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PHAR 224 > Medical Sticks and Suppositories > Flashcards

Medical Sticks and Suppositories Flashcards

1
Q

What is a main difference between soft and hard sticks?

A

hard sticks require moisture to activate them; hard sticks not really used in pharmaceutics anymore

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2
Q

How are medical sticks made?

A

Molding/fusion

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3
Q

Fatty base agents for sticks?

A

cocoa butter, vegtable oils, hydrogenated vegtable oil, waxes

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4
Q

Water-soluble bases agents for sticks?

A

Sodium stearate, glycerol PEGs

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5
Q

Case: Why use a suppository for an infant for constipation?

A

Acts quickly, safe, localized absorption

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6
Q

Suppository definition?

A

A solid dosage form used for rectal, vaginal, or urethral admin
Consists of a dispersion of active ingredient in an inert matrix (rigid/semi-rigid)

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7
Q

What are advantages of suppositories?

A

less invasive than injectables?
limit first pass effect
limit DI’s when given in combo w/ other therapies
can be used for local or systemic effect
accomadates pts who have difficulty swallowing
accomodates admin in unconscious pt or infants
Increases F of drugs

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8
Q

What are the limitations of suppositories?

A

not for long-term treatment (lower acceptance rate)
user discomfort
Special storage condtions like low temp
Difficult for self admin for some pts

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9
Q

Explain which vein is systemic and wich is not in rectal absorption of drugs

A

Absorbed through inferior middle rectal vein that leads into inferior vena cava –> direct systemic absorption
Superior rectal veins drain into portal vein which bases into liver prior to reaching systemic absorption

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10
Q

Steps of rectal absorption

A

Fusion.dissolution –> diffusion –> mucus layer –> rectal mucosa –> transport

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11
Q

What formulation factors can impact drug absorption?

A

pKa
physical state of the drig in formulation
solubility; degree of ionization and particle size
solubility of drug in rectal fluid
Partition coefficient of drug
particle size (want lower)

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12
Q

What physiological factors impact drug absorption?

A

Anatomical size
site ofdrug delivery in the rectum
change in rectal pH based on age or disease conditions
presence of stool in the rectum
frequecny of bowel movements
pathological chagnes in tissue integrity ; changes in thickness of mucosa

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13
Q

Sizes/shapes of Rectal, Vaginal, and Urethral suppositories in Adults/children?

A

Rectal: 2g/1g bullet/ torpedo shaped (32mm long)
Vaginal: 5g(varies) globular, oviform or cone shaped(pessaries)
Urethral: Males: 140 mm x 3-6mm ~4g shape: slender, pencil shaped

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14
Q

Why use suppostory over oral?

A

poorly absorbed orally
taste unacceptable
irritates GI
drug of abuse
Acid liable drugs
Drugs prone to enzymatic degradation

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15
Q

What characteristics should a vehicle/base have for suppository sticks?`

A

Able to:
melt
soften
dissolve at body temp
promote drug release
stay stable during manufacturing and storage
inert
esthetically acceptable

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16
Q

What are bases used for suppositories?

A

Fatty: cocoa butter, hydrogenated vegtable oil, hydrogenated palm oil
Water: glycerine, PEG

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17
Q

When do you use a fatty or water-soluble base for a suppository?

A

Fatty: if drug is highly soluble in water, low solubility in fat
Water: drug highly souble in fat, low soluble in water
This is because it promotes drug release

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18
Q

Characteristics of Cocoa Butter?

A

Natural TG
Melting Point: 31-35 (low)
Solid @ 25
4 polymorphic forms w/ different MP’s (major limitation)
Requires lubrication of the mold when compounding

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19
Q

Characteristics of hydrogenated vegtable ois (witepsol)

A

Suppocire
Semi-synthetic –> resistant to oxidation/hydrolysis
Waxy solids
MP: 33-45
No polymorphism
more flexible and less brittle character
lower viscosity –> separation/sedimentation risk of API while cooling (lack of uniformity potential)
Self lubricating but, contract in mold

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20
Q

Acid value and Hydroxyl nomber for Cocoa butter, hydrogenated oil, suppocire?

A

<5, 0
<2, 5-30
Low, <10-30

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21
Q

Characteristic of glycerol-gelatin base?

A

Rare to use b/c not inert (laxative effect)
hygroscopic so storage condtions very important
dissolution varies w/ age of suppository –> unpredictable API response

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22
Q

Characteristics of PEG?

A

slow drug release
MP’s differ based on combination components
Chemically stable but not physically stable, inert compatible
Limited by:
- hygroscopic
- incompatabilities w/ API’s
- May become brittle on storage
Prepared by molding and compression, no lubrication needed

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23
Q

What additives are used to improve incorporation of API’s?

A

Fixed oils (levegate solids), water

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24
Q

What additives are used to increase hydrophilicity and dissolution characteristics?

