takayama, Kozo Imai, Keiji
Copyright Year	2011
Abstract	Multivariate statistical analysis has and will continue to play an important role in the development of pharmaceutical products. Although many examples have been reported, few have applied multivariate statistical analysis to the overall manufacturing process. In this study, the model drug core tablets were manufactured under different conditions, and the challenge to understand the cause-and-effect relationship between process parameters and response variables was addressed by applying three different multivariate statistical methods. It was confirmed that conventional multivariate statistical methods were able to extract the process parameters (granulation time, drying temperature, blending time, and compression force) that affected both the average and the variance of the response variables (hardness, content uniformity, and dissolution) with a science-based rationale. In order to overcome the multiobjective optimization problem among the response variables, an advanced multivariate statistical method was also applied. It was confirmed that the mathematical models of response variables were determined with sufficiently high accuracy and the optimal levels of both process parameters and response variables were determined with high reliability, which provided a more profound understanding of the process. These methods enable us to develop pharmaceutical products more efficiently and accurately.
Starting Page	157
Ending Page	169
Page Count	13
File Format	PDF
ISSN	18725120
Journal	Journal of Pharmaceutical Innovation
Volume Number	6
Issue Number	3
e-ISSN	19398042
Language	English
Publisher	Springer US
Publisher Date	2011-08-23
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Quality by design Process understanding Multivariate statistical analysis Confidence intervals Bootstrap resampling technique Biotechnology Industrial and Production Engineering Pharmacology/Toxicology Biochemical Engineering
Content Type	Text
Resource Type	Article
Subject	Drug Discovery Pharmaceutical Science

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Application of Quality by Design Principles to Legacy Drug Products

Modeling and Optimization of a Tablet Manufacturing Line

Model-Guided Design Space Development for a Drug Substance Manufacturing Process

A PAT Approach to Enhance Process Understanding of Fluid Bed Granulation Using In-line Particle Size Characterization and Multivariate Analysis

Development of a Statistical Tolerance-Based Fluid Bed Drying Design Space

Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Model-Based Robust Parametric Design of Automatic Cleaning Process

API Quality by Design Example from the Torcetrapib Manufacturing Process

A Science and Risk Based Proposal for Understanding Scale and Equipment Dependencies of Small Molecule Drug Substance Manufacturing Processes

Optimization of the Manufacturing Process for Oral Formulations Using Multivariate Statistical Methods

Similar Documents

Application of Quality by Design Principles to Legacy Drug Products

Modeling and Optimization of a Tablet Manufacturing Line

Model-Guided Design Space Development for a Drug Substance Manufacturing Process

A PAT Approach to Enhance Process Understanding of Fluid Bed Granulation Using In-line Particle Size Characterization and Multivariate Analysis

Development of a Statistical Tolerance-Based Fluid Bed Drying Design Space

Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Model-Based Robust Parametric Design of Automatic Cleaning Process

API Quality by Design Example from the Torcetrapib Manufacturing Process

A Science and Risk Based Proposal for Understanding Scale and Equipment Dependencies of Small Molecule Drug Substance Manufacturing Processes

Optimization of the Manufacturing Process for Oral Formulations Using Multivariate Statistical Methods