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Saturday, January 22, 2011

Photostability Of Drugs And Drug Formulations, 2nd Edition




Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features · Assists non-experts in this field design a test protocol and interpret the results · Covers in vitro and in vivo aspects of interactions between drugs and light · Explores the kinetic and chemical aspects of drug photodecomposition · Discusses the problems frequently encountered in photochemical stability testing · Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs · Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint · Offers specific guidance in photostability testing and screening of drug photoreactivity

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Absorption and Drug Development: Solubility, Permeability, and Charge State



Many times drugs work fine when tested outside the body, but when they are tested in the body they fail. One of the major reasons a drug fails is that it cannot be absorb by the body in a way to have the effect it was intended to have. Permeability, Solubility, Dissolution, and Charged State of Ionizable Molecules:
  • Helps drug discovery professionals to eliminate poorly absorbable molecules early in the drug discovery process, which can save drug companies millions of dollars.
  • Extensive tabulations, in appendix format, of properties and structures of about 200 standard drug molecules.

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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition



Thoroughly updated and expanded, this new 3rd edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Formsis easily the most comprehensive book available on the market today.
New to the 3rd Edition:
· the interaction of drugs with functional polymers
· the influence of processing parameters on coating quality
· the stabilization of polymeric film coats
· plastisizers and their applications in pharmaceutical coatings
· adhesion of polymeric films to solid substrates
· basic properties of latex and pseudolatex colloidal dispersions
Key topics included:
· polymer interactions with drugs and excipients
· physical aging of polymeric films.
· A complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system
· illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing and stability problems to achieve an optimized dosage form.

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Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs



Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.


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Microencapsulation: Methods and Industrial Applications, Second Edition



Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

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Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition



Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition, is a comprehensively updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume III describes technologies for yielding liposomes that can function in a targeted fashion, and highlights methods for studying the interaction of liposomes within the biological environment to be applied in the detection, therapy, or prevention of disease. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.

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Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products




The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.

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British National Formulary 56




Compiled with the advice of clinical experts, the British National Formulary (BNF) provides up-to-date guidance on prescribing, dispensing and administering medicines.
The BNF details medicines prescribed in the UK, with special reference to their uses, cautions, contra-indications, side-effects, dosage and relative costs.
Updated every six months, the BNF reflects current best practice as well as legal and professional guidelines relating to the use of medicines. It is intended for use by prescribers, pharmacists and other healthcare professionals.
  • Designed for rapid reference
  • Authoritative, impartial and, where available, evidence-based advice on prescribing, dispensing and administering medicines
  • Updated twice a year to reflect promptly changes in product availability as well as emerging safety concerns and shifts in clinical practice

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Cosmetic Formulation of Skin Care Products



Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care products including advances in formulation and development, raw materials and active ingredients, compound testing, and clinical assessment. Organized by product category, then by body application area, this guide supplies all one needs to know to create effective skin care products for men and women in a diverse range of ethnic populations.


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Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form


Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.



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Pharmaceutical Compounding and Dispensing



This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.

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The Veterinary Formulary



The sixth edition of The Veterinary Formulary has been updated and revised by 51 expert contributors and reviewed by an advisory committee of veterinarians and pharmacologists. Features of this edition include: Revision of over 780 drug monographs from the fifth edition Some 55 new drug monographs Over 1650 UK veterinary preparations Preparation and dosage details for over 700 human-authorised products Existing sections re-arranged to reflect current veterinary practice Many new sections, eg Prescribing for rabbits, Canine pheromonatherapy, and Teat sealants New table giving husbandry requirements for common pet terrestrial invertebrates Revised BVA code of practice on medicines - includes essential legislation and information New easy-to-read appendix on Drug interactions.


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Pharmaceutical Formulation Development of Peptides and Proteins



This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from synthesis to protein purification.

