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PHPR 802 Pharmaceutics and Biopharmaceutics > Solutions > Flashcards

Solutions Flashcards

1
Q

Physicochemical Terms

A

Solution can be prepared from combination of solid, liquid and gas

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2
Q

Pharmaceutical Terms

A

Solutions are liquid preparation containing drug or chemical substances dissolved in solvent of mixture of mutually miscible solvents

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3
Q

Pharmaceutical Solutions

A

Generally, solutions as liquid dosage forms contains solid drug dissolved in liquid medium

Monophasic system

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4
Q

Advantages of solution

A

Homogenous and monophasic mixtures
- Typically, no need to shake well before use

Easy to measure accurately
- Volumetric devices can be very precise and accurate if YOU take care

Easy to swallow (children, elderly, and disabled person)

Amenable to administration by any route
- For example:
- suspension cannot be given IV

No lag time due to dissolution
- Rapid onset of action

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5
Q

Disadvantages of solutions

A

Not a unit dosage form
- Bulky and typically not convenient to carry around

Solution chemistry poses many stability issues
- Physicochemical degradation (shelf-life, storage requirement)
- Reactivity (containers, tubing, etc.)
- Shorter expiry than other dosage forms

Additional sterility concerns

Solubility may be limiting

Need to mask taste (oral)
- Example:
- suspension is “harder” to taste

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6
Q

Solutions

A

Homogenous mixtures of solutes dissolved in solvents

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7
Q

Syrups

A

Aqueous solutions containing a high concentration of sugar or sugar-substitute with or without medicinal substances

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8
Q

Elixirs

A

Flavored, sweetened hydro-alcoholic solutions for use

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9
Q

Spirits

A

Solutions of aromatic materials in alcohol

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10
Q

Aromatic Waters

A

Solutions of aromatic material in water

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11
Q

Tinctures

A

Alcoholic solutions prepared by extracting active constituents from crude drugs

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12
Q

Tinctures / Spirit / Elixirs

A

May be useful for delivering lipophilic constituents at a required concentration

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13
Q

Sprays

A

Aqueous or oleaginous solutions in the form of coarse-droplets or as finely divided solids to be applied topically (nasal / skin)

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14
Q

Collodions

A

Liquid preparations composed of nitrocellulose in a solvent mixture (alcohol + ether)

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15
Q

Liniment

A

Alcoholic solutions or emulsions of various medicinal substances to be rubbed on the skin

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16
Q

Typical composition of pharmaceutical solutions

A

Calling a homogenous mixture a solution does NOT imply that it is composed of one solute solvent
- Active component
- Flavorants
- Sweeteners
- Colorants
- Stabilizers
- Viscosity modifiers
- Preservatives
- Co-solvents

When preparing a solution, the pharmacist must consider the solubility and compatibility of each ingredient that will be present in the solution

17
Q

Solvent Selection Considerations

A

Solubility

Low Toxicity

Compatibility with other ingredients

Chemical Inertness

Clarity

Palatability (for oral preps)

Odor

Color

Cost

18
Q

Solvents used for liquid preparations

A

Alcohol, USP: Ethyl Alcohol, Ethanol

Diluted Alcohol, NF

Alcohol, Rubbing

Glycerin, USP (Glycerol)

Isopropyl Rubbing Alcohol

Propylene Glycol, USP

Purified Water, USP

Fixed Oils

19
Q

Alcohol, US: Ethyl Alcohol, Ethanol (C2H5OH)

A

Alcohol is the most useful solvent in pharmacy next to water

Alcohol, USP = 94.9 to 96% C2H5OH by volume (v/v) at 15.56 degrees Celsius

Dehydrated Alcohol, USP = absolute alcohol contains not less than 99.5% v/v C2H5OH
- Used when water-free alcohol is desired

Together with water, it forms a hydroalcoholic mixture that dissolves both alcohol-soluble and water-soluble substances, a feature especially useful in the extraction of active constituents from crude drugs

It is also used in liquid products as an antimicrobial preservative alone or with parabens, benzoates, sorbates, and other agents

Alcohol is frequently used with other solvents, such as glycols and glycerin, to reduce the amount of alcohol required

However, concern has been expressed over the undesired pharmacologic and potential toxic effects of alcohol

