Oral Lipid-Based Formulations PDF Download
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Author: David J. Hauss
Publisher: CRC Press
ISBN: 1420017268
Category : Medical
Languages : en
Pages : 370
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Book Description
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Author: David J. Hauss
Publisher: CRC Press
ISBN: 1420017268
Category : Medical
Languages : en
Pages : 370
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Book Description
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Author: David J. Hauss
Publisher: CRC Press
ISBN: 9780824729455
Category : Medical
Languages : en
Pages : 0
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Book Description
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.
Author: Nikoletta Fotaki
Publisher: John Wiley & Sons
ISBN: 1118341473
Category : Science
Languages : en
Pages : 312
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Book Description
Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.
Author: Kazi Mohsin
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 558
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Book Description
The work presented in this thesis has provided additional information regarding the utilisation of lipid-based self-emulsifying formulations for lipophilic drugs, making use of fenofibrate as a model. Specifically the work focused on lipid-based formulation in the context of the emerging "Lipid Formulation Classification System" (LFCS) which has been previously proposed as a new means of classifying lipid-based formulations. This is the first study to address lipid formulations using a small group of related excipients to cover a wide range of lipid formulations. The roles of the lipid phase, the effect of the ratio of lipid to surfactant and the presence of cosolvent on the performance of formulations were investigated. A series of phase diagrams were constructed to examine the phase behaviour during dispersion of anhydrous formulations. Type II, IIIA, IIIB and IV (SEDDS & SMEDDS) were investigated using medium chain glycerides (MCGs), polysorbates and propylene glycol (PG) as excipients. Equilibrium solubilities of the drug were determined in mixtures equivalent to diluted formulations to examine the likelihood of precipitation on dispersion. These data were compared with drug precipitation data obtained in dynamic dispersion experiments. Precipitation was measured over time after 1 in 100 dilutions of formulations in aqueous media. Aqueous dispersion of Type II lipid formulations resulted in turbid emulsions, followed subsequently by very slow precipitation of fraction of the drug dose. Type IIIA formulations, which carried less drug in solution at equilibrium, nevertheless typically maintained drugs in a metastable state for several hours or even days. These studies suggested that Type II and Type IIIA formulations were the most appropriate for fenofibrate. Diluted formulations were also subjected to in vitro digestion to predict the fate of the drug in the gastrointestinal (GI) tract after exposure of the formulation to pancreataic enzymes and bile. In vitro digestion experiments were carried out using a pH-stat maintained pH 7.5 for 30 minutes using intestinal fluids simulating the fed and fasted states (FeSSIF and FaSSIF). The digestion rate was higher in Type II & IIIA systems. Formulations with higher content of hydrophillic materials (Type IIIB or Type IV) resulted in more rapid precipitation, and extensive precipitation of drug from Type IV formulations took place rapidly. The high concentration of surfactant and or cosolvent lowered the rate of digestion but considerable precipitation occurred due to lack of solvent capacity of diluted formulations. Digestion experiments suggested that drug was in a supersaturated state which could be maintained in the presence of mixed bile salt micelles. The fate of fenofibrate is dependent on the choice of lipid formulation as exemplified by the LFCS. In particular the current study suggests that Type IIIB or Type IV formulation may be unsuitable for highly lipophilic drugs, but in vitro tests suggested that after digestion there was a considerable risk of precipitation from all formulations.
Author: Linda Joy Solomon
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Yogeshwar Bachhav
Publisher: John Wiley & Sons
ISBN: 3527343962
Category : Science
Languages : en
Pages : 470
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Book Description
Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
Author: Barkat, Md. Abul
Publisher: IGI Global
ISBN: 1522547827
Category : Technology & Engineering
Languages : en
Pages : 624
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Book Description
Advances in technology permeates every aspect of life, including the healthcare system. Nanotechnology based systems have gained popularity based upon their promise, size, and other characteristics. Multifunctional Nanocarriers for Contemporary Healthcare Applications is a critical academic publication that explores advancements in nanostructured systems, applications of these systems in healthcare, and biomedical applications of these systems. Featuring coverage on a wide range of topics, such as hydrogels, controlled drug delivery systems, and nanomedicine, this book is geared toward researchers, students, and academicians seeking current research on advancements and applications of nanostructured systems in the healthcare industry.
