US Pharm. 2014;39(2):55-56.
Method of Preparation: Calculate the quantity of
each ingredient for the amount to be prepared. Accurately weigh or
measure each ingredient. Pulverize the required number of tablets to a
fine powder, or use the powder. Add a portion of the Ora-Plus and mix
until a smooth paste is obtained. Add the remainder of the Ora-Plus
geometrically and mix well. Add the Ora-Sweet in portions to the final
volume and mix until uniform. Package and label.
Note: An alternative vehicle consisting of a 1:1 mixture of
syrup NF and 1% methylcellulose solution may be used if the combination
of Ora-Plus and Ora-Sweet is not suitable. The 1% methylcellulose
solution is prepared by mixing methylcellulose 4,000 cps (1 g),
methylparaben (20 mg), propylparaben (10 mg), and sufficient hot
purified water to 100 mL and allowing the mixture to cool.1
Use: This preparation has been used in the treatment of pediatric patients with hypertension.
Packaging: Package in tight, light-resistant containers.
Labeling: Keep out of reach of children. Discard after ____ [time period]. Shake well before administration.
Stability: A beyond-use date of up to 91 days at
refrigerated temperature or 56 days at room temperature for the
Ora-Plus/Ora-Sweet preparation and up to 56 days at refrigerated or room
temperature for the syrup NF/1% methylcellulose solution preparation
has been reported.1-4
Quality Control: Quality-control assessment can
include weight/volume, pH (approximately 4.6 for the “Ora” preparation
and 6.5 to 7.0 for the syrup preparation), specific gravity, active drug
assay, color, rheologic properties/pourability, physical observation,
and physical stability (discoloration, foreign materials, gas formation,
Discussion: Amlodipine besylate (Norvasc, C20H25ClN2O5.C6H6O3S,
MW 567.05) is a calcium channel blocker that is used as an
antihypertensive agent. This liquid dosage form is suitable for
pediatric patients and for other patients who cannot swallow a solid
oral dosage form. Amlodipine besylate occurs as a white or almost-white
powder that is slightly soluble in water and sparingly soluble in
Ora-Plus is an oral suspending vehicle that accepts dilution of up to
50% or more with water, flavoring agents, or syrups while still
retaining its suspending properties. It has a pH of approximately 4.2
and an osmolality of about 230 mOsm/kg. Ora-Plus is a thixotropic
vehicle with a viscosity of approximately 1,000 cps at 25°C. It contains
purified water, microcrystalline cellulose, sodium
carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate, and
citric acid as buffering agents; simethicone as an antifoaming agent;
and potassium sorbate and methylparaben as preservatives.6
Ora-Sweet syrup vehicle is a flavoring vehicle for oral
extemporaneous preparations. It is flavored with a citrus-berry flavor
blend and contains glycerin and sorbitol to prevent cap lock, a problem
associated with many syrups. Ora-Sweet is buffered to a pH of
approximately 4.2 and has an osmolality of about 3,240 mOsm/kg. It
contains purified water, sucrose, glycerin, sorbitol (5%), flavoring,
sodium phosphate, and citric acid as buffering agents, and potassium
sorbate and methylparaben as preservatives.7
Syrup (simple syrup) is a clear, sweet vehicle used as a sweetening
agent and as the base for many flavored and medicated syrups. It
contains 85% w/v sucrose in water and has a specific gravity of not less
than 1.30. Syrup is generally self-preserving as long as the sucrose
concentration is maintained at a sufficiently high level. It should be
stored in tight containers, preferably in a cool place.2
Methylcellulose (Methocel) is a practically odorless and tasteless,
white to yellowish-white granule or powder that is widely used in oral
and topical formulations. It is hygroscopic and is practically insoluble
in acetone, ethanol, saturated salt solutions, and hot water, but it is
soluble in glacial acetic acid. In cold water, methylcellulose swells
and disperses to form a viscous, colloidal dispersion.8
1. Nahata MC, Hipple TF. Stability of amlodipine besylate in two liquid dosage forms. J Am Pharm Assoc (Wash). 1999;39:375-377.
2. U.S. Pharmacopeia 36/National Formulary 31. Rockville, MD: U.S. Pharmacopeial Convention, Inc; 2013:335-398,1242,2262.
3. Nahata MC, Hipple TF. Pediatric Drug Formulations. 4th ed. Cincinnati, OH: Harvey Whitney Books; 2000.
4. Trissel LA. Trissel’s Stability of Compounded Formulations. 5th ed. Washington, DC: American Pharmacists Association; 2012:34.
5. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
6. Ora-Plus product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
7. Ora-Sweet product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
8. Allen LV Jr, Luner PE. Methylcellulose. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. Washington, DC: American Pharmaceutical Association; 2009:438-441.
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