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PHAR 124* > Solutions > Flashcards

Solutions Flashcards

1
Q

How can mixtures be divided into two main groups?

A

Homogenous (uniform composition)

Heterogenous (non-uniform composition)

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2
Q

What is the only type of homogenous mixture?

A

Solutions (particles are small and evenly dispersed)

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3
Q

What are the types of heterogenous mixtures?

A

Colloid (particles are medium and dispersed, but do not settle)

Suspension (Particle are large and settle out)

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4
Q

What is the definition of a pharmaceutical solution?

A

A chemicaly and physically homogenous liquid preparations of two or more substances

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5
Q

What are some excipients added to solutions?

A

Flavouring, sweeteners, colourants, and preservatives are some examples

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6
Q

What solvents are used in pharmaceutical solutions?

A

Water is most commonly used and desirable, but other solvents are also used

Alcohol (94-96%)
Glycerin
Propylene glycol
Oils

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7
Q

For topical applications, are polar solvents better compared to non-polar solvents?

A

No, non-polar solvents are more liklely to absorb into the skin (lipid-based)

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8
Q

What is the utility of solutions as a dosage form?

A

Injectable drugs
Pediatric formulations
Opthalmic preparations
Some lotions
Sprays

Liquid dosage forms are prefered by children and people who have a hard time swallowing other oral dosage forms

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9
Q

What are the advantages of solutions in pharmacy?

A

Solutions skip disintegration and dissoultion, therefore the absorb the faster compared to solid dosage forms

Can be intended for multiple routes of administration

Flexible dosing, different volumes can be used depending on the circumstances

No shaking needed (solute is completely disolved into the solvent)

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10
Q

What are some disadvantages of solutions in pharmacy?

A

Increased sensitivity to environmental conditions

Reduced technical accuracy

Solubilty of drug must match excipients

Bulky storage and transport

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11
Q

What is the difference between solubility and dissolution?

A

Solubility: The quantity of solute to form a saturated solution (constant at a given temperature)

Dissolution: The transfer of molecules and ions from a solid phase into a solution (describes the process)

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12
Q

How can dissolution be enhanced?

A

Trituration can reduce particle size and decreases solution time

Heat

Vigourous shaking

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13
Q

What physiochemical factors affect solubility?

A

Molecular weight and volume

Precense of functional groups and their position (structure)

Acids or bases (pH dependent solubility)

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14
Q

Do aqueous solutions have different boiling and freezing points compared to pure water

A

Solutes increase boiling point and reduce freezing point

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15
Q

What are the different types of solutions?

A

Gases in Liquids (effervescent tablets)

Liquids in Liquids (elixirs)

Solids in Liquids (drug powders for injectable reconstitution)

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16
Q

Does pressure increase solubilty of gases in liquids?

A

Yes

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17
Q

Does temperature increase solubility of gases in liquids?

A

No, increased temperatures reduce the amount of solvent that can be dissolved into the solvent

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18
Q

What happens to gases in liquids when a different solute is added to the solution?

A

If the solute has a greater affinity for water than the dissolved gas, the solution will bubble of some gas

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19
Q

What is miscibility?

A

Expresses the mutual solubility of components in a liquid-liquid system (mixes without separating)

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20
Q

Are all liquids miscible with each other?

A

No, some are only miscible under certain conditons (proportion and temperature), while others are completely immiscible

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21
Q

How does temperature impact solubility?

A

With endothermic substances, solubility increases with temperature (disolution requires the input of energy)

With exothermic substances, solubility decreases with increases in temperature (dissolution results in the release of energy)

With Normothermic substances, solubility does not change with temperature (energy is neither absorbed or released during dissolution)

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22
Q

What is polarity?

A

It is the separation of electric charge leading to a molecule or its chemical groups having an electric dipole moment, with a negatively and positively charged ends

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23
Q

What are some non-polar solvents used in pharmceutical preparations?

A

Fixed oils (non-volatile): ex. vegetable oils

Hydrocarbons: ex. mineral oils

Non-polar solvents are used as a vehicle for injections and for external preparations (topical)

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24
Q

What is the most desirable polar solvent?

A

Distilled Water

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25
Q

What is potable water?