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Delivery System Handbook for Personal Care and Cosmetic Products : Technology, Applications and Formulations



Novel delivery systems designed to facilitate the use of “fountain of youth” and other functional actives is an idea whose time has come. In a rapidly growing global market eager for products that really work, accelerating market pull and technology push forces have set the stage for this Foundation text. This “must have” book is the first volume of a new series entitled “Breakthroughs in Personal Care and Cosmetic Technology.” It has been carefully designed for training, development, and the empowerment of synergistic technology transfer across the personal care, cosmetic, and pharmaceutical industries.
This book is intended to cause a breakthrough in effective communication and interaction among technology and marketing functions. It is a showcase for understanding, using, and marketing the technology of why and how delivery systems work, as well as current, emerging/potential applications and working formulations. Each chapter is written by one or more experts in the field. A wide range of companies serving the global marketplace are represented. These companies offer numerous types of delivery systems containing highly desirable functional actives, delivery system technology development services, and opportunities for technology licensing, mergers, and acquisitions. A unique feature of the book is the use of Mind Map™ technology to capture and present the essence of the inner-thinking of over 80 authors in a Book-at-a-Glance Executive Overview section. This section has been specifically designed to powerfully impact decision making leading to the development of innovative product differentiation in a global context.


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Pharmaceutical Emulsions and Suspensions: Second Edition, Revised and Expanded

University Montpellier, France. Covers fundamental and applied knowledge of emulsions and suspensions. Assists those working in all spheres of pharmacy in solving the problems posed by by emulsion and suspension formulations and applications. Diagrams, charts.

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Intelligent Software for Product Formulation


The process of formulating pharmaceuticals, agrochemicals, speciality chemicals or any of the other many formulated products is a highly formulated task. Intelligent software tools are a means of capturing this knowledge to enable all users to benefit from expert advice, as well as providing the means for more consistent decision making. The implementation of intelligent software can also lead to significant improvements in knowledge protection, cost reduction, training consistency and improved communication. Many applications ranging from agrochemicals and aluminium alloys to pharmaceuticals and textile finishing are reviewed.; This is an account of the applicability of expert systems, neural networks, genetic algorithms and other intelligent software in product formulation, which includes an explanation of the technology involved and examples of two commerical software packages specifically developed for product formulation.


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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control



This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!




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Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice


This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms

Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies

New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development

The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards

It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter

A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies.

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Protein Formulation and Delivery





Protein Formulation and Delivery (Drugs and the Pharmaceutical Sciences)
By Mcnally

* Publisher: Informa Healthcare
* Number Of Pages: 278
* Publication Date: 1999-09-21
* Sales Rank: 878225
* ISBN / ASIN: 0824778839
* EAN: 9780824778835
* Binding: Hardcover
* Manufacturer: Informa Healthcare
* Studio: Informa Healthcare


This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability! Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery · includes a discussion of accelerated stability testing and its limitations in identifying stable formulations · details analytical methods commonly used in stability assessment and formulation development · stresses the importance of demonstrating the stability-indicating nature of an assay · describes the drug substance manufacturing process succinctly · examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration · covers aseptic processing in drug development and the potential development of a freeze-drying cycle · explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms · discusses the physical and chemical characteristics of proteins in microsphere delivery systems · analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation · explores formulations intended for injection, inhalation, and controlled delivery · and more! Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.



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Pharmaceutical Suspensions: From Formulation Development to Manufacturing


Pharmaceutical Suspensions: From Formulation Development to Manufacturing

Publisher: Springer | Pages: 323 | 2009-10-16 | ISBN 1441910867 | PDF | 5 MB

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 themanufacturing 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 thistextbook 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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Physical Pharmacy


This is a revision guide for students giving bullet points of basic information on physical pharmacy followed by questions and answers.Fast Track is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Physicochemical Principles of Pharmacy", this title is a concise guide providing the physicochemical background to the design and use of pharmaceutical dosage forms.


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Pharmaceutical Compounding and Dispensing


This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.



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FASTtrack: Pharmaceutics - Dosage Form and Design



Jones, David


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Contract research news in brief

Outsourcing-Pharma.com rounds up recent developments among contract research organisations, including WuXi PharmaTech, AMRI, Physiomics, Biofocus and Metabolon.

