T1 - Week 7 Flashcards

1
Q

What is a solution?

A

A homogeneous mixture of two or more components that form a one-phase system which is homogeneous down to the molecular level

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2
Q

What are the advantages of solution dosage forms?

A
  1. Solution state facilitates absorption
  2. Physicochemically uniform
  3. Fluidity
  4. Have eye appeal
  5. Liquids, dose adjustment afforded
  6. Liquids, solutions swallowed easily
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3
Q

What are the disadvantages of solution dosage forms?

A
  1. Prone to chemical instability
    1. Prone to microbial contamination
    2. Liquids, solutions are bulky
    3. Liquids, dosing precision is lost
    4. Liquids, difficult to hold in place
    5. Oral liquids, often not palatable
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4
Q

What is the main solvent to solution preparation?

A

Water

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5
Q

What ways is alcohol used for solution preparation?

A
  1. Primary co-solvent in pharmaceuticals
  2. When present in formulations, the label usually lists the percentage of alcohol in the formulation
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6
Q

What ways is diluted alcohol used for solution preparation?

A
  1. 50% Water, 50% Alcohol
  2. Volume contracts upon mixing, 50 mL of each produces 97 mL solution
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7
Q

What ways is rubbing 70% alcohol used for solution preparation?

A
  1. Infused with ingredients with bitter taste to discourage ingestion
  2. Denatured with Ketones to prevent distillation of alcohol
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8
Q

What ways is isopropyl rubbing alcohol used for solution preparation?

A
  1. Isopropyl Alcohol
  2. Vehicle for topical preparations
  3. Rubefacient or soothing rub at 70% Disinfectant at 91%
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9
Q

What ways is glycerin used for solution preparation?

A
  1. Sweet viscous vehicle
  2. Miscible with water, alcohol, propylene glycol, polyethylene glycol 400
  3. Without the CNS depressant activity
  4. Has preservative qualities
  5. Solutes dissolve slowly in glycerin unless heated
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10
Q

What ways is propylene glycol used for solution preparation?

A
  1. Miscible with water, alcohol, polyethylene glycol 400
  2. Often used as substitute for glycerin
  3. Has preservative qualities
  4. Without CNS depressant activity
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11
Q

How is solubilizers used for solution preparation?

A

Used when the active ingredient dose is large relative to its aqueous solubility

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12
Q

How is buffers used for solution preparation?

A

Employed to control pH

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13
Q

What are examples of buffers as excipients?

A
  1. Citrate
  2. Acetates
  3. Phosphate
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14
Q

How is preservatives used for solution preparation?

A

Chemical compounds that are added to formulations to protect them from microbial contamination

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15
Q

What are examples of preservatives as excipients?

A
  1. Benzoic acid and salts
  2. Sorbic acid and salts
  3. Parabens
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16
Q

How is viscosity enhancers used for solution preparation?

A

Viscosity ensures accurate measurement of the volume to be dispensed and increases palatability

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17
Q

What are examples of viscosity enhancers as excipients?

A
  1. Hydrophilic polymers
  2. CMC
  3. Sodium alginate
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18
Q

How is antioxidants used for solution preparation?

A

Compounds that inhibit oxidation

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19
Q

What are examples of antioxidants as excipients?

A
  1. Ascorbic acid
  2. Potassium and sodium metabisulfite
  3. Ascorbyl palmitate
  4. Butylated hydroxyanisole (BHA)
  5. Butylated hydroxytoluene (BHT)
  6. Alpha-tocopherol
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20
Q

How is chelating agents used for solution preparation?

A

Interfere with oxidative processes by binding metallic ions

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21
Q

What are examples of chelating agents as excipients?

A

Disodium edatate and edetic acid (EDTA)

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22
Q

How is sweetners used for solution preparation?

A

Are added to enhance the palatability and appearance of solutions

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23
Q

What are exmple sweetners as excipients?

A
  1. Sucrose
  2. liquid glucose
  3. glycerol, sorbitol
  4. saccharin sodium
  5. aspartame
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24
Q

How is flavoring agents used for solution preparation?

A

Mask the unpleasant taste of drug

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25
Q

What are example flavoring agents as excipients

A
  1. Alcohol solubilize oil-based flavoring agents
  2. Flavor adjuncts desensitize taste receptors
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26
Q

How is coloring agents used for solution preparation?

