Pharm Chem 11

Pharmacopoeia
&
Formulary
Prepared by: N.M. Hinaut, RPh

Pharmaceutical Inorganic Chemistry

 Pharm Chem 11

At the end of the lecture, students are

expected to:

 demonstrate knowledge on the description and

the content of a Pharmacopoeia and Drug
Formulary
 identify various forms and learn its
importance
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TOPIC OUTLINE
 Types of Pharmaceutical Reference Books
Pharmacopoeia National Formulary
 definition  definition
 history  history
 Forms  Forms
 content  content
 importance  importance
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What is a
Pharmacopoeia?

Pharmaceutical Inorganic Chemistry

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Pharmacopoeia
 comes from the Greek word “pharmakon” meaning
drug and “poieo” meaning make
 the combination means any formula or standards
required to make a drug.

 a book containing collection of monographs,

directions for the identification of sample and the
preparation of compound medicines and published
by the authority of a government or a medical or a
pharmaceutical society

Pharmaceutical Inorganic Chemistry

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Pharmacopoeia
 An official book of standards for drugs prepared
by any country or regulatory body to specify the
standards of identity, purity and strength for the
drugs imported, manufactured or distributed
throughout the country or a specific region.
 legally recognized compendium of standards for
drugs
 revised periodically

Pharmaceutical Inorganic Chemistry

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Brief history of Pharmacopoeia

1617
Until 1617 such drugs 1618
and medicines as were 1858
in common use were To stop the
sold in England by the inappropriate Medical Act of 1858 ordained
apothecaries and dispensing the issue of that the General Medical
grocers. a Pharmacopoeia in Council should publish a book
May 1618 by the containing a list of medicines
and compounds, to be called
College of Physicians, the British Pharmacopoeia,
London which would be a substitute
throughout Great Britain and
Ireland for the separate
pharmacopoeias.

Pharmaceutical Inorganic Chemistry

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Pharmacopoeia
 Various versions:
a. USP
b. Indian Pharmacopeia
c. Europe Pharmacopeia
d. USSRP
e. PP 1

Pharmaceutical Inorganic Chemistry

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International Pharmacopoeia
To achieve a
global/international
Issued by World uniformity of quality
Health specifications and
Organization as a standardization for all
pharmaceutical products,
recommendation excipients and dosage
forms

The content prioritizes

medicines that are widely first volume was
used throughout the world, produced or
especially those important
to WHO health programs released in 1951 in
and may not appear in any multilanguages
other pharmacopoeias

Pharmaceutical Inorganic Chemistry

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What is the importance

of Pharmacopeia?
 sets standards and required quality indices for medicaments, raw materials
and preparations employed in the manufacture of drugs ( official book of
standards)
 maintain the uniformity and control the standards of the drugs available in
market and avoid adultered drugs
 useful in determining if pharmaceutical compounds and drug preparations
even assays and identification and limit tests, reagents and solutions,
indicators used are official or unofficial as per standard
 serves as a comprehensive and complete reference of information of drugs
and their dosage forms for practicing pharmacist and even physicians aiming
to provide unbiased concise report on the actions and uses
 provide historical record of pharmacy practice, drug use and drug
availability
 Reference for laboratory, industry and academic institutions.

Pharmaceutical Inorganic Chemistry

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FORMULARY
- most basic level,
British a formulary is a list
Pharmaceutical of medicines
Codex (BPC)
British - was first published

Pharmaco in 1907,
supplement the BP
to

poeia (BP) which although

extensive, did not
(1858) cover all the
medicinal items that
a pharmacist might
require in daily
work.
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British Pharmacopoeia British Pharmaceutical

Codex
 1st pharmacopoeia published
by General Medicine  prepared as a reference book
Commission/ General to physicians and dispensing
pharmacists in 1907 as per the
Medical Council and was Council of Pharmaceutical
later done by Pharmaceutical Society.
Commission.  the decision of medicine
 the source of official commission stated that there
standards of drugs in UK and should be only one book of
standards of medicine, so BPC
other parts of the world were was discontinued.
published.  Later BPC was published as
“The Pharmaceutical Codex”
and plans to be encyclopedia.
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The BPC differs from BP in:

• BPC contains more drugs and preparations.

• It contains additional information on standard of drugs,
surgical dressing, pharmaceutical preparations, etc
• It provides action and uses of drugs.
• It contains formula and preparation methods of some
other formulations.
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What is a
FORMULARY?

