EVOLUTION OF TRANSFORMING TECHNOLOGY: BY PIYUSH TRIPATHI

The art of the drug compounder Pharmacopoeia, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

HISTORY
• Arabic Book of Simple Drugs from Dioscorides’ De Materia Medica. Cumin & dill. c. 1334 By Kathleen Cohen in London's British Museum.
• Dioscorides, De Materia Medica, Byzantium, 15th century.
• Dioscorides De Materia Medica in Arabic, Spain, 12th-13th century.

Pharmacopoeia is considered to be the cradle of pharmacotherapy. Pedanius Dioscorides is famous for writing a five volume book in his native Greek (De Materia Medica - in the Latin translation) that is a precursor to all modern pharmacopoeias, and is one of the most influential herbal books in history. In fact it remained in use until about CE 1600.

Pharmacopoeia books were written by Persian physicians. These included The Canon of Medicine of Avicenna in 1025, and other pharmacopoeia books by Abu-Rayhan Biruni in the 11th century, Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century.

The term pharmacopoeia first appears as a distinct title in a work published at Basel in 1561 by Dr A. Foes, but does not appear to have come into general use until the beginning of the 17th century.

Over the years and century many revision and consideration from authorities, and regulatory act changed comities were formed. Finally, the first Edinburgh Pharmacopoeia was published in 1699 and the last in 1841; the first Dublin Pharmacopoeia in 1807 and the last in 1850.

The preparations contained in these three pharmacopoeias were not all uniform in strength, a source of much inconvenience and danger to the public, when powerful preparations such as dilute hydrocyanic acid were ordered in the one country and dispensed according to the national pharmacopoeia in another. As a result, the Medical Act of 1858 ordained that the General Medical Council should publish a book containing a list of medicines and compounds, to be called the British Pharmacopoeia, which would be a substitute throughout Great Britain and Ireland for the separate pharmacopoeias. Hitherto these had been published in Latin. The first British Pharmacopoeia was published in the English language in 1864, but gave such general dissatisfaction both to the medical profession and to chemists and druggists that the General Medical Council brought out a new and amended edition in 1867. This dissatisfaction was probably owing partly to the fact that the majority of the compilers of the work were not engaged in the practice of pharmacy, and therefore competent rather to decide upon the kind of preparations required than upon the method of their manufacture. The necessity for this element in the construction of a pharmacopoeia is now fully recognized in other countries, in most of which pharmaceutical chemists are represented on the committee for the preparation of the legally recognized manuals.

There are national and international pharmacopoeias, like the EU and the US pharmacopoeias. All the pharmacopoeias were issued under the authority of government, and their instructions have the force of law in their respective territories, except that of the United States, which was prepared by commissioners appointed by medical and pharmaceutical societies, and has no other authority, although generally accepted as the national textbook.

Increased facilities for travel have brought into greater prominence the importance of an approach to uniformity in the formulae of the more powerful remedies, in order to avoid danger to patients when a prescription is dispensed in a different country from that in which it was written. Nonetheless, some progress has been made under the banner of the ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use:www.ich.org), a tri-regional organisation that represents the drug regulatory authorities of the European Union, Japan and the United States. Representatives from the Pharmacopoeias of these three regions have met twice yearly since 1990 in the Pharmacopoeial Discussion Group to try to work towards "compendial harmonisation"’. Specific monographs are proposed, and if accepted, proceed through stages of review and consultation leading to adoption of a common monograph that provides a common set of tests and specifications for a specific material.

The rapid increase in medical and pharmaceutical knowledge renders necessary frequent new editions of the national pharmacopoeias, the office of which is to furnish definite formulae for preparations that have already come into extensive use in medical practice, so as to ensure uniformity of strength, and to give the characters and tests by which their purity and potency may be determined. each new edition requires several years to carry out numerous experiments for devising suitable formulae, so that the current Pharmacopoeia can never be quite up to date. This difficulty has hitherto been met by the publication of such nonofficial formularies as Squire's Companion to the Pharmacopoeia and Martindale: The complete drug reference (formerly Martindale's : The Extra Pharmacopoeia), in which all new remedies and their preparations, uses and doses are recorded, and in the former the varying strengths of the same preparations in the different pharmacopoeias are also compared (Squire's was incorporated into Martindal in 1952). The need of such works to supplement the Pharmacopoeia is shown by the fact that they are even more largely used than the Pharmacopoeia itself, the first issued in 18 editions and the second in 13 editions at comparatively short intervals. In the UK, the task of elaborating a new Pharmacopoeia is entrusted to a body of a purely medical character, and legally the pharmacist has not, contrary to the practice in other countries, a voice in the matter, notwithstanding the fact that, although the medical practitioner is naturally the best judge of the drug or preparations that will afford the best therapeutic result, he is not so competent as the pharmacist to say how that preparation can be produced in the most effective and satisfactory manner, nor how the purity of drugs can be tested.

