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Dosage Forms: INTRODUCTION

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Dosage Forms: INTRODUCTION Powered By Docstoc
					Chapter 1

   Introduction to
        Drugs
   and Pharmacy
      PHARMACY
“The Right Choice for a Promising
            Future”
                 Pharmacy
The word ‘Pharmacy’ is derived
from the Greek work
‘Pharmakon’, meaning drug.

The word ‘Pharmacy’ has
two meanings :

     General sense – it is a
place or shop where drugs or
medicines are sold.

     Professional sense – it
is the profession, the members
of which deal with drugs.
                 Pharmacy

# Pharmacy is the art and science of preparing and
     dispensing medications and the provision of
      drug and related information to the public.
                          Or
 #   Pharmacy is the study of the science of drugs-
             Where they come from?
           How they act on the body?
         How to turn drugs into medicines?
             Pharmacist
 A pharmacist is one who is educated and
  licensed to prepare and dispense drugs and
  to provide drug and related information to
          the public-An expert on drugs.
              “I am a Pharmacist
       I am a specialist in medications
  I am a custodian of medical information
     I am a companion of the physician
        I am a counselor to the patient
       I am a guardian of public health
               This is my calling
               This is my pride.”
Dosage Forms
also known as “Pharmaceuticals”. It
is defined as a preparation devised to
make possible the administration of
medications in measured or prescribed
amount.
Definition Of Terms

Drug
      is any agent
intended for use in the
diagnosis,mitigation,
treatment, cure,
prevention of disease
of man or in animal as
well.
Drug & Medicine
►A   drug is any substance that
  acts on the living body to alter
  the physiological process and
  are used for the prevention,
  diagnosis and treatment of
  diseases.

►A   medicine is any drug which
  has a definite form & dose and
  are therapeutically used for
  the treatment of diseases of
  living subjects.
Pharmaceutical Preparations are the forms in which
drugs are prepared by the pharmacist for administration in the
treatment of the sick.

Dosage is the giving of medicine or other therapeutic agent in
prescribed amount.

Shelf - life refers to the length of time that a drug produced
may remain on the pharmacist shelf in the original packages and
under usual environmental conditions and retain an acceptable
level of its potency and overall quality.

Stability refers to the maintenance of the original physical,
chemical and therapeutic properties over extended period of time
or until the expiry date assigned.
DRUGS
  = stimulates the cardiac muscle, CNS, GIT
  = some have the opposite effects
  = render blood more coagulable or less coagulable
  = increase the hemoglobin content of the
         erythrocytes
  = reduce serum cholesterol, or expand blood
        volume
  = can be used to reduce pain, fever, thyroid activity,
        rhinitis, insomnia, gastric acidity, motion
        sickness, blood pressure and mental
        depression.
DRUGS
  =   can combat infectious disease, destroy intestinal
         worms, or act as antidotes against the
         poisoning effects of other drugs
  = can assists in smoking cessation or alcohol
         withdrawal or can modify obsessive
         compulsive disorders.
  = used to treat common infections, benign prostatic
        hyperplasia, cancer, cardiovascular disease,
        asthma, glaucoma, Alzheimer’s disease, male
        impotence.
  = to diagnose diabetes, liver malfunction, tuberculosis,
          or pregnancy and others
DRUGS
        = can prevent pregnancy, assists fertility, and sustain
            life itself.
        = can replenish a body deficient in antibodies, vitamins,
          hormones, electrolytes, protein, enzymes, or blood.
Examples:
        Mydriatic = dilate the pupil of the eye
        Miotics = constrict or diminish pupillary size
        Emetics= induce vomiting
        Diuretic = increase the flow of urine
        Antiemetic = prevents vomiting
        Expectorant = increase respiratory tract fluid
        Cathartic/Laxative = evacuate bowel
Note: other drugs decrease the flow of urine, diminish body
        secretions, or induce constipation
SOURCES OF NEW DRUGS
1. Naturally occurring materials in both plants and animals
  Examples: Ergot, Opium, Curare, Cinchona
2. Synthesis of organic compounds whose structure are
   closely related to those naturally occurring compounds
  Examples: Morphine, Atropine, Cortisone, Cocaine
3. Pure synthesis in which no attempt has been made to
   pattern after a known naturally occurring compounds
   exhibiting some activity
  Examples: Antihistamines, Barbiturates, Diuretics,
  Antiseptics
New Drug May Be Derived From
1. Plant or animal source
2. By products of microbial growth
3. Through chemical synthesis
4. Molecular modification
5. Biotechnology
Process of drug discovery and
development is complex Include:

