PdF lec Flashcards

1
Q

Is defined as an agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in human or in other animals.

A

Drugs

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2
Q

has been defined as the profession which is concerned with the art and science of preparing drugs either from natural or synthetic sources in a suitable and convenient dosage form for administration of treatment, and prevention of diseases both of man and animals.

A

Pharmacy

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3
Q

The word Pharmacy is derived from the Greek word _______, meaning medicine or drug.

A

Pharmakon

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4
Q

is the person considered the expert on drugs

A

Pharmacist

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5
Q

Are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components in a particular configuration, and apportioned into a particular dose.

A

DOSAGE FORMS

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6
Q

According to Stedman’s medical dictionary, ________ is the giving of medicines or other therapeutic agent in prescribed amount.

A

DOSAGE

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7
Q

Is a preparation devised to make possible the administration of medications in measured or prescribed amounts.

A

Dosage

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8
Q

Is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life.

A

Medical Device

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9
Q

is a noun to denote preparations of such nature.

A

Pharmaceuticals

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10
Q

THE HERITAGE OF PHARMACY:
4

A

 The First Apothecary
 Introduction of the Scientific Viewpoint
 Early Drugs
 Early Research

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11
Q

DRUG STANDARDS: 2

A

USP
NF

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12
Q

USP means

A

United States Pharmacopoeia

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13
Q

NF means

A

National Formulary

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14
Q

New Drug Development

A

NPIPCNP
1. New Chemical Entity (sources)
2. Preclinical Studies
3. Investigational New Drug Application (IND)
4. Preclinical Studies (continued #2)
5. Clinical Trials
6. New Drug Application (NDA)
7. Post Marketing

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15
Q
  1. New Chemical Entity (sources) : 3
A

 Organic synthesis
 Molecular Modification
 Isolation from Plants

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16
Q
  1. Preclinical Studies
A

 Chemistry
 Physical Properties
 Preformulation
 Biological
(Pharmacology, toxicology)

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17
Q
  1. Investigational New Drug Application (IND)
A

 Submission
 FDA Review

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18
Q
  1. Preclinical Studies (continued #2)
A

 Long-term Animal Toxicity
 Product Formulation
 Manufacturing and Controls
 Package and Label Design

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19
Q
  1. Clinical Trials
A

 Phase I  Phase II  Phase III

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20
Q
  1. New Drug Application (NDA)
A

 Submission
 FDA Review
 FDAAction
 Pre-approval Plant Inspection

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21
Q
  1. Post Marketing
A

 Phase IV Clinical Studies
(Clinical Pharmacology/Toxicology)
 Product Defect Reporting
 Product Line Extension
 Adverse Reaction Reporting

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22
Q

General Considerations in designing of Dosage Forms

A

A. Preformulation Studies
B. Drug and Drug Product Stability
C. Definition and Types
D. Handbook of Pharmaceutical Excipients
E. Harmonization of Standards
F. Appearance and Palatability
G. Preservatives

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23
Q

A. Preformulation Studies

A

 Solubility
 Solubility and Particle
 Physical Description Size
 Microscopic Examination
 Melting Point Depression
 The Phase Rule
 Particle Size
 Polymorphism
 Solubility and pH
 Dissolution
 Membrane
Permeability
 Partition Coefficient
 pKa/Dissolution
Constants

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24
Q

B. Drug and Drug Product Stability

A

 Drug stability: Mechanism of Degradation
 Drug and Drug Product Stability: Kinetics and
Shelf Life
 Rate Reactions
 Q10 Method of shelf-Life Estimation
 Enhancing Stability of Drug Products
 Stability Testing

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25
Q

Pharmaceutic Ingredients:

A

C. Definition and Types
D. Handbook of Pharmaceutical Excipients E. Harmonization of Standards
F. Appearance and Palatability
G. Preservatives

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26
Q

F. Appearance and Palatability

A

 Flavoring and Sweetness Pharmaceuticals
 Coloring

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27
Q

G. Preservatives

A

 Sterilization and Preservation
 Preservative Selection
 General Preservative Considerations
 Mode of Action
 Preservation Utilization

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28
Q

 The concern goes beyond labeling. Mislabeling is rare, observations should be made as to the appearance of the preparations (color, odor, shape, and texture)

A

QUALITATIVE ACCURACY

29
Q

 Does not apply to the counting of discrete objects (tablets, capsules, bottles), it applies to measurement (weight and volume).

A

QUANTITATIVE ACCURACY

30
Q

is measured by means of a balance. A balance is in balance or at equilibrium when the weights on both pans are equal.

A

WEIGHT

31
Q

Right pan

A

weights

32
Q

Left pan

A

substance

33
Q

Methods in Determining a Balance:

A

Down balance method
Fixed balance method
Swinging balance method

34
Q

Adding the substance until the weights is overbalance; rapid and grossly inaccurate.

A

Down balance method

35
Q

 The pointer remains at the central position when the beam is made free to swing
 More nearly accurate

A

Fixed balance method

36
Q

 The pointer swings an equal number of divisions to both sides of the central position
 Most accurate

A

Swinging balance method

37
Q

 It is customary to measure amounts of liquid by volume, and solid by weight.
 An exception to this generalization: Glycerin, Acids, Oils are purchase by weight and dispense them by volume.
 An important factor in the accuracy of an instrument used for measuring volume is the surface area of the liquid in it. As the accuracy increase, the surface area will decrease, because a perceptible difference in the height of the liquid represents a smaller volume. The convenience of transferring of a liquid to and from the instrument is decreased. Therefore, there must be a compromise between accuracy and convenience.

