84 Handbook of Pharmaceutical Formulations: Liquid Products
Ascorbic Acid Solution
Bill of Materials
Scale (mg/mL) Item Material Name Quantity/L (g)
100.00 1 Ascorbic acid 100.00
q.s. 2 Propylene glycol q.s. to 1 L
MANUFACTURING DIRECTIONS ing to mix. Also, while cooling, change CO2
addition from tank bottom to tank top.
Keep under CO2 protection at all times. Avoid contact with 6. q.s. to 1 L, using propylene glycol and mix for
iron. Use stainless steel or glass-lined equipment only. at least 10 minutes.
Propylene glycol must be water white. 7. Use a prefilter pad and a lint-free filter paper,
E&D No. 950 or its equivalent; alternatively, a
1. Load 86.8 g propylene glycol into a glass-lined Sparkler filter (or equivalent) may be used.
or suitable stainless steel-jacketed tank. 8. Recirculate the product through the filter press
2. While mixing, heat to 70˚ to 80˚C. until sparkling clear.
3. Bubble CO2 gas into the propylene glycol from 9. Flush a suitable storage tank with CO2 gas and
the bottom of the tank. continue CO2 gas protection while product is
4. Add and dissolve the ascorbic acid into the being collected.
propylene glycol with a minimum of stirring 10. Filter the product into the storage tank and hold
under CO2 protection. under CO2 protection.
5. When the ascorbic acid is in solution, immedi- 11. Flush headspace of storage tank with CO2 gas
ately cool to approximately 25˚C while continu- protection.
Atovaquone Suspension
MEPRON suspension is a formulation of microfine parti- bright yellow with a citrus flavor. Each teaspoonful (5 mL)
cles of atovaquone. The atovaquone particles, reduced in contains 750 mg of atovaquone and the inactive ingredi-
size to facilitate absorption, are significantly smaller than ents benzyl alcohol, flavor, poloxamer 188, purified water,
those in the previously marketed tablet formulation. saccharin sodium, and xanthan gum.
MEPRON suspension is for oral administration and is
Bill of Materials
Scale (mg/mL) Item Material Name Quantity/L (g)
150.00 1 Atovaquone microflulidizeda 150.00
5.00 2 Poloxamer 188 5.00
10.00 3 Benzyl alcohol 10.00
q.s. 4 Water, purified q.s. to 1 L
aPreparation of microfluidized particles of atovaquone: 600 mL of a mixture
consisting of 2.5% w/v atovaquone in 0.25% w/v aqueous Celacol M2500
and passed through fluidizer such as model 120B Microfluidizer connected
to a 90-psi pneumatic supply and adjusted to produce a fluid pressure of
15,000 psi. Recirculate continuously through the interaction chamber for at
least 45 minutes (65 to 77 passes) to achieve particle size less than 3 microns.
MANUFACTURING DIRECTIONS 2. Add and mix item 2 with gentle mixing.
3. Add gradually item 1 and mix; pass through
1. Charge items 4 and 3 in a suitable stainless steel homogenizer.
vessel and mix well.
© 2004 by CRC Press LLC