A

Water that is “fit to drink”

It may contain impurities and minerals:
Ions
Organic matter
Atmospheric gases
Suspended materials (clay, silt, etc)

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26
Q

How is water made potable from raw sources?

A

Removal of insoluble matter via settling and filtration

Destruction of pathogenic organisms by chlorination (boil and treat with chlorinating agent)

Once processed, potable water contains less than 0.1% of total solids

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27
Q

Is potable water an acceptable ingredient in pharmaceutical preparations?

A

No, potable water still contains many impurities. It serves as the starting point for further processing

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28
Q

What types of water are used in pharmaceutical preparations?

A

Purified water (dilutin for non-sterile preparations)

Water for injections (sterile, no particles or pyrogens)

Sterilized water

Bacteriostatic Water for Injection (used in multi-dose sterile preparations

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29
Q

Do formulations that use sterile water need preservatives?

A

Single dose formulations can sometimes go without preservatives, but multi-dose formulations need preservatives. Preservatives prevent contamination following each use

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30
Q

What are some semi-polar solvents commonly used in pharmaceutical preparations?

A

Alcohol (Ethanol) is the most common semi-polar solvent. It is often used to dissolve organic compounds.

The following are also used in pharmaceutical preparations:
Isopropyl alcohol
Glycerin
Propylene glycol
Polyethylene glycol 400

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31
Q

What is an elixir?

A

Alcohol+water=hydroalcoholic solution (elixir)

Elixirs can dissolve both alcohol and water soluble compounds

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32
Q

What are the advantages of semi-polar solvents?

A

Better solubility for many compunds

Better drug stability (reduced hydrolysis and bacterial growth)

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33
Q

Is alcohol (ethanol) miscible in a wide variety of other solvents?

A

Yes

ex. Caster oil (not other fixed or mineral oils), Water, other semi-polar solvents

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34
Q

What are the limits for alcohol content in OTC products?

A

Children under 6: below 0.5%

Children 6-12: below 5%

12+ (Teens and Adults): below 10%

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35
Q

What are the different types of alcohol?

A

Denatured alcohol (ketones or kerosene): not fit for internal use

Absolute alcohol (99.5% ethanol v/v): water-free ethanol

Diluted Alcohol NF (equal amounts of water and alcohol)

Rubbing Alcohol (70% alcohol): for external use only

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36
Q

Are mixed solvents more effective in their ability to dissolve solutes?

A

In some cases, water and alcohol mixed solutions have better solubility compared to either solvent on their own

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37
Q

How should solutes be added to a mixed solution?

A

It is important that each solute is first dissolved into the solvent it is most soluble. The two solutions are then blended into a mixed solution. Usually the solution without actual drug compound is poured into the drug containing solution (ensures the drug solution concentration remains well above near zero, prevents the drug from precipitating out)

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38
Q

What is complexation?

A

They are loose molecular associations that can either increase or decrease solubility

Ex. Tetracycline complexes with Ca2+ from mil/milk products to form an insoluble complex that decreases the drug’s dissolution and absorption

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39
Q

What types of drugs are susceptible to complexation with di/trivalent ions?

A

Certain antibiotics (tetracyclines, fluoroquinolones)

Certain osteoporosis drugs (risedronate)

Thyroid medications (levothyroxine)

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40
Q

What is the difference between molarity and morality?

A

Molarity: mol/L

Molality: mol/kg

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41
Q

What are some different ways drug concentration can be represented?

A

Molarity and Molality

Osmolarity: Osmol/L(# of moles contributing to osmotic pressure of the solution, moles of ions following dissolution into water)

Units of potency/unit volume: I.U/L

Weight/Unit Volume: g/L, mg/mL, etc.

Percentage: w/v, v/v, w/w, mg%, etc.

Parts per million (PPM): #of parts of substance/1 million units of solvent

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42
Q

What is the use of excipients in solutions?

A

Help increase storage stability, enhance solubility, taste, etc.

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43
Q

What are some conversion rates between metric and pharmacy units?

A

5mL = one tsp

10mL= two tsp

15mL=three tsp(one tbsp)

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44
Q

What are some requirements for an oral solution?

A

Physical stability

Chemical stability

Microbiological stability

Palatability

Pleasing appearance

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45
Q

What does physical stability in oral solutions look like?