Author: Kathy Wai Yu Lee
Publisher:
ISBN:
Category :
Languages : en
Pages : 458
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Book Description
The absorption and oral bioavailability of poorly water-soluble drugs is often limited by poor aqueous solubility and slow dissolution in the gastrointestinal (GI) tract. Lipid-based formulations are a popular formulation approach to enhance oral bioavailability for drugs where water solubility is the primary limitation to absorption. The research undertaken in this thesis examines the use of different types and masses of lipids to improve drug solubilisation and absorption, and investigates the contribution of gastric processing to the improvements in oral bioavailability typically seen after co-administration of poorly water-soluble drugs with lipids and lipid-based formulations. A simple in vitro lipid digestion model was used to assess the effect of lipid type and mass on the solubilisation of three model lipophilic drugs (danazol, cinnarizine and halofantrine). Digestion of medium chain triacylglyceride (MCT) formulations yielded improved drug solubilisation (and resulted in drug supersaturation) at high lipid mass (250 mg). In contrast, for long chain triacylglyceride (LCT) formulations, drug concentrations in the aqueous phase of the digests were higher after digestion of the smallest lipid masses, regardless of drug lipophilicity. In all cases, digestion of the LCT formulations was incomplete, resulting in a residual oil phase. At low masses of LCT lipid (50 mg), digestion was more complete, resulting in increased drug transfer into the aqueous phase. For the more lipophilic drugs, partitioning into the residual oil phase increased. Drug lipophilicity, the choice and quantity of lipid, and the need for complete digestion of the formulation were therefore important indicators of the performance of the in vitro lipid digestion assay. Cinnarizine (CZ) was subsequently chosen as a model poorly water-soluble drug to exemplify the effects of lipid load on drug exposure in in vivo studies and to compare in vitro and in vivo performance. In vivo bioavailability studies were undertaken at fixed and varied lipid:CZ ratios and after administration with LCT and MCT. In all cases, the bioavailability of CZ was higher after administration of LCT rather than MCT formulations, regardless of lipid mass. At a fixed lipid:CZ ratio, increasing the quantity of formulation did not affect oral bioavailability, and linear pharmacokinetics were observed. When the lipid:CZ ratio was increased, CZ absorption increased at lipid doses from 50 mg to 250 mg, but did not increase further beyond 250 mg. The data suggest that the type and mass of lipid co-administered are important, but that in most cases, LCT formulations outperform the equivalent MCT formulation.The same lipids were also given by intraduodenal administration as both a lipid solution and as a dispersed lipid formulation, to assess the contribution of gastric processing to oral bioavailability. CZ bioavailability was reduced when either formulation was administered intraduodenally and similar trends were evident for MCT and LCT. The data suggest that gastric and intestinal processing contribute to improved CZ absorption. Finally, aspiration of GI content after formulation administration revealed that the digestion of MCT was more prevalent in the stomach than LCT. Gastric processing may explain the improvements in bioavailability when MCT formulations (both solution and dispersion) were administered orally when compared to intraduodenally. Surprisingly, LCT formulations were seemingly less dependent on gastric processing. In summary, the research described in this thesis highlights the potential utility (and drawbacks) of in vitro lipid digestion models to predict in vivo absorption, and further shows that the mass and type of lipid, and processing in both the stomach and the intestine are important determinants of oral bioavailability from lipid-based formulations.
Author: Kishor M. Wasan
Publisher: John Wiley & Sons
ISBN: 0470097973
Category : Science
Languages : en
Pages : 217
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Book Description
This comprehensive resource covers the fundamentals, formulation, and biopharmaceutical issues of lipid-based drug delivery. It presents the principles of lipid absorption and covers formulation issues, such as dissolution testing and stability testing, and physiological and biopharmaceutical issues, including the role of specific enzymes, the evaluation of transport systems in the body, and the mechanisms governing the transport of water-insoluble drugs.
Author: Vivek Dave
Publisher: John Wiley & Sons
ISBN: 1119711681
Category : Computers
Languages : en
Pages : 467
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Book Description
The book provides a single volume covering detailed descriptions about various delivery systems, their principles and how these are put in use for the treatment of multiple diseases. It is divided into four sections where the first section deals with the introduction and importance of novel drug delivery system. The second section deals with the most advanced drug delivery systems like microbubbles, dendrimers, lipid-based nanoparticles, nanofibers, microemulsions etc., describing the major principles and techniques of the preparations of the drug delivery systems. The third section elaborates on the treatments of diverse diseases like cancer, topical diseases, tuberculosis etc. The fourth and final section provides a brief informative description about the regulatory aspects of novel drug delivery system that is followed in various countries.
