scholarly journals Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Pharmaceutics ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 453
Author(s):  
Eun Ha Jang ◽  
Yun Sang Park ◽  
Min-Soo Kim ◽  
Du Hyung Choi
Keyword(s):  
Pharmaceutical Industry ◽  
Process Parameters ◽  
Drug Product ◽  
Scale Up ◽  
Quality Attributes ◽  
Modeling Method ◽  
Drug Products ◽  
Model Based ◽  
Process Strategy

In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry.

scholarly journals Comparison of Techniques to Control Ice Nucleation during Lyophilization

Processes ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. 1439
Author(s):  
Jacob Luoma ◽  
Erika Ingham ◽  
Carmen Lema Martinez ◽  
Andrea Allmendinger
Keyword(s):  
Drug Product ◽  
Quality Attributes ◽  
Ice Nucleation ◽  
Residual Moisture ◽  
Critical Quality Attributes ◽  
Stability Behavior ◽  
Drug Products ◽  
Ice Fog ◽  
Comparison Of Techniques ◽  
Enzyme Formulation

Controlling ice nucleation during lyophilization of parenteral drug products increases the homogeneity of critical quality attributes, such as residual moisture, across drug product batches and shortens lyophilization cycle time. In the present study, we compare three mechanistically different techniques to control ice nucleation during the freezing step of lyophilization, which are referred to as “depressurization”, “partial vacuum”, and “ice fog” techniques. The techniques are compared with respect to their operational limitations and challenges. Installation considerations are also discussed. Using the aforementioned nucleation techniques, we investigated a monoclonal antibody formulation and an enzyme formulation at different protein concentrations using feasible nucleation temperatures and different vial formats and fill volumes. Samples were compared for solid state properties and other critical quality attributes on stability. When nucleated at the same temperature, the three techniques produced products with the same quality attributes and stability behavior. Under conditions resulting in micro-collapse, stability behavior can be different. We found that each technology had considerations for achieving robust nucleation. The present comparison may serve as guidance in selecting a nucleation method.

scholarly journals Recent Trends, Opportunities and Challenges in 3D Printing Technology for Personalize Medicine

2020 ◽  
Vol 10 (4) ◽  
pp. 242-252
Author(s):  
Shrikrishna T. Mule ◽  
O.G. Bhusnure ◽  
S.S. Waghmare ◽  
Mamta R. Mali
Keyword(s):  
Pharmaceutical Industry ◽  
3D Printing ◽  
Medical Devices ◽  
Drug Product ◽  
Production Method ◽  
Current Status ◽  
Printing Technology ◽  
3D Printing Technology ◽  
Drug Products ◽  
Personalize Medicine

The scrutiny of medical devices industry as well as pharmaceutical industry for its application in health care industry on different platform is captured the 3D printing technique.  3D printing technology withstand for a very long duration only because of the approval of medical devices, 3D printed tablets and also with the advent of USFDA guideline on technical consideration. This technology is specific to devices utilizing preservative manufacturing. Many thoughts are triggered by 3D printing this technology and for successful delivery of intended product which is necessarily take into a consideration. In this review paper expectation limitations of some regulatory companies, Advantages, disadvantages, what type problems are arises while establishing this setups for drug product production, method, application, and manufacturing risk are represented. It also gives information about the current status of 3D printing technology in research and development of drug products.  For the fabrication of novel solid dosage form a number of 3D printing technology have been developed. This review is mainly focused on describing different technology used for the application of 3D printing in pharmaceutical industry.  Keywords: - 3D printing technology, recent trend, Opportunities, personalize medicine, challenges, future.

scholarly journals Evaluation of Excipient Risk in BCS Class I and III Biowaivers

2022 ◽  
Vol 24 (1) ◽  
Author(s):  
Melissa Metry ◽  
James E. Polli
Keyword(s):  
Drug Product ◽  
Scale Up ◽  
Drug Formulation ◽  
Product Regulatory ◽  
Drug Bioavailability ◽  
Drug Products ◽  
Fda Guidance ◽  
Regulatory Guidance

