Drug solubility and bioavailability improvement. Possible methods with emphasis on liquisolid systems formulation

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Publisher : GRIN Verlag
ISBN 13 : 3668810451
Total Pages : 175 pages
Book Rating : 4.6/5 (688 download)

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Book Synopsis Drug solubility and bioavailability improvement. Possible methods with emphasis on liquisolid systems formulation by : Jan Gajdziok

Download or read book Drug solubility and bioavailability improvement. Possible methods with emphasis on liquisolid systems formulation written by Jan Gajdziok and published by GRIN Verlag. This book was released on 2018-10-04 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: Document from the year 2018 in the subject Pharmacology, grade: 1, , course: Pharmaceutical Technology, language: English, abstract: The aim of this book is to provide a brief but comprehensive overview on the issue of drug bioavailability improvement by preparation of a perspective dosage form – liquisolid systems. The introduction chapter about drug solubility and bioavailability is followed by a description of the general methods which could be used to improve drug bioavailability using approaches of chemistry, physical modification, and primarily pharmaceutical technology. Benefits and practical use of each method are documented by examples. The main part of the book is aimed at characterization and description of liquisolid systems (LSS) – perspective dosage form for bioavailability improvement. Elementary principles of LSS formulation are described in detail, e.g. how to perform a preformulation study; how to choose the correct type and amount of excipients; how to evaluate the dosage forms, etc. All the above mentioned principles are documented with practical examples. The book could be used as a textbook for students of natural, medical and pharmaceutical sciences as well as by researchers in this field or industrial area. Contemporary pharmacotherapy is characterized by the increasing amount of active substances that are only poorly soluble in water. This may lead to the limitation of their systemic absorption on oral administration which is closely related to the bioavailability. This category is estimated to include more than forty percent of active substances that are in general use. So far, this poor aqueous solubility has been improved by physical or chemical modification of the active substance. In general, such changes are very expensive and troublesome, often leading to problems in stability, marketing authorization process, or administration comfort of the particular drug. This is one of the reasons why modern pharmaceutical technology has focused on those dosage forms that can increase the bioavailability of some active substances while maintaining suitable stability and administration comfort. Several processes that improve solubility, respectively bioavailability have been described and published. These include micronization, nanocrystals, and formulation of solid dispersions. Only recently, a novel trend has appeared – to take advantage of good solubility of active substances in chosen solvents, that is, to use the active substances in a liquid phase.

Formulating Poorly Water Soluble Drugs

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 1461411440
Total Pages : 656 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Formulating Poorly Water Soluble Drugs by : Robert O. Williams III

Download or read book Formulating Poorly Water Soluble Drugs written by Robert O. Williams III and published by Springer Science & Business Media. This book was released on 2011-12-04 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.

Solubility enhancement of poorly water-soluble drugs by solid dispersion

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Publisher : Cuvillier Verlag
ISBN 13 : 3736941412
Total Pages : 198 pages
Book Rating : 4.7/5 (369 download)

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Book Synopsis Solubility enhancement of poorly water-soluble drugs by solid dispersion by : Adela Kalivoda

