عنوان

Inhalation drug delivery :

1118354125 (hardback)

9781118354124 (hardback)

dltt

Inhalation drug delivery :

[Book]

techniques and products /

Paolo Colombo, Daniela Traini, Francesca Buttini

Hoboken, NY :

Wiley-Blackwell,

2013

xiv, 197 p. :

ill. ;

26 cm

ULLA postgraduate pharmacy series

Includes bibliographical references and index

1.Inhalation drug delivery / Daniela Traini -- 1.1.Introduction -- 1.2.Brief review of the respiratory system and its physiology -- 1.3.Deposition and the fate of particles in the respiratory tract -- 1.4.Deposition mechanisms -- 1.5.Parameters influencing particle deposition -- 1.6.The clearance of deposited particles -- 1.7.Airways geometry and humidity -- 1.8.Lung clearance mechanisms -- 1.9.Local and systemic drug delivery -- 1.10.Conclusion -- References -- 2.Inhalation and nasal products / Daniela Traini and Paul M. Young -- 2.1.Introduction -- 2.2.Dry powder inhalers (DPIs) -- 2.3.Liquid and propellant-based inhalers -- 2.3.1.Pressurized metered-dose inhalers (pMDIs) -- 2.3.2.Nebulizers -- 2.4.Nasal formulations -- 2.4.1.Nasal physiology -- 2.4.2.Delivery issues and concerns -- 2.4.3.Strategy for enhanced nasal delivery -- 2.4.4.Marketed nasal products -- 2.4.5.Pharmaceutical development studies for nasal products -- 2.5.Conclusion -- References --

3.Formulation of inhalation medicines / Daniela Traini and Paul M. Young -- 3.1.Introduction -- 3.2.Pressurized metered-dose inhaler (pMDI) formulation -- 3.2.1.Suspension technology -- 3.2.2.Solution technology -- 3.3.Dry powder inhaler (DPI) formulation -- 3.3.1.Carrier technology -- 3.3.2.Agglomerate technology -- 3.4.Conclusion -- References -- 4.Novel particle production technologies for inhalation products / Hak-Kim Chan and Philip Chi Lip Kwok -- 4.1.Introduction -- 4.2.Conventional crystallization and milling -- 4.3.Specialized milling -- 4.3.1.Fluid-energy milling at elevated humidity -- 4.3.2.Wet-milling nanotechnology -- 4.4.Solvent precipitation -- 4.4.1.Sono-crystallization -- 4.4.2.Microprecipitation by opposing liquid jets and tangential liquid jets -- 4.4.3.High-gravity controlled precipitation -- 4.5.Spray-drying and related droplet evaporation methods -- 4.5.1.Spray-drying -- 4.5.2.Controlled evaporation of droplets -- 4.5.3.Evaporation of low-boiling-point solutions --

4.5.4.Spray freeze-drying -- 4.6.Supercritical fluid (SCF) technology -- 4.7.Conclusion -- Acknowledgements -- References -- 5.Methods for understanding, controlling, predicting, and improving drug product performance / David A.V. Morton -- 5.1.Introduction -- 5.1.1.The complexities and challenges of aerosol performance -- 5.1.2.Understanding powder/particle characteristics: implications for aerosol product performance -- 5.1.3.Liquid systems -- 5.1.4.Summary -- 5.2.Particle sizing -- 5.2.1.Sieve analysis -- 5.2.2.Image analysis -- 5.2.3.Light scatter -- 5.2.4.Time-of-flight -- 5.2.5.Other methods -- 5.3.Powder and particulate characterization systems -- 5.3.1.Introduction -- 5.3.2.Powder cohesion and adhesion -- 5.3.3.Microscopic material characterization -- 5.3.4.Methods for studying bulk powders -- 5.4.Practical issues in process control -- 5.4.1.Common primary and secondary processing methods and issues arising for control --

