Pharmaceutical Suspensions: From Formulation Development to Manufacturing

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.

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Cell Therapy: cGMP Facilities and Manufacturing

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

Standard operating procedures
Supply management
Facility equipment
Product manufacturing, review, release and administration
Facility master file

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Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement.
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.

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Handbook of Pharmaceutical Excipients, 6th Edition

"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

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Martindale: The Complete Drug Reference, 36th Edition

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".

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Wilson & Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry 11th Ed.

Oregon State Univ., Corvallis. Blends the chemical and pharmaceutical principles necessary for understanding structure-activity relationships and molecular mechanisms of drug action. Offers new information on emerging trends and advances and the challenges posed by new diseases. Features a new chapter on combinatorial chemistry.

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USP NF 2009 (United States Pharmacopeia 32 / National Formulary 27)

The United States Pharmacopeia–National Formulary and its Supplements become official six months after being released to the public. The USP–NF, which is released on November 1 of each year, becomes official on May 1 of the following year.

This change was adopted to give users more time to bring their methods and procedures into compliance with new and revised USP–NF requirements.

The table below describes the new official dates. The 2008 USP31–NF26, and the Supplements and Interim Revision Announcements (IRAs) to that edition, will be official until May 1, 2009, at which time the USP32–NF27 becomes official.

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Pharmaceutical Microbiology

The textbook on `Pharmaceutical Microbiology` has been adequately developed and expanded according to the AICTE- Approved Syllabus-2000 meant for the Pharmacy Degree Programme across all the Indian Universities, and others abroad offering similar curricula.

Specific attention has been duly paid to the presentation of each chapter that essentially includes: brief introduction, theoretical aspects, classification, neat and vivid diagrammatic illustrations of figures-graphics-equipments, lucid explanations, supportive classical examples, and profusely supplemented with explanatory`foot notes`-references in addition to further reading bibliography.

The text content runs over ten chapters that may prove to be of paramount interest and enormous readability not only confined to the B.Pharm., students but also to various M.Sc., academic curricula in such disciplines as: Food Microbiology, Environmental Science, Microbiology etc.

Key Features IncludeConcise and exhaustive presentation of scientific informations from several sources.A wealth of theoretical information that opens newer possibilities.Detailed classification of various microbial aspects.Pharmaceutical assays and methodologies.Comprehensive index includes significant terminologies.Well documented statement of facts.

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Non-Prescription Medicines 2nd Edition

This revised edition assesses the range of non-prescription, over-the-counter medicines that can be recommended for the most frequently encountered minor illnesses. The first edition has been updated to reflect changes in the legal status and availability of products and new opinions on and approaches to treatment. A new section on emergency hormonal contraception is also included. The information is presented in a structured formulary format with products described both generically and by brand name along with supplier details. Each chapter also contains a summary of key points with suggestions regarding the most appropriate products. The book should enable pharmacists, GPs, nurses and other healthcare professionals to make well-informed recommendations and to give patients and customers sound advice on non-prescription medicines.

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