1. Organic                     8. Toxicologists
2. Physical and analytical chemist 9. Hematologists
3. Biochemist                 10. Immunologists
4. Molecular biologists       11. Endocrinologists
5. Bacteriologists            12. Pathologists
6. Physiologists              13. Biostatisticians
7. Pharmacologists            14. Clinical
                                   pharmacists/others
The most effective routes of administration must be
determined
       1. Oral                2. Rectal      3. Parenteral
and guidelines for the dosage recommend for persons of
varying ages
       1. Neonates    2. Children     3. Adult/geriatrics
weights, and states of illness have to be established


To facilitate administration of the drug by the selected routes,
appropriate dosage forms, such as
       1. Tablets     2. Ointments 3. Suppositories/others
are formulated and prepared
Each particular product is a formulation unique
unto itself
      1. Active ingredients
      2. Non therapeutic or pharmaceutical
           ingredients



Pharmaceutical Ingredients: fillers,
thickeners, solvents, suspending agents, tablet
coatings and disintegrants, stabilizers flavors,
colorants, preservatives and others
THE HERITAGE OF PHARMACY
The First Apothecary
     - priestcraft
     - pharmakon - connotes charm, drugs that can
           be used for good and evil

Apothecary’s Failure
1. Due to impotent or inappropriate
2. Underdosage
3. Overdosage
4. Poisoning
Apothecary’s Success
1. Attribute to experience
2. Mere coincidence of appropriate
    drug selection
3. Natural healing
4. Inconsequential effect of the drug,
     or “placebo effects”
Early Drugs
    Ebers papyrus - a continuous scroll some 60 feet
           long and foot wide dating to the 16th century.
    - 800 formulas or prescriptions being described and
           more than 700 drugs mentioned.
    - the drugs are chiefly botanical - acacia, castor bean,
           fennel
    - the vehicles of the day were: beer, wine, milk and
           honey
    - many pharmaceutical formulas employed 2 dozen or
           more medicinal agents, a type of preparation is
           called   “Polypharmacal”
Egyptians commonly used:

1. Mortar and pestles   for their compounding of
2. Hand mills           suppositories, gargles, pills
3. Sieves               inhalations, troches, lotions
4. Balances             ointments, plasters and enemas
Sumerian Clay Tablet
     = world’s oldest written prescription
      =preparation of the seed of carpenter
plant, gum resin of markhazi, and thyme,
all pulverized and dissolved in beer, and
combination of powdered roots of “moon
plant” and white pear tree, also dissolved
in beer.
Introduction of the Scientific Viewpoint

1.   Hippocrates - Greek physician, is
     credited with the introduction         of
     scientific pharmacy and medicine
     - oath of ethical behavior for the healing
           profession
     - honored by being called the Father of
          Medicine
2.   Dioscorides - Greek physician and
     botanist, deal with botany as   an
     applied science of pharmacy
     - De Materia Medica - study of naturally
          occurring materials
     - today known Pharmacognosy -
           pharmakon=drug; gnosis=
           knowledge
     - some of the drugs are opium, ergot
          and hyoscyamus
3. Claudius Galen -Greek pharmacist-
    physician
    - credited with 500 treatises on medicines
           and some 250 others on philosophy,
           law, and grammar
    - originated many preparations of vegetable
          drugs by mixing or melting the
          individual ingredients that the field of
          pharmaceutical preparations was
          once commonly referred to as
          “Galenic Cerate”
    - introduced cold cream, called Galen’s
           cream
4.Emperor Frederick II
 -officially separate medicine and pharmacy
 -regulate the practice of pharmacy called Two
     Sicilies.