AbstractThe objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here.

scholarly journals Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

2018 ◽  
Vol 24 (21) ◽  
pp. 2456-2472 ◽  
Author(s):  
Chandrakant R. Malwade ◽  
Haiyan Qu
Keyword(s):  
Pharmaceutical Industry ◽  
Process Analytical Technology ◽  
Polymorphic Form ◽  
Active Pharmaceutical Ingredients ◽  
Drug Products ◽  
Pharmaceutical Ingredients ◽  
Particle Size And Shape ◽  
And Control

Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities. Crystallization with its ability to engineer the final product to the desired qualities such as purity, polymorphic form, particle size and shape is one of the most important steps involved in the manufacturing of APIs. Therefore, development of crystallization processes with better understanding of process parameters and their impact on quality of APIs and subsequently the drug products assume great significance for the pharmaceutical industry. Methods: This review paper focuses on the application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design of crystallization processes in the manufacturing of APIs. Results: Firstly, various steps involved in the drug development process are introduced briefly with emphasis on crystallization as one of the most important steps in manufacturing of drug products. Secondly, Critical Quality Attributes (CQAs) of drug products, their dependence on material attributes of APIs and role of crystallization in manipulating material attributes of APIs has been discussed. Finally, application of PAT tools such as advanced process analyzers for continuous monitoring, chemometric methods for multivariate data analysis, and control strategy for APIs crystallization processes has been reviewed along with some examples. Conclusion: Application of PAT in crystallization of APIs facilitates development of robust processes that works within the design space to produce the drug products of consistent quality. Furthermore, it opens up the opportunities for continuous improvement of the process by generating knowledge base of existing processes.

A Statistical Quality Control (SQC) methodology for gold nanoparticles based Immune-chromatographic rapid test kits validation

2021 ◽  
Vol 10 ◽  
Author(s):  
Prince Manta ◽  
Nitin Wahi ◽  
Alok Bharadwaj ◽  
Gurmeet Kour ◽  
Deepak N Kapoor
Keyword(s):  
Gold Nanoparticles ◽  
Process Parameters ◽  
Manufacturing Process ◽  
Scale Up ◽  
Rapid Test ◽  
Regulatory Compliance ◽  
Quality Attributes ◽  
Statistical Quality Control ◽  
Critical Process Parameters ◽  
Critical Process

: In the current virus infection and pandemic situation, the extremely convenient gold nanoparticles sensor (AuNPs) dependent antibody & antigen detection kits are very important assays for infection detection. Various laboratories & manufactures across the globe are utilizing different kits development & manufacturing process but development of kits and large scale manufacturing are two different things. A manufacturing process needs to be controlled for financial, quality and regulatory compliance. The best way to control the process is by statistical method. The process produces products that contain variables as critical quality attributes (dependent variables) are predicted over the processing time. There are distinct immune –chromatographic point to care diagnosis devices and kits available with different quality attributes like antigenantibody proteins, aptamers, markers (nanoparticles, latex beads, and fluorescence) and devices performance attributes etc. Such attributes add uncertainty to the durability of such instruments. The gold nanoparticles are one of key attribute, which certainly defines the performance of kits (sensitivity, specificity and uniformity). To establishing the manufacturing process capability, the static tolerance intervals are critical for the synthesis of gold nanoparticles, protein conjugation and nitrocellulose membrane coating. . In the immune test kits, critical process parameters (independent variable) that affect dependent responses can be controlled statistically by fitting purpose methodology. The manufacturing process is to be established in the state on engineering control by setting up the critical process parameters. Statistically, the manufacturers can predict and handle out-of-specification (OOS) results even if the process is inconsistent and unstable. This article provides scientific tools to the reader to determine whether or not a gold nanoparticles based immune-chromatographic development process is statically capable for scale-up.

scholarly journals Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

Pharmaceutics ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 252 ◽  
Author(s):  
Jong Kwon Han ◽  
Beom Soo Shin ◽  
Du Hyung Choi
Keyword(s):  
Multivariate Analysis ◽  
Process Parameters ◽  
Scale Up ◽  
Pilot Scale ◽  
Quality Attributes ◽  
Wet Granulation ◽  
High Shear ◽  
Critical Quality Attributes ◽  
High Shear Wet Granulation ◽  
The Relationship