Download or read book Solubility enhancement of poorly water-soluble drugs by solid dispersion written by Adela Kalivoda and published by Cuvillier Verlag. This book was released on 2012-06-25 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary Solid dispersions are a promising approach for controlled release drug delivery systems as both the bioavailability enhancement of poorly water-soluble drugs as well as the sustained release of water-soluble drugs are possible to optimize their in vivo performance. Different methods for the manufacture of solid dispersion systems have been introduced in literature. In the present work, two methods are compared: hot-melt extrusion and ultrasound-assisted compaction technique. Various carrier systems and drugs with different physicochemical properties are applied to investigate the feasibility of the technologies for pharmaceutical formulation. The formulations are compared to the corresponding untreated physical blends of the components regarding their solid state structure and dissolution behavior to assess the effect of the manufacturing technique. Ultrasound-assisted compaction technique improves the initial dissolution rate of fenofibrate, a poorly water-soluble model drug. The crystalline API is partially converted into its amorphous state. As equivalent results can be achieved if the polymers are added directly to the dissolution medium, the dissolution enhancement is attributed to an improved wettability of the drug. A statistical design of experiments is employed to investigate the effect of the process parameters on the results. Difficulties are encountered in the determination of process parameters which result in an optimal outcome. The process is very sensitive to the smallest changes of settings, for example of the position of the sonotrode. Additionally, the delivery of ultrasound energy is inhomogeneous. There is no or only insufficient user control of these parameters available. Furthermore, the duration of ultrasound energy delivery which is identified as a crucial parameter cannot be set by the user. The variable factors ultrasound energy, pressure of the lower piston and pressure of the upper piston affect the defined responses in the opposite direction. Hence, there are no settings which result in a satisfactory outcome. A strong influence of the material characteristics on the process is observed leading to a batch to batch variability. Due to an insufficient reproducibility of results, the application of the technology cannot be recommended in its current state in the pharmaceutical formulation development and/or production. Improvements in homogeneity of energy delivery, process monitoring, user control and amount of leakage are mandatory for an acceptable performance and a future application in the pharmaceutical sector. The polymers COP, HPMC and PVCL-PVAc-PEG are well suitable as carriers for hot-melt extruded formulations of fenofibrate. All three extrudates are amorphous one-phase systems with the drug molecularly dispersed in the polymer. The enhancement of the initial dissolution rate and the maximum concentration level achieved are dependent on the applied carrier system. Supersaturation levels of up to 12.1 times are reached which are not stable due to recrystallization processes. The application of blends of polymers as carriers reduces the decrease rate after cmax. Because of water absorption and polymer relaxation, the overall dissolution performance decreases with increasing storage times which can be avoided through an optimization of the packaging. If oxeglitazar is used as API, the initial dissolution rate of the extrudates is below that of the untreated drug, with the exception of the ternary blend of COP, HPMC and oxeglitazar which shows a substance-specific super-additive effect. In contrast to the other extrudates, the formulation of PVCL-PVAc-PEG and oxeglitazar does not form a molecularly dispersed solid solution of the drug in the carrier. Instead, an amorphous two-phase system is present. No changes are observed after storage, presumably due to higher glass transition temperatures of the hot-melt extruded systems which are considerably above those of the corresponding fenofibrate extrudates. With felodipine as API, the dissolution profile is enhanced with COP as single carrier. If HPMC or PVCL-PVAc-PEG is used as single or additional polymeric carriers, the dissolution is equivalent (HPMC) or lower (PVCL-PVAc-PEG) than that of the pure drug although molecularly disperse systems are present in all cases. Out of the two investigated methods only hot-melt extrusion is a suitable technology to manufacture solid dispersions with an improved dissolution behavior. The dissolution profile of the extrudates can be influenced by adding polymers with differing physicochemical characteristics. Predictions on the dissolution behavior of the extrudates with polymeric blends as carriers can be made if there is knowledge on the dissolution profiles of the corresponding single polymeric extrudates. Due to substance-specific effects, the results are not transferable from drug to drug. Even so, the data are promising as the release behavior of the manufactured extrudates can be easily modified and readily adapted to one's needs. Further research