Private equity firm Warburg Pincus has taken a 5.4 per cent stake in China's WuXi PharmaTech, which recently withdrew from plans for a public offering of up to 10.1m American depositary shares.
"Warburg Pincus not only will strengthen our investor base, but more importantly we believe that it will provide strategic and business assistance to us," said WuXi's chief executive, Ge Li.
Albany Molecular Research Inc (AMRI) says it has more than doubled the capacity of its Science Park III facility in Singapore with a 10,000 square foot laboratory expansion for its medicinal chemistry unit and the opening of an in vitro biology lab.
The in vitro biology group will test compounds synthesized by the chemistry teams and deliver potency data using cell-based or biochemical assays, allowing the firm to carry out complex drug discovery projects in a shorter time.
AMRI said it expects to hire at least 70 additional chemists and biologists to staff the Singapore facility over the next three years to meet increasing demand.
The US National Institutes of Health (NIH) have extended their agreement with Galapagos' service division BioFocus DPI for the operation of the Molecular Libraries Small Molecule Repository (MLSMR) until December 2010.
The MLSMR acquires and stores compounds under the contract with NIH and distributes these compounds for high-throughput biological screening throughout the NIH's academic network in the US.
According to the terms of this agreement, Galapagos will receive more than $9m (€5.7m) over the course of the two-year extension.

Systems biology specialist Physiomics has been contracted to perform two new cancer-related research projects for Eli Lilly, after a successful collaboration earlier this year in a study of cancer cellular processes for drugs targeting the cell cycle.
UK-based Physiomics will perform two new projects for in silico simulations in the field of oncology for Lilly. The first has the aim of finding a way to identify patients who are likely to respond to an unnamed Lilly drug, while the second will investigate the mechanistic link between various biomarkers and certain other Lilly compounds.
Metabolon has expanded its multi-study agreement with Mitsubishi Tanabe Pharma, giving the latter 'preferred' access to its biochemical profiling services, and forged new collaborations with Pfizer and the University of Texas. Metabolon's platform technology is used to analyse biological samples for the discovery of markers and pathways associated with drug action and disease.
Mitsubishi Tanabe has committed several upcoming research studies to Metabolon, and the two companies say they are in the process of publishing joint study results in peer-reviewed publications. Meanwhile, Pfizer is tapping the company's metabolomics platform for its bioprocess division, and will use it to try to optimise bioprocesses and reduce manufacturing costs. The agreement with the University of Texas will focus on finding new biomarkers relating to diabetes.
CeeTox, a CRO based at Michigan University's Business Technology and Research Park, has been awarded state-funding of $150,000 in order to hire Pfizer staff that lost their jobs when the multinational shut down some of its R&D functions in Kalamazoo, Michigan, last year. Ceetox, which tests the toxicity of potential new drugs, has agreed to hire three former Pfizer scientists. Two other companies in the area have agreed to similar deals.
Synomics Pharmaceutical Services, a US CRO which provides bioanalytical, stability and analytical testing services for the pharmaceutical industry, has cleared an inspection of its facilities and operations in Wareham, Massachusetts, by the Food and Drug Administration (FDA).

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Torrent Pharm posts lower net of Rs.76.91 cr in Q3

Torrent Pharmaceuticals has suffered minor set back in profits during the third quarter ended December 2010 on account of higher R&D expenditure, employees cost and raw material costs. Further, investment in expansion in domestic and international market and adverse currency movements also impacted profits. Its consolidated net profit declined by 7.3 per cent to Rs.76.91 crore from Rs.82.95 crore in the similar period of last year. Its net sales, however, increased by 19.5 per cent to Rs.554.82 crore from Rs.464.20 crore. With margins under pressure, its earnings per share declined to Rs.9.09 from Rs.9.80 in the last period.

The company's R&D expenditure went up by 24.3 per cent to Rs.34.79 crore from 28 crore and its employees cost increased by 27.8 per cent to Rs.97.92 crore from Rs.76.64 crore. The EBDITA saw a nominal growth of 4.6 per cent to Rs.116.81 core from Rs.111.73 crore.

During the third quarter, its domestic formulation business recorded sales of Rs.214 crore, growing 17 per cent. Sales outside India jumped by 19 per cent to Rs.292 crore. Operations in Brazil registered impressive performance with sales growth of 15 per cent and revenues moving up from Rs.89 crore to Rs.102 crore. Germany-based Heumann operations recorded sales of Rs.76 crore with growth of 15 per cent. Europe (other than Heumann), Russia and CIS and Rest of he world operations grew by 22 per cent with sales
of Rs.78 crore rising from Rs.64 crore in comparable quarter. This company has recently entered the
Mexico and has plans to enter UK & Romania markets shortly.

