Pharmaceutics

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Pharmaceutics
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1. Introduction to Drugs and Pharmacy

1. Heritage of pharmacy
2. Drug standards (????)
3. The Pharmacists contemporary role

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• A drug is defined as an agent intended for use
  in the diagnosis, mitigation, treatment, cure, or
  prevention of disease in humans or in other
  animals.
• ??????????????????????????????????

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• Emetic (induce vomiting???) and antiemetic
  (prevent vomiting???) drugs
• Diuretic drugs (increase the flow of urine???)

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• Expectorant drugs (increase respiratory tract
  fluid???)
• Cathartics or laxatives (evacuate the bowel??)
• Other drugs decrease the flow of urine, diminish
  body secretions, or induce constipation (??)

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• Drugs may be used to reduce pain, fever,
  thyroid(???) activity, rhinitis(??), insomnia
  (??), gastric acidity, motion sickness, blood
  pressure, and mental depression.
• Other drugs can elevate mood, blood pressure, or
  activity of the endocrine glands.

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• Drugs are used to treat
• common infections,
• AIDS,
• benign prostatic hyperplasia,
• cancer,
• cardiovascular disease,
• Asthma (??,??)
• Glaucoma (???), etc.

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Where do new drugs come from?

• New drugs may be derived from
• Plant
• Animal sources
• As byproducts of microbial growth
• Through chemical synthesis
• Molecular modification
• Biotechnology

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The process of drug discovery and development

• Complex
• Organic, physical, and analytical chemists
• Biochemists
• Molecular biologists
• Bacteriologists
• Physiologists(????)
• Pharmacologists

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• Toxicologists
• Hematologists(????)
• Immunologists
• Endocrinologists(?????)
• Pathologists(????)
• Biostatisticians
• Pharmaceutical scientists
• Clinical pharmacists
• Physicians
• Many others

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After a potential new drug substance is discovered

• 1) A great deal of biologic information must be
  gathered
• basic pharmacology
• toxicologic features
• ADME
• short term and long term effects of the drug on
  various body cells, tissues and organs

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• 2) The most effective routes of administration
  must be determined
• And Guidelines for dosages recommended for
• Persons of varying ages (e.g., neonates,
  children, adults, geriatrics)
• Weights
• States of illness
• have to be established.

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• 3) Formulation
• Active therapeutic ingredients
• Fillers
• Thickeners
• Solvents
• Suspending agents
• Tablet coatings
• Disintegrants
• Stabilizing agents
• Antimicrobial preservatives
• Flavors
• Colorants
• sweeteners

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• 4) Stability
• the principles of chemistry,
• physical pharmacy,
• microbiology,
• pharmaceutical technology must be applied.

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1. The Heritage of Pharmacy

• Early drugs
• ? Ebers papyrus, a continuous scroll (16th
  century)-???????
• ?The text of the Ebers papyrus is dominated by
  drug formulas, with more than 800 formulas or
  prescriptions being described and more than 700
  drugs mentioned.

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• The drugs are chiefly botanical, although
  mineral and animal drugs are also noted.
• Acacia (?????)
• Castor bean (???)
• Iron oxide
• Sodium carbonate
• Sodium chloride
• Sulfur
• Animal excrements (???)

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• The vehicles were
• Beer
• Wine
• Milk
• honey

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• Mortars
• Pestles (?)
• Hand mills
• Sieves
• Balances

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• 2) Introduction of the scientific viewpoint
• Hippocrates, a Greek physician, is credited with
  the introduction of scientific pharmacy and
  medicine.
• He rationalized medicine, systematized medical
  knowledge, and put the practice of medicine on a
  high ethical plane.

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• Dioscorides, a Greek physician and botanist, was
  the first to deal with botany as an applied
  science of pharmacy.
• Claudius Galen, a Greek pharmacist-physician,
  aimed to creat a perfect system of physiology,
  pathology, and treatment.

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• Paracelsus, a Swiss physician and chemist, he
  influenced the transformation of pharmacy from a
  profession based primarily on botanical science
  to one based on chemical science.

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• 3) Early research
• 1) Swede Karl Wilhelm Scheele (1742-1786)
• Lactic acid (??)
• Citric acid (???)
• Oxalic acid (??)
• Tartaric acid (???)
• Arsenic acid (??)
• Identified glycerin

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• Invented new methods of preparing calomel (??)and
  benzoic acid (????)
• Discovered oxygen

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• 2) Friedrich Serturner (1783-1841), German
  pharmacist
• Isolation of morphine from opium(??)
• 3) Joseph Caventou (1795-1877) and Joseph
  Pelletier (1788-1842)
• isolation quinine and cinchonine (?????) from
  cinchona and strychnine (???) and brucine (????)
  from nux vomica.

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2. Drug standards

• The united states pharmacopeia (??) and the
  national formulary (??????)
• Pharmakon, meaning drug poiein, meaning
  make
• The combination indicates any recipe or formula
  or other standards required to make or prepare a
  drug.
• Organized sets of monographs or books of these
  standards are called pharmacopeias or formularies.