A robust manufacturing process and the relationship between intermediate quality attributes (IQAs), critical quality attributes (CQAs), and critical process parameters (CPPs) for high-shear wet granulation was determined in this study. Based on quality by the design (QbD) approach, IQAs, CQAs, and CPPs of a telmisartan tablet prepared by high-shear wet granulation were determined and then analyzed with multivariate analysis (MVA) to evaluate mutual interactions between IQAs, CQAs, and CPPs. The effects of the CPPs on the IQAs and CQAs were quantitatively predicted with empirical models of best fit. The models were used to define operating space, and an evaluation of the risk of uncertainty in model prediction was performed using Monte Carlo simulation. MVA showed that granule size and granule hardness were significantly related to % dissolution. In addition, granule FE (Flow Energy) and Carr’s index had effects on tablet tensile strength. Using the manufacture of a clinical batch and robustness testing, a scale-up from lab to pilot scale was performed using geometric similarity, agitator torque profile, and agitator tip speed. The absolute biases and relative bias percentages of the IQAs and CQAs generated by the lab and pilot scale process exhibited small differences. Therefore, the results suggest that a risk reduction in the manufacturing process can be obtained with integrated process parameters as a result of the QbD approach, and the relationship between IQAs, CQAs, and CPPs can be used to predict CQAs for a control strategy and SUPAC (Scale-Up and Post-Approval Guidance).

scholarly journals Significance of Personnel Hygiene Practices in Pharmaceutical Industry

2021 ◽  
Vol 9 (4) ◽  
pp. 1-5
Author(s):  
Anuradha Shenvi ◽  
Krishnananda Kamath K ◽  
E.V.S. Subrahmanyam ◽  
A R Shabaraya
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Vital Role ◽  
Hygiene Practices ◽  
Policies And Procedures ◽  
Hygiene Factors ◽  
Safe Product ◽  
Safe Working Condition

Personnel hygiene is very important in the pharmaceutical industry to prevent or reduce any kind of contamination which can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors must to be upheld. Good personnel hygiene policies and practices are the foundation for successful product safety and purity. They are the backbone of a meaningful Good manufacturing Practices (GMP). Proper personnel training and sanitation are of prime importance. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. All personnel should undergo medical check-up which may be a prerequisite for safe working condition. Personnel hygiene policies and procedures are to be followed by all personnel including management, visitors, production, sanitation and maintenance staff, for reducing the chance of product contamination. Personnel hygiene practices and procedures play a vital role in pharmaceutical industry in order to achieve a good quality and safe product.

Application Of Cusum Chart In Control Of Paper Quality

GIS Business ◽  
2020 ◽  
Vol 14 (6) ◽  
pp. 1062-1069
Author(s):  
S.Ramesh ◽  
B.A.Vasu
Keyword(s):  
Process Parameters ◽  
Manufacturing Process ◽  
Paper Industry ◽  
Primary Data ◽  
Cusum Chart ◽  
Paper Machine ◽  
Statistical Control ◽  
Operating Characteristics ◽  
Small Shift

This paper is an attempt to assess if the manufacturing process of paper machine is in statistical control thereby improving the quality of paper being produced in a paper industry at the time of process itself. Quality is the foremost criteria for achieving the business target. Therefore, emphasis was made on controlling the quality of paper at the time of manufacturing process itself, rather than checking the finished lots at a later time.  This control on quality will help the industry deduct the small shift in the process parameters and modify the operating characteristics at the time of production itself rather than receiving complaints from customers at a later stage.  This paper describes controlling quality at the time of manufacture itself and helps the industry to concentrate on quality at low cost. The researcher has collected primary data at a leading paper industry during October, 2019.  Though X-bar and Range charges were primarily used, CUSUM charts were used to sense the minor shifts in manufacturing process, to explore the possibility of adjusting process parameters during manufacture of paper.

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