Pharmaceutical Suspensions: From Formulation Development to Manufacturing

My Collections November 10th, 2009

The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.

After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically detail the development of pharmaceutical suspensions, from pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to pharmaceutical filed is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists skilled in their specific areas. Contributing authors represent a cross-sections of scholars from Academic Institutions, Pharmaceutical Industries and Regulatory Agency.

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

My Collections October 20th, 2009

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Publisher:Pharmaceutical Press; Rev Ed edition( 27 April 2007) | ISBN-10: 0853697191 | PDF | 9.3 Mb | 430 pages
Since the 2002 edition of ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’, commonly known as the ‘Orange Guide’, there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community Code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.

From its first publication in 1971 the ‘Orange Guide’, has been an essential reference for all involved in the manufacture and distribution of medicines in Europe.

The ‘Orange Guide’ collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation.

It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.

HVAC Water Chillers and Cooling Towers: Fundamentals, Application, and Operation

My Collections October 20th, 2009

HVAC Water Chillers and Cooling Towers provides fundamental principles and practical techniques for the design, application, purchase, operation, and maintenance of water chillers and cooling towers. Written by a leading expert in the field, the book analyzes topics such as piping, water treatment, noise control, electrical service, and energy efficiency for optimal system and equipment performance and offers extensive checklists, troubleshooting strategies, and reference data, as well as recommended specifications for the procurement of new or replacement equipment. This reference also discusses proper installation and placement of chillers and cooling towers, start-up, and capacity. Very useful book for pharmaceutical engineers.

HVAC Inspection Notes: Up to Code

My Collections October 20th, 2009

Up to Code: HVAC Inspection Notes is an on-the-job “cliff notes” resource, packed with information that will save time and money while ensuring quality. To-do checklists, charts and tables with at-a-glance calculations, who’s-responsible-for-what info, and diagrams that clearly illustrate complicated information make it fast and easy for busy building professionals to do their jobs thoroughly and efficiently, and avoid costly mistakes. The books help building pros establish and meet inspection guidelines, and provide clients with schedules and specifications. Each of the Up to Code: Inspection Notes is focused on the IBC (International Building Code), the most widely adopted building code in North America. HVAC will also focus on information from the SMACNA Duct Manual. Each guide covers: Responsibility; Authority; Quality Control and Assurance; Plans and Specifications; Shop Drawings; Inspectors Daily Report; Pre-Construction Meeting; Equipment Proposal; Claims; Progress Schedules; Labor Enforcement; Storage of Materials; Contractor’s Payment; Rights-of-Way; Record Drawings; Project Turnover; Inspection Files; Recommended Equipment; Inspection; Safety.

HVAC Licensing Study Guide

My Collections October 20th, 2009

Get All the Practice Questions and Answers, Calculations, and Troubleshooting Tips You Need to Ace the major HVAC Licensing Exams!

HVAC technicians and students alike can turn to the HVAC Licensing Study Guide for everything they need to prepare for and pass the major HVAC licensing exams on the very first try! Designed to boost confidence, skills, and knowledge, this unique career-building resource contains over 800 practice questions and answers, essential calculations, and step-by-step troubleshooting tips for the job site.

Written by two of the most experienced and successful authors in the HVAC field, this on-target book presents a wealth of current information on heating boilers ventilation ductwork air conditioning systems and methods refrigeration electrical systems control devices materials and equipment design and codes and standards. Filled with over 200 detailed illustrations and handy tip boxes on important code matters and exam questions, the HVAC Licensing Study Guide enables readers to:

* Develop skills with material most likely to appear on the NATE, ICE,. RSES, and HVAC licensing exams .
* Improve test-taking ability with over 800 exam-style multiple-choice. and true/false questions and answers .
* Learn about the latest refrigerant usage and regulations.
* Keep up with the most recent codes and standards.
* Acquire the confidence, skills, and knowledge needed to pass your. licensing exam on the first try

HVAC Systems Design Handbook, 4th edition

My Collections October 20th, 2009

The third edition of this practical, hands-on reference is revised and updated to provide HVAC professionals with complete guidance on the design of effective, efficient HVAC systems. Packed with over 300 clear illustrations and tables, the book reflects the latest technological and procedural developments in HVAC systems and components for residential, commercial, and industrial buildings. Readers will find details on the new refrigerants now being used in HVAC equipment–information of new concerns related to indoor air quality–and numerous applications and on-the-job insights that will be helpful in the successful design, operation, and maintenance of peak-performing systems.

