Mathematical Modelling of Coating Film Application Onto Pharmaceutical Solid Dosage Forms PDF Download
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Author: Charalampos Christodoulou
Publisher:
ISBN:
Category :
Languages : en
Pages : 150
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Book Description
Information related to spray impingement onto tablets, coating film drying and water absorption in tablet cores under pharmaceutical coating process conditions is limited. In this work, we therefore investigate the fundamental phenomena that are taking place at the point of contact between the tablet and the coating in an effort to reduce the number of defective tablets, to maximize tablet shelf-life and to enable a more accurate selection of the optimal process conditions. Recent models, which simulate coating behavior on tablets, have been mainly focused on single droplet impact cases. On the contrary, the current model is able to predict film formation on tablets during spray impingement while accounting for spray droplet-film interactions. Thus, the model developed in this work provides useful insight into coating spreading efficiency that can indicate defect formation. Main outputs of this work include predictions of the amount of water and polymer that penetrate into the porous tablet core and the percentage of water that evaporates from within the tablet. Knowledge of the amount of water and polymer in the tablet core can be used to optimize the shelf-life of the tablet and control the adhesion of the dry coating film. The current model assumptions, which are solely based on physics and are specific to the tablet coating process, allow one to solve coating flow problems much faster than equivalent models in commercial CFD software. The mathematical model is implemented in gPROMS employing the Modelbuilder modeling platform and it is validated against experimental data taken from the literature.
Author: Charalampos Christodoulou
Publisher:
ISBN:
Category :
Languages : en
Pages : 150
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Book Description
Information related to spray impingement onto tablets, coating film drying and water absorption in tablet cores under pharmaceutical coating process conditions is limited. In this work, we therefore investigate the fundamental phenomena that are taking place at the point of contact between the tablet and the coating in an effort to reduce the number of defective tablets, to maximize tablet shelf-life and to enable a more accurate selection of the optimal process conditions. Recent models, which simulate coating behavior on tablets, have been mainly focused on single droplet impact cases. On the contrary, the current model is able to predict film formation on tablets during spray impingement while accounting for spray droplet-film interactions. Thus, the model developed in this work provides useful insight into coating spreading efficiency that can indicate defect formation. Main outputs of this work include predictions of the amount of water and polymer that penetrate into the porous tablet core and the percentage of water that evaporates from within the tablet. Knowledge of the amount of water and polymer in the tablet core can be used to optimize the shelf-life of the tablet and control the adhesion of the dry coating film. The current model assumptions, which are solely based on physics and are specific to the tablet coating process, allow one to solve coating flow problems much faster than equivalent models in commercial CFD software. The mathematical model is implemented in gPROMS employing the Modelbuilder modeling platform and it is validated against experimental data taken from the literature.
Author: Linda A. Felton
Publisher: CRC Press
ISBN: 1315352923
Category : Medical
Languages : en
Pages : 668
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Book Description
Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.
Author: Linda A. Felton
Publisher: CRC Press
ISBN: 1498732097
Category : Medical
Languages : en
Pages : 407
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Book Description
Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.
Author: Herbert Lieberman
Publisher: CRC Press
ISBN: 1000148416
Category : Medical
Languages : en
Pages : 558
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Book Description
Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.
Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Category : Medical
Languages : en
Pages : 465
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Book Description
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 810
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Book Description
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Kurt H. Bauer
Publisher: Medpharm scientific
ISBN:
Category : Drugs
Languages : en
Pages : 286
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Book Description
Author: K. J. Laru
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
A novel method for tablet coating was studied where a thin polymer film was cast (pre-formed film), dried and applied as a coating hence eliminating the need for using any solvent during the actual coating process. A pre-formed film is initially heating to a temperature where it becomes flexible, a vacuum is applied and the film is then pulled around the tablet. The proposed films (gelatine or cellulose-based) were characterised in terms of their dissolution, swelling, mechanical and thermal properties prior to using them in the novel coating process; selected films were then coated onto tablets containing paracetamol or ibuprofen and the effect of the film on the subsequent dissolution was evaluated. It was found that the pre-formed films could be designed to be fast dissolving and mechanically strong to withstand the stress from the coating process. Also metoclopramide was incorporated in a gelatine film-coating formulation which was then successfully coated on paracetamol-containing core. Gelatin-based films were found to be successful in the novel coating process therefore to be suitable as finished coatings for immediate release dosage forms. Orally disintegrating dosage forms have been identified as a favourable dosage form due to the following reasons: fast onset of drug release, easy to use, not painful and possible increase of amount absorbed to systemic circulation. Selected films formulated for coating studies were also successfully formulated to contain active ingredient suitable for orally disintegrating dosage form; cellulose-based naratriptan-films were studied as orally disintegrating dosage forms of where the effect of formulation on the film properties was studied. It was found that strength of the film can affect the dissolution of the film but it may be the inclusion of specific excipients in the formulation which affect the penetration of the drug through mucosa.
Author: Otilia M. Y. Koo
Publisher: John Wiley & Sons
ISBN: 1118992415
Category : Medical
Languages : en
Pages : 358
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Book Description
This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients
Author: Mary T. am Ende
Publisher: John Wiley & Sons
ISBN: 111928550X
Category : Technology & Engineering
Languages : en
Pages : 1435
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Book Description
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