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• In 1778, the first American Pharmacopeia (Lititz
  Pharmacopeia) was published.
• 32-page booklet containing information on 84
  internal and 16 external drugs and preparations.
• In 1808, Massachusetts pharmacopeia
• 272 page, 536 drugs and pharmaceutical
  preparations

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• In 1820, the first USP was published.
• In 1900, issue supplements to the USP
• In 1940, it was decided to revise the USP every 5
  years

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• In 1888, National Formulary of Unofficial
  Preparations was published.
• The formulary containing many of the popular
  drugs and formulas denied admission to the USP.
• In 1906, the title was changed to National
  Formulary (NF)
• Both USP and NF as establishing legal standards
  for medicinal and pharmaceutical substances.

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• In 1980, the first combined compendium (??,??),
  comprising the USP XX and NF XV became official.
• In 1995, the USP 23-National Formulary 18 was the
  first edition to drop the use of roman numerals
  in favor of arabic numerals.

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• In 2002, the USP-NF became an annual publication
  with USP 25-NF 20
• The 2003 edition, USP 26-NF 21, contains
  approximately 4000 drug monographs.
• The newest edition 2010, USP 33- NF 28

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• USP and NF adopt standards for
• drug substances
• pharmaceutic ingredients
• dosage forms
• reflecting the best in the current practices of
  medicine and pharmacy
• provide suitable tests and assay procedures for
  demonstrating compliance with these standards.

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• Standards Set Forth in FDA-Approved New-drug
  applications
• FDA???????????????

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• International Organization for standardization
  (ISO)
• is an international consortium of representative
  bodies constituted to develop and promote uniform
  or harmonized international standards.
• ???????????????????,????????????????????????
• ISO 9000-ISO9004 used in the pharmaceutical
  industry

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• ISO included standards pertaining to development,
  production, quality assurance, quality control,
  detection of defective products, quality
  management, and other issues as product safety
  and liability.
• ISO ??????????????????????????????????????????????
  ????
• Internationally recognized quality-management
  system.

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Drug Regulation and Control

• The federal food, drug, and cosmetic act (??)of
  1938
• Comprehensive drug abuse prevention and control
  act of 1970
• Drug listing act(?????????)
• of 1972
• Drug price competition and patent term
  restoration act(?????????????) of 1984
• Drug product recall

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Drug Regulation and Control

• Prescription Drug Marketing Act(??????) of 1987
• Dietary Supplement Health and Education
  Act(??????????? )of 1994
• The FDA and the Food and Drug Administration
  Modernization ActFDA?????????????) of 1997
• Code of Federal Regulations and Federal
  Register(???????????? )
• Drug product recall

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????

• 1)?? (pharmacopoeia)??????????????????????????????
  ?,????????,?????????
• ?????????
• 1949?,??????? ?????????,??????

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• 1953??,??????531?
• 1957?????????1953???????
• 1963??????????1963??,???????,??????1310??

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• ????1977??,?1980?1? 1?????
• ???????1925?
• ???????????1152?
• ????773?,??????????????????????????????????

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• ????? 1985??,?????????????????????
• ??????????????????????????????????????????????????
  
• ????1990??, 1991?7?1???????
• ???????1751?
• ?????????????????????784?

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• ????????????????????????????967?
• ?????????? 1990??????

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• ????1995???1996?4?1???????
• ???????2375?,???920?,???1455?
• ????????????????????????????
• 1995?????????????,?????????,????????????
• ?????????????????,??????????????????

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• ????2000??,
• ???????2691?,???992?,???1699?
• ??????????????????
• ???????????????????????
• ?????????
• ???????????
• ???????????????
• ???????????????

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• ????2005?
• 2005. 7. 1 ??

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• 2)??????
• ???????????????????,??????????????????,??????
  ???????
• ???????????????????,?????????
• ??????????????????????????????????????
• ?????????????????????

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????????

• ???????????????????????????,?????????????
• ????(Over The Counter,??OTC)??????????????????????
  ??,??????????????????

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??? GMP?GLP?GCP

• GMP (Good Manufacturing Practice) ??????????
• GLP (Good Laboratory Practice)
• ?????????????
• GCP (Good Clinical Practice)
• ??????????

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GMP?????

• ?
• ????
• ??????????

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GMP?????
1?????????????
2??????????????? ?????
3??????????????
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GLP
?????????????,?????????????????,???,??????,??
??,??,??,???????????????????????,?????????????
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GLP?????

• ???????????? ?????
• ?

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GCP

• ?????????????(?????????)??????????,???????????????
  ??????

• ??GCP?????????????,??????,???????????????

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GCP?????

• ?

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??????

•          ???(Pharmaceutics)??????????????????????
  ??????????????

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????

• 1.??????????????
• 2.????????????????????????????????
• 3.??????????????

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????
?????????????????????,??????,????(Dosag
e form)?

