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PHARMA > 1B CONCEPTS: INTRODUCTION TO PHARMA > Flashcards

1B CONCEPTS: INTRODUCTION TO PHARMA Flashcards

1
Q

DRUG

A

A substance, material or product used for the purpose of diagnosis, prevention and relief of symptoms or cure of disease.

A substance, material or product used or intended to be used to modify or explore the physiological processes or pathological states for the benefit of the recipient.

Drogue “a dry herb”

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2
Q

MEDICINE

A

Chemical preparation administered with the intention of producing a therapeutic effect

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3
Q

Excipient

A
  • long-term stabilization
  • bulking up solid formulations, often referred to as “bulking agents”, “fillers”, or “diluents”
  • therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility
  • considered to be pharmacologically inactive and safe

Adverse effects are generally uncommon but the potential for toxicity is increased at high mg per kg doses especially in neonates and infants. Dose related toxicity and hypersensitivity reactions are well documented

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4
Q

Solvent

A

•dissolves a solute, resulting in a solution

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5
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Diluents

A

Provide bulk and enable accurate dosing of potent ingredients

ex.

Sugar compounds e.g., lactose, dextrin, glucose, sucrose, sorbitol

Inorganic compounds e.g., silicates, calcium and magnesium salts, sodium or potassium chloride

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6
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Binders, compression aids, granulating agents

A

Bind the tablet ingredients together giving form and mechanical strength

Mainly natural or synthetic polymers e.g., starches, sugars, sugar alcohols and cellulose derivatives

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7
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Disintegrants

A

_Aid dispersio_n of the tablet in the gastrointestinal tract, releasing the active ingredient and increasing the surface area for dissolution

ex. Compounds which swell or dissolve in water e.g., starch, cellulose derivatives and alginates, crospovidone

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8
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Glidants

A

Improve the flow of powders during tablet manufacturing by reducing friction and adhesion between particles. Also used as anti-caking agents.

ex. Colloidal anhydrous silicon and other silica compounds

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9
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Lubricants

A

they may slow disintegration and dissolution.

Stearic acid and its salts (e.g., magnesium stearate)

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10
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Tablet coatings and films

A

Protect tablet from the environment (air, light and moisture), increase the mechanical strength, mask taste and smell, aid swallowing, assist in product identification. Can be used to modify release of the active ingredient. May contain flavours and colourings.

Sugar (sucrose) has now been replaced by film coating using natural or synthetic polymers. Polymers that are insoluble in acid, e.g., cellulose acetate phthalate, are used for enteric coatings to delay release of the active ingredient.

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11
Q

Common Excipients Used in Tablets

FUNCTION AND EXAMPLE

Colouring agents

A

Improve acceptability to patients, aid identification and prevent counterfeiting. Increase stability of light-sensitive drugs

Mainly synthetic dyes and natural colors. Compounds that are themselves natural pigments of food may also be used.

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12
Q

Study of the effects of drugs on the function of living systems

a biomedical science

A

Pharmacology

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13
Q

•a health services profession concerned with THE application of the principles learned from pharmacology

A

Pharmacy

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14
Q

BRANCHES OF PHARMACOLOGY

A

Following are the important branches of Pharmacology:

  1. Pharmacokinetics
  2. Pharmacodynamics
  3. Therapeutics
  4. Chemotherapy
  5. Toxicology
  6. Clinical Pharmacology
  7. Pharmacy
  8. Pharmacognesy
  9. Pharmacogenetics
  10. Pharmacoeconomics
  11. Pharmacoepidemiology
  12. Comparative Pharmacology
  13. Animal Pharmacology
  14. Pharmacoeconomics
  15. Posology
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15
Q

Clinical Pharmacology

main objectives?

A

Clinical pharmacology is the scientific study of drugs in man.