will have to be conducted to verify the concept and the relevance of the results in vivo. Zusammenfassung Feste Dispersionen sind ein vielversprechender Ansatz zur Herstellung von Drug Delivery-Systemen mit kontrollierter Wirkstofffreisetzung, da sie sowohl die Bioverfügbarkeit schlecht wasserlöslicher Arzneistoffe verbessern als auch die Freisetzung gut wasserlöslicher Arzneistoffe verzögern können und so deren in vivo Verhalten optimieren. Verschiedene Herstellungsmethoden wurden in der Literatur vorgestellt. In der vorliegenden Arbeit werden zwei Technologien miteinander verglichen: Schmelzextrusion und Ultraschall gestützte Verpressung (USAC). Verschiedene Trägersysteme und Arzneistoffe mit unterschiedlichen physikochemischen Eigenschaften werden untersucht, um die Einsatzmöglichkeit im pharmazeutischen Bereich zu überprüfen. Die Struktur der hergestellten Systeme und deren Freisetzungsverhalten werden mit den physikalischen Mischungen der Komponenten verglichen, um den Einfluss der Formulierung zu bestimmen. Durch USAC wird die initiale Freisetzungsrate von Fenofibrat, einem schlecht wasserlöslichen Modellarzneistoff, verbessert. Eine teilweise Umwandlung vom kristallinen in den amorphen Zustand tritt auf. Vergleichbare Ergebnisse werden bei einer Polymerzugabe zum Freisetzungsmedium erreicht; daher wird davon ausgegangen, dass vor allem eine verbesserte Benetzbarkeit des Arzneistoffs eine Rolle spielt. Mittels statistischer Versuchsplanung wird der Einfluss der verschiedenen Prozessparameter untersucht. Die Einstellung der Prozessparameter, um ein optimales Ergebnis zu erhalten, gestaltet sich schwierig. Der Prozess reagiert auf kleinste Veränderungen, zum Beispiel der Position der Sonotrode, überaus sensitiv. Außerdem wird die Ultraschallenergie nicht homogen übertragen. Die Kontrolle dieser Parameter durch den Anwender ist nicht oder nur unzureichend möglich. Ebenso kann die Dauer der Ultraschallapplizierung, die essentiell für den Prozess ist, nicht eingestellt werden. Die Prozessparameter Ultraschallenergie, Unterstempeldruck und Sonotrodendruck beeinflussen die Zielgrößen in entgegengesetzter Richtung. Daher gibt es keine Einstellung, die für alle Zielgrößen optimale Ergebnisse liefert. Zusätzlich ist der Prozess stark abhängig von den Eigenschaften des verwendeten Materials: Die Verwendung unterschiedlicher Polymerchargen macht eine Anpassung der Prozessparameter notwendig, um vergleichbare Ergebnisse zu erhalten. Eine ausreichende Reproduzierbarkeit der Ergebnisse für einen Einsatz dieser Technologie in Formulierungsentwicklung oder Produktion ist nicht gegeben. Eine homogene Ultraschallenergiezufuhr sowie Verbesserungen der Prozessüberwachung, der Benutzerkontrolle und eine Verminderung der austretenden Materialmenge sind für eine akzeptable Leistung und eine zukünftige Anwendung im pharmazeutischen Bereich zwingend erforderlich. Die Polymere COP, HPMC, PVCL-PVAc-PEG sind für eine Freisetzungsverbesserung von Fenofibrat mittels Schmelzextrusion geeignet. Es liegen einphasige, molekulardisperse feste Lösungen vor. Abhängig von der Trägersubstanz wird die initiale Freisetzungsrate unterschiedlich stark erhöht, ebenso die maximale Konzentration des Arzneistoffes in Lösung. Eine bis zu 12.1-fache Übersättigung wird erreicht, die aufgrund von Rekristallisationsprozessen nicht stabil ist. Der Einsatz von polymeren Mischungen reduziert die Geschwindigkeit des Konzentrationsabfalls. Die Absorption von Wasser und Relaxationseffekte vermindern die Freisetzungserhöhung mit zunehmender Lagerdauer; dieser Entwicklung kann durch eine Optimierung des Packmittels entgegengewirkt werden. Wird der ebenfalls schwer wasserlösliche Arzneistoff Oxeglitazar verwendet, so ist die initiale Freisetzungsrate der Extrudate der des reinen Arzneistoffs unterlegen, mit Ausnahme der ternären Mischung von COP, HPMC und Oxeglitazar, die einen substanzspezifischen überadditiven Effekt aufweist. PVCL-PVAc-PEG-Oxeglitazar-Extrudate bilden im Gegensatz zu den übrigen Formulierungen keine molekulardisperse feste Lösung, sondern ein amorphes Zwei-Phasen-System. Eine Veränderung während der Lagerzeit wird nicht beobachtet, vermutlich aufgrund der höheren Glasübergangstemperaturen dieser Systeme. Lediglich das Freisetzungsprofil von COP-Felodipin-Extrudaten ist verbessert. Gegenüber dem reinen Arzneistoff ist die Freisetzung der übrigen Extrudate vergleichbar (HPMC) oder verringert (PVCL-PVAc-PEG), obwohl auch hier molekulardisperse Systeme vorliegen. Von den beiden untersuchten Technologien ist lediglich die Schmelzextrusion geeignet, um feste Dispersionen mit einem verbesserten Freisetzungsverhalten herzustellen. Das Freisetzungsprofil der Extrudate kann durch den Zusatz von Polymeren mit unterschiedlichen Eigenschaften optimiert und vorhergesagt werden, wenn das Freisetzungsprofil der Einzelpolymer-Extrudate bekannt ist. Die Ergebnisse sind aufgrund von substanzspezifischen Effekten nicht von Arzneistoff auf Arzneistoff übertragbar. Nichtsdestotrotz sind die Erkenntnisse dieser Arbeit vielversprechend, da gezeigt wird, dass das Freisetzungsprofil der Extrudate leicht beeinflusst und an spezifische Anforderungen angepasst werden kann. Weitere Untersuchungen sind notwendig, um das Konzept und die Relevanz der Ergebnisse in vivo zu überprüfen.

