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Flint/ Colorless glass container
light transmission above 300 nm.
Amber/ Light resistant glass container
light transmission above 470 nm
1. pH
2. Temperature
3. Concentration of the Reactants
4. Light or Radiation
5. Packaging Components
Instability as a technical problem may be caused by the following conditions:
○ Glass
○ Plastic
○ Metal
○ Rubber
Container Components
● Soda lime glass
● Borosilicate glass
decreasing the soda content in the glass
Type 1
Highly Resistant Borosilicate Glass
Type 2
Treated Soda Lime Glass
Type 3
Soda lime Glass for Dry Products
Type 4
General Purpose Soda lime Glass
Type 4
not for parenterals use; suitable only for tablets, capsules, suspensions, ointments and extractives.
Type 3
suitable for anhydrous parenterals liquids or dry substances
Type 2
treated with sulfur dioxide; suitable for parenterals solutions, which is buffered; has a pH below 7; not reactive with the glass
Type 1
generally suitable for all parenterals
SiO2 + B2O3
Type 1 Constituent:
POWDERED GLASS TEST
WATER ATTACK TEST
TEST FOR GLASS CONTAINERS
POWDERED GLASS TEST
Performed on ground or powdered glass to expose internal surface
POWDERED GLASS TEST
Tests the leaching potential of the glass
0.02 N sulfuric acid
POWDERED GLASS TEST
Alkali treated with
WATER ATTACK TEST
Exposure of the glass with sulfur dioxide at 121°C
WATER ATTACK TEST
Specifically performed with TYPE II GLASS.
Polyethylene
Polystyrene
Polypropylene
Polyvinyl chloride
Polyethylene terephthalate
PLASTIC CONTAINERS
Polyethylene terephthalate
● For beverages
● Have transparency and luster
● Gamma radiation sterilization
Polyvinyl chloride
● Rigid and has good clarity
● Used for blister packaging
● CARCINOGENIC
Polypropylene
autoclavable
Polyethylene
● Cannot be autoclaved - it will melt
● Low density = droppers and sprays
● High density = solid oral preparations
PLASTIC CONTAINERS
These are high molecular weight polymers,
ORGANOLEPTIC CHARACTERISTICS
Taste (flavoring)
Appearance depends on the color and clarity.
1. Selection
2. Evaluation
The process of choosing flavoring agents may be divided
into two major categories, such as:
Physical stability
shown by the maintenance of the physical properties such as the color, clarity, taste, viscosity and odor throughout its shelf life or until the expiry date is reached.
Chemical stability
also considered in the formulation because the instability is magnified in solution as against solid and suspension systems.
Co-solvents
may be used in the formulation of aqueous liquid, such as alcohol, sorbitol, glycerin, propylene glycol
1. Solubility
2. Stability
3. Organoleptic characteristics
4. Preservatives
5. Sweetening agents
6. Viscosity
To avoid problems on formulation of liquids, the following considerations should be studied:
● Co-solvency
● pH control
● Solubilization
● Complexation
● Hydrotrophy
● Chemical Modification of the drug
SPECIAL TECHNIQUES REQUIRED FOR POORLY SOLUBLE DRUGS
METAL CONTAINERS
Disperse systems having a consistency of a soft paste, gel, cream, or ointment can be conveniently packed into “collapsible tubes”
a. Tin
b. plastic coated tin
c. tin-coated lead
d. Aluminum
e. plastic coated aluminum
METAL CONTAINERS commonly made of
○ Collapsible polyethylene bags
○ Collapsible plastic tubes
○ Plastic film
○ Plastic vials
○ Compact type container
Variety of dosage forms maybe found packaged in plastic containers, such as:
Saccharin
250 to 500 x sweeter than sucrose
Cyclamates
15 to 30 x sweeter than sucrose
LIQUID GLUCOSE
is an extremely sweet viscous substance, which imparts both body (viscosity) and sweetness to liquid formulations
SUSPENSIONS
It is a disperse system in which solid, vehicle-insoluble particles (internal phase) are uniformly suspended by mechanical agitation and formulation design throughout the liquid vehicle (external phase).
The continuous phase
also called the external phase or dispersion system. (medium used)
The discontinuous phase
also called the internal phase or dispersed phase (insoluble phase)
Sustaining effect
Stability
Taste
Basic solubility
PURPOSES OF SUSPENSION
AI+3, Fe+3, and Ca+2 are done.
If high concentrations of carboxymethylcellulose (CMC)
are used, incorporation of
PVP, methylcellulose and sodium CMC
Viscosity controlling agents are