A

When used in combination with flavors, selected color should “match” flavor of the formulation

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27
Q

What is the general principle for most solution preparation?

A

If more than one solid is to be dissolved, they are dissolved one-by-one, in order of their solubility (starting with the least soluble first)

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28
Q

What is the general principle for complex solution preparation?

A

Organic components are dissolved in alcoholic solvents and water-soluble components dissolved in aqueous solvents

Then, aqueous solutions are added to alcoholic solutions with stirring to maintain the alcohol concentration as high as possible

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29
Q

How do you aid dissolution?

A
  1. Size reduction of solids
  2. Elevating temperature
  3. High viscosity liquids should be added to low
  4. Completely dissolve salts in a small amount of water prior to the addition of other solvent elements
  5. Solutes present in low concentrations, particularly dyes, are often pre-dissolved in a small volume of the solvent and then added to the bulk
  6. Volatile material should be added at the end when mixture is cooled
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30
Q

How are solutions classified?

A

Route of administration

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31
Q

What is an oral solution?

A

Liquid preparations intended for oral administration

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32
Q

What are the active and inactive ingredients of oral solutions?

A
  1. Purified water (USP) is a common vehicle used in the preparation of aqueous dosage forms
  2. Solubilizers, stabilizers, buffers, preservatives, flavoring agents, coloring agents, and sweetening agents
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33
Q

What is a syrup?

A

Concentrated aqueous solutions of sugar or sugar substitutes intended for oral administration of bitter-tasting drugs

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34
Q

What are the types of syrups?

A
    1. Simple
    2. Flavored
    3. Medicated
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35
Q

What are the types of syrups?

A
  1. Simple
    1. Flavored
    2. Medicated
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36
Q

What are non-medicated or flavored vehicles?

A

Serve as pleasant-tasting vehicles for drug substances to be added later in the preparation of medicated syrups

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37
Q

What aspects of the syrup mask the taste of drugs?

A

Viscosity and sweetness

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38
Q

What are concentrated sugar solutions?

A

Solutions that are hyperosmolar and resistant to the growth of microorganisms

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39
Q

What is an elixirs?

A

Clear, hydro-alcoholic (5% - 40% v/v) solutions intended for oral use

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40
Q

How should elixirs be stored?

A

Cool-tight, and light-resistant containers due to presence of alcohol and volatile oils

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41
Q

What are the advantages of elixirs?

A
  1. Insoluble drugs can be incorporated into the hydro-alcoholic vehicle
  2. Self-preserving due to the hydro-alcoholic vehicle
  3. Less viscous and contain a lower proportion of sugar
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42
Q

What are the disadvantages of elixirs?

A
  1. Cannot be administered to pediatric patients and patients on antidepressant medication due to alcohol
  2. If not stored in cool places in a tightly closed container, water-insoluble drugs may precipitate and the concentration of active and inactive ingredients may vary due to alcohol evaporation
43
Q

What are mouthwashes?

A

Concentrated aqueous solutions containing one or more active ingredients and excipients

44
Q

What are the active ingredients of mouthwashes?

A

Thymol, eucalyptol, hexetidine, menthol, and chlorhexidine gluconate

45
Q

What are the excipients of mouthwashes?

A

Alcohol as a solubilizer, preservatives, humectants, antioxidants, chelating agents, flavoring agents, and coloring agents

46
Q

What are mouthwashes used for?

A

Treatment, diagnostic and cosmetic purposes

47
Q

What are gargles?

A

Aqueous solutions containing Antiseptics, antibiotics, or anesthetics, intended to relieve or treat sore throats

48
Q

What are examples of gargles?

A
  1. Betadine: sore throat
  2. Chlorhexidine: bleeding of gums
49
Q

What are ophthalmic liquids?

A

Sterile preparations intended for application to the conjunctiva, conjunctival sac, or eyelids

50
Q

What solvents are used for ophthalmic liquids?

A
  1. Water
  2. Boric acid
51
Q

What excipients are used for ophthalmic liquids?

A

Buffering agents, preservatives, tonicity-adjusting agents, viscosity-enhancers, chelating agents and antioxidants

52
Q

What is the difference between ophthalmic drops and irrigation solutions?

A
  1. Ophthalmic drops can be formulated as aqueous solutions, suspensions, emulsions, or reconstitutable powders
  2. Irrigation solutions maintain hydration and clarity of the cornea, providing a clear view of the surgical area
53
Q

What are otic solutions?