Pharmaceutical Inorganic Chemistry

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FORMULARY
contained a - main function of a
- the development is
collection of formulary is to based on evaluations of
formulas for the specify particular efficacy, safety, and
compounding and medications that are cost-effectiveness of
testing of approved to be drugs.
medication prescribed at a - developed by
particular hospital, committees consisting
a resource closer to in a particular health of physicians, nurse
what would be system, or under a practitioners, public
referred to as a health experts and
particular health pharmacists.
pharmacopoeia insurance policy
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TYPES OF FORMULARY
State DRUG Hospital
Formulary Formulary

– published by - published by
some state / some large
governments hospitals

-
- SUMC NF
- British NF
- PGH NF
- Philippine NF
- Chonghua NF
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Types of Drugs found in the Formulary

Drugs used at
Primary Level of care

Drugs used at
Secondary Level of
care

Drugs used at
Tertiary Level of care
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Generic medications in the formulary

• Preferred brand name medications

Tier 1

• Other brand name medications

Tier 2

• Specialty medications
Tier 3

• Drugs require close monitoring for

Tier 4 safety and efficacy
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NF (National Formulary)
 a book of standards for reference of
certain pharmaceuticals and
preparations NOT included in the
USP
 contains a list of medicines that are
approved for prescription throughout
the country, indicating which
products are interchangeable

 includes key information on the

composition, description, selection,
prescribing, dispensing and
administration of medicines.

 those drugs considered less suitable

for prescribing are clearly identified
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National Formulary
1st National Formulary of US was published
in 1888 by American Pharmaceutical
Association.

revised regularly by the same

committee who developed it

recognized also by FDA

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WMF Reflects evidence-based recommendations

of WHO and other reputable clinical
guidelines

Validated using current, reputable drug

information resources & WHO documents
Design and organization is modeled on the
successful and widely used British National
Formulary (BNF)

Produced in collaboration between –BNF

editorial team, Royal Pharmaceutical
Society of Great Britain and –The
Essential Medicine Department of WHO
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WMF Purpose:
To promote safe and cost-effective use of
medicines included in the WHO Essential
Medicines List

a resource and model for

developing national and
institutional formularies

a high quality, independent drug information

resource during the review of existing
formularies an essential medicines/ clinical
guideline resource for individual prescribers
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DRUG
Pharma Formu COMPEN
copoeia laries DIA

 USP-NF represents 25th revision of USP & 20th revision of NF

official in 2002.
 NF covers over 3800 monographs for excipients and dietary
supplements.
 USP contains over 3400 monographs for drug substances
and products, together with over 160 general chapters that
describe specific procedures to support monograph tests
and other information as well.
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USP-NF
 recognized as the official compendia and are used as
reference books for determining the strength, quality,
purity, packaging and labeling of drugs and other related
articles.

 focuses on things like drug substances, drug dosages, to

compounded preparations which can also be found in
USP but more focused on excipients given that the USP-
NF itself plays a very important role as a reference for
the Federal Food, Drug, and Cosmetic Act

 mainly includes specific matters consisting of a variety

or series of tests, various procedures for particular
tests, and acceptance criteria.
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USP-NF
 equipped with various
information about the name of
the substance or composition of
the drug substance, its
definition, packaging, storage, to
labeling requirements.

 All pharmaceutical products

(medicines), whatever they are,
if it meets USP-NF requirements,
it is already confirmed that the
level of quality, purity, and
strength are guaranteed in
accordance with the health
standards.
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TYPES OF COMPENDIA
the compilation of NON-
OFFICIAL drugs and other the books other than
substances OFFICIAL
official drug
recognized as legal compendia which are
standards of purity, used as secondary
quality and strength reference sources for
by government drugs and other
agency of respective related substances
countries
British Pharmacopoeia
(BP)
British Pharmaceutical Merck Index
Codex (BPC)
United States
Martindale (The
Pharmacopoeia (USP) extra
Indian Pharmacopoeia Pharmacopoeia)
(IP) Japanese
pharmacopoeia (JP)
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3 main parts of Pharmacopoeia

• Introduction including general
1 notices

• Monographs of the official

2 drugs and compounds

• Appendices
3
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1st section: Introduction including general notices

it is a useful pointer to pharmaceutical progress
since the last edition
it summarizes the different changes including
additions / deletions in the current edition
compared to the last edition
paying attention to this section is very important
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2nd section: Monograph of the official drugs

 include general requirements of general application and all preparations

 and the opening statement of this section of an individual drug product is

the term of the API ( Active Pharmaceutical Ingredient) which comply the
the Pharmacopoeial requirements

 A collection of detailed descriptions/ information of pharmaceutical

preparations or a reference work for pharmaceutical drug specifications
such as its dosage forms ansd method of analysis

 Contains: name/title, chemical formula, atomic and molecular weight,

definition, statement of content, category, dose, usual strength,
description, solubility, identification test, assay, other test, limit of
impurities, quantities and condition for storage, others such as solubility,
loss on drying, sulphated ash and pH

Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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Pharmaceutical Inorganic Chemistry

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3rd section: Appendix / Appendices

 includes standards of
apparatus, reagents and
solutions, indicators,
reference substances, test
animals, calculation of
results, other chemical
techniques , processes,
etc.. of the concerned
pharmaceuticals and
Acronyms, Abbreviations
and Initialisms
Pharmaceutical Inorganic Chemistry
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Pharmaceutical Inorganic Chemistry