20
Q

Alcohol, USP: Ethyl Alcohol, Ethanol (C2H5OH) Limits

A

Children < 6 years of age = alcohol (OTC) limit 0.5%

6-12 years of age = 5%

Over 12 years of age and adults = 10%

21
Q

Rubbing Alcohol

A

It is employed as a rubefacient externally and as a soothing rub for bedridden patients, a germicide for instruments, and a skin cleanser prior to injection

It is also used a vehicle for topical preparations

The product is volatile and flammable and should be stored in tight containers away from fire hazards

22
Q

Isopropyl Rubbing Alcohol

A

70% isopropanol

Water, color additives, stabilizers, fragrances

Commonly used for diabetics for the preparation of needles and syringes for insulin injection

23
Q

Isopropyl Alcohol Solution

A

91% isopropanol

Commonly used for diabetics for the preparation of needles and syringes for insulin injection

24
Q

Polyhydric Alcohols

A

Glycerin, USP (Glycerol)

Propylene Glycol, USP

25
Q

Glycerin, USP (Glycerol)

A

Clear, viscous liquid with sweet taste

Miscible with water and alcohol

Solvent properties similar to ethanol
- Viscosity causes solutes to dissolve very slowly
- Heating reduces viscosity

Preservative, stabilizer

26
Q

Propylene Glycol, USP

A

Clear, viscous liquid

Miscible with water and alcohol

Commonly substituted for glycerin

27
Q

Purified Water, USP (H2O)

A

Water obtained by distillation, ion-exchange treatment, reverse osmosis of other suitable process. It is prepared from water complying with the regulations of the US

Environmental Protection Agency (EPA) with respect to drinking water. It contains no added substances
- nmt 0.001% total solids (1 mg in 100 ml)
- nmt 100 cfu/ml (guideline)
- pH between 5 and 7
- Less solid impurities than the drinking water

Purified Water, USP = intended for use in the preparation of aqueous dosage forms, EXCEPT those intended for parenteral administration (injections)

28
Q

Distillation Method

A

The first portion of aqueous distillate (about the first 10 to 20%) must be discarded
- Contain many foreign volatile substances in the urban drinking water

The last portion of water (about 10% of the original volume of water) remaining in the distillation apparatus must be discarded and not subjected to further distillation
- Distillation to dryness will result in decomposition of solid substances and possible contamination

29
Q

Ion-Exchange Method

A

On a large or small scale, the ion-exchange method for the preparation of purified water offers a number of advantages over the distillation method
- No heat is required, less energy consumption

The ion-exchange process permits ease of operation, minimal maintenance, and a more mobile facility

30
Q

Cation Exchange

A

H-Resin + M+ + X- + H2O –> M-resin + H+ + X- + H2O (pure)

31
Q

Anion Exchange

A

Resin-NH2 + H+ + X- + H2O –> Resin-NH2 (HX) + H2O (pure)

32
Q

Cation & Anion Exchange

A

These two processes are successively or simultaneously employed to remove both cations and anions with water

Water purified in this manner is referred to as demineralized or de-ionized water

33
Q

Osmosis

A

Diffusion of water molecules across semi permeable membrane from a solution with no or low concentration of solute to the solution with high concentration of solute

34
Q

Membrane Filtration Processes

A

Cross-flow filter membranes can remove particles defined in the range of
- microfiltration (0.1 to 2 microns, e.g. bacteria)
- ultrafiltration (0.01 to 0.1 microns, e.g. virus)
- nanofiltration (0.001 to 0.01 microns, e.g., organic compounds in the molecular weight range of 300 to 1000)

Reverse osmosis (particles smaller than 0.001 microns)

35
Q

Reverse Osmosis Removes Virtually All

A

Viruses

Bacteria

Pyrogens

Organic molecules

90-99% of all ions

36
Q

Fixed Oils

A

Esters of glycerin and fatty acids derived from plants and animals

Used for solubilizing lipophilic drugs
- Can be used for IM depot formulations or for emulsions

Must remain clear when cooled to 10 degrees Celsius (USP requirement)

Toxicity is typically low but allergic reactions possible

Useful for the preparation of Oleaginous Solutions for Injection
- Corn Oil
- Cottonseed Oil
- Peanut Oil
- Sesame Oil
- Soybean Oil
- Castor Oil & Olive Oil (less common)

37
Q

Why to use mixture of co-solvents?

A

Attain desired solubility without using high levels of any single cosolvent

Minimize toxicity in formulations

Minimize residual solvents in crystallizations

“Tune” solvent mix for crystal properties

PHPR 802 Pharmaceutics and Biopharmaceutics (4 decks)

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