Water-Insoluble Drug Formulation

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Author :
Publisher : CRC Press
ISBN 13 : 1351646826
Total Pages : 781 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Water-Insoluble Drug Formulation by : Ron Liu

Download or read book Water-Insoluble Drug Formulation written by Ron Liu and published by CRC Press. This book was released on 2018-03-12 with total page 781 pages. Available in PDF, EPUB and Kindle. Book excerpt: Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds under development. In the most comprehensive resource on the topic, this third edition of Water-Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe the detailed discussion on solubility theories, solubility prediction models, the aspects of preformulation, biopharmaceutics, pharmacokinetics, regulatory, and discovery support of water-insoluble drugs to various techniques used in developing delivery systems for water-insoluble drugs. This book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies and featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. The aim of this book is to provide a handy reference for pharmaceutical scientists in the handling of formulation issues related to water-insoluble drugs. In addition, this book may be useful to pharmacy and chemistry undergraduate students and pharmaceutical and biopharmaceutical graduate students to enhance their knowledge in the techniques of drug solubilization and dissolution enhancement.

Bioequivalence Studies in Drug Development

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Publisher : Wiley
ISBN 13 : 9780470094754
Total Pages : 328 pages
Book Rating : 4.0/5 (947 download)

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Book Synopsis Bioequivalence Studies in Drug Development by : Dieter Hauschke

Download or read book Bioequivalence Studies in Drug Development written by Dieter Hauschke and published by Wiley. This book was released on 2007-02-27 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.

Physical Characterization of Pharmaceutical Solids

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Publisher : CRC Press
ISBN 13 : 9780824793722
Total Pages : 440 pages
Book Rating : 4.7/5 (937 download)

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Book Synopsis Physical Characterization of Pharmaceutical Solids by : Harry G. Brittain

Download or read book Physical Characterization of Pharmaceutical Solids written by Harry G. Brittain and published by CRC Press. This book was released on 1995-07-19 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.

Pharmaceutical Amorphous Solid Dispersions

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Publisher : John Wiley & Sons
ISBN 13 : 1118455207
Total Pages : 502 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Pharmaceutical Amorphous Solid Dispersions by : Ann Newman

Download or read book Pharmaceutical Amorphous Solid Dispersions written by Ann Newman and published by John Wiley & Sons. This book was released on 2015-03-09 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world

Recent Advances in Novel Drug Carrier Systems

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Publisher : BoD – Books on Demand
ISBN 13 : 9535108107
Total Pages : 516 pages
Book Rating : 4.5/5 (351 download)

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Book Synopsis Recent Advances in Novel Drug Carrier Systems by : Ali Demir Sezer

Download or read book Recent Advances in Novel Drug Carrier Systems written by Ali Demir Sezer and published by BoD – Books on Demand. This book was released on 2012-10-31 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contribution book collects reviews and original articles from eminent experts working in the interdisciplinary arena of novel drug delivery systems and their uses. From their direct and recent experience, the readers can achieve a wide vision on the new and ongoing potentialities of different drug delivery systems. Since the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. On the other hand, this reference discusses advances in the design, optimization, and adaptation of gene delivery systems for the treatment of cancer, cardiovascular, pulmonary, genetic, and infectious diseases, and considers assessment and review procedures involved in the development of gene-based pharmaceuticals.

Drug Delivery Systems

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Publisher : CRC Press
ISBN 13 : 1420040146
Total Pages : 464 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Drug Delivery Systems by : Vasant V. Ranade

Download or read book Drug Delivery Systems written by Vasant V. Ranade and published by CRC Press. This book was released on 2003-08-26 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, Drug Delivery Systems, Second Edition covers the latest developments in both

Drug-like Properties: Concepts, Structure Design and Methods

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Publisher : Elsevier
ISBN 13 : 0080557619
Total Pages : 549 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Drug-like Properties: Concepts, Structure Design and Methods by : Li Di

Download or read book Drug-like Properties: Concepts, Structure Design and Methods written by Li Di and published by Elsevier. This book was released on 2010-07-26 with total page 549 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process. The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties. Serves as an essential working handbook aimed at scientists and students in medicinal chemistry Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies Discusses improvements in pharmacokinetics from a practical chemist's standpoint

Amorphous Solid Dispersions

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Publisher : Springer
ISBN 13 : 1493915983
Total Pages : 702 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Amorphous Solid Dispersions by : Navnit Shah

Download or read book Amorphous Solid Dispersions written by Navnit Shah and published by Springer. This book was released on 2014-11-21 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.

