1. Sclera
2. Tears
3. Drainage

1. Sterility
2. Preservation
3. Isotonicity (0.6% to 2% in terms of NaCl equivalence)
4. Buffering

1. Increase residence time (ointments, gels, suspensions)
2. Do not administer too much volume (eye can only hold 10 microL of fluid)
3. Occlude the nasolacrimal duct with mild finger pressure
4. Instruct the patient to use the "eye cup" technique
5. Make sure patients knows to wash their hands
6. Avoid touching the dropper surface

1. Small surface area for absorption (adults ~ 180 cm²)
2. Presence of drug-degrading enzymes
3. Tonicity requirements

1. physicochemical properties of the drug
2. formulation
3. delivery device
4. patient (breathing pattern and condition)

The first two CANNOT be altered

The last two CAN be altered

Particle Size

Too big: particle cannot reach alveoli

Too small: particle is expelled upon exhalation

particle density is also important

these parameters make proper storage an important factor in successful delivery

Parental Articles

Parental articles are preparations intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substances they contain are administered, using gravity or force, directly into the blood vessel, organ, tissue, or lesion.  Parental articles must meet the Pharmacopeial requirements for sterility, pyrogens, particulate matter, and other contaminants, and where appropriate contain inhibitors of the growth of microorganisms.

The absence of viable microorganisms.  Because sterility cannot usually be confirmed with certainty, statistical probability is used to describe it.

This term is used to designate the probability of finding a nonsterile unit (such as bacterium) following a sterilization step or procedure.  Usually, it is expressed as a negative power of ten (e.g., 1 in 1 million or 10^-6).

Terminal Sterilization

A procedure carried out at the end of processing, when a product is in its final sealed container, that destroys all viable microorganisms.  Terminal sterilization is usually intended to achieve SAL of less than 10^-6.

Surfaces that come into contact with sterile product, container, or closures.  For example, the needle shaft that is used for transferring a drug solution from a vial to an IV container is a critical surface.

Validation

With regard to sterile product processing, the USP defines it as follows; “the act of validation of a sterilization or aseptic process involves planned testing designed to demonstrate that microorganisms will be effectively destroyed, removed, or prevented from inadvertently being introduced by personnel or by process-related activities”.

High-Efficiency Particulate Air

A filter that provides this type of environment is an essential component of both horizontal and vertical laminar airflow workbenches and other aseptic processing areas.  For these purposes, the HEPA filters are certified to provide air that is filtered with minimum 0.3 micron particle retaining efficiency of 99.97%

Also called buffer room

Such a room is assigned and meets air cleanliness classification such as Class 10,000 or Class 100,000

• Provides a Laminar Airflow Workbench that is completely enclosed
• For the operator, access to the work surface is through glovebox-type portals

This refers to the potential risk to patients caused by the introduction of microbial contamination into a finished sterile product and subsequent opportunity for growth of inadvertently added contaminants

Level 1 = low risk

to

Level 3 = high risk

• This is a procedure in which personnel who do aseptic processing prepare a simulated product using culture medium
• The simulated product is then incubated to determine if the product was contaminated during the procedure

• The preparation of multiple units of a sterile product by the same worker during the same time period
• For example, if a worker prepares 30 syringes of a given dose of an antibiotic at one time, this is a batch preparation

• Double or Triple lumen type
• Flush with heparinized solutions for patency
• Open at both ends
• You can sample blood with this type

Double or Triple lumen type

One-way valve at tip - solution can only flow into the body

1. Phlebitis
2. Infection
3. Extravasation
4. Infiltration
5. Infiltration Necrosis

• Ampules, Vials, Bags: < 1 L
• Must be made isotonic before use
• Free water, no solute load
• Intended for reconstitution and compounding of other IV solutions (TPN solutions)

Ampules, Syringes, and Vials: < 30 mL

Most common agent, benzyl alcohol 0.9%

Not for use in newborns

Compatibility issue with other drugs

• Ampules, Syringes, and Vials: < 30 mL
• Most common agent, benzyl alcohol 0.9%
• Not for use in newborns
• Compatibility issues with other drugs

154 mEq/L, 308 mOsm/L

1 mEq/mmol because highest charge is 1

2 mOsm/mmol because Na and Cl can dissociate

Strong Acid + Strong Base = pH 7

Strong Acid + Weak Base = pH 3.5-5.5

Weak Acid + Strong Base = pH 8.5-10.5

Weak Acid + Weak Base = pH 4.5-9.5, variable

In general, if you mix an acidic solution with an alkaline solution the resulting neutralization usually results with one or both drugs precipitating

Ranitidine + HCl = Ranitidine HCl

Homatropine + HBr = Homatropine HBr

Morphine + H₂SO₄ = Morphine Sulfate

Pilocarpine + HNO₃ = Pilocarpine Nitrate

Codeine + H₃PO₄ = Codeine Phosphate

Chlorpheniramine + Malic Acid = Chlorpheniramine Maleate

pH range should be between 3.5-5.5

Phenobarbital + NaOH = Sodium Phenobarbital

Calvulanic Acid + KOH = Potassium Clavulenate

Saccharic Acid + Ca(OH)₂ = Calcium Saccharate

pH range should be between 8.5-10.5

1-10 kg wt: 100mL/kg/day

11-20 kg wt: 1000mL + 50mL/kg for 11-20 kg

>20 kg wt: 1500 mL + 20mL/kg for wt greater than 20 kg

1. Diazepam
2. Nitroglycerin
3. Insulin

• pH
• Total tubing length