A

Ionic surfactants (Anionic, SDS, SLS, TEA-stearate), non ionic surfactants (TWEEN)

25
Q

What additives are used to improve viscosity?

A

Al-monostearate, glyceryl monostearate, steryl/myristyl/ - cetyl alcohols, bentonite, colloidal silica

26
Q

What additives are used to modify MP?

A

FA’s, fatty alcohols, waxes

27
Q

What additives are used to protect against degradation?

A

antimicrobial, antifungal, antioxidant

28
Q

When should you consider rectal route as a pharmacist?

A

peds
pts w/ dysphagia
pts w/ N&V
refusal of oral meds/ spitting out tablets
pts w/ GI blockage/obstruction
pts w/ esophageal stricture or malignancy
loss of consciousness/palliative care
decreased mental status

29
Q

When should you not consuder rectal route as pharmacist?

A

neonatal pts
pts w/ conditions assocaited w/ meutropenia
thrombocytopenia
chronic constipation
increased GI motility (diarrhea)
placement of medication causes pain

30
Q

What are the preparation steps for suppositories?

A

Mold prep
Mold calibration
Base prep
API incorporation
mixing and pouring
cooling and finishing
packaging, storage and labelling

31
Q

What is the displacement factor?

A

Measures amount of ctive substance that dispalces 1 gram of suppository base
Available in literature for common drugs
Affects final suppository wt and dosing uniformity of the formulation especially for drugs which exhibit high displacement factors

32
Q

Benefits of cold compression?

A

increased rate of production
No sedimentation problems
eliminates temp changes related problems
suitable for thermoliable and insoluble drugs

33
Q

How does cold compression work?

A

base and drug mixture is forced into a mold under pressure using a wheel operated pressing into open molds

34
Q

Disadvantages of cold compression?

A

Requires finely powdered excipients
Not used for extemporaneous compounding

35
Q

What are the problems w/ hand rolling? When is it used?

A

tedious, not very uniform
Usually used for cocoa butter

36
Q

How are suppositories usually packaged?

A

Individually wrapped
Fatty base: 2-8
Water base: tightly closed containers to avoid moisture
PEG can be stored at room temp

37
Q

What causes craching, splitting, and pitting? How can it be fixed?

A

Excipient contracts strongly, large time gap between pouring and cooling –> temp fluctuations
Fix:
Use an excipient which crystalizes slower, maintain optimum control of steps pouring and cooling to minimize temp changes

38
Q

What causes sticking to mold? Fix?

A

fatty molds (gaps between molds upon closure), premature removal from mold, insuffeceint cooling, insuffecient lubrication
Fix: Use appropriate equipment, prolong molding period/cooling period, use an excipient whcih crystalzies more rapidly, reduce cooling temp, sufficient lubrication

39
Q

What causes thickening prior to pouring? fix?

A

High proportion of finely powedered API’s, high viscosity base mixtures.
Fix: PEG select the mixture of right PEGs, adjust [ ] of the API in the dosage form

40
Q

What causes poor product homogeneity?Fix?

A

dispalcement factor not taken into account, cooling to slow or too weak leading to drug sedimentation.
Fix: calculation should be carefully perfomed, increase vsicosity of the base

41
Q

What causes product insufficiently solid? FIx?

A

Inclusion of air
Fix: check the stirring levle and limit formation of air bubbles

42
Q

What cuases surface anomalies? Fix?

A

High melting point excipients, >60 MP = longer residence in mold leading to shape abnormalities, excipient to API ratio
Fix: Ensure mold is appropriately sealed, use excipients to stabalize the system such as surfactants

43
Q

Patient counseling points for supositories?

A

follow package instructions
to lubricate use water soluble (do not use petrolatum jelly)
Insert the medication about a finger length into rectum and place against rectal wall
close legs and sit or lay still for ~15 minutes
avoid emptying bowels for about 1 hour
Avoid exercise and excessive movement for about 1 hour
Vaginal and urethral almost always come w/ applicator

44
Q

What is needed to activate hard sticks?

A

moisture

45
Q

Which base contracts in the mold?

A

Hydrogenated oils (witepsol)

46
Q

Which base needs lubricating when compounding?

A

cocoa

47
Q

Which form of cocoa butter is needed

A

beta

48
Q

What does a high melting point of base tell us?

A

sustained release

49
Q

Which base is not inert?

A

glycerol-gelatin= laxative

50
Q

How does age effect glycerol bases?

A

changes dissolution= not always the same dose

51
Q

Which bases need to be stored in a cool place?

A

fatty

52
Q

What type of lube should be used for insertion?

A

water soluble

53
Q

How far to insert?

A

finger length

54
Q

How long to sit still after application?

A

15 min

55
Q

How long should you avoid BM and exercise?

A

1 hour

56
Q

What is always given with a urethral suppository?

A

applicator

57
Q

How far do you insert for vaginal and urethral?

A

as far as comfortable

58
Q
A
59
Q
A

PHAR 224 (7 decks)

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