  1. Maximize the effect of drug
  2. Minimize the adverse effects

3.Promote safety of prescription

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16
Q

•what drugs do to the body and how

A

PHARMACODYNAMICS

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17
Q

what happens to the drug while in the bod

A

PHARMACOKINETICS

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18
Q

Phases or steps of pharmacokinetics

A

Liberation

Absorption

Distribution

Metabolism

Excretion

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19
Q

•process by which medication enters the body and liberates the active ingredient that has been administered

A

LIBERATION

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20
Q

generally refers to breaking a compound into smaller pieces TO FORM A SOLUTION

A

Dissociation

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21
Q

•movement OF drug into the bloodstream

A

Absorption

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22
Q

•transmission of the drug from one location to the other in the body

A

Distribution

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23
Q

how the drug is processed IN THE BODY

A

Metabolism

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24
Q

how the drug is expelled from the body

A

Excretion

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25
•The branch of pharmacology that deals with the **art and science of treatment of disease**. It is the **application of pharmacological information** together with the knowledge of disease, for the **prevention and cure of the disease.**
Therapeutics
26
the treatment of diseases by chemicals that kill the cells, specially those of microorganisms and neoplastic cells.
Chemotherapy
27
two divisions of chemotherapy
Antibiotics Anti-neoplastics
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* the branch of pharmacology which **includes the study of adverse effects of drugs** on the body. * **deals** with the **symptoms**, **mechanisms**, **treatment** and **detection** of **poisoning** caused by different chemical substances. * The ***_main criterion is the dose._*** Essential medicines are poisons in high doses and some poisons are essential medicines in low doses.
Toxicology
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•study of how drugs affect each other
DRUG INTERACTIONS
30
RATIONAL PRESCRIBING ABOUT using the RIGHT:
* medICATION * dose * route * frequency of administration * DURATION
31
•Branch of health economics that aims to quantify in economic terms the cost and benefit of drugs used therapeutically
PHARMACOECONOMICS
32
identification of drugs by just seeing or smelling them. It is a crude method no longer used •Basically, it deals with the drugs in crude or unprepared form and study of properties of drugs form natural sources or identification of new drugs obtained from natural sources.
PHARMACOGNOSY
33
•Study of pharmacology through bioassay to test the efficacy and potency of a drug
EXPERIMENTAL PHARMACOLOGY
34
* Study of how medicines are dosed * Depends upon various factors including age, weight, sex, elimination rate of drug, genetic polymorphism and time of administration
POSOLOGY
35
•Branch of pharmacology dealing with the genetic variations that cause difference in drug response among individuals or population.
PHARMACOGENETICS
36
•Study of the effects of drugs in large numbers of people
PHARMACOEPIDEMIOLOGY
37
Substances that act on biologic systems at the chemical (molecular) level and alter their functions
Drugs
38
The molecular components of the body with which drugs interact to bring about their effects
Drug receptors
39
The phase of drug movement from the site of administration into the tissues
Distribution phase
40
The phase of drug inactivation or removal from the body by metabolism or excretion
Elimination phase
41
Absorption of material across a cell membrane by enclosing it in cell membrane material and pulling it into the cell, where it can be processed or released
Endocytosis
42
Expulsion of material from vesicles in the cell into the extracellular space
Exocytosis:
43
Movement of a molecule (eg, drug) through the biologic medium
Permeation
44
The actions of a drug on the body, including receptor interactions, dose-response phenomena, and mechanisms of therapeutic and toxic actions
Pharmacodynamics
45
The actions of the body on the drug, including absorption, distribution, metabolism, and elimina tion. Elimination of a drug may be achieved by metabolism or by excretion
Pharmacokinetics
46
term sometimes used to describe the processes of metabolism and excretion
Biodisposition
47