A

No discolouration/cloudiness

No precipitation

No loss of elegance

No loss of taste

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46
Q

What does chemical stability look like in oral solutions?

A

There must not be changes to the molecular structure of the drug (maintain integrity and potency of drug)

pH must be controlled to ensure stability

Hydrolysis also needs to be limited, this can be done with the use of non-aqueous solvents like alcohol

Oxidation can be controlled through the use of antioxidants like ascorbic acid

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47
Q

What does microbiological stability mean in oral solutions?

A

Preservatives are commonly added to improve shelf life. Examples of preservatives include glycerin, alcohol, and anti microbial

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48
Q

What are some characteristics held by the “ideal” additive to an oral solution?

A
  1. Pharmacologically inactive and non-toxic
  2. Potent, therefore can be used in low concentrations
  3. No unpleasant odour or flavour
  4. Compatible with drug and other excipients
  5. pH stable and resistant to light energy
  6. Soluble in vehicle/solvent
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49
Q

What are some types of additives in oral solutions?

A

Flavouring agents

Sweeteners

Colouring agents

Antimicrobial preservatives

Antioxidants

Buffers

Viscosity-inducing agents

Surface active ingredients

50
Q

How does the tongue detect taste?

A

The solution comes in contact with the taste cells on the tongue and initiates a nerve impulse. The impulse is transmitted via the cranial nerve to the brain, where it is interpreted as a specific taste.

*The drug must be dissolved in the mouth before it can be tasted

51
Q

What are the four primary tastes?

A

Sweet: (low molecular weight poly-hydroxyl compounds, ex. sucrose, mannitol)

Sour: (H+ ions cause acidity, sour is sensed if acidic compounds are tasted)

Bitter (most common in pharmaceutical preparations): high molecular weight salts, free bases and nitrogen-containing compounds (ex. caffeine and codeine)

Salty: (low molecular weight salts and ionic compounds, ex. NaCl, ammonium chloride)

52
Q

What are some flavouring techniques used in pharmaceutical preparations?

A

Physiological

Physical

Masking or overshadowing

Blending

Chemical

53
Q

Describe the physiological flavouring technique

A

In this approach, the goal is to anesthetize the taste buds/receptors

ex. menthol and other mint flavours, carbonated beverages, cooled liquid

54
Q

Describe the physical flavouring techniques

A

In this approach, the goal is to prevent dissolution of drug or preventing drug from coming in contact with taste buds/receptors.

Viscous liquids are employed to reduce the dissolution rate

Tablets can be coated to contain bitter compounds inside

55
Q

Describe the overshadowing flavouring technique

A

Addition of a flavour whose intensity is longer and stronger than the taste of the drug

ex. Methyl salicylate

This technique uses the same concept of adding lemon juice to food to make it taste less salty because the lemon juice overpowers other flavours

56
Q

Describe the blending flavouring technique

A

In this approach, the goal is to add flavours which complement the taste and modify the flavour perception. Add fruit flavours to drugs that are sour tasting and add salty or sweet and sour flavours to bitter tasting drugs

ex. Vanillin, benzaldehyde

57
Q

Describe the chemical flavouring technique

A

A drug compound can be complexed or delivered as a prodrug, a new substance that has a better flavour profile. These modifications should not affect the overall therapeutic profile of the drug.

ex. Tetracycline dispensed as a HCl salt

58
Q

What are some other factors besides flavouring that can affect taste?

A

Aroma is a strong determinant of taste perception (scent shoulkd be pleasant and correlate with flavour)

Texture is also iprtant for taste perception and acceptance

Viscosity of syrups have a positive effect on patient acceptance (les viscous: perception of watered down, and if a preparation is too viscous, it is seen as slimy or gooey

59
Q

What are the two catagories of sweeteners?

A

Natural and artificial sweeteners

60
Q

What are some desired properties in sweetners?

A

Colourless

Dodourless

Pleasant tasting

No aftertaste

Stable over a wide pH range

61
Q

What compound is the gold-standard for sugar-based sweetening agents in pharmaceutical agents

A

Sucrose (cane sugar, beet sugar)

Other sweeteners are compared to sucralose

62
Q

What are some examples of sugar-based sweeteners?

