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Dosage Forms 2 > Lecture 1 > Flashcards

Lecture 1 Flashcards

1
Q

Solution

A

Homogeneous molecular dispersion

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2
Q

Emulsion

A

Oil in water, water in oil, looks like bubbles

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3
Q

Suspension

A

Solid in water or oil, looks like dirt

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4
Q

Solution dosage form examples

A

Injectables, nasal solutions, opthalmic solutions, otic solutions, irrigation solutions, enemas, douches, gargles, mouthwashes, juices

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5
Q

Advantages of solution dosage forms

A

Homogeneous no problems of content uniformity, easy to manufacture, good bioavailability

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6
Q

Components of solution dosage forms

A

Active ingredient = drug
Solvent = water, vegetable oils
Cosolvent = ethanol, glycerin, propylene glycol
Buffering agent
Preservative
Antioxidant, chelating agent
Flavor and sweetener = sucrose, sorbitol

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7
Q

Buffer

A

Solution of weak acid and salt of its conjugate base

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8
Q

Weak acid removes

A

added base

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9
Q

Salt removes

A

added acid

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10
Q

Henderson hasselbalch equation

A

ph=pka + log A-/HA

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11
Q

Buffering capacity

A

Ability of a buffer to resist a change in pH due to added OH or H

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12
Q

Van slyke equation

A

b=2.3C ka[H3O]/Ka+[H3O]^2
C = total buffer concentration
Max when pH=pka

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13
Q

Selection of pH

A

Use pH that provides maximum stability for drug
Minimize irritation with parenteral, opthalmic, or nasal dosage forms by adjusting to be the same pH of body fluid

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14
Q

pH of blood, interstitial fluid, and tears

A

7.4

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15
Q

Other ways to minimize buffering capacity besides pH

A

Minimize volume, administer slowly

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16
Q

Antimicrobial preservative purpose

A

protect patient from pathogens
maintain potency and stability of dosage forms

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17
Q

Antimicrobial preservative mechanism of action

A

Preservatives adsorb to bacterial membrane and disrupt it. Bacterial membrane is lipophilic and has a net negative surface charge

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18
Q

Adsorption due to lipid solubility

A

alcohols, acids, esters

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19
Q

Adsorption due to electrostatic attraction

A

Quaternary ammonium compounds

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20
Q

Ampules allowed bacterial content

A

Must be sterile, single dose, no preservative needed

21
Q

Multiple dose vial allowed bacterial content

A

must be sterile, may contain 10 doses, need a preservative to kill microorganisms introduced during use

22
Q

Opthalmic solution allowed bacterial content

A

must be sterile, must contain a preservative if packaged in multiple dose container

23
Q

Oral liquid allowed bacterial content

A

need not be sterile but should not contain pathogens. FDA limits number of organisms to be less than 100 per mL, need preservative for multiple dose packages

24
Q

Oral solids allowed bacterial content

A

Less likely to carry bacterial than liquid forms, test raw materials to be sure manufacturing facility is clean

25
Ideal preservatives
effective in low concentrations against a wide variety of organisms soluble in formulation non toxic stable
26
Pharmaceutical preservatives
Alcohols, acids, esters of p hydroxybenzoic acid (parabens), quaternary ammonium compounds
27
Alcohols
Ethanol, benzyl alcohol, chlorobutanol
28
Ethanol
requires greater than 15% limited to oral products, may be lost due to volatility
29
Benzyl alcohol
Local anaesthetic action, burning taste (not use orally), water soluble, stable over wide pH range, widely used in parenterals
30
Chlorobutanol
Campor like odor and taste, not used orally, used in parenterals and Opthalmics, volatile, lost through rubber stoppers and plastic containers
31
Acids
only active in unionized lipid soluble form
32
benzoic acid
pka 4.3, used in oral products
33
Sorbic acid
pka 4.8, used in oral products, excellent in molds and yeast
34
Esters of p-hydroxybenzoic acid (Parabens)
Widely used orally, hydrolyze rapidly at pH values above 7, anesthetize tongue Low solubility is problem, causes skin sensitization when used in dermatological products
35
Propyl paraben and butyl paraben
Most lipophilic esters, best against mold and yeast
36
Methyl paraben and ethyl paraben
Lease lipophilic esters, best against bacteria
37
Quaternary ammonium compounds
Benzalkonium chloride (zephirin), cetyltrimethylammonium chloride (cepryn), widely used in opthallmics, water soluble and fast killing, incompatibility issues due to positive charge
38
pH affect on preservative action
Only unionized species of weak acids are effective as preservative, add more total weak acid when pH is above pka to have effective concentration of unionized species
39
Complex formation effect on preservative action
Only uncomplexed free preservative is active
40
Adsorption by solids effect on preservative action
only the unadsorbed preservative is active
41
Chemical stability effect on preservative action
Consider the shelf life
42
Antioxidants
Drug substances that are less stable in aqueous media than in solid dosage forms, reactions may occur from ingredient-ingredient interactions/container product interactions
43
Oxidation
Main degradation pathway of pharmaceuticals, initiated by heat, light, peroxides, metals (copper or iron)
44
Auto-oxidation
automatic reaction with oxygen without drastic external interference
45
Free radical scavengers
retard, delay oxidation by rapidly reacting with free radicals
46
Examples of free radical scavengers
Propyl, octyl, dodecyl esters of gallic acid, BHA, BHT, tocopherols, Vitamin E
47
Reducing agents
Have lower redox potentials than drug, more readily oxidized
48
Examples of reducing agents
Sodium bisulfite, ascorbic acid, thiols
49
Chelating agents
Antioxidant synergists, little antioxidant effects, remove trace metals like citric acid, EDTA

Dosage Forms 2 (3 decks)

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