A

VOLUME

38
Q

CLASSIFICATION OF PHARMACEUTICAL
D O S A G E F O R M S

A

 Method of Administration
 Physical Nature

39
Q

Method of Administration

A

 Rectal/Vaginal
 Oral
 Parenteral
 Epicutaneous – Topical drugs  Ocular, Otic, and Nasal
 Other Routes – Aerosol, Insert

40
Q

 Are intended to be taken by mouth or by oral administration.
Tablets
Capsules
Syrups
Suspensions

A

ORAL Route

41
Q

 Are intended into a body orifices, where it soften, melt or dissolve, release their
medication and exert their drug effect. Suppositories
Inserts

A

RECTAL/VAGINAL Route

42
Q

 Are intended into the body by injection through the skin, mucous or serous membranes.
 Intramuscular (IM)
 Intravenous (IV)
 Intradermal (ID)
 Intraspinal
 Intrathecal
 Subcutaneous (SC)

A

PARENTERAL Route

43
Q

 Are administered topically, or applied to the skin for their action at the site of application or systemic drug effects.
 Ointments
Creams
 Pastes
 Gels
 Plasters
 Patches

A

EPICUTANEOUS Route

44
Q

 Are frequently applied topically to the eye, ear, and the mucous membranes of the nose.
Solutions
 Sprays
Ointments
Creams

A

OCULAR, OTIC and NASAL Route

45
Q

 Are very minute particle liquids or solid.
Inhalers, Aerosols, Nebulizers
 Are inserted into the vagina and urethra.
Tablet inserts,suppositories,ointments,
emulsion foams or solutions.

A

OTHERS Routes

46
Q

Physical Nature

A

 Liquids
 Extracts
 Parenteral Preparations
 Intravenous Admixtures
 Medicated Applications
 Ophthalmic Preparations
 Oral Solid Dosage Forms
 Biological Products
 Aerosols
 Radiopharmaceuticals
 Powders

47
Q

Are homogenous mixture that is prepared by dissolving a solid or liquid or gas in another liquid.

A

Solutions

48
Q

3 types of Solutions:

A

Aqueous Solutions
Non-Aqueous Solutions
Sweet/Other Viscid Aqueous Solutions

49
Q

Aqueous Solutions

A

 Aromatic Water
 Aqueous Acids
 Diluted Acids
 Solutions
 Douches
 Enemas
 Gargles
 Mouthwashes
 Juices
 Nasal Solutions
 Otic Solutions

50
Q

Sweet/Other Viscid Aqueous Solutions

A

 Syrups
 Honeys
 Mucilages
 Jellies

51
Q

Non-Aqueous Solutions

A

 Collodions
 Elixirs
 Glycerites
 Inhalants/Inhalations
 Liniments
 Oleovitamins
 Spirits
 Toothache drops

52
Q

A two-phase system prepared by combining immiscible liquids, one of which is uniformly dispersed through the other.

A

EMULSIONS

53
Q

Is incorporated to prevent the separation of two phases.

A

Emulsifying agent

54
Q

Kinds of Emulsions

A

 Water in Oil Emulsion – W/O
 Oil in Water Emulsion – O/W
 Multiple Emulsion – W/O or O/W
 Microemulsions – translucent or
transparent

55
Q

A two-phase system consisting of finely divided solid dispensed in a solid, liquid, or gas.

A

SUSPENSIONS

56
Q

is added to ensure appropriate dispersion of the solid in the vehicle.

A

Suspending agent

57
Q

Liquids:

A

Suspensions
Emulsions
Extracts

58
Q

Extracts

A

 Tinctures
 Fluidextracts
 Extracts

59
Q

Intravenous Admixtures

A

 Intravenous Fluids
 Intravenous Admixtures
Total Parenteral Nutrition (TPN)

60
Q

Opthalmic Solutions:

A

 Solutions
 Suspensions
 Ointments
 Lens Care Products
Wetting Solutions
Cleaning Solutions
Soaking Solutions
Artificial Tears

61
Q

Medicated Applications:

A

 Ointments
 Creams
 Cataplasm (Poultices)
 Pastes
 Powders
 Plasters
 Suppositories
 Inserts
 Dressings

62
Q

Powders

A

 Oral Powders
 Dentifrices
 Douche Powders
 Dusting Powders
 Insufflations
 Triturations

63
Q

Oral Dosage Solid Forms

A

 Tablets
 Capsules
 Cachets
 Pills
 Pellets
 Troches
 Losenges

64
Q

Tablets

A

Compressed
Molded/Triturates

65
Q

Aerosols

A

Oral Aerosol
Topical Aerosol

66
Q

Biological Products

A

Biological for Active Immunity
*Vaccines
*Toxoids
Biologics for Human Immunity
1. Human Immune Sera
*Immune Globulin
*Hyperimmune Serum
2. Animal Immune Serum
*Antitoxin
*Antiviral
*Antivenin

67
Q

Liquids:

A

Emulsions
Suspensions

68
Q

Parenteral Preparations

A

Ampules
Vials