• 1. ??

???????????????????????????????
??????????????????????????,??????,????(Prep
erations)?
2. ????
? ????????????? ? ??????????????
3. ????
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????

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????

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  ????????????????,?????????????????

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?????

• ? ??????????

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??? ????????

• ?????
• ?????
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?????
?????(industrial pharmaceutics)???????,???????????
??????????????????
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?????

• ????
• ??????????????????????????????
• ??
• ????????????????????????

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?????

• ?????(physical pharmaceutics)?????????????,???????
  ??????????????????????????????
• ?????????????????????????????????????????????????
  ???????????????????? ?????

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????????

• ????????(polymers in pharmaceutics)???????????????
  ??????????????????????????????????????

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?????

• ?????(biopharmaceutics)??????????????????????????,
  ??????????????????????????????????????????????????
  ??????????????

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?????

• ?????(pharmacokinetics)????????,??????????????????
  ???????????????,????????????????(???)?????????????
  ????????????????????????

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?????

• ?????(clinical pharmaceutics)???????,?????????????
  ??????????????,??(???)????????????????????????????
  ????
• ??????????????????????????????????????????????
  ???????????????????????????
• ?????????????????????????,??????????

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??? ?????DDS

• ??????????
• ?????????,???????????

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?????????

• ????????????????,?????????????????????????????????
  ???????????

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????????

• 1. ?????????????
• 2. ?????????????
• 3. ?????????????
• 4. ???????????
• 5. ????????

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?????????(DDS)

• ??????(drug delivery system,DDS)
• ???????
• ????(??????)
• ??????
• ??????
• ???????
• ??????
• ??????
• ??????

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3. The Pharmacists contemporary role

• Community pharmacies
• Patient-care institutions
• Managed care
• Home health care
• Military and government service
• Academic settings
• Professional associations
• Pharmaceutical research and manufacturing industry

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Community pharmacy

• Pharmacist plays an active role in
• the patients use of prescription and
  nonprescription medication,
• diagnostic agents,
• durable medical equipment and devices,
• other health-related products.

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Hospitals, clinics

• Pharmacists
• 1) Manage drug distribution and control systems
• 2) Provide a variety of clinical services as
• drug utilization reviews,
• drug use evaluations,

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• therapeutic drug monitoring,(???????)
• intravenous admixture programs(????????)
• pharmacokinetic consult service,
• investigational drug supplies,
• poison control,
• drug information.

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Pharmaceutical Industry
Pharmacist
Drug discovery, Drug analysis and quality
control, Product development and
production, Clinical studies and drug
evaluation, Labeling and drug literature, Marketin
g and sales, Management.
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• In government service, pharmacists perform
  professional and administrative functions
• in the development and implementation of
  pharmaceutical care delivery programs(???????? )
• in the design and enforcement of regulations
  involving drug distribution and drug quality
  standards.

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Government service
Military service, Public Health Service, Food
and Drug Administration, Veterans Administration
(??????), Department of Health and Human
Services, Drug Enforcement Administration(????),
National Institutes of Health
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State and local level
Health department, Family and childrens
services, Drug investigation and regulatory
control, Clinics, other health-care institutions.
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New positions
Pharmacy benefits managers(??????), Disease
management specialists(?????? ), Drug formulary
managers, Therapeutic outcomes researchers, Drug
utlization review specialists, etc.
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The mission of Pharmacy

• The mission of pharmacy is to serve society as
  the profession responsible for the appropriate
  use of medications, devices, and services to
  achieve optimal therapeutic outcomes.
• ??????????,????????????????????????????

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Definition of Pharmaceutical care

• Pharmaceutical care is that component of pharmacy
  practice which entails the direct interaction of
  the pharmacist with the patient for the purpose
  of caring for that patients drug-related needs.
• ??????????????,???????????,??????????????

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• The mission of the pharmacist is to provide
  pharmaceutical care. Pharmaceutical care is the
  direct, responsible provision of
  medication-related care for the purpose of
  achieving definite outcomes that improve a
  patients quality of life.
• ?????????????????????????????????????,????????????
  ????????

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• The successful pharmacy graduate must be
• A problem solver, capable of adapting to changes
  in health care
• Able to achieve health outcomes through effective
  medication use that are valued by the health care
  system
• Able to collaborate with and be a resource to
  physicians, nurses, and other health care team
  members,
• A committed life-long learner

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• Pharmacy Practice Standards
• The Omnibus Budget Reconsiliation Act
• ???????)of 1990
• Code of Ethics for Pharmacists of the
• American Pharmaceutical Association
• Code of Ethics of the American
• Association of Pharmaceutical
• Scientists

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Questions

• 1.What is pharmaceutics? How many branches of
  pharmaceutics ?
• 2. What is a drug? Give some examples
• 3. Where do new drugs come from? Give examples.
• 4. Explain drug standards, pharmacopeia, ISO
• 5. How do you understand your role as a clinical
  pharmacist?