5.Aureolus Theophrastus Bombastus von
  Hohenheim
 - Swiss physician and chemist who called himself
     Paracelsus
 - He believed it was possible to prepare a specific
     medicinal agent to combat each specific disease
     and introduced a host of chemical substances to
     internal therapy.
EARLY RESEARCH
KARL WILHELM SCHEELE
     lactic acid, citric acid, oxalic acid, tartaric acid and arsenic
     acid, glycerin, methods of preparing calomel and benzoic
     acid
FRIEDRICH SERTURNER
     isolation of morphine from opium
JOSEPH CAVENTOU AND JOSEPH PELLETIER
     isolation of quinine and cinchonine from cinchona
MAGENDIE
     isolation of strychnine and brucine from nux vomica,
     administration of strychnine in animals, the first experimental
     in medicine resulting to convulsion and asphyxia (stopping of
     pulse)
PAUL EHRLICH
        methylene blue as antimalarial, followed by plasmoquine and
        atabrine also antimalarial, then SALVARSAN (#606) – for
        syphilis


THE CHEMICAL REVOLUTION
PENICILLIN – first antibiotic produced by several molds
ASPIRIN – by Charles Gerhardt, derived salicin, pain killer and
      antiinflammatory
PRONTOSIL – the first antibacterial by Gerhard Domagk. Prontosil
     is converted in the body to SULFANILAMIDE. SULFONAMIDE
     (diuretic)
Pelletier and Pierre Robiquet - isolated caffeine, and
        Robiquet independently separated codeine from opium.
Contemporary examples of drugs isolated
from natural source
1. Paclitaxel -Taxol - antitumor activity derived
      from the Pacific yew tree (Taxus baccata)
      employed in the treatment of metastatic
      carcinoma of the ovary
2. Vincaleukoblastine - antineoplastic drug - from
      Vinca rosea
3. Digoxin - cardiac glycoside - from Digitalis lanata
DRUG STANDARDS
1. USP/NF – published in 1820
  Pharmacopeia – from Greek word PHARMAKON
                 meaning drug
  POIEIN – meaning to make


  COMBINATION: RECIPE or FORMULA required to
                   make or to prepare drug
PARTS OF THE MONOGRAPH
1. Generic or nonproprietary name
2. Graphic or Structural formula
3. Empirical formula
4. Molecular weight
5. Established chemical name
6. Drugs chemical abstract service/CAS registry number
7. Statement of chemical purity
8. Packaging and storage
9. Labeling
10. USP Reference standard
11. Identification
12. Assay
OTHER PHARMACOPEIAS
1. USPDI
2. HPUS = homoios – meaning similar
             pathos – meaning disease
           = Samuel Hahnemann
3. IP
4. Other pharmacopeias
5. EP or Ph Eur
Controlled Substances/5 Categories called
“SCHEDULES”

SCHEDULE 1
     *almost all drugs are illegal
     *have high potential for dependence and
      abuse


     EXAMPLES: Heroin, LSD, Marijuana
Controlled Substances/5 Categories called
“SCHEDULES”

SCHEDULE 2
     * highly addictive
     * remain in medical use because no
          satisfactory non addictive alternative
          medication is available
     * renewal of Rx is not allowed w/o a new Rx
           from Physician
     EXAMPLES: Cocaine, Amphetamines,
              Morphine, some Barbiturates
Controlled Substances/5 Categories called
“SCHEDULES”

SCHEDULE 3
     * some potential for abuse or dependence
     * Rx can be renewed up to 5 times in 6
           months if Physician authorized


     EXAMPLES: Acetaminophen or aspirin with
              codeine; some appetite
              suppressants
Controlled Substances/5 Categories called
“SCHEDULES”

