Unit14PharmaceuticsI

A usually inert substance that forms a vehicle

• Solvents
• Preservatives
• Antioxidants
• Buffers
• Viscosity inducers
• Surfactants and emulsifying agents
• Colors, flavors, sweeteners, and scents

Most commonly used and most desirable solvent-vehicle for liquid drug products and preparations for all uses

• Alcohol, Isopropyl Alcohol, Glycerin, Propylene Glycol, and Polyethylene Glycol 400
• Oils as solvents
• Ether, chloroform

Concentration of solid in the solvent must be at, or below the solubility for the solid in that solvent

• Capable of mixing in any ratio without separation of the two phases
• i.e. alcohol/ water

• In gram of solute per milliliter of solvent (not per mL of solution)
• Solubility of Boric Acid is 1 g/ 15mL water

• Soluble
• Slightly soluble
• Sparingly soluble

Potable water

“Water used in the production of drug substances or as source or feed water for the preparation of various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) issued by the U.S. Environmental Protection Agency (EPA)”

• Purified Water USP
• Sterile Purified Water USP
• Water for Injection USP
• Sterile Water for Injection USP
• Sterile Water for Inhalation USP
• Sterile Water for Irrigation USP
• Bacteriostatic Water for Injection USP

• Bacterial endotoxins: no standard
• Bateriologic purity: complies with EPA regulations for drinking water

As a solvent-vehicle for the preparation of pharmaceutical dosage forms for internal or external use

When sterility is required unless it meets the requirements under USP Sterility Tests<71> or is first sterilized by filtration or autoclaving

Protected from microbial contamination

Making parenteral products unless it can be assured that it meets the requirements for sterility and bacterial endotoxins for parenteral administration

• Bacterial endotoxins: no standard
• Bacteriologic purity: Meets requirements in Chapter<71> for sterility
• pH: between 5.0 and 7.0

Label with method of preparation and that this is not for parenteral use

• It is used as a solvent-vehicle for the preparation of
• pharmaceutical dosage forms for internal or external use

It is not for parenteral administration

• Bacterial endotoxins: Not more than 0.25 USP Endotoxin Units per mL
• All requirements of Purified Water

Water for injection is a starting material for making parenteral products. It must be processed further either before use or during product preparation

Bacterial endotoxins: not more than 0.25 USP Endotoxin Units per mL

Additional note: label that it is not suitable for intravascular injection prior to being made approximately isotonic

• Bacterial endotoxins: not more than 0.5 USP Endotoxin Units per mL
• pH: 4.5 – 7.5

For inhalation therapy only and not for parenteral use

Note in USP: “Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms.”

• Bacterial endotoxins: Meets the endotoxin test under Water for Injection
• Bacteriologic purity: Meets requirements given for Sterile Purified Water

• No preservatives or other substance has been added
• Additional labeling: “For irrigation only” and “Not for injection”

Solvent for drugs to be administered by irrigation (local effect)

NOT FOR USE IN NEWBORNS

It is not to be used when large volumes are needed for parenteral administration

All statements of percentages of alcohol refer to percentage, by volume of C2H5OH at 15.56o

46.07

• >92.3% and < 93.8% (w/w), &
• >94.9% and < 96.0% (v/v)

Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78o

Miscible with castor oil, but immiscible with other fixed oils and mineral oil

Tight containers, away from fire

Solvent-vehicle for internal or external use. Effective antiseptic-disinfectant in concentrations > 60%

Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78o

Tight containers, away from fire

Use when “dehydrated” or “absolute” alcohol is designated in the formula

Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78

• Single-dose containers (Type I glass preferred)
• Container headspace may have inert gas

• Suitable for parenteral use
• Meets requirements for parenteral products found in USP Chapter<1> Injections of the General Tests and Assays

Mixture of alcohol and water.

Clear, colorless, mobile liquid; characteristic odor

Tight containers, away from fire

• Made by mixing equal volumes of Alcohol USP and Purified Water.
• Mixing 500 mL of each yields 970 mL of Diluted Alcohol USP

• 68.5 % to 71.5% (v/v) of Dehydrated Alcohol
• May contain stabilizers, perfumes, or dyes

Like alcohol, except that it may be colored; Odor dependant on presence of additives.

• External use only
• Effective antiseptic-disinfectant

60.10

>99.0%

Transparent, colorless, mobile, volatile, flammable liquid with characteristic odor

Tight containers, away from heat

• External use only; Solvent-vehicle for topical products;
• Effective disinfectant at concentrations >70%
• Superior to ethyl alcohol as an antiseptic.

• Alcohol: >68.0% and <72.0% by volume (v/v)
• Other: water with or without stabilizers, perfumes, and color additives

Like Isopropyl Alcohol except that it may be colored; Odor dependant on additives

Tight containers, away from heat

External use only; Solvent-vehicle for topical products; Effective antiseptic-disinfectant

Like Isopropyl Alcohol

• More than one site for hydrogen bonding
• Higher water solubility
• Higher boiling points (less volatile)
• Vary greatly in their toxicities
• Use only glycols approved for their intended purpose

92.01

• Clear, colorless, viscous liquid.
• Practically odorless, hygroscopic, neutral pH

Tight containers

• Solvent-vehicle for internal and external use
• Humectant and preservative properties

Like glycerin USP, except pH between 5.5 and 7.5

Tight containers

Solvent-vehicle for oral dosage forms

Other: May contain one or more suitable antimicrobial preservatives

Like Glycerin Oral Solution USP, except it is sterile

• Tight containers of glass or plastic
• Volume<15mL and protected from light
• Container is sealed and tamper-proof to ensure sterility

For ophthalmic use

76.09

Clear, colorless, viscous liquid. Practically odorless, hygroscopic

• Solvent-vehicle for internal and external use
• Humectant and preservative properties

• Number indicating average MW (200 to 8000)
• PEGs 200 - 600 are liquid at room temp
• Higher MW PEGs are waxy solids at room temp

• All PEGs are soluble in water
• PEG 400

Recommended tight containers

PEG 400 is the most common liquid PEG. Used as a solvent-vehicle for internal and external use. Clear, colorless, slightly hygroscopic, viscous liquid with a slight odor

• Acetone /Methyl Isobutyl Ketone
• Can dissolve anything bu limited usefullness because:
• Volatile
• Highly flammable
• Toxic

58.08

Flammable

Tight containers; remote from fire

• pH
• Solubility
• Toxicity
• Route of administration
• Packaging and storage

Substances added to non-sterile dosage forms to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent to the manufacturing process.

Added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses

• Good manufacturing practices
• Good compounding practices
• Good technique

• The preparation will be used immediately
• No water is present
• The pH of the preparation is either < 3 or > 9
• One or moreingredients have antimicrobial properties are already present

• Neonates
• Ophthalmic solutions intended for use during eye surgery, with not-intact corneas, or for intraocular injection
• Parenteral products with volumes greater than 30 mL

• Prepare a single dose for immediate use
• Prepare a limited (small) quantity
• Use within a short time period
• Store under refrigeration
• Label with a short expiration date