5.5.Biopharmaceutical powder stability -- 5.6.Liquids: solutions and suspensions -- 5.6.1.Liquid formulation stability -- 5.7.Conclusion -- References -- 6.Aerodynamic assessment for inhalation products: fundamentals and current pharmacopoeial methods / Francesca Buttini, Gaia Colombo, Philip Chi Lip Kwok and Wong Tin Wui -- 6.1.Introduction -- 6.2.Impactor/impinger design -- 6.3.Aerodynamic assessment -- 6.4.Inertial impaction and cut-off diameter -- 6.5.Pharmacopoeial procedure -- 6.5.1.The duration of in vivo inspiration needed for 4L -- 6.5.2.Setting flow rate, Q, to give a pressure drop of 4 kPa -- 6.5.3.Flow-rate stability -- 6.6.Cascade impactor: general set-up and operation -- 6.7.Impactor/impinger characteristics -- 6.7.1.Twin-stage impinger (or glass impinger, apparatus A) -- 6.7.2.Multistage liquid impinger (MSLI) -- 6.7.3.Andersen cascade impactor (ACI) -- 6.7.4.Next-generation impactor (NGI) -- 6.8.Data analysis -- 6.9.Cleaning instructions for impactors -- 6.10.Test limitations --

6.11.Future considerations -- 6.11.1.Electrical low-pressure impactor (ELPI) -- References -- 7.Proteins, peptides, and controlled-release formulations for inhalation / Philip Chi Lip Kwok, Rania Osama Salama and Hak-Kim Chan -- 7.1.Proteins and peptides for inhalation -- 7.1.1.Stability of proteins -- 7.1.2.Nebulizers and the AERx pulmonary delivery system -- 7.1.3.Metered-dose inhalers (MDIs) -- 7.1.4.Dry powder inhalers (DPIs) -- 7.2.Controlled-release formulations for inhalation -- 7.2.1.Challenges facing controlled-release inhalation therapy -- 7.2.2.Production of inhalable controlled-release formulations -- References -- 8.Pharmaceutical development studies for inhalation products / Gaia Colombo, Chiara Parlati, and Paola Russo -- 8.1.Introduction -- 8.2.Pharmaceutical development studies for inhalation products -- 8.2.1.Studies demonstrating product performance with respect to formulation, delivery device, and their combination --

8.2.2.Studies demonstrating product performance in the hands of the patient (handling, use, storage) -- 8.2.3.Additional studies demonstrating specific development requirements -- 8.3.Conclusion -- Acknowledgements -- References -- 9.Quality of inhalation products: specifications / Paolo Colombo, Francesca Buttini, and Wong Tin Wui -- 9.1.Introduction -- 9.2.Inhalation-product specifications -- 9.2.1.Description -- 9.2.2.Identification -- 9.2.3.Drug content -- 9.2.4.Impurities and degradation products -- 9.2.5.Preservative content -- 9.2.6.Microbial limits -- 9.2.7.Sterility -- 9.2.8.Delivered-dose uniformity -- 9.2.9.Content uniformity/uniformity of dosage units -- 9.2.10.Mean delivered dose -- 9.2.11.Number of actuations per container -- 9.2.12.Fine-particle mass -- 9.2.13.Spray pattern and plume geometry -- 9.2.14.Leak rate -- 9.2.15.Moisture content -- 9.2.16.Leachables -- 9.2.17.pH -- 9.2.18.Osmolality -- 9.2.19.Extraneous particles -- 9.3.Additional quality aspects --

9.3.1.Drug substances -- 9.3.2.Excipients -- 9.3.3.Container closure systems -- 9.3.4.Inhalation-product stability -- 9.3.5.Package inserts and labels -- 9.3.6.Clinical/bioequivalence requirements -- References

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"Provides students and those in industry with concise clear guide to the essential fundamentals in inhalation drug delivery"--Provided by publisher

Aerosol therapy

Inhalers

Pharmaceutical technology

Respiratory therapy

Administration, Inhalation

Drug Delivery Systems-- methods

Colombo, Paolo,1944-

Buttini, Francesca

Traini, Daniela

20130619040613.0

[Book]

Y