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Ideal Suppository:
1. clear melt
2. doesnt melt at room temperature
3. inert and compatible to other substances
4. acid value of <0.2
5. 200-245 saponification
6. non-irritating
7. iodine value of <7
Note:
> 5 pH of value >freshly prepared (pure)
> Saponification formation of esters
> Fixed Oils (liquid, solid, pH)
>Steric acid: stiffening agent
> Above local effect; Below systemic effect
Procedure:
1. Heat the glycerin using direct heat with constant stirring
until it has reached the temp of 120 F (49C)
2. In another container, dissolve Na2CO3.H2O in H2O
Add Steric Acid. Mix thoroughly until dissolved
3. Add #2 to #1
4. Continue heating until all effervescence (CO2 ^) is gone or
until the liquid is clear
5. Transfer the melted suppositories in a previously chilled
molder
6. Place the molder in the freezer for 10-20 min
7. Wrap the suppositories individually using aluminum foil
(trapezoid shape)
3. Vaginal Suppositories
- Pessaries
- globular, oviform, cone-shaped
- weight: 5g
- Uses: anti-fungal, anti-infective, contraceptive
4. Nasal Suppositories
- slender& pencil shape
- Burginatium
5. Otic/Oral Suppositories
- pencil shape
Three Methods of preparation
1. Melting from a Melt or Fusion
- (melt all ingredients > pour on molder while hot > freezer >
wrap individually)
- Nickel or Bronze
2. Compression (more elegant products)
- small scale only
- avoids sedimentation
- suppository compression device (mix >scd>pressure
applied>cooled>ejected)
3. Hand Rolling and shaping (ancient)
Suppository Bases:
1. Tends to Melt
- Cocoa Butter &Theobroma Oil (most widely used)
- Theobroma Oil (polymorphic- inability to absorb in
aqeoussoln; rectal; lower melting point {chloralhydrine}
- Witepsol (do not exhibit polymorphism; natural saturated
fatty acid chain between C12 and C18)
- Wecobee(from coconut oil)
2. Tends to be dissolved
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Procedure:
1. Melt the white wax on a water bath
2. Add white petrolatum with constant stirring
3. Pour to the ointment jar while hot. Let it congeal
4. Cover with circular glassine paper
Procedure:
1. Melt spermaceti/cetyl alcohol and white wax with mineral
oil using steam bath
2. In another container, dissolve sodium borate solution to the
melted wax, stirring rapidly & continuously, until a viscous
white cream is formed
4. Pour to the container
5. Allow to congeal
White Ointment
Uses: - emollient
- protective barrier or vehicle
2 ingredients:
- active ingredient and ointment base
- no color, no flavorant
Packaging:
- tubes (plastic/aluminum/tin)
- jar (plastic, aluminum) can be clear, opal, amber, and green
glass or white or green plastic ointment jars
Note:
> Dark Brown ointment Oxidized
- to prevent oxidation anti-oxidant (vit C / E)
>Yellow Wax and White Wax difference
> Microbial Content test > Preservative
Preparation 9 (Zinc Oxide Ointment)
- red label
Ointments
- Salve or Chrisma
- may be medicated or not
- Unmedicated ointments (serve as vehicles for topical
application of medicina substances or used as protective,
emollient, or lubricant)
2. Absorption bases
- non-water washable; anhydrous & insoluble can absorb
water
- eg. Hydrophilic petrolatum, wool fat (anhydrous lanolin)
Mechanical Incorporation
- levigation
- mineral oil zinc oxide and sulfur are insoluble on water
- for smooth dispersion;to prevent grittiness
3. Water-removable bases
- oil-in water bases; water-washable bases
- eg. Hydrophilic ointment USP, vanishing cream, galens
cream, petrolatum rose water ointment
4. Water-soluble bases
- water washable; greaseless
- eg. Polyethylene Glycol ointment (PEG), propylene glycol,
propylene glycol ethanol
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10. Washable
11. Minimum number of ingredients to b used
12. Ease in compounding
Procedure:
Zinc Oxide (triturate) + mineral oil >levigate +white ointment
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