Handbook of Preformulation

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Publisher : CRC Press
ISBN 13 : 135158233X
Total Pages : 442 pages
Book Rating : 4.3/5 (515 download)

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Book Synopsis Handbook of Preformulation by : Sarfaraz K. Niazi

Download or read book Handbook of Preformulation written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-03-22 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity. Features: Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material

Pharmaceutical Salts and Co-crystals

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Publisher : Royal Society of Chemistry
ISBN 13 : 1849733503
Total Pages : 407 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Salts and Co-crystals by : Johan Wouters

Download or read book Pharmaceutical Salts and Co-crystals written by Johan Wouters and published by Royal Society of Chemistry. This book was released on 2011-11-04 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: From crystal structure prediction to totally empirical screening, the quest for new crystal forms has become one of the most challenging issues in the solid state science and particularly in the pharmaceutical world. In this context, multi-component crystalline materials like co-crystals have received renewed interest as they offer the prospect of optimized physical properties. As illustrated in this first book_ entirely dedicated to this emerging class of pharmaceutical compounds_ the outcome of such endeavours into crystal engineering have demonstrated clear impacts on production, marketing and intellectual property protection of active pharmaceutical ingredients (APIs). Indeed, co-crystallization influences relevant physico-chemical parameters (such as solubility, dissolution rate, chemical stability, melting point, hygroscopicity, à) and often offers solids with properties superior to those of the free drug. Combining both reports of the latest research and comprehensive overviews of basic principles, with contributions from selected experts in both academia and industry, this unique book is an essential reference, ideal for pharmaceutical development scientists and graduate students in pharmaceutical science.

Dendrimers for Drug Delivery

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Publisher : CRC Press
ISBN 13 : 135136068X
Total Pages : 406 pages
Book Rating : 4.3/5 (513 download)

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Book Synopsis Dendrimers for Drug Delivery by : Anil K. Sharma

Download or read book Dendrimers for Drug Delivery written by Anil K. Sharma and published by CRC Press. This book was released on 2018-07-27 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: With chapters from highly skilled, experienced, and renowned scientists and researchers from around the globe, Dendrimers for Drug Delivery provides an abundance of information on dendrimers and their applications in the field of drug delivery. The volume begins with an introduction to dendrimers, summarizing dendrimer applications and the striking features of dendrimers. It goes on to present the details of usual properties, structure, classification, and methods of synthesis, with relevant examples. The toxicity of dendrimers is also discussed. The chapter authors provide an exhaustive amount of information about dendrimers and their biomedical applications, including biocompatibility and toxicity aspects, a very useful feature. This informative volume will be valuable resource that will help readers to create products derived from dendrimers and navigate through the regulatory, manufacturing, and quality control hurdles. It will be an important resource for researchers, scientists, upper-level students, and industry professionals.

Pharmaceutical Solid Dispersion Technology

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Publisher : CRC Press
ISBN 13 : 9781566768139
Total Pages : 114 pages
Book Rating : 4.7/5 (681 download)

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Book Synopsis Pharmaceutical Solid Dispersion Technology by : Muhammad J. Habib

Download or read book Pharmaceutical Solid Dispersion Technology written by Muhammad J. Habib and published by CRC Press. This book was released on 2000-10-05 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has not, until now, been a single up-to-date volume to provide those in drug R&D with practical information on all aspects of solid dispersion technology for drugs. This forthcoming volume finally provides such a guide and reference. The unified presentation by a team of specialists in this field is designed for practical application. Theoretical concepts are covered for a fuller understanding of current techniques. All significant recent developments are included.

Oral Drug Absorption

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Publisher : CRC Press
ISBN 13 : 1420077341
Total Pages : 432 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Oral Drug Absorption by : Jennifer B. Dressman

Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an

Hot-Melt Extrusion

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Publisher : John Wiley & Sons
ISBN 13 : 1118307879
Total Pages : 404 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Hot-Melt Extrusion by : Dennis Douroumis

Download or read book Hot-Melt Extrusion written by Dennis Douroumis and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.