Drug Development Process

Question 1

That which hold the article and is or maybe in direct contact with the article

Answer 1

Containers

Question 2

That which is in direct contact with the article at all times

Answer 2

Immediate container

Question 3

The _______ is part of the container

Answer 3

closure

Question 4

According to their ability to protect their contents from external conditions

Answer 4

USP Classifies container

Question 5

Examples of USP Containers

Answer 5

Well-closed container
A tight container
Hermetic container
Single-unit container

Question 6

What are some examples of Hermetic container?

Answer 6

• Single dose container (ampule)
• Multiple dose container (vial)

Question 7

protects the contents from contamination by extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution

Answer 7

well-closed container

Question 8

that protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure

Answer 8

tight container

Question 9

that protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. A clear and colorless or a translucent container may be made light-resistant by means of an opaque covering or by use of secondary packaging, in which case the label of the container bears a statement that the opaque covering or secondary packaging is needed until the articles are to be used or administered

Answer 9

Light-resistant container

Question 10

impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution

Answer 10

Hermetic container

Question 11

Example of a single dose container

Answer 11

ampoule

Question 12

example of multiple dose container

Answer 12

vial

Question 13

Holds a quantity of drug intended as a single dose

Answer 13

Single-unit container

Question 14

Contain more than a single unit or dose of the medication

Answer 14

Multiple unit container

Question 15

Official Glass Types

Answer 15

Type I – Highly resistant borosilicate glass
Type II – Treated soda lime glass
Type III – soda lime glass
NP – general purpose soda lime glass

Question 16

Types of Plastic Container

Answer 16

PVC – Polyvinyl chloride = chlorine atom is added to every other carbon in polyethylene polymer
- Rigid and has good clarity
- In blister packaging of tablets and capsules
PET – polyethylene terephthalate
APET – amorphous polyethylene terephthalate glycol
PETG - polyethylene terephthalate glycol
APET & PETG – can be sterilized with gamma radiation

Question 17

Problems in the use of plastics

Answer 17

1. Permeability of the container to atmospheric oxygen and to moisture vapor
2. Leaching of the constituents of the container to the internal contents
3. Absorption of drugs from the contents to the container
   Transmission of light through the container
   Alteration of the container upon storage