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Biopharmaceutics III
First exam stuff
36
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1st Grade
08/24/2009

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Cards

Term
Barriers to Intraocular Delivery
Definition
  1. Sclera
  2. Tears
  3. Drainage
Term
Pharmaceutical Requirements for Ophthalmic Solutions
Definition
  1. Sterility
  2. Preservation
  3. Isotonicity (0.6% to 2% in terms of NaCl equivalence)
  4. Buffering
Term
Ways to Improve Intraocular Delivery
Definition
  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
Term
Problems with Nasal Drug Delivery
Definition
  1. Small surface area for absorption (adults ~ 180 cm2)
  2. Presence of drug-degrading enzymes
  3. Tonicity requirements
Term
Deposition of Drug in Pulmonary Delivery depends on 4 Factors:
Definition
  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

Term
What is the fundamentally important physical property of a drug in pulmonary delivery?
Definition

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

Term

 

Parental Articles

Definition

 

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.

Term
Sterility
Definition

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

 

Term
Sterility Assurance Level (SAL)
Definition

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).

 

Term

Terminal Sterilization

 

Definition

 

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.

 

Term
Critical Surfaces
Definition

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.

 

Term
Critical Area
Definition
This is an area where sterile products, containers, and closures are exposed to the environment.
Term

 

Validation

Definition

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”.

 

Term
Large-Volume Intravenous Solutions
Definition
Also called Large-Volume Parenterals (LVPs), these are single-dose injections containing more than 100 mL of sol'n that are intended for IV use
Term
Small-Volume Parenterals
Definition
These are injections of 100 mL or less.  They may be either single-dose and multidose products.
Term
Class 100
Definition
A designation for air quality.  A class 100 room has less than 100 particles 0.5 microns or larger per cubic foot of air.
Term
HEPA Filter
Definition

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%

Term
Cleanroom
Definition

Also called buffer room

 

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

Term
Anteroom
Definition
This is a room adjacent to the cleanroom; although of high quality, it may have a lesser air cleanliness classification than the cleanroom.  For example, if the cleanroom is maintained as a Class 10,000 space, the anteroom may be Class 100,000.  Activities in the anteroom include things like washing and gowning and unpacking of cleanroom supply packages.
Term
Barrier Isolator
Definition
  • Provides a Laminar Airflow Workbench that is completely enclosed
  • For the operator, access to the work surface is through glovebox-type portals
Term
Risk Levels
Definition

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

Term
Media Fill
Definition
  • 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
Term
Batch Preparation
Definition
  • 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
Term
Hickman Catheter
Definition
  • Double or Triple lumen type
  • Flush with heparinized solutions for patency
  • Open at both ends
  • You can sample blood with this type
Term
Groshong Catheter
Definition

Double or Triple lumen type

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

Term
Some IV Problems
Definition
  1. Phlebitis
  2. Infection
  3. Extravasation
  4. Infiltration
  5. Infiltration Necrosis
Term
Sterile Water for Injection
Definition
  • 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)
Term
Bacteriostatic Water for Injection
Definition

Ampules, Syringes, and Vials: < 30 mL

Most common agent, benzyl alcohol 0.9%

Not for use in newborns

Compatibility issue with other drugs

Term
Bacteriostatic NaCl for Injection
Definition
  • Ampules, Syringes, and Vials: < 30 mL
  • Most common agent, benzyl alcohol 0.9%
  • Not for use in newborns
  • Compatibility issues with other drugs
Term
What is the mEq/L and the mOsm/L value for NaCl 0.9%?
Definition

154 mEq/L, 308 mOsm/L

 

1 mEq/mmol because highest charge is 1

2 mOsm/mmol because Na and Cl can dissociate

 

 

Term
Salts and Solution pH
Definition

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

Term
Some examples of Neutral Weak Bases with Mineral Acids and Organic Acids
Definition

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

Term
Some examples of Neutral Weak Acids with Hydroxide Bases
Definition

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

Term
Holliday-Segar Method
Definition

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

Term
Drug Sorption: Examples
Definition
  1. Diazepam
  2. Nitroglycerin
  3. Insulin
Term
Drug Sorption depends on:
Definition
  • pH
  • Total tubing length
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