In the modern pharmaceutical industry, high-performance liquid chromatography (HPLC) is the major and integral analytical tool applied in all stages of drug discovery, development, and production. The development of new chemical entities (NCEs) is comprised of two major activities: drug discovery and drug development. The goal of the drug discovery program is to investigate a plethora of compounds employing fast screening approaches, leading to generation of lead compounds and then narrowing the selection through targeted synthesis and selective screening (lead optimization).
The primary focus of this chapter in on general approaches and considerations toward development of high-performance liquid chromatography (HPLC) methods for separation of pharmaceutical compounds, which may be applied within the various functions in the drug development continuum. It is very important to understand the aim of analysis and the requirements for a particular method to be developed. The aim of analysis of each HPLC method may vary for each developmental area in the drug development process and speciﬁc examples are given in Section 8.2.
The method validation process is to conﬁrm that the method is suited for its intended purpose. Although the requirements of validation have been clearly documented by regulatory authorities [ICH, USP, and FDA], the approach to validation is varied and open to interpretation. Validation requirements differ during the development process of pharmaceuticals. The method validation methodologies in this chapter will focus on the method requirements for preliminary and full validation for both drug substance and drug product.
Developing fast high-performance liquid chromatography (HPLC) methods can improve work efﬁciency during research, development, or production of a drug substance or a drug product. HPLC is a key technique in all of these areas. Until recently, analysis times of greater than 30 minutes were common. Modern pharmaceutical R&D, with its high-throughput screening, demands high-throughput methods to deal with the large number of samples. To reduce production cycle time, fast HPLC methods are essential for on-line or at-line process control and for rapid release testing.
Analytical technology transfer and manufacturing is the mechanism by which knowledge acquired about a process for making a pharmaceutical active ingredient or dosage form during the clinical development phase is transferred from research and development to commercial scale-up operation or shared between internal groups or with third parties. Analytical technology transfer guarantees that laboratories can routinely execute tests, obtain acceptable results, and be able to accurately and independently judge the quality of commercial batches.
The most widely used analytical separation technique for the qualitative and quantitative determination of chemical mixtures in solution in the pharmaceutical industry is high-performance liquid chromatography (HPLC). However, conventional detectors used to monitor the separation, such as UV, refractive index, ﬂuorescence, and radioactive detectors, provide limited information on the molecular structure of the components of the mixture. Mass spectrometry (MS) and nuclear magnetic resonance (NMR) are the primary analytical techniques that provide structural information on the analytes.
It has been over eight years since the first edition of the Handbook of Pharmaceutical
Granulation Technology was published. The enthusiastic reception afforded by the
scientific community was heartwarming.
The basic science of granulation has not changed much over the last few years;
however, a better understanding of the theory of granulation and the proliferation of
different dosage forms has.
Chirality plays a major role in biological processes, and the enantiomers of a bioactive molecule often possess different biological effects. For example, all pharmacological activity may reside in one enantiomer of a molecule, or enantiomers may have identical qualitative and quantitative pharmacological activity. In some cases, enantiomers may have qualitatively similar pharmacological activity, but different quantitative potencies.
Environmental considerations: treatment of exhaust gases from film-coating processes
Graham C.Cole SUMMARY Solvents such as acetone, methylene chloride, chloroform, ethanol and methanol must be prevented from entering the environment. Two options are available: convert all the processes to aqueous-based formulations or recover all the solvent by the use of an appropriate system. Recovery is expensive and is generally the reason for pharmaceutical companies to convert coating formulations to aqueous systems or formulate aqueous coating for all new products.
The art of compliance is a craft much like that of a carpenter who learns to
work with various kinds of wood and designs. Ours is an industry wrought
with differences. While the regulations that govern FDA-regulated industries
are proscribed, how the regulations are interpreted and applied really
depends on experience and how well one has mastered the craft of compliance.
There are no proscribed procedures, but there are guideposts common
to all FDA-regulated industries, whether a firm manufactures medical
devices, pharmaceuticals, or biological products....
.PHARMACEUTICAL APPLICATIONS OF RAMAN SPECTROSCOPY
ˇ ˇ ´ SLOBODAN SASIC
Pﬁzer, Ltd., Sandwich, UK
WILEY-INTERSCIENCE A JOHN WILEY & SONS, INC., PUBLICATION
..PHARMACEUTICAL APPLICATIONS OF RAMAN SPECTROSCOPY
This chapter contains a comprehensive listing of research papers, reviews, book chapters and theses covering the subject of pharmaceutical film coating. Coating is a very extensive subject and so this bibliography is restricted to those publications of direct pharmaceutical relevance or authorship. Nonpharmaceutical polymer science or coating processes of other industries are not included. While the listing is extensive, it is by no means exhaustive. Indeed, the author would welcome notification of any missing articles in order that this work can be included in the next edition.
What is the deﬁnition of a formulation? Why is it needed? What is the importance of a formulation? These are some important questions that need to be addressed during the development of a potential drug product. The strict definition of the word is to specify a formula or to express a formula in systematic terms or concepts. The formula, in the current case, is a pharmaceutical dosage form. A formulation is needed to deliver the drug or the active pharmaceutical ingredient (API) to its targeted site. In order to overcome some of the physiochemical limitations of an API,...
Over the past 2 decades the implications of endocrine disruption and modula-
tion have permeated public consciousness, scienti fi c inquiry, regulatory frame-
works, and management decisions in the environmental and biomedical sciences.
This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing.
Pharmaceutical packaging technology structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
(BQ) Part 2 book "Textbook of organic medicinal and pharmaceutical chemistry" presents the following contents: Centralnervous system depressants, central dopaminergic signaling agents, anticonvulsants, central nervous system stimulants, adrenergic agents, drugs acting on the renal system,...
(BQ) Part 1 book "Textbook of organic medicinal and pharmaceutical chemistry" presents the following contents: Drug design strategies, metabolic changes of drugs and related organic compounds, biotechnology and drug discovery, immunobiologicals, anti infective agents, antibacterial antibiotics, antiviral agents,...
Over 25 years ago, Horvath and Melander, in their fundamental work , discussed the reason behind the explosive popularity of reversed-phase liquid chromatography (RPLC) for analytical separations. It was estimated that about 80–90% of all analytical separations were performed in RPLC mode, and the authors noted that “the variation of eluent composition alone extends both retention and selectivity in HPLC [high-performance liquid chromatography] over an extremely broad range.
This would appear to be a very good reason for painting anything (film coating is a painting process)
and while the penalty for coating tablets the wrong colour is unlikely to be so extreme, the Queen (FDA,
MCA, etc.) is likely to extract very costly and damaging retribution. No doubt ‘heads would roll’
metaphorically. So why are tablets coated? After all, it is a messy, complicated and expensive process.