Pharmacopoeia - WikiHQ

thumb|The 1699 [[Edinburgh Pharmacopoeia]]

A pharmacopoeia, pharmacopeia, or pharmacopoea (or the typographically obsolete rendering, pharmacopœia), meaning "drug-making", in its modern technical sense, is a reference work containing directions for the identification of compound medicines. These are published or sanctioned by a government or a medical or pharmaceutical society, giving the work legal authority within a specified jurisdiction. In a broader sense it is a collection of pharmaceutical drug specifications. Descriptions of the individual preparations are called monographs.

There are national, supranational, and international pharmacopoeias.

Etymology

The term derives from "making of (healing) medicine, drug-making", a compound of "medicine, drug, poison" (), with the verb "to make" (), and the abstract noun suffix -ία -ia.

In early modern editions of Latin texts, the Greek diphthong οι (oi) is latinized to its Latin equivalent oe which is in turn written with the ligature œ, giving the spelling pharmacopœia; in modern British English, œ is written as oe, giving the spelling pharmacopoeia, while in American English oe becomes e, resulting in pharmacopeia. The plural form is pharmacopoeiae, pharmacopoeias, or pharmacopeias.

Early history

Although older writings exist which deal with herbal medicine, the major initial work in the field is considered to be the Edwin Smith Papyrus in Egypt, Pliny's pharmacopoeia.

A number of early pharmacopoeia books were written by Persian and Arab physicians. These included The Canon of Medicine of Avicenna in 1025 AD, and works by Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century. The Shen-nung pen ts'ao ching (Divine Husbandman's Materia Medica) is the earliest known Chinese pharmacopoeia. The text describes 365 medicines derived from plants, animals, and minerals; according to legend it was written by the Chinese god Shennong. One of the earliest surviving pharmacopoeias from medieval Europe is the Lorsch Pharmacopoeia, which dates to around 800, and draws on classical and post-classical sources.

Pharmacopeial synopsis were recorded in the Timbuktu manuscripts of Mali.

China

The earliest extant Chinese pharmacopoeia, the Shennong Ben Cao Jing was compiled between 200–250 AD. It contains descriptions of 365 medications.

The earliest known officially sponsored pharmacopoeia was compiled in 659 AD by a team of 23 pharmaceutical scientists led by Su jing during the Tang dynasty (618–907 AD) and was called the Xinxiu bencao (Newly Revised Canon of Material Medical). The work consists of 20 volumes with one dedicated to the table of contents, and 25 volumes of pictures with one volume dedicated to the table of contents. A third part consisting of seven volumes contained illustrated descriptions. The text contains descriptions of 850 medicines with 114 new ones. The work was used throughout China for the next 400 years.

City pharmacopoeias

A dated work appeared in Nuremberg in 1542; a passing student Valerius Cordus showed a collection of medical prescriptions, which he had selected from the writings of the most eminent medical authorities, to the physicians of the town, who urged him to print it for the benefit of the apothecaries, and obtained the sanction of the senatus for his work. A work known as the Antidotarium Florentinum, was published under the authority of the college of medicine of Florence

thumb|Engraved frontispiece of the 1703 Pharmacopoeia Bateana

The term Pharmacopoeia first appears as a distinct title in a work published at Basel, Switzerland, in 1561 by A. Foes, but does not appear to have come into general use until the beginning of the 17th century. Michel De Villeneuve (Michael Servetus) also published a pharmacopoeia. De Villeneuve, fellow student of Vesalius and the best galenist of Paris according to Johann Winter von Andernach, published the anonymous "Dispensarium or Enquiridion" in 1543, at Lyon, France, with Jean Frellon as editor. This work contains 224 original recipes by De Villeneuve and others by Lespleigney and Chappuis. As usual when it comes to pharmacopoeias, this work was complementary to a previous Materia Medica that De Villeneuve published that same year. This finding was communicated by the same scholar in the International Society for the History of Medicine, with agreement of John M. Riddle, one of the foremost experts on Materia Medica-Dioscorides works.

Nicolaes Tulp, mayor of Amsterdam and respected surgeon general, gathered all of his doctor and chemist friends together and they wrote the first pharmacopoeia of Amsterdam named Pharmacopoea Amstelredamensis in 1636. This was a combined effort to improve public health after an outbreak of the bubonic plague, and also to limit the number of quack apothecary shops in Amsterdam.

London, Edinburgh, Dublin

Until 1617, such drugs and medicines as were in common use were sold in England by the apothecaries and grocers. In that year the apothecaries obtained a separate charter, and it was enacted that no grocer should keep an apothecary's shop. The preparation of physicians' prescriptions was thus confined to the apothecaries, upon whom pressure was brought to bear to make them dispense accurately, by the issue of a pharmacopoeia in May 1618 by the College of Physicians, and by the power which the wardens of the apothecaries received in common with the censors of the College of Physicians of examining the shops of apothecaries within of London and destroying all the compounds which they found unfaithfully prepared. This, the first authorized London Pharmacopoeia, was selected chiefly from the works of Mezue and Nicolaus de Salerno, but it was found to be so full of errors that the whole edition was cancelled, and a fresh edition was published in the following December.

Emergence in Britain and Ireland

The preparations contained in the three city pharmacopoeias of Britain and Irelandpublished by the Colleges of Physicians of Edinburgh, London, and Dublinin use from the 17th to the mid-19th century, were not all uniform in strength. This was 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 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 not competent to decide upon the kind of preparations required for 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. In the U.S. when there is an applicable USP-NF quality monograph, drugs and drug ingredients must conform to the compendial requirements (such as for strength, quality or purity) or be deemed adulterated or misbranded under the Federal food and drug laws.

Supranational and international harmonization

Internationalization attempts

Attempts have been made by international pharmaceutical and medical conferences to settle a basis on which a globally international pharmacopoeia could be prepared, 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.

International pharmaceutical congresses (1864–1902)

The first international pharmaceutical congress was held in Strasbourg in 1867, and emitted the wish that an international pharmacopoeia be compiled.

Brussels Agreements (1902–1951)

The Conference for the Unification of the Formulae of Potent Medicaments was held in Brussels in 1902. It was also the 10th pharmacists' congress. It resulted in the 1902 Agreement for the Unification of the Formulae of Potent Medicaments (First pharmacopoeia agreement) although "it took four years of textual adjustments before the Agreement could enter into force as a multilateral treaty in 19 (mostly European) countries, in December 1906"

A second conference met in Brussels' Academy Palace in 1925, resulting in a revised international agreement, the Second Pharmacopoeia Agreement (1925).

WHO International Pharmacopoeia (1951–present)

The World Health Organization discontinued and replaced the 1925 Brussels Agreement with the International Pharmacopoeia (Ph.Int.), edited since 1951.