A specialized molecule, usually a protein, that carries a drug, transmitter, or other molecule across a membrane in which it is not permeable, eg, Na+/K+ ATPase, serotonin reuptake transporter, etc
Transporter
48
An effect on the inheritable characteristics of a cell or organism—a mutation in the DNA; usually tested in microorganisms with the Ames test
Mutagenic
49
An effect of inducing malignant characteristics
Carcinogenic
50
An effect on the in utero development of an organism resulting in abnormal structure or function; not generally heritable
Teratogenic
51
An inactive “dummy” medication made up to resemble the active investigational formulation as much as possible but lacking therapeutic effect
Placebo
52
A clinical trial in which the investigators—but not the subjects—know which subjects are receiving active drug and which are receiving placebos
Single-blind study
53
A clinical trial in which neither the subjects nor the investigators know which subjects are receiving placebos; the code is held by a third party
Double-blind study
54
Investigational New Drug Exemption; an application for FDA approval to carry out new drug trials in humans; requires animal data
IND
55
New Drug Application; seeks FDA approval to market a new drug for ordinary clinical use; requires data from clinical trials as well as preclinical (animal) data
NDA
56
Three parts of a clinical trial that are usually carried out before submitting an NDA to the FDA
Phases 1, 2, and 3 of clinical trials
57
A known standard therapy, to be used along with placebo, to evaluate the superiority or inferiority of a new drug in relation to the other drugs available
Positive control
58
Drugs developed for diseases in which the expected number of patients is small. Some countries bestow certain commercial advantages on companies that develop drugs for uncommon diseases
Orphan drugs
59
Emergency Use Authorization
* Risk-based procedure for assessing unlicensed (under development) vaccines, therapeutics * During public health emergencies of international concern * Aim of expediting availability to people affected by a public health emergency * Based on essential set of available quality, safety, and efficacy performance data * all safety data accumulated from phase 1 and 2 studies * Portion of phase 3 data * will include a median follow-up of at least 2-months * will include a phase 3 safety database of well over 3,000 recipients * E.g., covid 19 vaccines, IL-6 inhibitor (Tocilizumab), Anti-SARS-CoV-2 Monoclonal Antibodies (sotrovimab), nucleotide antiviral drug (remdesivir)
60
four statutory criteria to be considered fro Emergency Use Authorization
1 •There must be a **_serious or life-threatening illness_** ***caused*** by ***a specified chemical, biological, radiological, or nuclear agent***. * There must be **_no adequate approved, alternative medical countermeasures available_** for the situation. * The **_known and potential benefits need to outweigh the known and potential risks_**. * It must be **reasonable to believe that the product** covered by the EUA **_is going to be effective for the intended us_**e—diagnosing, treating, or preventing either an illness or condition caused by a specific agent, or an illness or condition caused by an approved or authorized medical countermeasure deployed against the agent.
61
What other countries have a mechanism similar to an EUA?
* US Food and Drug Administration- * Emergency Use Authorization * China National Medicinal Products Administration- * Emergency Use Authorization * European Medicines Agency – * Conditional Marketing Authorization * Australia Therapeutic Goods Administration * Provisional pathway * Japan Pharmaceuticals and Medical Devices Agency- * Conditional Early Approval System
62
EAU
**•shall be valid until expressly withdrawn by the FDA Direc**tor General or **upon issuance of full market authorization/Certificate of Product Registration** **•immunity from liability if something unintention**ally goes wrong with their products, unless there’s “willful misconduct” by the company * **individuals to whom the product is administered are informed of the option to accept or refuse administration of the product,** of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks. * **cannot purchase COVID-19 vaccines from private clinics or pharmacies**. At present, only the government is duly authorized to procure and administer vaccines. Until a full market authorization is issued by the Philippine FDA, any COVID-19 vaccine should not be sold to the public
63
•A Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product
shall refer to a special permit signed by the BFAD Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.
64
Compassionate Special Permit Criteria
