Good Compounding Practices And Techniques M1

Question 1

study that concerns itself with the physical, chemical and biological factors which influenced the formulation, manufacture, stability and effectiveness of phamaceutical dosage forms.

Answer 1

Pharmaceutics

Question 2

Maybe defined as an agent intended for use in diagnosis, mitigation, treatment, cure and prevention of disease in man or animal.

Answer 2

Drug

Question 3

are dosage forms in which drugs are prepared by the pharmacists for internal and external administration in the treatment of disease. Thus maybe done extemporaneously compounded by a pharmacist or manufactured for immediate distribution.

Answer 3

Pharmaceutical preparations

Question 4

Known as pharmaceuticals
Prepared by adding an active ingredients and non-active ingredient

Answer 4

Dosage forms

Question 5

Means the production, preparation, propagation, conversion, or processing of a drua or device, either directly of indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis.

Answer 5

Manufacturing vs. Compounding manufacturing

Question 6

The preparation of components into a drug product.

Answer 6

Compounding

Question 7

As the result of a practitioner’s prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional practice, or For the purpose of, or as an incident to, research, teaching, or
chemical analysis and not for sale or dispensing

Answer 7

Compounding

Question 8

Compounding is he preparation, mixing. assembling. altering packaging and labeling of a drug, drug delivery device, or device in
accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder
relationship in the course of professional Practice

Answer 8

United state pharmacopeia
USP

Question 9

is that which is in direct contact with the drug at all times.

Answer 9

Immediate container

Question 10

Protects the content from extraneous solids and from loss of the drug under ordinary conditions of handling, shipment, storage and distribution

Answer 10

Well closed container

Question 11

Protects the content from contamination by extraneous liquid, solid or vapors from loss of the drug and from efflorescence or evaporation under usual condition of handling, shipment, storage and distribution

Answer 11

Tight container

Question 12

impervious to air or any gas under ordinary or customary condition usually njectables and parenterals

Answer 12

Hermetic container

Question 13

once opened it cannot be resealed

Answer 13

Single dose container

Question 14

it permits withdrawal of successive portions of the contents without changing the strength of the remaining portion

Answer 14

Multiple dose container

Question 15

For aerosol products

Answer 15

Aerosol container

Question 16

Used for dispensing supp/powder prepared in packets

Answer 16

Hinged or slide boxes

Question 17

Used for powders to be applied by sprinkle

Answer 17

Sifter-top container

Question 18

Used for applying liquid medication to a wound or skin surface

Answer 18

Applicator bottle

Question 19

Used for dispensing opthalmic, nasal, otic and oral liquid to be administered by drops

Answer 19

Droppers bottle

Question 20

Used to dispense semi-solid dosage forms, such as ointments and creams

Answer 20

Ointment jar or collapsible tube

Question 21

Used for bulk powders, large quantities of tablets and capsules and viscous liquids that cannot be poured readily from the narrow neck standard Rx bottle

Answer 21

Wide mouth bottle

Question 22

Used for dispensing liquids of low viscosity

Answer 22

Rx bottle

Question 23

Used primarily for liquid dosage form, capsule and tablets

Answer 23

Round bottle

Question 24

5 types of stability

Answer 24

Physical stability
Chemical stability
Microbiological stability
Toxicological stability
Therapeutic stability

Question 25

No significant increase in toxicity occurs

Answer 25

Toxicological stability

Question 26

Therapeutic effect remains unchanged

Answer 26

Therapeutic stability

Question 27

Original physical properties including appearance, palatability, uniformity, dissolution and suspendability are retained

Answer 27

Physical stability

Question 28

Active ingredients retain its chemical integrity and labelled potency within the specified limits.

Answer 28

Chemical stability

Question 29

Sterility or resistance to microbial growth is retained according to the specified requirements. Antimicrobial agent that are present retain effectiveness within specified limits.

Answer 29

Microbiological stability

Question 30

5 storage requirements

Answer 30

Cold Cool Warm temperature Excessive heat Room temperature

Question 31

Cold

Answer 31

8°C

Question 32

Cool

Answer 32

Between 8-15°C

Question 33

Temp prevailing in working area

Answer 33

Room temperature

Question 34

Controlled room

Answer 34

15-30°C

Question 35

Official room temperature

Answer 35

25°C

Question 36

Warm temperature

Answer 36

Between 30-40°C

Question 37

Excessive heat

Answer 37

Above 40°C

Question 38

Refers to the length of time that a drug produced may remain on the pharmacist's shelf in the original packages and under usual environmental condition.

Answer 38

Shelf life

Question 39

Retain an acceptable level of its original potency and overall quality

Answer 39

Shelf life

Question 40

If storage condition are not met, either physical degradation or chemical deterioration may occur.

Answer 40

Shelf life

Question 41

Latest date at which the product is expected to be stable physically. chemically, therapeutically, identity, strength, quality and purity until that date if storage condition are met

Answer 41

Expiration date

Question 42

generic name

Answer 42

Non-proprietary or public name

Question 43

denoting a drug name, usually descriptive of the drug's chemical structure

Answer 43

Non-proprietary or public name

Question 44

brand name/trade name

Answer 44

Proprietary name

Question 45

given by the manufacturer or distributor

Answer 45

Proprietary name

Question 46

drugs which are deemed safe enough for use by the laymen in the self treatment of simple conditions

Answer 46

Over the counter

Question 47

sold without Rx

Answer 47

Over the counter

Question 48

are those which are considered to be useful only after expert diagnosis and dangerous for use in self-medication.

Answer 48

Legend drugs

Question 49

uses Yellow Prescription

Answer 49

Dangerous drugs

Question 50

Swallowed by mouth

Answer 50

Per-oral route

Question 51

Injected into thr body alimentary canal

Answer 51

Parenteral route

Question 52

Inserted or injected into the rectum

Answer 52

Rectal route

Question 53

Applied to a certain area of the skin

Answer 53

Topical route

Question 54

drugs are inhaled by the nose or mouth; used for the treatment of respiratory condition

Answer 54

Inhalation route

Question 55

Supp (pessaries)

Answer 55

Vaginal route

Question 56

not swallowed, drug are allowed to be dissolved in the oral cavity

Answer 56

Oral route

Question 57

Under the tongue

Answer 57

Sublingual

Question 58

Cheeks

Answer 58

Buccal

Question 59

Mouth

Answer 59

Perlingual