1.

Record Nr.

UNINA9910967615803321

Titolo

Pharmaceutical manufacturing handbook : production and processes / / [edited by] Shayne Cox Gad

Pubbl/distr/stampa

Hoboken, N.J., : Wiley-Interscience, c2008

ISBN

9786611237516

9781281237514

1281237515

9780470259818

0470259817

9780470259801

0470259809

Edizione

[1st ed.]

Descrizione fisica

1 online resource (xiii, 1370 pages) : illustrations

Collana

Pharmaceutical Development Series

Altri autori (Persone)

GadShayne C. <1948->

Disciplina

615.19

615/.19

Soggetti

Pharmaceutical technology

Materia medica

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 MANUFACTURING SPECIALTIES; 1.1 Biotechnology-Derived Drug Product Development; 1.2 Regulatory Considerations in Approval on Follow-On Protein Drug Products; 1.3 Radiopharmaceutical Manufacturing; SECTION 2 ASEPTIC PROCESSING; 2.1 Sterile Product Manufacturing; SECTION 3 FACILITY; 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors; 3.2 Packaging and Labeling; 3.3 Clean-Facility Design, Construction, and Maintenance Issues

SECTION 4 NORMAL DOSAGE FORMS; 4.1 Solid Dosage Forms; 4.2 Semisolid Dosages: Ointments, Creams, and Gels; 4.3 Liquid Dosage Forms; SECTION 5 NEW DOSAGE FORMS; 5.1 Controlled-Release Dosage Forms; 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic



Peptide/Protein; 5.3 Liposomes and Drug Delivery; 5.4 Biodegradable Nanoparticles; 5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation; 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs

5.7 Nasal Powder Drug Delivery; 5.8 Aerosol Drug Delivery; 5.9 Ocular Drug Delivery; 5.10 Microemulsions as Drug Delivery Systems; 5.11 Transdermal Drug Delivery; 5.12 Vaginal Drug Delivery; SECTION 6 TABLET PRODUCTION; 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization; 6.2 Role of Preformulation in Development of Solid Dosage Forms; 6.3 Tablet Design; 6.4 Tablet Production Systems; 6.5 Controlled Release of Drugs from Tablet Coatings; 6.6 Tablet Compression; 6.7 Effects of Grinding in Pharmaceutical Tablet Production

6.8 Oral Extended-Release Formulations; SECTION 7 ROLE OF NANOTECHNOLOGY; 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field; 7.2 Nanotechnology in Pharmaceutical Manufacturing; 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety; 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications; INDEX

Sommario/riassunto

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.