Pharmaceutical solutions Flashcards

1
Q

What is the definition of solutions?

A

Liquid preparations containing chemical substances dissolved in a solvent or mixture of miscible solvents

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2
Q

What is the definition of solubility?

A

Maximal concentration of a solute that can dissolve in a solvent at a given temperature

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3
Q

How to read the solubility table?

A

The more parts (can be g or ml) I need, to dissolve a solute, the weaker the solubility

If I don’t need much solvent to dissolve a solute, the solubility is strong

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4
Q

What are the components of a solution?

A
  1. API
  2. Vehicle
  3. Co-solvent
  4. Preservatives
  5. Stabilizers
  6. Color and Flavor
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5
Q

Which properties should an active pharmaceutical ingredient (API) have?

A

-soluble and stable in a solvent (hydrolyzes if not stable)
-in case of low solubility -> co solvent is added
-to be absorbed it need to be unionized -> so there are mostly weak acid or bases

-flavors may be added in case of bitterness

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6
Q

Why are Solvents needed?

A

-to enhance the solubility of semi-polar drugs that mix water only to a degree -> so we add a solvent that mixes with water and the drug

Water, Ethanol, Propylene glycol, Isopropyl glycol, Glycerin, Acetone, Non-polar solvents

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7
Q

What is the difference between Bulk and packaged water?

A

-Bulk water: produced and used on the same site, don’t need to package

-Packaged water: produced somewhere and need to be packed and sterilized to prevent microbial growth

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8
Q

What are the types of Bulk water?

A

-Purified water: used as a diluent in the production of non-sterile products -> not pyrogen-free

-Pure steam: used for sterilizing porous (steam gets easier into pores) equipment, pretreated water is vaporized and distributed under pressure (e.g. autoclaving)

-Hemodialysis: used for dilution of hemodialysis concentrate (dialyzer: artificial kidney to clean the blood) -> not for injection

-Water for injection (WFI): sterilized and pyrogen free for sterile products

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9
Q

What are the types of packaged water?
all STERILE

A

-Sterile purified water: for preparation of sterile products and analytical applications

-Sterile water for injection (WFI): sterile products used for IV packaged for a single dose

-Bacteriostatic WFI: preparation for sterile products (IV) for multiple doses -> PRESERVATIVES and ANTIMICROBIALS added

-Sterile water for inhalation: used in inhalators, but not as strict as with water for IV

-Sterile water for irrigation: used to clean body cavities, not as strict as with water for IV

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10
Q

What are other solvents/vehicles?

A

other solvents may be added to water for semi-polar drugs
-Ethanol -> ETHYL ALCOHOL: preservative, mixes easily with water, for internal and external use

-Isopropyl alcohol: similar to ethyl alcohol but can’t be used internally, it is used as a disinfectant when more than 91%

-Glycerin (diol) and Propylene glycol (Triol) have multiple OH groups making them easy to mix with water,
Glycerin can be used as a preservative at high concentrations and tastes sweet, both for internal and external use

-Acetone: doesn’t have OH group, hence no H-bonding, but dipole-dipole interactions - CANNOT BE USED INTERNALLY

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11
Q

When are non-polar solvents used?

A

If the drug doesn’t interact with water at all (not often), the form of interaction is dipole moments
-f.e. fixed oils -> often used external preparations, internally in form of emulsions

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12
Q

Other excipients:

A

Preservatives, Flavor, Color, Sweetener, Buffers, Viscosity enhancer, anti oxidants

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13
Q

When are preservatives added?

A

-if alcohol with more than 10% or Glycerin in high concentration is added we don’t need preservatives

-examples: Benzoic acid, Sodium benzoate, Methylparaben and other parabens

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14
Q

What might be an issue when adding flavors and colors?

A

They are not very soluble, alcohol might be added as a cosolvent

-synthetic or natural oils

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15
Q

Which sweeteners cant be used for certain patients?

A

-Sucrose: not for diabetic patients
-Sorbitol: not for patients with irritable bowel syndrome (IBS), bc it causes GI distress
-Aspartame: phenylketonuria patients cant metabolize it

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16
Q

What is the purpose of buffers and antioxidants?

