An Introduction to Pharmaceutical Sciences

Production, Chemistry, Techniques and Technology

Jiben Roy

• Publisher: Woodhead Publishing
• Year: 2011
• ISBN:
  9781908818041
• Topic: Medicine
• Subtopic: Pharmacology

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry.

• Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions
• Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes
• Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

1

Introduction

Learning objective

This introductory chapter provides students with a description of pharmaceutical science and its major components: pharmaceuticals and the pharmaceutical industry. There is a discussion of the gradual development of the industry, its multidisciplinary nature, its economics and technology, its impact on global health, and its ethical nature. Some pharmaceutical industries and their contributions to human life expectancy around the globe are briefly presented.

The mission of pharmaceutical science is to improve global health by discovering, developing, and producing quality medicines that are safe, appropriate, effective, affordable, and cost-effective, and widely distributing them around the world (Figure 1.1).

Figure 1.1 The mission of pharmaceutical science

Key concept terms

Absorption

movement of a drug from the site of entry into the blood circulation system

ACE inhibitor

angiotensin-converting enzyme

Administration

how a drug is taken

AIDS

Acquired Immune Deficiency Syndrome

API

active pharmaceutical ingredient

Apothecary

a pharmacist

Biopharmaceutical

biotechnology-based drugs, biologics

Blockbuster drug

a drug that has made more than US$1 billion/year

Bulk drug

API in bulk

Chronotherapy

administering a drug to work in coordination with a body’s biological clock

Distribution

the circulation of a drug in the body once absorbed

Dosage form

the physical form of a drug, such as tablet, capsule, ointment, and liquid injection

Elimination

removal of a drug from the body

Ethics

concepts of correct conduct

Excipient

non-active pharmaceutical ingredient

Formulated drug

dosage form of drugs made from APIs mixed with excipients

GMP

good manufacturing practice

HIV

Human Immunodeficiency Virus

IMS Health

Intercontinental Marketing Services, an information company

Injectable

intravenous or intramascular shot

Longevity

how long a person lives

Orange Guide

a book on GMP guidelines published by the Medicines and Healthcare Products Regulatory Agency

Parenteral

injectable

Pharmaceutical

synthetic chemical used as drugs

US FDA

US Food and Drug Administration

Pharmaceutical science is a multidisciplinary science combining many areas of the basic and applied sciences, such as chemistry, biochemistry, biology, mathematics, statistics, physics, medical sciences, and engineering.

1.1 The theme of the book

This book has been developed as a unified approach to topics ranging from bulk drugs to formulated medicines based on a course offered by the author as a special topic within the physical sciences at the Mississippi University for Women. The theme of the book is similar to the course theme: to explain what students should know about pharmaceuticals.

Staying in good health is important to most people, but many people become ill or have injuries at some time in their lives. Therefore, pharmaceuticals have a role in curing people or helping them return to good health. The importance of pharmaceuticals to the US population’s longevity cannot be understated.

Several books have been written on pharmaceutical topics, including pharmaceutical production, medicinal chemistry, drug design, dosage forms, pharmaceutical technology, quality assurance and control of pharmaceuticals, pharmaceutical research, and pharmaceutical marketing. These books are all specialized and very useful. This book is a little different as it is a biography of medicine. Beginning with the discovery of pharmaceutical applications, continuing through the manufacture of active pharmaceutical ingredients (APIs) and the preparation of various dosage forms, and finally marketing to patients, it explains pharmaceutical and medicinal ch...