A

Sucrose

Lactose (usually used as an inert filler)

Dextrose (less sweet than sucrose)

63
Q

What are some possible concerns for using sugar-based sweeteners in pharmaceutical formulations?

A

Sugar-based sweeteners have high water solubility, and this can salt out other solutes/drug

Poses concern for diabetics

They can crystalize on the bottle caps

Sugar can crystallize during heating

64
Q

What are some examples of artificial polyol-based sweeteners?

A

Glycerine

Propylene Glycol

These sweetners are less sweet compared to sucrose

65
Q

What are some examples of natural polyol-based sweeteners?

A

Sorbitol (less sweet compared to sucrose, can cause flatulence)

Mannitol (less sweet than sucrose, but has laxative effects at high doses)

Xylitol (similar sweetness as sucrose, but absorbed slower)

66
Q

What are examples of artificial sweeteners?

A

Saccharin (300 times sweeter than sucrose):
Often used in its sodium salt form due to better water solubility. Moderate amounts of saccharin is safe for consumption

Cyclamate (30 times sweeter than sucrose): Used as either a sodium or calcium salt. Due to safety concerns, it is only used in drugs and not food

Aspartame (180 times sweeter than sucrose): most commonly used and unstable at high temperatures

Sucralose (600 times sweeter than sucrose): stable at high temperatures

Stevia (200 times sweeter than sucrose): plant source, but has some drug interactions

67
Q

What are some problems associated with aspartame and heat?

A

Aspartame degrades into diketopiperazine when exposed to high temperatures (180*C).
Diketopiperazine has decreased sweetness, therefore aspartame shouldn’t be used in preparations that will involve high temperatures in their processing

68
Q

What are some problems associated with aspartame and PKU (phenylketonuria)?

A

Patients with PKU have an intolerance for aspartame

69
Q

When should sweeteners be added to a formulation in relation to flavoring agents?

A

When experimenting with formulations, always establish flavour concentration and then modify sweetener concentration

Most flavours are bitter, so they require sweetening to make taste more pleasant

70
Q

Why are colours added to drug formulations?

A

To enhance the esthetic quality of the preparation (elegance, attractiveness). Can be done with natural or synthetic dyes

To act as a sensory adjunct to flavour

71
Q

What colours are rejected by patients?

A

Dark colours such as dark purple, navy black, and brown because they are often associated with poisons

72
Q

How can colours improve taste?

A

Some drug manufacturers resort to visual distraction by colouring bitter drugs with bright colours. This can enhance palatability by fooling the brain into not fully perceiving bitter taste

73
Q

What situations make visual distraction ineffective as a way to mask taste?

A

Not practical in young children, because they do not yet associate colours, aromas, and taste

In drugs that need to be taken multiple times, visual distraction works the first few times, but that effect wears off

74
Q

Are liquid stock colourants found in grocery stores safe to use in pharmaceutical preparations?

A

No, they lack stability and contain impurities that could potentially affect the safety and efficacy of a given drug

75
Q

What is the difference between pigments and dyes?

A

Pigments are insoluble materials that give colours when dispersed in some liquid

76
Q

What are some examples of natural colouring agents used in pharmaceutical preparations?

A

Mineral pigments (used for lotions, cosmetics, and other external preparations)
ex. yellow ferric oxide or white titanium oxide

Plant pigments
ex. green chlorophyll, orange b-carotene, yellow saffron

Animal pigments
ex. purple murex (sea snails)

77
Q

What is the safety of colouring agents?

A

Colours used in foods, drugs, and cosmetics must be certified for such use:

FD&C: food, drugs, and cosmetics (safest)

D&C: drugs and cosmetics (no food)

External D&C: not allowed in products for lips, but can be applied on the skin

78
Q

Colouring agents are safe for use in ophthalmic solutions. True or False

A

False. No colour is certified for use in ophthalmic solutions

79
Q

Preservatives should never be added to opthalmic solutions. True or False

A

False. Preservatives are commonly added to opthalmic solutions especially if they are intended for multiple use

80
Q

What are some concerns with synthetic colouring agents?

