This three-volume set of Pharmaceutical Dosage Forms: Parenteral
Medications is an authoritative, comprehensive reference work on
the formulation and manufacture of parenteral dosage forms,
effectively balancing theoretical considerations with the practical
aspects of their development. As such, it is recommended for
scientists and engineers in the pharmaceutical industry and
academia, and will also serve as an excellent reference and
training tool for regulatory scientists and quality assurance
professionals.
First published in 1984 (as two volumes) and then last revised
in 1993 (when it grew to three volumes), this latest revision will
address the plethora of changes in the science and considerable
advances in the technology associated with these products and
routes of administration. The third edition of this book maintains
the features that made the last edition so popular but comprises
several brand new chapters, revisions to all other chapters, as
well as high quality illustrations.
Volume one presents:
A historical perspective of injectable drug therapy, common
routes of administration, and biopharmaceutics of NCEs and
NBEs.
An in-depth discussion on the preformulation and formulation of
small and large molecules, including ophthalmic dosage forms.
A presentation of parenteral primary packaging options - glass
and plastic containers, as well as elastomeric closures.
A definitive chapter on container-closure integrity.
New chapters on solubility and solubilization, formulation of
depot delivery systems and biophysical/biochemical characterization
of proteins.
Volume two presents:
Chapters on aseptic facility design, environmental monitoring,
and cleanroom operations.
A comprehensive chapter on pharmaceutical water systems.
A discussion of quality attributes of sterile dosage forms,
including particulate matter, endotoxin, and sterility testing.
A detailed chapter on processing of parenteral drug products
(SVPs and LVPs).
Presentations on widely used sterilization technologies steam,
gas / chemical, radiation, filtration and dry heat.
An in-depth chapter on lyophilization.
Volume three presents:
An in-depth discussion of regulatory requirements, quality
assurance, risk assessment and mitigation, and
extractables/leachables.
Specific chapters on parenteral administrations devices,
injection site pain assessment, and parenteral product
specifications and stability testing.
Forward-thinking discussions on the future of parenteral product
manufacturing, and siRNA delivery systems.
New chapters covering recent developments in the areas of visual
inspection, quality by design (QbD), process analytical technology
(PAT) and rapid microbiological methods (RMM ), and validation of
drug product manufacturing process.
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