For the first nine months of 2010-11, Torrent Pharma's net sales increased by 18 per cent to Rs.1662 crore from Rs.1411 crore in the same period of last year. Its domestic sales moved by 19 per cent to Rs.840 crore. The net profit increased sharply by 32 per cent to Rs.227 crore against Rs.172 crore in the last period.

The construction activities commenced at Dahej SEZ, where the company is setting up facilities for manufacture of API and formulations.

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Peregrine initiates Investigator-Sponsored Trial in HER2-negative metastatic breast cancer

Peregrine Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced the initiation of an Investigator-Sponsored Trial (IST) for patients with HER2-negative metastatic breast cancer, which accounts for 75% of metastatic breast cancers. This open-label phase I trial will treat patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapy agent paclitaxel.

“Bavituximab combined with chemotherapeutic agents has shown promising anti-tumour activity in two phase II breast cancer clinical trials and has repeatedly demonstrated synergistic anti-tumour activity in preclinical models,” said Alison Stopeck, MD, lead investigator of this trial and director of the clinical breast cancer program at the Arizona Cancer Centre at UMC North. “This safety study will also examine the role of cell-specific micro-particles, potentially providing novel insights into biomarkers that may correlate with a patient's response to therapy and ultimate prognosis.”

Currently, Peregrine's bavituximab is being evaluated in randomized phase II trials in front-line Non-Small Cell Lung Cancer (NSCLC), second-line NSCLC, pancreatic cancer, and HCV. Peregrine's first IST, a phase I/II trial in hepatocellular carcinoma, was initiated last month and additional studies are being planned.

“Our two signal-seeking phase II breast cancer trials combining bavituximab with taxane-based chemotherapy regimens showed promising tumour response and progression-free survival,” said Joseph S. Shan, vice president, clinical and regulatory affairs at Peregrine Pharmaceuticals. “We are delighted to support Dr Stopeck and her team as they elucidate the potential mechanisms behind the enhanced anti-tumour activity.”

In this phase I single-arm, open-label trial, up to 14 patients with HER2-negative metastatic breast cancer will be treated with paclitaxel (80 mg/m(2)) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. Patients will be treated until disease progression or intolerable toxicity. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Secondary endpoints include pharmacodynamics and coagulation marker changes. Patients will also be assessed for objective overall response rate and median Progression Free Survival (PFS) according to RECIST criteria.

Peregrine's IST programme offers oncologists the opportunity to conduct clinical trials with bavituximab.

The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that approximately 192,370 US women will be diagnosed with breast cancer in 2009 and 40,170 women will die of the disease in the US alone. HER2-negative accounts for approximately 75% of metastatic breast cancers.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.

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INTERPHEX 2011 to be held from March 29 to 31 in New York

INTERPHEX 2011,  world's leading forum for pharmaceutical manufacturing will be held at Jacob K. Javits Convention Center, New York from March 29 to March 31, 2011.

INTERPHEX addresses technology solutions and education for all aspects of drug manufacturing, from process development through delivery to market. This annual event  comprises four major segments: Facilities, Outsourcing & Contract Services, Information Technology and Manufacturing/Processing.

The INTERPHEX conference will feature two days of comprehensive educational opportunities to reflect the trends and challenges facing pharmaceutical and biopharmaceutical professionals today.

It is the  only meeting place where intelligence and passion intersect with the full spectrum of drug production products and services to create innovative solutions that improve manufacturing and supply chain performance for pharmaceutical, biologic, generic and service provider professionals.

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Wockhardt launches generic version of Protonix tablets in US

Wockhardt has received final approval from the US FDA for marketing 20mg and 40 mg pantoprazole delayed release tablets of pantoprazole (Protonix) that is used for treatment of GI ulcers and hyperacidity. Pantoprazole is the generic name for the brand Protonix marketed in the US by Pfizer. As the patent covering this product expired on January 19, 2011. Wockhardt launched the product immediately.

According to Wolters Kluwer, the total market for this product in the US is about $2 billion and belongs to the class of proton pump inhibitors. The product is a delayed release tablet and requires specialized technology and manufacturing capability.

Habil Khorakiwala, chairman, said, “This is yet another product that Wockhardt has been able to launch on the date of patent expiry. The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years. Wockhardt has been able to reinforce this capability on several occasions.”

The tablet will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and the Pantoprazole sodium API will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat. The tablets and the API were developed in-house.