Some difficulty has arisen since the passing of the Adulteration of Food and Drugs Act[citation needed] concerning the use of the Pharmacopoeia as a legal standard for the drugs and preparations contained in it. The Pharmacopoeia is defined in the preface as only "intended to afford to the members of the medical profession and those engaged in the preparation of medicines throughout the British Empire one uniform standard and guide whereby the nature and composition of, substances to be used in medicine may be ascertained and determined." It is obvious that it cannot be an encyclopaedia of substances used in medicine, and can only be used as a standard for the substances and preparations contained in it, and for no others. It has been held in the Divisional Courts (Dickins v. Randerson) that the Pharmacopoeia is a standard for official preparations asked for under their pharmacopoeial name. But there are many substances in the Pharmacopoeia which are not only employed in medicine, but have other uses, such as sulphur, gum benzoin, tragacanth, gum arabic, ammonium carbonate, beeswax, oil of turpentine, linseed oil, and for these a commercial standard of purity as distinct from a medicinal one is needed, since the preparations used in medicine should be of the highest possible degree of purity obtainable, and this standard would be too high and too expensive for ordinary purposes. The use of trade synonyms in the Pharmacopoeia, such as saltpetre for purified potassium nitrate, and milk of sulphur for precipitated sulphur, is partly answerable for this difficulty, and has proved to be a mistake, since it affords ground for legal prosecution if a chemist sells a drug of ordinary commercial purity for trade purposes, instead of the purified preparation which is official in the Pharmacopoeia for medicinal use. This would not be the case if the trade synonym were omitted. For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. This subject formed the basis of discussion at several meetings of the Pharmaceutical Society, and the results have been embodied in a work entitled Suggested Standards for Foods and Drugs, by C. G. Moor, which indicates the average degree of purity of many drugs and chemicals used in the arts, as well as the highest degree of purity obtainable in commerce of those used in medicine.

Another legal difficulty connected with modern pharmacopoeias is the inclusion in some of them of synthetic chemical remedies, the processes for preparing which have been patented, whilst the substances are sold under trade-mark names such as verona. The scientific chemical name is often long and unwieldy, and the physician prefers when writing a prescription to use the shorter name under which it is sold by the patentees. In this case the pharmacist is compelled to use the more expensive patented article and the patient complains of the price. If he uses the same article under its pharmacopoeial name when the patented article is prescribed s/he lays oneself open to prosecution by the patentee for infringement of patent rights. The only plan, therefore, is for the physician to use the chemical name (which cannot be patented) as given in the Pharmacopoeia, or for those synthetic remedies not included in the Pharmacopoeia, to use the scientific and chemical name given in the British Pharmaceutical Codex.

TRANSFORMATION

From new discoveries to developments, pharmacopoeia guides to technology, the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. Substances with medicinal properties, are considered pharmaceuticals. The field encompasses drug composition and properties, interactions, toxicology, therapy, and medical applications and antipathogenic capabilities. A variety of topics involved with pharmacology, including neuropharmacology, renal pharmacology, human metabolism, intracellular metabolism, and intracellular regulation. Pharmacology is not synonymous with pharmacy, which is the name used for a profession, though in common usage the two terms are confused at times. Pharmacology deals with how drugs interact within biological systems to affect function. It is the study of drugs, of the body's reaction to drugs, the sources of drugs, their nature, and their properties. In contrast, pharmacy is a medical science concerned with the safe and effective use of medicines.

An origin of clinical pharmacology is in middle Ages in Avicenna's The Canon of Medicine, Peter of Spain's Commentary on Isaac, and John of St Amand's Commentary on the Antedotary of Nicholas. Pharmacology as a scientific discipline did not further advance until the mid-19th century amid the great biomedical resurgence of that period. Before the second half of the nineteenth century, the remarkable potency and specificity of the actions of drugs such as morphine, quinine and digitalis were explained vaguely and with reference to extraordinary chemical powers and affinities to certain organs or tissues. The first pharmacology department was set up by Buchheim in 1847, in recognition of the need to understand how therapeutic drugs and poisons produced their effects.

In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements:

1. The drug must be found to be effective against the disease for which it is seeking approval.
2. The drug must meet safety criteria by being subject to extensive animal and controlled human testing.

Gaining FDA approval usually takes several years to attain. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a therapeutic effect or desired outcome.

The safety and effectiveness of prescription drugs in the U.S. is regulated by the federal Prescription Drug Marketing Act of 1987.

