434 - Midterm 1 Flashcards

1
Q

Magnesium Oxide
/Carbonate

A

ADSORBANT
Excipient to keep powders dry

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2
Q
  • *ASCORBIC ACID**
  • *asc**obyl palmitate, sodium ascorbate
A
  • *ANTIOXIDANT**
  • *ASC** the antioxidant

prevents oxidation

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3
Q

SHELLAC** + **GELATIN

A

COATINGS

Prevent degradation due to oxygen, light, moisture, mask unpalatable taste

(regular coatings)

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4
Q

Starches, calcium salts, lactose, Cellulose

(and other sugars including mannitol and sorbitol)

A

DILUENTS / FILLER
To add size to very small dosages.

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5
Q
  • *SACCHARIN**
  • *Mannitol / Sorbitol**

Syrups, oils, saccharin, lactose, mannitol, sorbitol, phenylalanine, xylitol

A

Flavoring Agents / Sweeteners

Masks bitter flavors, gives sweetness to a preparation.

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6
Q

MAGNESIUM STEARATE

calcium, PEG, glycerin, mineral oil

A

Lubricant / Anti-adherant

Helps keep ingredients from sticking to each other and to the equipment.

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7
Q

Sodium benzoate

benzoic acid

benzalkonium chloride

cetylepyridinium

A

PRESERVATIVES

BENZ / CETYL / PHENYL / PHENOL / PARABENS

Prevent growth of bacteria and other pathogens.

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8
Q

Mortar & Pestle

Coarse vs Smooth

A

•Coarse surface

•Particle size reduction of hard solids

•Emulsion formulation

•Caution – drug loss in mortar

Smooth = All other applications

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9
Q

COMMUNITION

A

Particle size reduction

Trituration – dry

Levigation – wet

Pulverization by intervention – dissolution and evaporation
for crystalline powders

Mechanical – electric grinder

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10
Q

Capsule Size

A

OPPOSITE DIRECTION

000 = LARGEST

2/3 = most common human caps

5 = smallest

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11
Q

Sweetener in oral Solutions

Saccharin, USP

A

0.02% to 0.1% w/w

Oil soluble;
bitter aftertaste

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12
Q

Saccharin Sodium, USP

Sweetener in Oral solutions

A

0.0075 to 0.6%

Water soluble;
bitter aftertaste

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13
Q

Stoke’s Law

A

Used to determine the

  • *VELOCITY**
  • Greater RADIUS = Faster Settling*
  • *Rate of settling** can be modified by:
  • Decreasing the difference between the density of the solid and liquid*

Increasing the viscosity of the fluid

Viscosity is best controlled by
adding viscosity enhancers or suspending agents

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14
Q

MethylCellulose

A

SUSPENDING AGENT
HydroPhylic Polymer

Grade number refers to the viscosity of a
2% aqueous solution

The greater the number, the greater the viscosity

4000cps = 4000x thicker than water

Prepared with
Heat & Tituration

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15
Q

Benzalkonium chloride NF

Polysorbate 20 NF (Tween 20)*

Polysorbate 80 NF (Tween 80)*

Sodium lauryl sulfate NF*

Sorbitan monostearate NF* (Span)

Glycerin

Mineral Oil**

A

Wetting/solubilizing agents

◦Used to lower surface tension between solid particles and liquids

Removes air from the powder in order to improve the ability of the powder to mix with the vehicle

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16
Q

Acacia, NF

Bentonite, NF

Bentonite Magma*

Carbomer resins, NF

Carboxymethylcellulose Sodium, USP

Colloidal Silicon Dioxide, NF

Tragacanth, NF

Xanthum Gum*

A

SUSPENDING AGENTS

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17
Q

Oral Suspension Components

A

◦Active drug

◦Inactive excipients:

Suspending agent/gelling agent
(surfactant, acacia, tragacanth, others)

Wetting agent

◦Sweetener (syrup)

◦Flavor

◦Color

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18
Q

Principles of Compounding Suspensions

WET HydroPhylic powders with?

A

HydroPhylic liquid** or **Surfactant
LIKE-LIKE

◦Thoroughly wet powders prior to adding the vehicle

Use the minimum amount of wetting agent required to produce the desired product

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19
Q

Principles of Compounding Suspensions

WET HydroPHOBIC powders with?

A

HydroPHOBIC liquid
LIKE-LIKE

◦Thoroughly wet powders prior to adding the vehicle

Use the minimum amount of wetting agent required to produce the desired product

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20
Q

EMULSIONS

3 Major Terms

A

Flocculation
controlled lacework-like structure of particles held together through weak van der Waals forces.

Creaming
Migration of the droplets of the internal phase to the top or bottom of the emulsion. The migration is caused by the difference in density between the two phases and the direction of the movement depends on whether the internal phase is more or less dense than the continuous or external phase.