SCHEDULE 4
     * less likely to cause dependence or to be
            abuse as much as the drugs in S-3
     * Rx are covered by the same regulations
           that govern S-3


     EXAMPLES: Diazepam, Chloral hydrate,
              Phenobarbital
Controlled Substances/5 Categories called
“SCHEDULES”

SCHEDULE 5
     * they contain small amounts of narcotics -
           regulated
     * they are least likely to be abused


     EXAMPLES: Some antidiarrheal medications;
              cough medications
         FDA INFORMATION RECEIVED
1. A list of all drug products
2. A list of all drug products broken down by labeled
   indications or pharmacologic activity
3. A list of all products, broken by manufacturer
4. A list of all products active ingredient
5. A list of all products inactive ingredient
6. A list of all products containing particular ingredient
7. A list of all products newly marketed or remarketed
8. A list of all products discontinued
9. All labeling of drug product
10. All advertising of drug product
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


Pharmacy - is the health profession that concerns itself with the
      knowledge system that results in the discovery,
      development, and use of medications and medication
      information in the care of patients. It encompasses the
      clinical, scientific, economic, and educational aspects of
      the profession’s knowledge base and its communication to
      others in the health care system.
Society - encompasses patients, other health-care providers,
        health-policy decision makers, corporate health benefits
        managers, the healthy public, and other individuals and
        groups to whom health care and medication use are
        important.
Appropriate - refers to the pharmacist’s responsibility to ensure
      that a medication regimen is specifically tailored for the
      individual patient, based on accepted clinical and
      pharmacological parameters. Evaluate the regimen to
      assure maximum safety, cost effectiveness, and compliance
      by the patient.
Medications - refers to legend and non legend agents used in the
       diagnosis, treatment, prevention, and/or cure of disease.
Devices - refers to the equipment, process, biotechnological
       entities, diagnostic agents, or other products that are used
       to assists in effective management of the medication
       regimen.
Services - refers to patient, health professional and public education
        services, screening and monitoring programs, medication-
        regimen management, and related activities that contribute
        to effective medication use by patients.
Optimal therapeutics - outcomes declares the profession’s ultimate
       contribution to public health. Pharmacy asserts it unique
       rights, privileges, and responsibilities-accepts the attendant
       liabilities-associated with medication use.
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 patient’s drug
      related needs.
       The mission of the pharmacist is to provide pharmaceutical
       care. Pharmaceutical care is the direct, responsible
       provisions of medication-related care for the purpose of
       achieving definite outcomes that improve a patient’s quality
       of life.
       Pharmaceutical care is patient-centered, outcomes oriented
       pharmacy practice that requires the pharmacist to work in
       concert with the patient and the patient’s other healthcare
       providers to promote health, to prevent disease, and to
       assess, monitor, initiate,and modify medication use to
       assure that drug therapy regimens are safe and effective.
       The goal of pharmaceutical care is to optimize the patient’s
       health-related quality of life and achieve positive outcomes,
       within realistic economic expenditures.
Pharmacy Practice Standards
1. General management and administration
         POSDICON, establishes pricing, administers budgets and
         negotiates, develop and maintain a purchasing and inventory
         system
2. Processing the prescription
         verifies Rx for legality and physical and chemical compatibility,
         checks patient’s record before dispensing Rx, measures          quantities
         needed to dispense Rx, performs final check of finished Rx,
         dispense Rx.
3. Patient care function
         clarifies patient’s understanding of dosage, integrates drug
         with patient information, advises patient of potential drug-related
         conditions, refers patient to other health care resources, monitors
         and evaluates therapeutic response of patient, reviews and/or seeks
         additional drug-related information
4. Education of health care professionals and patients
         organizes, maintains, and provides drug information to other health
         care professionals, organize and/or participates in in-pharmacy
         education programs for other pharmacists, recommends regarding
         drug therapy to physician or patient, develops and maintains system
         for drug distributions and quality control

				
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