A

Carcinogenicity

Hypersensitivity (potential to develop allergic symptoms)

Hyperactivity in kids

Dyes can be affected by changes in pH

Are subject to oxidation/reduction reactions

They can be incompatible with large cationic compounds such as alkaloids

81
Q

What is the concentration of colouring agents in pharmaceutical preparations?

A

For colour: use a concentration of between 0.0005-0.001%

For a tint: use a concentration of as low as 0.0001%

These low concentrations are achieved through repeated dilutions of stock solutions

82
Q

When are preservatives added to pharmaceutical formulations

A

Added to non-sterile dosage forms to protect drug from microbial growth and proliferation of microorganisms

Preservatives are also added to sterile multiple-dose formulations

83
Q

In what cases is a preservative not needed?

A

No water is present (tablets, powders, and hydrocarbon ointments)

If the formulation is acidic or basic (less than 3 or more than 9)

Other ingredients with antimicrobial properties (high sugar or alcohol content)

Large volume parenteral drugs are free of preservatives due to bulk exposure to preservatives (potential toxin)

84
Q

In what products are preservatives contraindicated?

A

Drugs for neonates

Opthalmics

Parenteral solutions with volumes greater than 30mL

85
Q

What are some strategies used to prolong shelf life without the addition of preservatives?

A

Prepare single sterile doses

Prepare smaller quantities

Refrigerate formulation

86
Q

What requirements must an excipient meet to be officially classed as a preservative?

A

Actvity needs to be broad spectrum

Must reduce a microbial population significantly and prevent subsequent re-growth

87
Q

How do antioxidants work in basic terms?

A

They divert the oxidative process by reacting with one or more compounds in the formulation to prevent a free radial mediated chain reaction

88
Q

What antioxidants are used in pharmaceutical preparations?

A

For aqueous systems (ascorbic acid, sodium sulfite, and bisulfite)

For oil systems (BHA, Vitamin E)

89
Q

What is the purpose of buffers?

A

They control the pH of a solution and therefore the stability of the product

They always contain a weak acid and its conjugate base

90
Q

When are buffers used in pharmaceutical preparations?

A

Used in formulations applied to sensitive membranes, of eye or nasal passages or injected into muscles, blood, organs, tissues or lesions

91
Q

What is the use of viscosity-inducing agents in pharmaceutical preparations?

A

They can change the consistency of a preparation. If used, they have a concentration of 2-10% w/v

The product becomes easier to pour vs. something that is less viscous

May improve appearance and palatability

Great for achieving desired smoothness and consistency, especially in topical solutions

Ease in the application of topical solutions

92
Q

What are some examples of viscosity-inducing agents?

A

Methylcellulose
Carboxymethylcellulose
Acacia
Bentonite

93
Q

Does viscosity affect dissolution?

A

Yes, higher viscosity liquids have more difficulties dissolving solutes thoroughly

This issue is solved by mixing solutes into solvents before adding viscosity-inducing agents

94
Q

What are surface active agents (surfactants)?

A

Chemicals that contain both hydrophillic and hydrophobic regions. They are also called wetting agents.

Surfactants modulate solubility of ingredients in order to improve stability and sometimes bioavailability

ex. sodium lauryl sulfate

95
Q

How can oral solutions be divided based on solvent type?

A

Aqueous solutions (syrups and aromatic waters)

Non-aqueous solutions (elixirs, spirits, and tinctures)

96
Q

Describe aqueous solutions?

A

They are the most prevalent of the oral solutions

Dissolving any drug in distilled or purified water along with other excipients makes an aqueous solution

97
Q

What are syrups?

A

Syrups are concentrated, viscous and sweetened aqueous solutions that contain less than 10% alcohol

98
Q

What can syrups be sweetened with?

A

Sucrose, other natural sugars, non-sugar polyols, non-nutritice artifical sweeteners (aspartame, saccharin)

99
Q

What are some common non-medicinal ingredients besides sweeteners?

A

Citric acid, glycerin, polyethylene glycol, sodium benzoate, sorbitol, sucralose, water

100
Q

When do syrup not need antimicrobial preservatives?

A

If the sucrose content is above 80%

101
Q

What is special about cherry syrup?

A

A sucrose-based syrup containing 47% by volume cherry juice

102
Q

What is special about cocoa syrup?