The Medicines and Healthcare products Regulatory Agency (MHRA) has a similar role in the UK.

Early pharmacologists focused on natural substances, mainly plant extracts. Pharmacology developed in the 19th century as a biomedical science that applied the principles of scientific experimentation to therapeutic contexts.

The genetic revolution has pushed to the forefront a concept that is at the very heart of pharmacology and therapeutics – the right drug for the right target in the right patient and delivered at the right dose. In some areas such as cancer treatments, examples of specific tumour mutations that dictate the response to drugs is a reality. This will influence the nature of future clinical trials. The bigger challenge lies in understanding whether the same will be true for common germline genetic variation (polymorphisms) in the general population. Will common genetic variation influence response to treatment? The complexity of turning this into a clinically meaningful risk score is such that attention has turned towards pharmaceuticals. Is drug failure due in individual patients due to genetic variation? Could drug safety be improved by taking into account individual genetic risk? Data on genetic variation influencing efficacy are sparse.
On another level, by taking reductionism and integrated approaches, genetics and molecular pharmacology are beginning to unravel the enigmatic problem of drug receptor heterogeneity. The future promises new generations of drugs that could selectively target one subtype in a family of similar proteins to the therapeutic advantage of the patient while limiting commonly accepted and often debilitating side effects.

Pharmacology as a chemical science is practiced by pharmacologists. Viz.:

• Clinical pharmacology - the medical field of medication effects on humans

Clinical pharmacology connects the gap between medical practice and laboratory science. The main objective is to promote the safety of prescription, maximize the drug effects and minimize the side effects. It is important that there be association with pharmacists skilled in areas of drug information, medication safety and other aspects of pharmacy practice related to clinical pharmacology.

Clinical pharmacologists have a rigorous medical and scientific training which enables them to evaluate evidence and produce new data through well designed studies. Clinical pharmacologists have access to enough outpatients for clinical care, teaching and education, and research as well be supervised by medical specialists. Their responsibilities to patients include, but are not limited to analyzing adverse drug effects, therapeutics, and toxicology including reproductive toxicology, cardiovascular risks, perioperative drug management and psychopharmacology.

• Neuro- and psychopharmacology (effects of medication on behavior and nervous system functioning),

Neuro is a study a wide range of substances with various types of psychoactive properties. The professional and commercial fields of pharmacology and psychopharmacology do not mainly focus on psychedelic or recreational drugs, as the majority of studies are conducted for the development, study, and use of drugs for the modification of behavior and the alleviation of symptoms, particularly in the treatment of mental disorders (psychiatric medication). While studies are conducted on all psychoactives by both fields, psychopharmacology focuses primarily on the psychoactive and chemical interactions with the brain.

Psychoactive drugs may originate from natural sources such as plants and animals, or from artificial sources such as chemical synthesis in the laboratory. These drugs interact with particular target sites or receptors found in the nervous system to induce widespread changes in physiological or psychological functions.

• Pharmacogenetics (clinical testing of genetic variation that gives rise to differing response to drugs)

The terms pharmacogenomics and pharmacogenetics tend to be used interchangeably, and a precise, consensus definition of either remains elusive. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing response to drugs, while pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.


• Pharmacogenomics (application of genomic technologies to new drug discovery and further characterization of older drugs)

Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. By doing so, pharmacogenomics aims to develop rational means to optimise drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches are advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.

Pharmacogenomics is the whole genome application of pharmacogenetics, which examines the single gene interactions with drugs.


• Pharmacoepidemiology (study of effects of drugs in large numbers of people)

Pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology can be called a bridge science spanning both pharmacology and epidemiology. Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs in humans. Part of the task of clinical pharmacology is to provide a risk benefit assessment for the effect of drugs in patients. Doing the studies needed to provide an estimate of the probability of beneficial effects in populations, or the probability of adverse effects in populations and other parameters relating to drug use may benefit from using epidemiological methodology. Pharmacoepidemiology then can also be defined as the application of epidemiological methods to pharmacological issues.

Pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop them for applications of such methodology unique to pharmacoepidemiology. There are also some areas that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring for unwanted effects and other safety-related aspects of drugs that are already on the market. In practice, pharmacovigilance refers almost exclusively to the spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions to a central agency. The central agency can then combine reports from many sources to produce a more informative safety profile for the drug product than could be done based on one or a few reports from one or a few health care professionals.

• Toxicology study of harmful effects of drugs
Study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people.

Theoretical pharmacology
Posology - how medicines are dosed

Pharmacognosy a branch of pharmacology dealing especially with the composition, use, and development of medicinal substances of biological origin and especially medicinal substances obtained from plants also known as deriving medicines from plants