A

Administered in small volumes for treating ear ailments

54
Q

What solvents are used for otic solutions?

A

Glycerin, propylene glycol, polyethylene glycol 300 or 400

55
Q

What is the purpose for propylene glycol in ear solutions?

A

Lowers surface tension & improves drug contact time with infected tissues

56
Q

What is the purpose for dehumidifying agents in ear solutions?

A

Lower the moisture content needed for bacteria to survive, thus limiting the spread of infection

57
Q

What is an Antipyrine and benzocaine Otic solution?

A
  1. Contains active analgesics (antipyrine) and local anesthetics (benzocaine)
  2. Vehicles: Anhydrous glycerin or propylene glycol
  3. Preservatives and buffers are also used
58
Q

What are nasal solutions?

A

Most are administered as nasal drops or sprays for local and systemic purposes

59
Q

How are nasal solutions formulated?

A

Water and co-solvents (ethanol, propylene glycol, polyethylene glycol 400)

60
Q

What are some excipients of nasal solutions?

A

Preservatives, buffering agents, antioxidants, isotonic adjusting agents, viscosity enhancers, absorption enhancers, flavoring agents, and sweetening agents

61
Q

What are enemas?

A

Oily or aqueous solutions that are administered rectally

62
Q

How are enemas packaged?

A

Plastic containers with a nozzle for insertion into the rectum

63
Q

What are retention enemas?

A

Administered for local action (e.g., prednisolone), systemic absorption (e.g., diazepam), or topical irrigation purpose (e.g., sodium phosphate, sodium citrate, or docusate sodium)

64
Q

What are type of external solutions?

A
  1. Tinctures
  2. Liniments
65
Q

What are tinctures?

A
  1. Alcoholic or hydro-alcoholic solutions prepared from vegetable materials or from chemical substances
  2. Contain alcohol in amounts ranging from approximately 15% to 80%
66
Q

What are liniments?

A
  1. Liquid preparation intended to be rubbed with friction and massaged onto the skin to obtain analgesic, rubefacient or generally stimulating effects
  2. Should not be used on broken skin
  3. Usually are solutions of oils, alcohols or soaps, but may be formulated as emulsions
67
Q

How are parenteral products prepared?

A

Sterility, pyrogens-free (microbial byproducts such as endotoxins and exotoxins), particulate matter, and other contaminants

68
Q

What are the 5 USP/NF classes of sterile preparations for parenteral use?

A
  1. Solutions
  2. suspensions
  3. emulsions
  4. dry solids
  5. liquid concentrates
69
Q

What is USP chaper <797>?

A

Prevent patient harm from ingredient errors and microbial contamination

70
Q

What is the difference between small and large volume parenterals?

A
  1. Large volume parenterals are single-dose injections that contain more than 100 mL
  2. Small volume parenterals are either single or multi-dose products that contain 100 mL or less
71
Q

What is a sterile dosage forms?

A
  1. Small and large volume injectable preparations
  2. Irrigation fluids (intended to bathew body wounds or surgical openings)
  3. Dialysis solutions
  4. Biological preparations (vaccines, toxoids, and antitoxins)
72
Q

What are the common characteristics of sterile dosage forms?

A
  1. Sterility
  2. Free from contaminating microorganisms
73
Q

Why is sterility essential?

A

Being placed in direct contact with internal body fluids and tissue

74
Q

What is a parenteral?

A

Refers to injectable routes of administration

75
Q

What are the characteristics for injections?

A
  1. Sterile and pyrogen-limited prepartationsintended to be administered
  2. Used in hospital, extended care facilities, and clinics
  3. The pharmacist supplies injectable preparations to the physician and nurse in the institutional settings
76
Q

What are pyrogens?

A

Bacterial endotoxins that are shedded metabolic products of Gram-negative bacteria

Can cause fever and hypotension in excessive amounts of injections

77
Q

Where can parenterals be administered?

