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Dispensing Lab > PACKAGING OF MEDICINES > Flashcards

PACKAGING OF MEDICINES Flashcards

1
Q

container-closure system. The sum of packaging components and materials that together contain and protect the article.

A

Packaging System

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2
Q

components when such components are requires to provide additional protection.

A

Secondary packaging

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3
Q

A receptacle that holds an intermediate compound, API, excipient, or dosage form, and is in direct contact with the article

A

Container

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4
Q

Container example

A

ampules,
vials,
bottles,
syringes,
pen injectors

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5
Q

A material that seals an otherwise open space of a Container and provides protection for the contents. It also provides access to the contents of the Container

A

Closure

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6
Q

Closure example

A

screw caps and stoppers

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7
Q

the act of removing a drug product from the original manufacturer’s packaging system
and placing it into another, usually of smaller size

A

Repackaging

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8
Q

PACKAGING CONSIDERATIONS

A
  1. Pre-formulation information on the drug substance
  2. The nature of the dosage form
  3. Drug product information
  4. Container material qualification
  5. Container/product compatibility
  6. Impact of the packaging operation on the drug product
  7. Ruggedness of the container system under actual conditions of packaging, shipping, storage and use
  8. Performance
  9. Cosmetic features
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9
Q

Pre-formulation information on the drug substance

A

sensitivity to heat,
oxygen,
humidity,
light,
glass,
metals,
pH,
reactivity with plastics, metals, or types of glass

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10
Q

The nature of the dosage form

A

solid oral,
liquids
powders,
creams,
ointments,
biodegradable polymers,
implants,
transdermals

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11
Q

Drug product information

A

humidity,
light,
heat,
pH,
compatibility studies w/ components

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12
Q

It should also be noted, further, that
drugs used or dispensed in __________need not be
dispensed with safety closures unless they are intended for patients who are leaving the confines of the institution.

A

inpatient institutions

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13
Q

For dispensing liquids of low viscosity

A

Prescription Bottles

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14
Q

For bulk powders and viscous liquids

A

Wide-mouth Bottle

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15
Q

For ophthalmic, nasal, otic, or oral liquid administered by drop

A

Dropper Bottle

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16
Q

Used for applying liquid medication to a wound or skin surface

A

Applicator Bottle

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17
Q

For semisolid DF such as ointments and creams

A

Ointment Jar & Collapsible Tube

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18
Q

Single-unit containers for solid DFs like tablets, capsules & lozenges

A

Blister and Foil Packs

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19
Q

For topical powders to be applied by sprinkling. Bottle sprays are for applying liquid medication in mist

A

Sifter-top Container & Spray Bottle

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20
Q

Used for dispensing suppositories
and powders prepared in packets

A

Slide or Hinge-lid Boxes

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21
Q

For small and large volume parenterals and admixtures

A

Ampules, Vials, IVF Bags

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22
Q

PRODUCT INSTABILITIES WHEN PACKAGING

A
  1. Moisture
  2. Oxidation
  3. Light
  4. Microbial contamination
23
Q

are hydrolyzed in the presence of moisture and broken down into acetic acid
and salicylic acid.

A

Aspirin tablets

24
Q

is the chemical reaction or process in which a molecule is split into two different species on reaction with water.

A

Hydrolysis

25
Q

tablets are always dispensed in their original glass bottles to minimize exposure to air and moisture.

A

Sublingual nitroglycerin

26
Q

is one of the most common environmental factors to cause degradation.

A

Oxygen

27
Q

in screw-cap closures

A

Rubber gaskets

28
Q

with a foil containing multilayer liner in a closure

A

Heat induction seals

29
Q

Introduction of an _________ (e.g., Nitrogen or Argon) into the package

A

inert gas

30
Q

is the most energetic form of light and is present in sunlight.

A

Ultraviolet light

31
Q

such as hydrocortisone, prednisolone, and methyprednisolone are examples of drugs that are susceptible to changes from light.

A

Steroids

32
Q

Package sterilization methods

A

i. Superheated steam (i.e., autoclaving)
ii. Chemical sterilant along with modest heat

33
Q

Packaging of compounded sterile preparations must be completed while strictly observing aseptic
technique with all procedures done under a __________

A

laminar flow hood (with HEPA filter)

34
Q

Maalox® Plus

A

Aluminum Hydroxide-Magnesium Hydroxide
Antacids

35
Q

Aluminum Hydroxide-Magnesium Hydroxide

A

Symptomatic relief of hyperacidity & as an antiflatulent

Non-Rx

chewable tab, oral susp

36
Q

Iselpin®

A

Sucralfate
Antacids

37
Q

Sucralfate

A

Gastric & duodenal ulcer & chronic gastritis

Rx

tab

38
Q

Nexium®

A

Esomeprazole
Antacids

39
Q

Esomeprazole

A

symptomatic treatment of GERD

Rx

granules for oral susp,
tab,
powd for inj

40
Q

Mucosta®

A

Rebamipide
Antacids

41
Q

Rebamipide

A

Treatment of gastric mucosal lesions in acute gastritis

Rx

tab

42
Q

Buscopan®

A

Hyoscine-N-butylbromide
Antispasmodics

43
Q

Hyoscine-N-butylbromide

A

GIT spasm, GUT spasm

Tab:Non-Rx;
Inj:Rx

Inj, sugar-coated tab

44
Q

Hidrasec®

A

Racecadotril
Antidiarrheals

45
Q

Racecadotril

A

Symptomatic treatment of acute diarrhea

Rx

granules for oral susp,

46
Q

Senokot® Forte

A

Calcium Sennoside
Laxatives

47
Q

Calcium Sennoside

A

Used as a natural laxative for the relief of constipation

Non-Rx

Tab

48
Q

Zofran®

A

Ondansetron
Antiemetics

49
Q

Ondansetron

A

the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy

Rx

Tablets, oral solution, orally disintegrating tablets

50
Q

Ursofalk®

A

Ursodeoxycholic acid
Cholelitholytics

51
Q

Ursodeoxycholic acid

A

Dissolution of gallstones in the gallbladder & for the treatment of biliary reflux gastritis & cholestatic liver disease

Rx

Cap, tab

52
Q

Xenical®

A

Orlistat
Anti-Obesity Agents

53
Q

Orlistat

A

treatment of obese or overweight patients w/ associated comorbidities

Non-Rx

cap

54
Q

Liquids

A

aqueous,
alcohol,
oil,
suspensions,
inhalation

Dispensing Lab (8 decks)

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