Coalescence
The merging of small droplets into larger droplets with eventual complete separation of phases so that the droplets cannot be re-emulsified by simple shaking of the product. With coalescence, the barrier formed by the emulsifying agent is broken or destroyed.
This _irreversible_ coalescence of the droplets is also called cracking.

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21
Q

Desired properties of liquid emulsions

A

FINE DROPLET SIZES
Porcelain helps breaking up oil globules à uniform

Slow aggregation of droplets and product creaming
Most emulsions will eventually cream
Slow rate of creaming desired

Ease of redispersion when shaken
Aggregation and creaming may occur
Product should be formulated so that the internal phase readily redisperses to give a uniform emulsion when the product is shaken

Coalecence should not occur

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22
Q

Oleic Acid

Acacia

Span 80 = Sorbitan Monooleate

Tween 20

A

EMULSIFYING AGENTS

Different

HLB VALUE

HLB 10+ = HydroPhylic

HLB 10< = HydroPHOBIC

23
Q

HLB > 10

Ex.
Tween 20

A

HydroPhylic
emulsifying agents

More WATER SOLUBLE

Forms better OIL in WATER EMULSIONS

O/W

24
Q

HLB < 10

Ex.
Oleic Acid / Span 80

A

HydroPHOBIC
emulsifying agents

Better Water in Oil solutions

w/o

25
Q
  • *Emulsions:**
  • *Considerations of what determines EMULSION TYPE?**
A

Emulsifier
Surfactants/emulsifying agents can form either w/o or o/w emulsions

Phase ratio
Ratio of internal phase volume to external phase volume

Order of mixing
The phase being added, usually by portions, tends to be the internal phase

The phase present in the greater concentration tends to be the external phase

26
Q

If an excessive amount of internal phase is added any of the following may occur:

Internal Phase = Phase that is being ADDED
EX.
O/W –> Adding Oil so OIL = Internal Phase
HydroPhylic

A

It will all be emulsified and remain as separate droplets

◦The emulsion will coalesce

Phase inversion occurs
The external phase becomes the dispersed droplets (internal phase)

27
Q

Continental method = Dry Gum

A

4:2:1

Initial emulsion formed with a prescribed ratio of ingredients

4 parts oil : 2 parts water : 1 part emulsifier

DRY = Oil is mixed with the Gum/emulsifier
VVV
As water is added LAST –> PHASE INVERSION
O/W Emulsion

28
Q

What type of topical base?

White petrolatum

White ointment

Yellow petrolatum

A

Oleaginous Base
Hydrocarbons

Levigating Agent = Mineral Oil

Occlusive

29
Q

What type of topical base?

Aquabase

Aquaphor

HydroPhilic Petrolatum

A

Absorption Base
Hydrocarbon + w/o Surfactant

2nd most Oily

Solid + Oils + Small # of aqueous solustions

Mineral Oil + Low HLB surfactant

30
Q

What type of topical base?

Eucerin

Hydrocream

Nivea

A

W/O BASE
Hydrocarbon base + <45% w/w water + w/o Surfactant HLB _<_8

3rd most Oily

Moderate greasiness / occlusion

31
Q

What type of topical base?

VANISHING CREAM

Hydrophilic Ointment

Dermabase

A

O/W BASE
Water-removable base
Hydrophobic compounds + water + o/w surfactant

Easy Spread / Washale / Hydrous

Glycerin + HIGH HLB surfactant

32
Q

What type of topical base?

PEG Ointment

PolyBase

A

Water-Soluble Base
PEG

Easy spread/wash + not greasy

Glycerin + Propylene Glycol

33
Q

What type of topical base?

MethylCellulose

Carbomer Gels

A

HydroPhylic Base = GELS
Methylcellulose or Carbomer Dispersion

>95% water content

Glycerin + High HLB Surfactant

34
Q

Excipients

In Semisolid Dosage Forms

A

Stiffening Agents
Waxes w/ HIGH melting points
Blend into oleaginous bases to ↑viscosity, uses heat

Emulsifying Agents

  • *Humectants**
  • decrease the EVAP rate of water*
  • *Preservatives**
  • if there is WATER –> NEED THIS*

Absorption Enhancers
for TDDD

35
Q

Ointment Preparation

What to Levigate the solid material with if…?

OIL = EXTERNAL PHASE

A

MINERAL OIL

Levigate the solid material in a vehicle in which it is INSOLUBLE WITH
to make a smooth dispersion

External Phase = Most used base

36
Q

Ointment Preparation

What to Levigate the solid material with if…?