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Adventrx Pharma receives PDUFA date for Exelbine NDA

Adventrx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA). The acceptance of the Exelbine NDA is the FDA's determination that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.

“With a September PDUFA date established in the day 74 letter from the FDA, we look forward to working closely with the Agency on moving Exelbine toward approval this year,” said Brian M. Culley, chief executive officer of Adventrx.

Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. Adventrx submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by Adventrx to be bioequivalent.

Adventrx retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted “Exelbine” as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims issued in January 2011 and will expire in November 2027.

Adventrx Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.

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Indian Academy of Sciences confers fellowship on IICT scientist

The Indian Academy of Sciences (IAS), Bangalore has conferred fellowship on Dr Srivari Chandrasekhar, a scientist of the Indian Institute of Chemical Technology (IICT), Hyderabad.

Dr Chandrasekhar's contribution is in the field of organic chemistry and medicinal chemistry, which helped in solving fundamental problems in developing new reactions and also addressed the environmental issues.  His major contributions include synthesis of complex natural products, especially of marine origin with anti-cancer and anti depressant properties, green chemistry and automation chemistry to make large number of new chemicals. He has published more than 200 papers in international journals. He has also solved several problems in process chemistry for the pharmaceutical industry. He is also a fellow of National Academy of Sciences.

The IAS is one of the oldest and prestigious academies of the country which honour distinguished scientists of the country in all branches of science and was started by Prof C V Raman.

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ADMA wants Dept of Ayush to enhance subsidy provided under scheme nos 4, 5

The Ayurvedic Drug Manufacturers' Association (ADMA) wants the Department of Ayush to increase the subsidy provided under scheme no 4 and 5 to 50 per cent so that the Ayurveda, Siddha & Unani (ASU) drug
manufacturers can utilise the scheme for the benefit of the industry. As of now, scheme no 4 and 5 provides only 30 per cent subsidy i.e. upto 30 lakh towards upgrading quality control facilities which is very low. Moreover the subsidy is available only for one scheme at a time which is not industry friendly.
This centrally sponsored scheme is provided for the ASU manufacturers of the country so that they can improve and upgrade their Quality Control (QC) and manufacturing facilities with the government support. Scheme no 4 deals with provision regarding assistance to ASU drug manufacturing units to establish an
in-house quality control laboratory for the purpose of QC testing of all raw materials or finished products as per pharmacopoeial parameters including testing of ingredients heavy metals, pesticide residue, microbial load etc. Whereas scheme no 5 deals with assistance to ASU manufacturing units having a turnover of upto Rs.20.00 crore for acquiring US FDA/EU good manufacturing practices certification for their units.
Chandrakanth Bhanushali, general secretary, ADMA, points out, “Though the vision of the Department is very commendable its not proving to be very effective as of now. Mainly because the subsidy provided by the government which is just 30 per cent i.e. upto 30 lakh towards upgrading quality control facilities and manufacturing facility is very low compared to the demand. The minimum requirement to reach the GMP is almost one crore, so how will it be possible for a small scale or micro level ASU manufacturer whose annual turn over is not more than Rs.25 lakh per annum to benefit with just 30 per cent of subsidy.”
Other major problem faced by the ASU manufacturers is that the scheme provides 30 per cent subsidy only for one scheme at a time. Which means that the ASU manufactures will get subsidy for only one scheme whereas he will have to invest money from his own pocket for the other scheme which is quite high and out of reach for many ASU manufacturers.
“We would request the government to make certain changes in this matter for the betterment of the industry. We want the government to amend the subsidy to 50 per cent for each scheme as well as ensure the availability of soft loans from banks for the up gradation process,” Bhanushali expressed.
This is not an ADMA recommendation alone. In fact it has been earlier referred in the planning commission's XIth. plan steering committee report for the AYUSH sector as well. He clarified. “We are at the fag end of the XIth plan and are yet to partake in the fruits of promised plan proposals.”

Further he pointed out that this schemes should also be extended for clinical trials and new entrepreneurs. Clinical trials expenditure goes to minimum of Rs.5 lakh, depending upon the protocol of the product and the institution conducting the trial, so if this scheme is extended here it will be a great boost for the industry.
Whereas if this scheme is extended for new entrepreneur who wants to enter in the manufacturing of ASU medicines as per WHO GMP or as per Ayush Premium Mark he will be not facing any funding problems and thus will also act as a model for others.

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