**•Patient’s disease is serious or immediately life-threatening.** •**No treatment is available**, or **patient has not been helped by approved treatments** for the disease. **•Patient is not eligible for clinical trials** of the experimental or investigational drug. •**Physician agrees that patient has no other options**, and the experimental treatment may help the patient. **•Physician feels the benefit justifies the potential risks of the treatment.** •The **company that makes the drug agrees to provide it**
65
Sources of drugs
* Plant sources * Animal sources * Mineral/ Earth sources * Microbiological sources * Semi synthetic sources/ Synthetic sources
66
the oldest source of drugs
Plant source eg., plant alkaloids
67
•Plant sources Leaves
* The leaves of **_Digitalis Purpurea are the source of Digitoxin and Digoxin_**, which are *cardiac glycosides* * Leaves of **_Eucalyptus give oil of Eucalyptus_**, which is important component of *cough syrup* **_•Atropa belladonna_** gives *atropine*
68
•Plant sources Flowers
**_•Poppy papaver somniferum_** gives *morphine (opioid)* •**_Vinca rosea_** gives *vincristine and vinblastine*
69
•Plant sources Fruits
•**Senna pod** gives **_SENNA_**, which is a *purgative* **•Calabar beans** give **_physostigmine_**, which is *cholinomimetic agent*
70
PLANT SOURCE Seeds
* **Castor oil seeds** give *castor oil.* * **Calabar** beans give *Physostigmine*, which is a cholinomimetic drug.
71
PLANT SOURCE Roots
•**Ipecacuanha root** gives **_Emetine_**, used to induce *vomiting* **•Rauwolfia serpentina** gives **_reserpine_**, a *hypotensive* agent
72
Plant Source: Bark
* **Cinchona** bark gives **_quinine and quinidine,_** which are *antimalarial* drugs. Quinidine also has *antiarrhythmic* properties. * **Atropa belladonna** gives **_atropine_**, which is *anticholinergic*. **Hyoscyamus Niger** gives **_Hyoscine_**, which is also *anticholinergic*
73
Plant Source: Stem
•**_Chondrodendron tomentosum_** gives **tuboCurarine**, which is *skeletal muscle relaxant* used in general anesthesia
74
•Animal sources
**•Sheep thyroid** is a source of **_thyroxin_**, used in *hypertension*. **•Cod liver** is used as a s**_ource of vitamin A and D._** •**Anterior pituitary** is a source of **_pituitary gonadotropin_**s, used in treatment of *infertility*.
75
•Mineral/ Earth sources
* **Iron** is used in treatment of **_iron deficiency anemia._** * **Zinc** is used as **_zinc supplement_**. **_Zinc oxide paste_** is used in *wounds* and in *eczema*. * **Iodine** is *antiseptic*. Iodine supplements are also used. * **Gold salts** are used in the treatment of *rheumatoid arthritis* * **Selenium** as **_selenium sulfide_** is used in *anti dandruff shampoos.*
76
•Microbiological sources
* **Penicillium notatum** is a **_fungus_** which gives *penicillin*. * **Actinobacteria** give *Streptomycin*.
77
•Semi synthetic sources or synthetic sources When the **nucleus of drug obtained from natural source is retained** but the **chemical structure is altered**
Semi-synthetic
78
Semi synthetic or synthetic When the nucleus of the drug from natural source as well as its chemical structure is altered
Synthetic
79
•involves **cleavage of DNA by** enzyme restriction endonucleases. **•desired gene is coupled to rapidly replicating DNA** (viral, bacterial plasmid) * The **new genetic combination is inserted** into the bacterial cultures which allow production of vast amount of genetic material * E.g., monoclonal antibodies produced ex vivo using tissue-culture techniques
•Recombinant DNA technology
80
**Recombinant DNA technology** •Advantages:
* **Huge amounts of drug**s can be produced * Drug can be obtained in **pure form** * It is **less antigenic**
81
Recombinant DNA technology •Disadvantages:
* Well equipped lab is required * Highly trained staff is required * It is a complex and complicated technique
82
DRUG DEVELOPMENT PROCESS Steps
Step 1: **Discovery and Development** Step 2: **Preclinical Reseacrh** Step 3: **Clinical Research** Step 4: **FDA Review** Step 5: **FDA Post-Market Safety Monitoring**
83
DRUG DEVELOPMENT PROCESS Steps Research for a new drug begins in the laboratory
Step 1: Discovery and Development
84
DRUG DEVELOPMENT PROCESS Steps Drugs are tested on people to make sure they are safe and effective
Step 3: Clinical Research
85
DRUG DEVELOPMENT PROCESS Steps Drugs undergo laboratory and animal testing to answer basic questions about safety
Step 2: Preclinical Research
86
DRUG DEVELOPMENT PROCESS Steps FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it
Step 4: FDA Review
87
DRUG DEVELOPMENT PROCESS Steps FDA monitors all drug and device safety once products are available for use by the public.
Step 5: FDA Post-Market Safety Monitoring
88

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