WATER = EXTERNAL PHASE

A

GLYCERIN

Levigate the solid material in a vehicle in which it is INSOLUBLE WITH
to make a smooth dispersion

External Phase = Most used base

37
Q

Ointment Preparation

FUSION

A

all or some components of the ointment are
combined by being MELTED TOGETHER
&
Cooled w/ constant stirring –> CONGEALED

Glass Beaker or Porcelain Evap Dish

Materials w/ LOWEST Melting points –> added LAST

38
Q

What type of Semisolid Dosage Form?

  • *either**:
  • *W/O emulsion** or O/W Emulsion

After applying –> water EVAPORATES
leaving a thin residue film of the oleaginous component

applied to:
Moist / Weeping Lesions

A

CREAMS

39
Q

Cream Preparations

A

Incorporation into existing cream/base
titurate –> rubber spatula to remove from M&P –> ointment slab

  • *Fusion Method**
  • *oil soluble + Water soluble** –> into SEPERATE BEAKERS

Both phases heated ABOVE MP of highest MP component

remove both from heat then ADD:
AQUEOUS PHASE –> OIL PHASE

40
Q

What type of Gel?

uniform distribution of gelling agent & Liquid
with no apparent boundaries

Gelling Agents = methylcellulose / tragacanth

A

SINGLE-PHASE GEL

41
Q

What type of Gel?

consists of floccules of small distinct particles
often referred to as: MAGMA

Gelling Agents = methylcellulose / tragacanth

A

TWO-PHASE GELS

42
Q

Suppository Bases

Oleaginous Fatty Base

A

MOST FREQUENTLY USED BASE

  • *Cocoa Butter**
  • low melting point* –> needs room temp / fridge

Hydrogenous Veggie Oils
palm / coconut oils

FattiBase** / **Witepsol** / **Fatty Blend

43
Q

Suppository Bases

Water-Soluble Bases

A

Glycerinated Gelatin
70 parts glycerin / 20 parts gelatin / 10 parts water
does NOT melt –> DISSOLVES
can adsorb moisture

  • *Polyethylene Glycol = PEG**
  • does NOT melt* @ body temp –> DISSOLVED into BODY’s FLUIDS
  • slower release of meds from the base*
44
Q

Suppository Preparation

Lubrication for Water-Soluble Base?

A

OPPOSITE OF THE BASE

MINERAL OIL LUBRICANT
for water-soluble base

use minimal lubricant
excessive lube –> pools / misshapes suppositories

45
Q

Suppository Preparation

Lubrication for Oil-Soluble Base?

A

OPPOSITE OF THE BASE

GLYCERIN or PEG lubricant
for oil-soluble base

use minimal lubricant
excessive lube –> pools / misshapes suppositories

46
Q

Suppository Preparation

Levigate drug with what?

for Water-Soluble Base

A
  • *GLYCERIN or PEG LUBRICANT**
  • *Levigate with wetting agent = same property as base!**

Preparation:
Tituration of drug into uniform/small partical
Drug is mixed directly into base OR wetted b4 incorperation

47
Q

Suppository Preparation

Levigate drug with what?

for Oil-Soluble Base

A
  • *MINERAL OIL LUBRICANT**
  • *Levigate with wetting agent = same property as base!**

Preparation:
Tituration of drug into uniform/small partical
Drug is mixed directly into base OR wetted b4 incorperation

48
Q

What type of Troche?

Sugar + Carbs
corn syrup / water / drug

Smooth Surface texture

HIGH TEMP to prepare
154-160 degrees –> need to monitor closely

A

HARD TROCHES

49
Q

What type of Troche?

PEGs + Acacia
drug / sugar / wax / various PEG’s

Flavored & colored

Slowly Dissolved in mouth or Chewed

A

SOFT TROCHES
pastilles

50
Q

What type of Troche?

formulated with a:
GELATIN BASE = Jello
drug/gelatin / glycerin / water

Highly Flavored

A

CHEWABLE TROCHES
gummies

51
Q

Sterile BUD - 797

CATEGORY 1

A

CAT 1 = Segregated Compounding Area
dirtier than cat 2

< 12 Hours @ Room temp

<24 hours @ Refridgeration

52
Q

Sterile BUD - 797

Category 2

A

EVERYTHING IN COMPOUNDING HOOD/AREA
Must follow manufacturer’s guidelines - if BUD is shorter

Made from 1+ Non-sterile Component:
1 - 4 - 45 days

ONLY STERILE starting products:
4 - 9 - 45 days

53
Q

Non-Sterile BUDs 795

A

ROOM TEMP
Solids = 180 days

​Non-Aqueous (suppositories, ointments) = 90 days

Preserved Aqueous = 30 days

Refrigerator
Non-preserved Aqueous = 14 days
Suspensions / emulsions / gels / creams /sprays