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Basic Concepts

Pharmaceutical Basic

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Hasan Rahi
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0% found this document useful (0 votes)
24 views

Basic Concepts

Pharmaceutical Basic

Uploaded by

Hasan Rahi
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Basic concepts

Introduction of Pharmacopoeia
Pharmacopoeia:
Pharmacopoeia is a prescribed book where the origin of medicine, name, formulation,
structure, use, doses, and side effects are written and which is published by the authority of a
government or a medical or pharmaceutical society.
➢ Criteria of pharmacopoeia:
1. It is a textbook.
2. Prescribed by the organization WHO.
3. It has the synthetic formula of medicines.
4. Raw materials and process of manufacture.
5. The structural method of preparation.
6. Effects use side effects.
7. Upgraded every day.
➢ Evolution of pharmacopoeia:
Behind modern pharmacopeia, there is a great history. Several early pharmacopeia books were
written by Persian and Arab physicians. The evolution of pharmacopeia’s in small words is
given below:
British pharmacopoeia (Pharmacopoeia Britannica):
The first list of approved drugs, with information on how they should be prepared, was the
London pharmacopeia, published in 1618. The British pharmacopeia was published in 1864 on
behalf of the health ministers of the United Kingdom. Here certain drugs and preparations are
included.
Pharmaceutical codex:
The British Pharmaceutical Codex (BPC) was first published in 1907, to supplement the British
Pharmacopoeia which although extensive, did not cover all the medicinal items that a
pharmacist might require in daily work. It gave information on drugs and other pharmaceutical
substances not included in BP and provided standards for these.
German pharmacopeia:
German pharmacopeia was first published in 1872. It is the pharmacopeia of the German
empire containing analytical procedures of drugs and other identification information. The
German pharmaceutical codex which contains manufacturing instructions is not part of the
pharmacopeia and is not an official work. It is not well known because of its language.
United States Pharmacopoeia (American pharmacopoeia):
USP is a pharmacopeia published by the United States Pharmacopeial Convention. USP
establishes written (documentary) and physical (reference) standards for medicines, food
ingredients, dietary supplement products, etc.
Chinese pharmacopoeia:
Chinese pharmacopeia mainly deals with herbal and traditional medicines. Mainly biological
preparations, traditional identity is found on the pharmacopeia.
Indian pharmacopeia:
The First Indian pharmacopeia was published in 1955. A drug manufactured in India has to be
formulated using this pharmacopeia.
Bangladesh National Formulary:
It was published in 2017 by the directorate general of drug administration. This is the
pharmacopeia of Bangladesh.

➢ Positive and negative aspects of pharmacopeia:


Positive aspects of pharmacopeia:
1. Ensuring quality specifications for API, excipients, and dosage forms.
2. Proper functioning or regulatory control of medicines.
3. Guidance for manufacturers of medicines.
4. Provides standards for pharmaceutical substances and medicinal products.
5. Enriched information in a very small space.

Negative aspects of pharmacopeia:


1. Autocratic business system.
2. Rich countries dominate over poor countries to enter the pharmaceutical business.
3. Don’t let new medicine enter
4.Political competition.
5. Royalty.
6. Expensive (Not cost-effective).
7. Monopoly business.
Lipinski’s rule of five (RO5)
Lipinski’s rule of five (RO5) is a rule of thumb to evaluate drug-likeness or determine if a
chemical compound with a certain pharmacological or biological activity has chemical
properties and physical properties that would make it a likely orally active drug in humans. The
rule was formulated by Christopher A. Lipinski in 1997.
The rule describes molecular properties important for a drug's pharmacokinetics in the human
body, including their absorption, distribution, metabolism, and excretion ("ADME")
Lipinski's rule states that, in general, an orally active drug has no more than one violation of
the following criteria:
1. No more than 5 hydrogen bond donors.
2. No more than 10 hydrogen bond acceptors.
3. The molecular weight is preferably under 500 daltons.
4. An acetone-water or octanol-water partition co-efficient (logP) that does not exceed 5
The rule of five is so-called because most of the features start with the number 5 or a multiple
of 5.
In an attempt to improve the predictions of drug-likeness, the rules have spawned many
extensions, for example, the Ghose filter:
1. Molar refractivity from 40 to 130
2. Molecular weight from 180 to 480
3. Number of atoms from 20 to 70
4. Partition coefficient logP in -0.4 to + 5.6 range
Nomenclature of drugs
➢ International Nonproprietary Names (INN):
International Nonproprietary Names (INN) identify pharmaceutical substances or active
pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is
public property. A nonproprietary name is also known as a generic name. The INN system was
initiated in 1950 by a World Health Assembly resolution WHA3.11 and has been coordinated
by the World Health Organization (WHO) since 1953.
✓ Use of INN
o Nonproprietary names are intended for use in:
o Pharmacopeias
o Labeling
o Product information
o Advertising and other promotional activities
o Drug regulation
o Scientific literature
o A basis for product names (generics)
➢ Types of drug nomenclature
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. Drugs
have 3 types of names:
1. Chemical name:
The chemical names are the scientific names, based on the molecular structure of the drug.
For example, N-acetyl-para-aminophenol (acetaminophen) is the chemical name of
paracetamol.
2. Generic name:
The generic name is the common name of the drug which is the non-proprietary name given
by INN. Example: Paracetamol is the generic name of acetaminophen.
3. Trade name:
The pharmaceutical company gives the drug a trading name, which is a standard term in the
pharmaceutical industry for a brand name or trademark name.
Example: Paracetamol is available as a generic medication with trade names including Napa,
Tamen, Ace, etc.
Drug and medicine
Drug:
Drugs are any substances that act on the living body to alter the physical or physiological
process and are used for the prevention, diagnosis, and treatment of diseases.
Example: Toxin, vaccine, etc.
Medicine:
Active pharmaceutical ingredients (API) associated with excipients are called medicine. In
other words, medicine is any drug that has a definite form of dose and is therapeutically used
for the treatment of diseases of living subjects.
Example: Metronidazole, ranitidine.

Drug abuse:
Drug abuse is the habitual intake of illegal drugs which is harmful to the individual or others.
It is defined as the use of certain Active pharmaceutical ingredients (API) to create pleasurable
effects on the brain.
The drugs that are often abused are:
1. Opioids are used to treat pain.
2. Central nervous system (CNS) depressants like benzodiazepines are used to treat anxiety
and sleep disorders.
3. Stimulants such as amphetamine are used to treat narcolepsy (a sleep disorder).
By illegally overdosing on these drugs people get addicted.
The drug is abused in the following ways:
1. Drug overdose: A drug overdose is the ingestion or application of a drug or other substances
in quantities greater than are recommended.
2. Misuse: The use of the substance for a purpose not consistent with legal or medical
guidelines. It means inappropriate use of drugs.
3. Using the wrong apparatus

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