PdF lec

Question 1

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

Answer 1

Drugs

Question 2

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.

Answer 2

Pharmacy

Question 3

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

Answer 3

Pharmakon

Question 4

is the person considered the expert on drugs

Answer 4

Pharmacist

Question 5

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.

Answer 5

DOSAGE FORMS

Question 6

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

Answer 6

DOSAGE

Question 7

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

Answer 7

Dosage

Question 8

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.

Answer 8

Medical Device

Question 9

is a noun to denote preparations of such nature.

Answer 9

Pharmaceuticals

Question 10

THE HERITAGE OF PHARMACY:
4

Answer 10

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

Question 11

DRUG STANDARDS: 2

Answer 11

USP
NF

Question 12

USP means

Answer 12

United States Pharmacopoeia

Question 13

NF means

Answer 13

National Formulary

Question 14

New Drug Development

Answer 14

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

Question 15

1. New Chemical Entity (sources) : 3

Answer 15

 Organic synthesis
 Molecular Modification
 Isolation from Plants

Question 16

2. Preclinical Studies

Answer 16

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

Question 17

3. Investigational New Drug Application (IND)

Answer 17

 Submission
 FDA Review

Question 18

4. Preclinical Studies (continued #2)

Answer 18

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

Question 19

5. Clinical Trials

Answer 19

 Phase I  Phase II  Phase III

Question 20

6. New Drug Application (NDA)

Answer 20

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

Question 21

7. Post Marketing

Answer 21

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

Question 22

General Considerations in designing of Dosage Forms

Answer 22

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

Question 23

A. Preformulation Studies

Answer 23

 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

Question 24

B. Drug and Drug Product Stability

Answer 24

 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

Question 25

Pharmaceutic Ingredients:

Answer 25

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

Question 26

F. Appearance and Palatability

Answer 26

 Flavoring and Sweetness Pharmaceuticals  Coloring

Question 27

G. Preservatives

Answer 27

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

Question 28

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

Answer 28

QUALITATIVE ACCURACY

Question 29

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

Answer 29

QUANTITATIVE ACCURACY

Question 30

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

Answer 30

WEIGHT

Question 31

Right pan

Answer 31

weights

Question 32

Left pan

Answer 32

substance

Question 33

Methods in Determining a Balance:

Answer 33

Down balance method Fixed balance method Swinging balance method

Question 34

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

Answer 34

Down balance method

Question 35

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

Answer 35

Fixed balance method

Question 36

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

Answer 36

Swinging balance method

Question 37

 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.

Answer 37

VOLUME

Question 38

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

Answer 38

 Method of Administration  Physical Nature

Question 39

Method of Administration

Answer 39

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

Question 40

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

Answer 40

ORAL Route

Question 41

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

Answer 41

RECTAL/VAGINAL Route

Question 42

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

Answer 42

PARENTERAL Route

Question 43

 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

Answer 43

EPICUTANEOUS Route

Question 44

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

Answer 44

OCULAR, OTIC and NASAL Route

Question 45

 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.

Answer 45

OTHERS Routes

Question 46

Physical Nature

Answer 46

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

Question 47

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

Answer 47

Solutions

Question 48

3 types of Solutions:

Answer 48

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

Question 49

Aqueous Solutions

Answer 49

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

Question 50

Sweet/Other Viscid Aqueous Solutions

Answer 50

 Syrups  Honeys  Mucilages  Jellies

Question 51

Non-Aqueous Solutions

Answer 51

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

Question 52

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

Answer 52

EMULSIONS

Question 53

Is incorporated to prevent the separation of two phases.

Answer 53

Emulsifying agent

Question 54

Kinds of Emulsions

Answer 54

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

Question 55

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

Answer 55

SUSPENSIONS

Question 56

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

Answer 56

Suspending agent

Question 57

Liquids:

Answer 57

Suspensions Emulsions Extracts

Question 58

Extracts

Answer 58

 Tinctures  Fluidextracts  Extracts

Question 59

Intravenous Admixtures

Answer 59

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

Question 60

Opthalmic Solutions:

Answer 60

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

Question 61

Medicated Applications:

Answer 61

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

Question 62

Powders

Answer 62

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

Question 63

Oral Dosage Solid Forms

Answer 63

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

Question 64

Tablets

Answer 64

Compressed Molded/Triturates

Question 65

Aerosols

Answer 65

Oral Aerosol Topical Aerosol

Question 66

Biological Products

Answer 66

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

Question 67

Liquids:

Answer 67

Emulsions Suspensions

Question 68

Parenteral Preparations

Answer 68

Ampules Vials