Overcoming Solubility Challenges
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Overcoming Solubility Challenges
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Author : C. Miya
language : en
Publisher:
Release Date : 2023-05-16
Overcoming Solubility Challenges written by C. Miya and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-16 with Law categories.
The commercially feasible formulation strategy for this confront is self-emulsifying drug delivery systems (SEDDS). SEDDS are isotropic and thermodynamically stable mixtures of oil, surfactant, cosurfactant and drug that structure fine oil-in-water (o/w) emulsion on addition to aqueous phases with moderate agitation. Traditionally, SEDDS are formulated as liquid dosage forms that are administered as soft gelatin capsules, with constraints such as higher manufacture cost, incompatibility with excipients, lower drug stability, drug seepage and precipitation, lower drug loading, etc. The SEDDS facilitate larger interfacial area for partition of drug amongst oil and aqueous phase's, thus enhancing drug dissolution and bioavailability
Poorly Soluble Drugs
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Author : Gregory K. Webster
language : en
Publisher: CRC Press
Release Date : 2017-01-06
Poorly Soluble Drugs written by Gregory K. Webster and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-01-06 with Medical categories.
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
Formulating Poorly Water Soluble Drugs
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Author : Robert O. Williams III
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-12-04
Formulating Poorly Water Soluble Drugs written by Robert O. Williams III and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-04 with Medical categories.
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.
Amorphous Drugs
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Author : Marzena Rams-Baron
language : en
Publisher: Springer
Release Date : 2018-02-09
Amorphous Drugs written by Marzena Rams-Baron and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-02-09 with Science categories.
This book explains theoretical and technological aspects of amorphous drug formulations. It is intended for all those wishing to increase their knowledge in the field of amorphous pharmaceuticals. Conversion of crystalline material into the amorphous state, as described in this book, is a way to overcome limited water solubility of drug formulations, in this way enhancing the chemical activity and bioavailability inside the body. Written by experts from various fields and backgrounds, the book introduces to fundamental physical aspects (explaining differences between the ordered and the disordered solid states, the enhancement of solubility resulting from drugs amorphization, physical instability and how it can be overcome) as well as preparation and formulation procedures to produce and stabilize amorphous pharmaceuticals. Readers will thus gain a well-funded understanding and find a multi-faceted discussion of the properties and advantages of amorphous drugs and of the challenges in producing and stabilizing them. The book is an ideal source of information for researchers and students as well as professionals engaged in research and development of amorphous pharmaceutical products.
Emulsions And Nanosuspensions For The Formulation Of Poorly Soluble Drugs
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Author : Rainer H. Müller
language : en
Publisher: CRC Press
Release Date : 1998
Emulsions And Nanosuspensions For The Formulation Of Poorly Soluble Drugs written by Rainer H. Müller and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Drug carriers (Pharmacy) categories.
Explore possible new approaches for overcoming poorly soluble drugs - a challenge to drug formulation work and an increasing problem. Many newly developed drugs are poorly soluble, very often simultaneously in aqueous and in organic media. Emulsions and Nanosuspensions for the Formulation of Poorly Soluble Drugs aims to: review the possibilities, limitations and future perspectives of emulsions as drug carriers considering technology from other than the phamaceutical industry (i.e food industry). show the production technology of nanosuspensions, explain the special dissolution properties (i.e. increased saturation solubility) and increased dissolution velocity (theory), and cover the possible applications. present the theory of high pressure homogenization and high pressure extrusion in dispersion techniques, including examples of applications and size measurements in concentrated dispersions.
Formulating Poorly Water Soluble Drugs
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Author : Robert O. Williams III
language : en
Publisher: Springer
Release Date : 2011-12-03
Formulating Poorly Water Soluble Drugs written by Robert O. Williams III and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-03 with Medical categories.
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.
Drug Delivery Strategies For Poorly Water Soluble Drugs
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Author : Dionysios Douroumis
language : en
Publisher: John Wiley & Sons
Release Date : 2012-12-19
Drug Delivery Strategies For Poorly Water Soluble Drugs written by Dionysios Douroumis and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-19 with Science categories.
Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development of techniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies. Drug Delivery Strategies for Poorly Water-Soluble Drugs provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self–microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer- drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on critical formulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues. Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drug delivery, polymers and biomaterials.
Amorphous Solid Dispersions
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Author : Navnit Shah
language : en
Publisher: Springer
Release Date : 2014-11-21
Amorphous Solid Dispersions written by Navnit Shah and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-21 with Medical categories.
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.
Prodrugs
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Author : Valentino Stella
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-03-12
Prodrugs written by Valentino Stella and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03-12 with Medical categories.
These volumes represent a comprehensive guide to prodrugs. They guide the reader through the current status of the prodrug concept and its many applications and highlight its many successes in overcoming formulation and delivery of problematic drugs. Replete with examples of approved and marketed prodrugs, these volumes introduce the topic to the novice as well as professional in the design of prodrugs.
Poorly Soluble Drugs
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Author : Lino Messana
language : en
Publisher:
Release Date : 2018
Poorly Soluble Drugs written by Lino Messana and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.
Solubility is the property of a solid, liquid, or gaseous chemical substance called solute to dissolve in a solid, liquid, or gaseous solvent to form a homogeneous solution of the solute in the solvent. The solubility of a substance fundamentally depends on the solvent used as well as on temperature and pressure. The extent of solubility of a substance in a specific solvent is measured as the saturation concentration where adding more solute does not increase its concentration in the solution. Solubility also plays a major role for other dosage forms like parenteral formulations as well. Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development of techniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies. This book provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs discusses the main instrumentation, operation principles and theoretical background, with a focus on critical formulation features and clinical studies. It provides a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Over 40% of new chemical entities developed in pharmaceutical industry are practically insoluble in water. These poorly water soluble drugs having slow drug absorption leads to inadequate and variable bioavailability and gastrointestinal mucosal toxicity. For orally administered drugs solubility is the most important one rate limiting parameter to achieve their desired concentration in systemic circulation for pharmacological response. Problem of solubility is a major challenge for formulation scientist. The improvement of drug solubility thereby its oral bioavailability remains one of the most challenging aspects of drug development process especially for oral-drug delivery system.