Example 1

An oral liquid suspension containing topiramate was formulated from the following substances in the amounts specified.

% W/V (mg/ml)Material/Component
2.5topiramate
0.1methylparaben
0.03sodium benzoate powder
0.08saccharin sodium dihydrate powder
0.25sodium phosphate dibasic
3sorbitol solution 70%
2.25propylene glycol
5glycerin 99% natural grade
1.26PROSOLV ® SMCC 50 (silicified
microcrystalline cellulose)
0.18carboxymethylcellulose sodium, medium viscosity
(2% aqueous solution at 25° C. is 400-800 cps)
0.18xanthan gum
79.67purified water
5polyethylene glycol 400
0.5sucralose
0.2cherry flavor (natural and artificial)
0.002FD&C red #40
0.0002FD&C yellow #6
TOTAL
100.2

Example 2

The oral liquid suspension containing topiramate of Example 1 was manufactured as follows.

Phase 1 Preparation;

    • 1. Mix propylene glycol and methylparaben until completely dissolved and homogeneous.
      Phase 2 Preparation:
    • 1. Mix water, sodium carboxymethyl cellulose, xanthan gum, and PROSOLV® SMCC 50M (microcrystalline cellulose and colloidal silicon dioxide) until completely dissolved and homogeneous.
    • 2. Add sodium benzoate, sodium phosphate dibasic, and sodium saccharin and mix until completely dissolved and homogeneous.
    • 3. Add polyethylene glycol; and mix until completely dissolved and homogeneous.
    • 4. Add sorbitol, 70% solution and mix until completely dissolved and homogeneous.
    • 5. Add topiramate and mix until completely dissolved and homogeneous.
      Phase 3 Preparation:
    • 1. Add Phase 1 into Phase 2 with continuous mixing, until completely dissolved and homogeneous.
    • 2. Add glycerin and mix until completely dissolved and homogeneous.
    • 3. Add FD&C Red #40, FD&C Yellow #6, cherry flavor, and sucralose; and mix until completely dissolved and homogeneous.
    • 4. Semi-automatic fill in packaging (bottle) and manual labeling.
    • 5. Optionally check appearance, pH, viscosity, particle size distribution (PSD), assay, dosage uniformity, sedimentation rate, dissolution, deliverable volume, and/or micro testing.

Example 3

The oral liquid suspension of Example 1 was manufactured for packaging, shipment, storage, and for use with the following.

ContainerOral Dispenser
Plastic bottleMeasuring cup
Glass bottleMeasuring syringe
Measuring dropper

Example 4

The oral liquid suspension of Example 1 was formulated for administration that includes the following.

    • 1. Shake well before using to ensure sufficient redispersion and content uniformity.
    • 2. Measure the prescribed dose of the oral liquid suspension into the dispenser.
    • 3. Orally administer the dose from the dispenser to the subject (with or without food). The medication may be administered by the patient, a caregiver, or a health professional.

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