DDS-Formulation and Production of Sterile Dosage Forms

Question 1

What are the components of Parenterals - The Vehicle

Answer 1

• non-irritating
• non-toxic
• no pharmacologic activity
• no effect on the active ingredient
• physical properties: stability at various pH, temperatures, viscosity, miscibility with body fluid

Question 2

What are the kinds of Vehicles that can be used for Parenteral

Answer 2

• aqueous vehicles
• water-miscible vehicles
• non-aqueous vehicles

Question 3

What are the solutes for Parenterals

Answer 3

• antimicrobial agents (thimerosal 0.01%, benzethonium chloride 0.01%)
• buffers (citrates, acetates, and phosphates)
• antioxidants (sodium bisulfite 0.1%)
• other added substances (sodium benzoate)

Question 4

General Manufacturing Process

Answer 4

• Procurement and selection of components and containers
• Product Preparation
• Quality Assurance
• Packaging and Labeling

Question 5

What possibilities make all containers insoluble

Answer 5

• leaching
• permeation
• adsorption

Question 6

What are the different options for container Selection

Answer 6

• glass
• plastic polymers
• rubber polymers

Question 7

Types of plastic containers

Answer 7

polyethylene
polypropylene
polyvinyl chloride (PVC)

Question 8

Different types of rubber containers

Answer 8

butyl
silicone
natural rubber

Question 9

Industrial Preparation of Parenteral Products

Answer 9

compounding->filtration->filing/sealing->sterilizing

Question 10

Methods of Sterilization

Answer 10

steam
dry heat
filtration
gas
ionizing radiation

Question 11

Steam Sterilization

Answer 11

bacteria coagulate with moisture and are destroyed at lower temperatures in an autoclave. Bacteria with larger % of water are killed more easily than spores. usually method of choice. -Denaturing and coagulation of bacteria’s essential protein

Question 12

Dry Heat

Answer 12

destruction done by dehydration in gas “ovens”. Less effective in killing than moist heat

Question 13

Filtration

Answer 13

removal of adsorption via filter medium. Electric charge of microorganism, pH of solution, temperature (most membranes are nitrate or acetate esters of cellulose -highly polar with residual –OH groups)

Question 14

Bubble Point Test

Answer 14

Used to filter integrity; minimum pressure required to force liquid out of the capillary space in the membrane; Smaller the pore size, higher bubble point –mfg gives standards for filter

Question 15

Gas sterilization

Answer 15

Use of ethylene oxide or propylene oxide gas. Though to inhibit bacterial cell wall formation-extremely flammable when mixed with air. gen 4-16 hours.

Question 16

Ionizing Radiation

Answer 16

Sterilization via gamma, cathode rays, or UV lamp. application is limited due to highly specialized equipment and the effects of radiation. thought to destroy vital chemicals and/or structures, such as chromosomal nucleoprotein

Question 17

USP 797

Answer 17

2000 chapters that provide guidelines on the minimum practice and quality standards to which sterile preparations should be compounded. Enforced by state boards of pharmacy and FDA

Question 18

Sources of ISO-Class 5

Answer 18

laminar airflow
compounding aseptic isolator

Question 19

Laminar Flow Workbench

Answer 19

Horizontal and Vertical flow hood
-HEPA filter (high efficiency particular air): type of pleated mechanical air filter; Can remove at least 99.97% of dust, pollen, mold, bacteria, and any airborne; particles with a size of 0.3 microns

Question 20

Proper Hygiene and Garbing

Answer 20

-remove personal outer garments
-remove cosmetics
-remove jewelry from hands, wrists, or any other visible body parts (no fake nails allowed)
-PPE in the proper order

Question 21

Proper order of PPE

Answer 21

-shoe covers
-head and facial hair covers
-face masks/eye shields
-perform hand cleansing procedures
-non-shedding gown

Question 22

Packaging

Answer 22

solutions ready for injection
dry soluble products ready to be combined with a solvent
-suspensions, emulsions ready for injection
-dry, insoluble products ready to be combined with a vehicle prior to use
-liquid concentrations ready for dilution

Question 23

packaging for vials

Answer 23

single dose-no preservatives–drawn from only once with 6 hours expiration in ISO class 6
multi-dose-preservatives–drawn from more than once and expires 28 days after opening

Question 24

Labeling

Answer 24

prep name; % of drug amount or drug/vol; amount of active ingredient; amount of solvent to add; ROA; storage conditions and exp; manufacturer and distributor; lot number