A

-Buffer: to control the pH
-Viscosity: for syrups you want a certain viscosity so that it suits a bit in the throat and GI to act there (cellulose)
-anti-oxidant: for substances that oxidize easily (not stable), e.g. Vitamin C

17
Q

What are the advantages and disadvantages of oral solutions?

A

Advantages:
-Taste
-Easier for patients with difficulties swallowing
-faster absorption (no disintegration step)
-simple preparation

Disadvantages: hard to produce if it is not stable in water or is not soluble in water (here you could add a non-polar solvent), bulky and inconvenient to transport

18
Q

Types for oral solution:
Dry Mixture for solution

A

-The powder needs to be reconstituted with a diluent -> afterward not stable for a long period of time
e.g. antibiotics must be kept in the fridge (expires after 14 days)

19
Q

Types for oral solution:
Oral solutions

A

-Oral colonic lavage solution: solution of electrolytes with Polyethylene glycol -> colonoscopy or surgery -> LAXATIVE

-Oral rehydration solution: for rehydration after diarrhea

-Magnesium citrate solution: saline laxative

-Sodium citrate/citric acid solution: for systemic alkalinization for patients with uric acid or to dissolve kidney stones

20
Q

Types for oral solution:
Syrups

A

-high concentration of sucrose, often used as a solvent/vehicle
-simple syrup, NF has 85% w/v or 65% w/w (at this concentration it acts as a preservative, if diluted you need one)

21
Q

Why does syrup need to be heated carefully?

A

-when heated add heat-stable ingredients -> then volatile ingredients -> let cool down

-has to apply heat gradually to prevent inverted syrup -> the breakdown in fructose and glucose (sweeter, darker) -> more heat leads to caramel

22
Q

What is the role of Disodium calcium EDTA?

A

-Act as a chelating agent; e.g. metal ions can cause oxidation
-> so it is a stabilizer for oxidation

23
Q

Types for oral solution:
ELIXIERS

A

-comparable to Syrup, but they have an alcohol content of 15-50% (not for kids and diabetics -> because it can cause hypoglycemia)

-it is not as sweet (less sucrose), less viscous as Syrups
-careful with closing bc alcohol is volatile and it need be me stored away from heat and light

24
Q

Types for oral solution:
Tinctures

A

-derived from vegetable materials or chemical substances
-might be more content of alcohol than in Elixier 15-80% (not for kids)
-mixing with water or another solvent can lead to the precipitation of the drug
-store away from heat and light

25
Q

Types for oral solution:
Aromatic water, fluid extract, Spirit

A

-Aromatic water: saturated aqueous solution of oil used for aromatic therapy

-Fluid extract: similar to a tincture but more concentrated

-Spirit: volatile drug put in alcohol or mixture of alcohol and water (for disinfecting) -> topically and orally

26
Q

What should be considered when dispensing solutions?

A

-use the calibrated device (tsp, tbsp - not from the kitchen)
-take a glassful of water
-alcohol containing (like elixirs and tinctures) are not for diabetics and it should not be taken with coated tablets + interaction with other drugs like antibiotics
-expiration days for compounded solutions (BUD)

27
Q

What are the properties of topical solutions?

A

-similar to oral ones but often alcohol vehicles bc we want them to sitck at the skin
-has an applicator to tip it to the skin
-are self-preservative or have preservatives
-has a die to mark the site

28
Q

What are Liniments?

A

-Alcoholic or oleaginous solution or emulsions
containing the medication -> made of oily substances

-is counterirritant -> countering the initial irritation to trick the brain

-may have menthol for a cooling sensation

29
Q

What are Collodions?

A

-Liquid preparations composed of pyroxylin (a form of nitrocellulose) dissolved in alcohol and ether
-leaves a thin layer on the skin

30
Q

What are topical oral solutions?

A

-Aqueous solutions often in concentrated form
containing an active ingredient and excipient

-therapeutic or cosmetic
-topical oral: because used in the oral cavity but not swallowed

31
Q

Topical tinctures:

A

-vegetable sources
-higher alcohol content 15-80% -> careful with storing
-used to desinfect