A

It is flavoured with vanilla and is effective in administering bitter tasting drugs to children

103
Q

What is a concern with flavoured syrups and drug stability?

A

Flavoured syrups can be acidic, neutral, or slightly basic

104
Q

What is the definition of a simple syrup?

A

A saturated solution of sucrose in water (85% w/v or 65% w/w)

The sugar content is so high that a preservative is not needed.

105
Q

What are the compounding methods for a drug within syrup-based formulations?

A

In formulas containing both drug and sucrose, each ingredient is usually dissolved separately and then mixed together in such a way to avoid precipitation

The drug is usually disolved in water or another solvent before mixing with the syrup vehicle

106
Q

What are aromatic waters?

A

Used as flavouring or perfuming solutions

They are clear, saturated aqueous solutions of volatile oils or other aromatic solutions of volatile oils or other aromatic substances

Talc is also added to these formulations

107
Q

What is the purpose of talc in aromatic water formulations?

A

It acts as a distribution agent. It increases the surface area of volatile substance to the water. This allows for better mixing of volatile substances and water

Talc is also a filter aid that helps remove excess volatile substance

108
Q

What types of non-aqueous solvents can be used for topical solutions

A

Saturated aliphatic hydrcarbons, ether and glyceryl ester of aliphatic acids

Commonly used in elixers, spirits, and tinctures

109
Q

What are elixirs?

A

Clear, sweetened hydroalcoholic (water and alcohol ) solution intended for oral use

Range: 3-44% (mostly between 5-10%)

110
Q

At what concentration of alcohol do elixirs need preservatives?

A

In elixers, which contain less than 10-12% alcohol

They require the addition of an antimicrobial preservative

111
Q

What are some properties that differentiate elixirs from syrups?

A

Compared to syrups, elixers are:
Less sweet
Less viscous
Less effective in masking bitter tasting drugs

More able to maintain water and alcohol soluble components in solution
More long-term stability
More strict storage conditions due to alcohol

112
Q

Why is the aqueous solution added to the alcohol solution with constant stirring?

A

Order is important to maintain the highest possible alcoholic strength at all time so that minimal separation of the alcohol soluble components occur

113
Q

What should a pharmacist do if an elixir shows preciptation?

A

Add glycerin, sorbitol, or propylene glycol aids in dissolution (synergistic solubility in mixed solvent solutions)

Allow elixir to stand for a few hours (gives time to ensure saturation and then remove the insoluble material by filtration)

114
Q

What are spirits in terms of pharmacological preparations?

A

They are alcoholic or hydroalcoholic solutions of volatile substances

Alcohol content range: 62-85%

Used frequently as flavouring agents in small quantities (serve as a stock solutuion for flavouring oils)

115
Q

What is the difference between aromatic waters and spirits?

A

Due to the higher alcohol content in spirits, they can contain a greater concentrations of volatile oils

116
Q

What are tinctures?

A

Alcoholic or hydroalcholic solutions of non-volatile substances preprared from vegetable or chemical substances

Alcohol content: 15-80%

Cannot be exposed to high temperatures

117
Q

How much potent drug can be dissolved into a tincture?

A

Up to a concentration of 10g of drug/100mL of tincture (10% tincture)
ex. Belladonna Tincture, opium tincture

118
Q

How much non-potent drug can be dissolved into a tincture?

A

Up to a concentration of 20g of drug/100mL of tincture (20% tincture)
ex. Tolu Balsam Tincture

119
Q

What are some disadvantages of tinctures?

A

Not prescribed any more due to high alcoholic content

TInctures are immiscible with liquids with very different solvent character without inducing precipitation of the solute

Light sensitive, therfore they need to be stored in light resistant containers

Unpleasant taste due to high alcohol content

120
Q

What are some other pharmaceutical liquids not already covered?

A

Gargles/mouthwashes
Otic solutons
Opthalimic solutions
Lotions
Liniments
Enemas
Parenteral injectables (SQ, IV, and IM)

121
Q

What is the advantage of reconstituted solutions?

A

By adding water/other solvent closer to time of administration, it greatly increaes shelf life and storage requirements

PHAR 124* (12 decks)

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