A
  1. Joints: intra-articular
  2. Joint fluid area: intra-synovial
  3. Spinal column: intra-spinal
  4. Spinal fluid: intrathecal
  5. Arteries: intra-arteria
  6. Heart: intra-cardiac
78
Q

Describe the intravenous route

A
  1. Small and large volumes of drug solutions can be administered
  2. Must be in an aqueous solution
  3. Should mix with blood and not for precipitate
79
Q

Describe the intramuscular route

A
  1. Deep into skeletal muscles and far from major nerves and blood vessels
  2. Les rapid onset but longer-lasting
  3. Aqueous or oleaginous solution and suspensions
  4. 2-5mL
80
Q

Describe the intradermal route

A
  1. Used for agents for diagnostics, desensitization, or immunization
  2. 0.1mL
81
Q

Describe the subcutaneous route

A
  1. Used for injection of small amounts of medication
  2. 1.3mL; >2mL causes pain
82
Q

What is an injection?

A

Liquid preparations that are drug substances or solutions

83
Q

What is injectable emulsion?

A

Liquid preparation of drug substance dissolved or dispersed in suitable emulsion medium

84
Q

What is for injection?

A

Dry solids that upon addition of suitable vehicles yielding solutions conforming in all respects to the requirements for injections

85
Q

What is an injectable suspension?

A

Liquid preparation of solid suspended in suitable liquid medium

86
Q

What is a for injectable suspension?

A

Dry solid that, upon addition of suitable vehicle, yields preparation conforming in all respects to the requirements for injectable suspensions

87
Q

How do you prepare a drug that is unstable in solution?

A
  1. A dry powder for reconstitution with a solvent at the time of administration
  2. A suspension
88
Q

How do you prepare a drug that is unstable in water?

A

Replace water in part or totally by a solvent in which the drug is insoluble

89
Q

How do you prepare a drug that is insoluble in water?

A
  1. An aqueous suspension
  2. A solution in a suitable non-aqueous solvent such as vegetable oil
90
Q

How do you prepare a desired aqueous solution?

A

A water soluble salt form of the insoluble drug is prepared

91
Q

How should aqueous or blood-miscible solutions be injected?

A

Can be injected directly into the blood stream

92
Q

How should blood-immiscible liquids be injected?

A

Restricted to other than IV administration

93
Q

What is water for injection?

A
  1. Used in large scale injection manufacturing
  2. Purified by distillation or reverse osmosis
  3. Contains not more than 1mg/100mL of total solids
  4. Not sterilized until added to drug
  5. Pyrogen free
  6. Stored in tight containers at set high or low temperatures to prevent microbial growth
  7. Used within 24hrs of collection
94
Q

What is sterile water for injection?

A
  1. Packaged in no larger than 1L
  2. Pyrogen free but contains less than 0.25 USP endotoxin unit/mL
  3. Does not contain additives
  4. Can’t administer 1L, because it is not tonic
  5. Used to reconstitute multiple anitbiotics
95
Q

What is sterile water used for?

A

Used as solvent, vehicle, or diluent to be added to already sterile additives

96
Q

What are the requirements for using bacteriostatic water for injection?

A
  1. Prefilled syringes or in vials not more than 30mL of water
  2. Sterile water containing one or more suitable antimicrobial agents
  3. Bacteriostatic agents gives the flexibility for multiple-dose vials
97
Q

What are bacteriostatic water used for?

A
  1. To avoid toxic amounts of antimicrobial agents administrated with the medication
  2. If more than 5 mL of solvent is required, sterile water for injection is preferred
98
Q

What is sodium chloride for injection?

A
  1. Sterile isotonic solution of sodium chloride in water
  2. No antimicrobial agents: 154mED of Na and Cl ions/L
99
Q

What is sodium chloride injections used for?

A
  1. Sterile vehicle in solutions or suspensions of drugs
  2. Used as a catheter or IV line flush to maintain potency
100
Q

What is bacteriostatic sodium chloride for injection?

A
  1. Sterile isotonic solution of sodium chloride in water for injection
  2. Contains one or more suitable antimicrobial agents
  3. Sodium chloride 0.9% renders the solution isotonic
  4. Used to flush a catheter or IV line to maintain its patency
101
Q

What is Ringer for injection?

A

Sterile solution of sodium chloride, potassium chloride, and calcium chloride in water for injection

102
Q

What is Ringer injection used for?

A

Used as a vehicle or alone as an electrolyte replenisher and plasma volume expander

103
Q

What is Lactated Ringer for injection?

A
  1. Has different quantities of the three salts in Ringer injection, and contains sodium lactate
  2. Is a fluid and electrolyte replenisher and a systemic alkalizer