Fundamentals of HVAC Systems

My Collections October 20th, 2009

Heating, Ventilation and Air-Conditioning (HVAC) systems are omnipresent in modern buildings. This book is an introduction for all those involved in the specification, design, manufacture, installation, operation or maintainance of these systems.

Developed jointly with the ASHRAE Learning Institute, the leading and recognised technical experts in the industry. This Inch-Pound edition is primarily for use in US markets. An SI version is also available on ISBN 0123739985.

The book explains:
The objectives to be achieved by a system in terms of environmental control.
The description of a system - including primary equipment, means of distribution, space and load determination, and operating strategy.
The basic function of components that form HVAC systems.
The layout and functioning of common HVAC systems, including all-air systems, air-water systems, and all-water systems.
The strategies for operating systems and their basic means of control.
Identifying the most suitable type of system for different types of application

* Air-conditioning is a major industry and growing. Shows how systems operate and how to select, design and operate them efficiently to minimise installation cost and ongoing energy cost
* Endorsed by, and developed with ASHRAE, the leading trade body and recognised technical experts
* Provides a thorough introduction to how HVAC systems function in controlling temperature, air quality, and air circulation in a controlled space.

ISPE Good Practice Guide - HVAC

My Collections October 20th, 2009

The Guide aims to provide a common understanding of critical HVAC issues and a set of common practices to address these issues, gathering together information which is currently included in appendices of the various Baseline Guides into a single resource. The Guide will provide supporting information and HVAC practices and will explore critical and non-critical HVAC issues for the production of pharmaceuticals, biopharmaceuticals, and medical devices.

HVAC Equations, Data, and Rules of Thumb, 2nd Ed.

My Collections October 20th, 2009

The Latest Information and “Tricks of the Trade” for Achieving First-Rate HVAC Designs on Any Construction Job!

HVAC Equations, Data, and Rules of Thumb presents a wealth of state-of-the-art HVAC design information and guidance, ranging from air distribution to piping systems to plant equipment. This popular reference has now been fully updated to reflect the construction industry’s new single body of codes and standards.

Featuring an outline format for ease of use, the Second Edition of this all-in-one sourcebook contains:

  • Updated HVAC codes and standards, including the 2006 International Building Code
  • Over 200 equations for everything from ductwork to air-handling systems
  • ASME and ASHRAE code specifications
  • Over 350 rules of thumb for cooling, heating, ventilation, and more
  • New material including: coverage of the new single body of construction codes now used throughout the country

Inside This Updated HVAC Design Guide

• Definitions • Equations • Rules of Thumb for Cooling, Heating, Infiltration, Ventilation, Humidification, People/Occupancy, Lighting, and Appliance/Equipment • Cooling Load Factors • Heating Load Factors • Design Conditions and Energy Conservation • HVAC System Selection Criteria • Air Distribution Systems • Piping Systems (General, Hydronic, Glycol, Steam, Steam Condensate, AC Condensate, Refrigerant) • Central Plant Equipment (Air-Handling Units, Chillers, Boilers, Cooling Towers, Heat Exchangers) • Auxiliary Equipment (Fans, Pumps, Motors, Controllers, Variable-Frequency Drives, Filters, Insulation, Fire Stopping) • Automatic Controls/Building Automation Systems • Equipment Schedules • Equipment Manufacturers • Building Construction Business Fundamentals • Architectural, Structural, and Electrical Information • Conversion Factors • Properties of Air and Water • Designer’s Checklist • Professional Societies and Trade Organizations • References and Design Manuals • Cleanroom Criteria and Standards.

Martindale: The Complete Drug Reference, 36th Edition

My Collections October 10th, 2009

This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? “Martindale” contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust “Martindale”.